Technical File of Wound Drainage System

8/18/2019 Technical File of Wound Drainage System

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Changshu Beyond Medical Device Co., Ltd CE Technical File Part ADocument № BYQA031-00 Revision 1 Issue Date: Mar 20th,2015

Product Master Document 1

CE Technical File of Wound Drainage System File No.: BYQA031-00

Master Document of Product Effective Date: May 20, 2014

:

Prepared by

_______________

_______________

Checked by

_______________

_______________

Approved by

_______________

_______________

Issuing List: Department Holder

1 Management office

2 QM department

3 Production department

4 European Representative

5 TUV SUD


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I. Product General Description

1. Product introduce:

Wound Drainage System is made up of three springs reservoir body , connecting

tube ,barium tube , adapter clamp, trocar with cover. Port A is the entrance jaw, port B is thedrain jaw (Picture below).

2 Use of instruction

I. Drain Placement

Place drains per physics directions and/or hospital procedure,

ensuring that all

perforations are in the wound area. On round drains, indicator

marks aid in drain placement.

II. System Set-up1). Attach the wound drain to the reservoir tube via the “Y”

connector.

2). Insert the free end of the reservoir tube into the reservoir Port A.

III. Activation

a).Close the clamp on the reservoir tube.

b).Place the reservoir in a firm, flat surface.

c).Fully compress the reservoir with one hand.

d).Attach the cap to the Exudate connector B.

e).To activate, release the clamp on the reservoir tube.

IV. To Attach the Pour-safe Exudate Bag

a).Close the clamp on the reservoir tube. Ensure the reservoir is resting on a flat

surface with the connections on top.

b).Remove the bag from the package. Remove the cap from the bag. Remove the cap

from B on the reservoir.

c).Mate the connector on the bag with the connector on the reservoir.

d).Invert and tilt the reservoir such that the contents drain toward B. Compress the

reservoir to empty the contents into the bag.

3. Intend UseThe Closed Wound Drainage System is used for sucking the wasted liquor from the patient’s body

when pressing the wound drainage cavity with the trocar puncturing the patient’s body and

leading the X-ray barium tube.

4. materials

Description Material SupplierRobert Clamp Pom,S761 Changshu QinhuaCo.,LtdConnection tube PVC,202 Shanghia yate industry Development

Co.LtdBarium Tube PVC,202,Stripe:barium sulfate Shanghia yate industry Development

Co.LtdTrocar Stainless Steel 304 Cahngshu Sanxing Spring Factory


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pouch 1059B uncoated Tyvek Alliantz Flexible Packaging,Pte,LtdPlate of Cover - Dseries

Pvc,204 Wuxi Jiahong Plastic Factory

Plate of Cover - D

series

Pvc,204 Wuxi Jiahong Plastic Factory

Entrance Jaw PVC,T-1 Nantong Zhanglian Industry Development

Co.,Ltd

Drain Jaw PVC,T-1 Nantong Zhanglian Industry Development

Co.,Ltd

Film of Cover, printed Pvc,0.35mm Shanghai Baojia Plastic Factory

Bottom Film, printed Pvc,0.35mm Shanghai Baojia Plastic Factory

Transparent Sidewall Pvc,0.25mm Shanghai Baojia Plastic Factory

5. Classification:The X barium tube of wound drainage system inroad the patients body, and remain less than 24 hours,

the trocar was used in 5 minutes. The ways of conformity certification is applying for product CE

certification in accordance with MDD93/42/EEC AS AMENDED BY 2007/47/EC Annex IX., rule 7 of

Annex Ⅸ The classification of the wound drainage system is IIa .


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II. Declaration of Conformity

Manufacturer: ChangshuBeyond Medica l Device Co., l td

No.386 Changkun Road Shajiabang Town215500 Changshu CityPEOPLE’S REPUBLIC OF CHINA

Tel:+86-512-89886868 Fax:+86-512-52939651

European Representative: Shanghai International Holding Corp. GMBH（Europe） Eiffestraβe 80, 20537 Hamburg, Germany.

Tel:+49-40-2513175 Fax:+49-40-255726

Product Name: Closed Wound Drainage System (Wound Drainage reservoir) Model Number: 200ml—800mlUMDNS Code: 16521Classification (MDD, Annex IX): Ⅱa, rule 7Conformity Assessment Route: Annex V. 3

We herewith declare that the above mentioned products meet the transposition into national law, theprovisions of the following EC Council Directives and Standards. All supporting documentations areretained under the promise of the manufacturer.

DIRECTIVES

General applicable directives:

Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC concerning medical devices (MDD93/42/EEC + 2007 47/EC).

Notified Body: TÜV Product Service GmbH, Ridlerstr. 65, 80339MÜnchen, Germany

Identification number: CE0123(EC) Certificate(s): G2 14 06 87225 003Expire date of the Certificate: 2019-08-28Start of CE Marking: Not Yet

Place, Date of Issue: Changshu, Jiangsu

Signature: _____朱建新 _____________________

Name: ZhujianxinPosition : General Manage


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III. List of Essential Requirement

Number Doc.No Version Document Name

1 ISO13485 2003Quality Management System—Medical Device

Requirement2 ISO10993-1 2009

Biological Evaluation of Medical Device-Part 1:

evaluation and testing

3 ISO10993-5 2009Biological Evaluation of Medical Device-Part 5:

Test for Cytotoxicity : in vitro methods

4 ISO10993-7 2008

Biological evaluation of medical

devices —Part 7:

Ethylene oxide sterilization residual

5 ISO10993-10 2009Biological Evaluation of Medical Device-Part 10:

Test for Irritation and Sterilization

6 ISO14155-1 2003 Medical device clinical investigation

7 MDD93/42/EEC1993.6.14

2007/47/ECMedical Device Directive 2007/47/EC

8 EN ISO14971 2009 Medical Device -Risk Analysis

9 EN980 2008Graphic Symbols for use in the labeling of

medical device

10 EN1041 2008

Terminology, Symbols and Information with

Medical Devices; Information supplied by the

manufacturer with medical devices

11 ISO11137-2 2006Medical Devices Sterilization: Confirmation and

Routine Control of Radio-Sterilization

12ISO 11135-1

2007 Sterilization of medical devices - Validation

and routine control of ethylene oxide

sterilization

13ISO11607-1

2006

Packing Materials for Sterilization of

Wrapped Goods-Part 1:Genenal Requirements and

Requirements for the Validation of Packing for

Terminally Sterilized Device

14 EN ISO 11737-1 2006

Sterilization of Medical

Device-Estimation of the Population of

Micro-organisms on Product Part

1:Requirements

16 EN ISO 11737-2 1996

Medical Device-Estimation of the

Population of Micro-organisms on Product

Part 2:Guidance

17 EN ISO8836:2009 2002Suction Catheters for Use in the Respiratory Tract

Note: Above EC and International Standards are listed in order for corresponding to the 12

items in the Basic Requirement Checklist.The reference records are hold by the supplier. We will provide for you according to the Quality

Assurance Contract if it is necessary.List of the records:


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1. Package Qualification Certificate ;

2. Sterilization Validation Report ;3. Environmental Examination Report ;

4. Clean workshop inspection Report;5. Primary Bacterial Contaminants Test Report ;

6. Verification report of heat-sealing process of leaking test;7 .Inspection regulation of the injection process;8. Inspection regulation of the outer box Protection, storage and transportation;

9. Verification report of heat-sealing process;10. Verification report of heat-sealing of inlet tube ;11. Verification report of heat-sealing of air film ;

12. Confirmation report of the injection process;

13 Experiment report of the aging test;14. Packaging qualification


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Product Master Document

III.-2 Essential Requirements checking list of the MDD (07/47/EC) Appl icable

(Y/N)

RequirementStandard

I. GENERAL REQUIREMENTS1. The devices must be designed and manufactured in such a way that, when used under

the conditions and for the purposes intended, they will not compromise the clinicalcondition or the safety of patients, or the safety and health of users or, whereapplicable, other persons, provided that any risks which may be associated with theiruse constitute acceptable risks when weighed against the benefits to the patient andare compatible with a high level of protection of health and safety.

This shall include:－ reducing, as far as possible, the risk of use error due

to the ergonomic features of the device and the environment in which the

device is intended to be used (design for patient safety), and

－ consideration of the technical knowledge, experience, education andtraining and where applicable the medical and physical conditions ofintended users (design for lay, professional, disabled or other users).

Y

ISO14971:2007

2. The solutions adopted by the manufacturer for the design and construction of thedevices must conform to safety principles, taking account of the generallyacknowledged state of the art. In selecting the most appropriate solutions, themanufacturer must apply the following principles in the following order:

Y

EN ISO8836:200

eliminate or reduce risks as far as possible (inherently safe design and construction), Y EN ISO8836:200

where appropriate take adequate protection measures including alarms if necessary,in relation to risks that cannot be eliminated,

Y EN1401:2008EN980:2008

inform users of the residual risks due to any shortcomings of the protection measures

adopted.

Y EN1401:2008EN980:2008


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(Y/N)

RequirementStandard

• the choice of materials used, particularly as regards toxicity and, where appropriateflammability,

Y ISO10993-1ISO10993-5,-1

• the compatibility between the materials used and biological tissues, cells and bodyfluids, taking account of the intended purpose of the device.

• where appropriate, the results of biophysical or modelling researchwhose validity has been demonstrated beforehand.

Y

N

ISO10993-1ISO10993-5,-1

7.2 The devices must be designed, manufactured and packed in such a way as tominimise the risk posed by contaminants and residues to the persons involved in thetransport, storage and use of the devices and to the patients, taking account of theintended purpose of the product. Particular attention must be paid to the tissuesexposed and the duration and frequency of the exposure.

Y ISO14971:2007

7.3 The devices must be designed and manufactured in such a way that they can be used

safely with the materials, substances and gases with which they enter into contactduring their normal use or during routine procedures; if the devices are intended toadminister medicinal products they must be designed and manufactured in such a wayas to be compatible with the medicinal products concerned according to the provisionsand restrictions governing those products and that their performance is maintained inaccordance with the intended use.

Y ISO14971:200


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(Y/N)

RequirementStandard

7.4 Where a device incorporates, as an integral part, a substance which, if usedseparately, may be considered to be a medicinal product as defined in Article1 of Directive 2001/83/EC and which is liable to act upon the body with actionancillary to that of the device, the quality, safety and usefulness of thesubstance must be verified by analogy with the methods specified in Annex Ito Directive 2001/83/ EC. For the substances referred to in the first paragraph,the notified body shall, having verified the usefulness of the substance as partof the medical device and taking account of the intended purpose of thedevice, seek a scientific opinion from one of the competent authoritiesdesignated by the Member States or the European Medicines Agency (EMEA)acting particularly through its committee in accordance with Regulation (EC)No 726/2004 (1) on the quality and safety of the substance including theclinical benefit/risk profile of the incorporation of the substance into the device.

When issuing its opinion, the competent authority or the EMEA shall take intoaccount the manufacturing process and the data related to the usefulness ofincorporation of the substance into the device as determined by the notifiedbody.

N/A N/A

Where a device incorporates, as an integral part, a human blood derivative,the notified body shall, having verified the usefulness of the substance as partof the medical device and taking into account the intended purpose of thedevice, seek a scientific opinion from the EMEA, acting particularly through itscommittee, on the quality and safety of the substance including the clinicalbenefit/risk profile of the incorporation of the human blood derivative into thedevice. When issuing its opinion, the EMEA shall take into account the

manufacturing process and the data related to the usefulness of incorporationof the substance into the device as determined by the notified body.

N/A N/A


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(Y/N)

RequirementStandard

• risks arising where maintenance or calibration are not possible (as with implants)from ageing of the materials used or loss of accuracy of any measuring or control

mechanism. 在不可能維修或校準的情況下（如植入新物），由於所使用材料的老化或任何測量和控制機制準確度降低所造成的危險。

9.3 Devices must be designed and manufactured in such a way as to minimise the risks offire or explosion during normal use and in single fault condition. Particular attentionmust be paid to devices whose intended use includes exposure to flammable

substances which could cause combustion. 器械的設計和製造必須使其在正常使用和單一故障情況下發生著火和爆炸的危險降低到最小。特別要注意其預定

用途是暴露于易燃或致燃物質中的器械。

N/A N/A

10. Devices with a measuring function

10.1 Devices with a measuring function must be designed and manufactured in such a wayas to provide sufficient accuracy and stability within appropriate limits of accuracy andtaking account of the intended purpose of the device. The limits of accuracy must beindicated by the manufacturer.

N/A N/A

10.2 The measurement, monitoring and display scale must be designed in line withergonomic principles, taking account of the intended purpose of the device.

N/A N/A

10.3 The measurements made by devices with a measuring function must be expressed inlegal units conforming to the provisions of Council Directive 80/181/EEC (OJ No L 39,15. 2. 1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ No L 357,7. 12. 1989, p. 28)).

N/A N/A

11. Protection against radiation


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(Y/N)

RequirementStandard

11.1

11.1.1General

Devices shall be designed and manufactured such that exposure of patients, usersand other persons to radiation shall be reduced as far as possible compatible with theintended purpose, whilst not restricting the application of appropriate specified levels

for therapeutic and diagnostic purposes. 器械的設計和製造應在兼顧其途的同時

盡可能減少對患者、使用者和其他人員的輻射，同時又不會限制使用規定的

適當劑量進行治療和診斷。

N/A N/A

11.2

11.2.1Intended radiation

Where devices are designed to emit hazardous levels of radiation necessary for aspecific medical purpose the benefit of which is considered to outweigh the risksinherent in the emission, it must be possible for the user to control the emissions. Suchdevices shall be designed and manufactured to ensure reproducibility and tolerance of

relevant variable parameters. 如果爲了特定的治療目的，設計的器械所發射的危險輻射水平，並且該輻射在治療方面的益處超過了他固有的危險，使用者

必須盡可能控制其輻射，這種器械的設計和生産必須確保相關可變參數的重

現性和允許誤差。

N/A

11.2.2 Where devices are intended to emit potentially hazardous, visible and/or invisibleradiation, they must be fitted, where practicable, with visual displays and/or audiblewarnings of such emissions.

N/A

11.3

11.3.1Unintended radiation

Devices shall be designed and manufactured in such a way that exposure of patients,users and other persons to the emission of unintended, stray or scattered radiation is

be reduced as far as possible. 器械的設計和製造應盡可能減少病人、使用者或

其他人員遭受未預期的漫射或散射的輻射。

N/A N/A


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(Y/N)

RequirementStandard

11.4

11.4.1

Instructions

The operating instructions for devices emitting radiation must give detailed informationas to the nature of the emitted radiation, means of protecting the patient and the userand on ways of avoiding misuse and of eliminating the risks inherent in installation.

NA NA

11.5

11.5.1Ionising radiation

Devices intended to emit ionising radiation must be designed and manufactured insuch a way as to ensure that, where practicable, the quantity, geometry and quality ofradiation emitted can be varied and controlled taking into account the intended uses.

N/A N/A

11.5.2 Devices emitting ionising radiation intended for diagnostic radiology shall be designedand manufactured in such a way, as to achieve appropriate image and/or outputquality for the intended medical purpose whilst minimising radiation exposure of thepatient and user.

N/A N/A

11.5.3 Devices emitting ionising radiation intended for therapeutic radiology shall be designedand manufactured in such a way as to enable reliable monitoring and control of thedelivered dose, the beam type and energy and where appropriate the quality of theradiation.

N/A N/A

12. Requirements for medical devices connected to or equipped with an energysource

12.1 Devices incorporating electronic programmable systems must be designed to ensurethe repeatability, reliability and performance of these systems according to theirintended use. In the event of a single fault condition (in the system) appropriate means

should be adopted to eliminate or reduce as far as possible consequent risks. 對於嵌

入了可編程系統的器械，其設計必須要根據預定的用途確保這些系統的重復

性、可靠性和性能。（系統中）出現了單一故障的情況下，應當盡可能地採用適當的方法消除或減少隨之發生的危險。

N/A N/A


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(Y/N)

RequirementStandard

13. Information supplied by the manufacturer

13.1 Each device must be accompanied by the information needed to use itsafely and properly, taking account of the training and knowledge of thepotential users, and to identify the manufacturer

Y EN980:2008EN1041:2008

13.2 Where appropriate, this information should take the form of symbols. Any symbol oridentification colour used must conform to the harmonised standards. In areas forwhich no standards exist, the symbols and colours must be described in thedocumentation supplied with the device.

Y EN980:2008EN1041:2008

13.3 The label must bear the following particulars:

a) the name or trade name and address of the manufacturer. For devicesimported into the Community, in view of their distribution in theCommunity, the label, or the outer packaging, or instructions for use,shall contain in addition the name and address of the authorisedrepresentative where the manufacturer does not have a registeredplace of business in the Community;

Y EN980:2008EN1041:2008

b) the details strictly necessary to identify the device and the contents ofthe packaging especially for the users;

Y EN980:2008EN1041:2008

c) where appropriate, the word "STERILE"; Y EN980:2008EN1041:2008

d) where appropriate, the batch code, preceded by the word "LOT", or the serialnumber;

Y EN980:2008

e) where appropriate, an indication of the date by which the device should be used, insafety, expressed as the year and month; 有效期？ Y EN980:2008


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(Y/N)

RequirementStandard

f) where appropriate, an indication that the device is for single use. Amanufacturer's indication of single use must be consihearing aid acrossthe Community;

Y EN980:2008

13.3 g) if the device is custom made, the words "custom made device"; Y EN980:2008

h) if the device is intended for clinical investigations, the words "exclusively for clinicalinvestigations";

Y EN980:2008

i) any special storage and/or handling conditions; Y EN980:2008

j) any special operating instructions; Y EN980:2008

k) any warnings and/or precautions to take; Y EN1401:2008

l) year of manufacture of active devices other than those covered by e). Thisindication may be included in the batch or serial number;

Y EN980:2008

m) where applicable, method of sterilisation. N/A N/A 13.4 If the intended purpose of the device is not obvious to the user, the manufacturer must

clearly state it on the label and in the instructions for use.Y EN1041:2008

13.5 Wherever reasonable and practicable, the devices and detachable components mustbe identified, where appropriate in terms of batches, to allow all appropriate action todetect any potential risk posed by the devices and detachable components.

Y EN1041:2008

13.6 Where appropriate for use, the instructions must contain the following particulars:

a) the details referred to in 13.3, with the exception of d) and e) Y EN1041:2008 b) the performances referred to in section 3 and any undesirable side effects; Y EN1041:2008

c) if the device must be installed with or connected to other medical devices orequipment in order to operate as required for its intended purpose, sufficient details

of its characteristics to identify the correct devices or equipment to use in order toobtain a safe combination;

N/A N/A


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(Y/N)

RequirementStandard

k) precautions to be taken in the event of changes in the performance of the device; Y EN1041:2008

l) precautions to be taken as regards exposure, in reasonably foreseeableenvironmental conditions, to magnetic fields, external electrical influences,electrostatic discharge, pressure or variations in pressure, acceleration, thermalignition sources etc.;

Y EN1041:2008

m) adequate information regarding the medicinal product or products which the devicein question is designed to administer, including any limitations in the choice ofsubstances to be delivered;

N/A

n) precautions to be taken against any special, unusual risks related to the disposal ofthe device;

Y EN1041:2008

o) medicinal substances, or human blood derivatives incorporated intothe device as an integral part in accordance with Section 7.4;

N/A

p) degree of accuracy claimed for devices with a measuring function. N/A

q) date of issue or the latest revision of the instructions for use Y EN1041:2008


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IV. Risk Management Report of Wound Drainage System

I. Purpose of Risk Analysis:

The single-use Wound Drainage System manufactured by our Company is recognized by worldwide medicalcircle as a mature product in respects of its design and structure. Its application method is in accordance with

the daily means taken by nursing professionals. Its safety and reliability are ensured. Potential risks still

exist, despite of its small probability. Taking effective preventive measures to prevent any potential safety

hazard and ensure the anticipant usage of products in application is both the goal and the responsibility

of the manufacturer.

1.1 Scope : This document is a RM plan for all the parts of the device, including tubing, reservior kit, trocar etc.

It’s applied for all stage of the life-cycle of the medical devices, including the process of design and

development, production and post-production traceability.

1.2 Members of the Risk Analysis Team

Mr. Peng QA Manager/Management Rep.

Mr. Guansanchao Product EngineerMr. Zhujianxing Technical Dept. Manager ()

II. List of some referenced Standards

The basis of the risk analysis is EN ISO:14971:2007: Medical Device – Applications of Risk Management. The

analysis is performed according to the process shown Figure.

Other information ⑴Feedback information from customer

⑵Samples from other manufacturers

⑶Dialect of newspapers and journalists

⑷Observation and research of market requirement

⑸Information during the development

III. Members of the Risk Analysis TeamTeam leader: organizing and reviewing RM during production life-cycle.

Generally Manager,Plant manager: make suggestions about the measure of risk control and other risk that not bediscovered.Manager of Marketing Department;

Manager of Quality Management Department:Risk management organized and actualized during production and

after marketing.

Responsibilities and authorities:

Title Responsibility Scope

Team leaderProject director, who is responsible for the planning and reviewing of

the procedure of risk analysis

Plant managerEvaluate the probability of generation of hardware failure from the

point of view of technique

QMr Identify the possible defect of manufacture from the point of view oftechnique


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Production

Manager

Evaluate the possible misuse of operator from the point of view of

package, label and transportation

Regulatory

affairs

engineer


Affairs of regulatory and EC harmonized standards applied to the

product

QMEvaluate the possible misuse of operator from the point of view of

clinical information

QAEvaluate the possible misuse of operator from the point of view of

bio-compatibility standards applied to the product

Marketing

Manager


application and affection of adverse events.

IV. Risk management procedure 1. Judgment list of character concerning with risk2. Risk management at the stage of post-product

stage of product

realization

Review action

design input输入阶段 Design input review 输入评审

sample 样品阶段 Sample review 样品评审

polite manufacture试生

产

Design review I 设计评审I

clinic stage临床阶段 Design review II 设计评审II

post- product上市阶段 Annual management review 年度管

理评审

Verification activate

• The verification of the implement of risk control measure will be checked by inspection ofthe risk management files .

• The verification of the effectiveness will be checked by inspection of the result of the riskmanagement.

3. Estimation of the occurrence probability of each hazard

3.1 Quantities and Qualitative Determination of the Features of the Applicant Medical DeviceFollowing question are answered according to Section 3.2 of ISO14971 :2007. To each applicant device, the

features that might cause safety hazards are identified.

3.2 Quantities and Qualitative Determination of the Features of Wound Drainage System

Product Name：Wound Drainage System Device Classification:Ⅱａ

Judgment list of character concerning with risk


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Quantities and Qualitative Determination of the Features of

Wound Drainage System

Item Feature that Might Cause Safety

Hazard

Description

1

What is the intended use/intended

purpose and how is the medical

device to be used?

Factors that should be

considered include the intended

user, ergonomic aspects, the

environment in which it is to be

used, by whom it will be installed

and whether the patient can

control or influence the use of

the medical device.

Special attention should be

paid to intended users with special

needs such as handicapped

persons, the elderly and children.

Their special needs might include

assistance by another person to

enable the use of a medical device

life sustaining or life supporting?Is special intervention

necessary in the case of failureof the medical device?

Are there special concerns

about interface design features

that could contribute to

inadvertent use error?

1. Intended use : The Closed Wound Drainage System

is used for sucking the wasted liquor from the patient’s

body when pressing the wound drainage cavity with the

trocar puncturing the patient’s body and leading the

X-ray barium tube.

2.Structure and use direction: Wound drainage system

is made up of trocar, with x-ray barium tube, adapter

clamp, with 3 springs reservoir body. There are two

jaws on the top of the reservoir body, one is entrance

jaw which connect with connecting tube and barium tube,the other is drain jaw with a cap.

3. Warnings/Complications for closed wound drainage

system.

To facilitate remove of the drain, the drain and

tubing portions should not be curled, pinched, over

stretch or sutured ,either internally or externally.

Do not suture the drains. Drains should be placed and

removed carefully by hand only with a slow, steady

pressure. Excessive force may result in breakage.

Drains or tubing should not be handed with any

instruments.Trocars, drains and reservoirs are for single patient use

only and should be discarded after use.

The drain must not be allowed to become occluded nor

the reservoir to completely fill, as all wound drainage

ceases. If occlusion does occur, the drain can be

aspirated by connecting suction to port B or by

applying suction directly to the drain.

All drainage holes must be located within the wound

site and an air tight seal achieved at the wound exit to

maintain vacuum.

Prior to surgery, the patient should be informed of therisk or complications arising from the patient’s degree

of intolerance to any foreign object placed in the body.

Do not re-sterilize.

2

Is the medical device intended to

contact the patient or other

persons? Factors that should be

considered include the nature of

the intended contact, i.e.

surface contact, invasive

contact, and/or implantation and,

for each, the period and frequencyof contact.

Wound drainage system is internal device which is used

to sucking the wasted liquid in patient’s body. And the

process will be operated by the professional nursing

staff. The X-ray barium tube remain in the body less

than 24 hours.


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Item Feature that Might Cause Safety Hazard Description

3

What materials are used to made the device ? Factors

that should be considered include the type of energy

transferred and its control quality, quantity and

duration.

There is vitriol barium mix and

ink with PVC on the side of the

connecting tube. Vitriolic

barium and ink ,being used onstomach clairvoyance, is well

recognized as a safe reagent

clinicly.

4

Is energy delivered to and/or extracted from the

patient? Factors that should be considered include the

type of energy transferred and its control, quality

quantity and duration.

No

5

Are substances delivered to and/or extracted from the

patient? Factors that should be considered include

whether the substance is delivered or extracted,

whether it is a single substance or range ofsubstances, the maximum and minimum transfer rates and

control thereof.

The process will be operated by

the professional doctor

staff.

6

Are biological materials processed by the medical

device for subsequent re-use? Factors that should be

considered include the type of process and

substance(s).

The wasted liquid sucked from

patient should be disposed by

doctor, and do not make

pollution .

7

Is the medical device supplied sterile or intended to

be sterilized by the user, or are other

microbiological controls applicable? Factors that

should be considered include whether the medical

device is intended for single-use or to be re-usable,

and also any packaging, the shelf-life and any

limitation on the number of re-use cycles or type of

sterilization process to be used.

The product is provided to

the customer in sterile

situation.. The product is

single-packed and its

expiration date is five years.

And the product is also

single-used

8

Is the medical device intended to modify the patient

environment? Factors that should be considered

include temperature, humidity, atmospheric gas

composition, pressure and light.

According to doctor’s

Prescription, suck the liquid

on the partial of the patient,

so relax the patient. Thetemperature can be

ameliorated.

9

Are measurements taken? Factors that should be

considered include the variables measured and the

accuracy and the precision of the measurement results.

There is a scale on the side of

the reservoir body, it can

measure the quantity of the

wasted liquid.

10

Is the medical device interpretative? Factors that

should be considered include whether conclusions are

presented by the medical device from input or acquired

data, the algorithms used and confidence limits.

No


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11

Factors that should be considered include identifying any

medicines or other medical technologies which can be involved

and the potential problems associated with such interactions,

as well as patient compliance with the therapy.

No

12

Are there unwanted outputs of energy or substances?

Energy-related factors that should be considered include noise

and vibration, heat, radiation(including ionizing,

non-ionizing and ultraviolet/visible/infrared

radiation),contact temperatures, leakage currents and

electric and/or magnetic fields.

Substance-related factors that should be considered include

discharge of chemicals, waste products and body fluids.

The connecting tube only

insert the drainage

partial, and controlled

the quantity of the

liquid.

13

Does the medical device influence the environment?

Factors that should be considered include the effects on power

and cooling supplies, emission of toxic materials and the

generation of electromagnetic interference

The device transportationand storage should be in

the condition of less than

40℃， humidity less

than 80%.

The device used in the

operating room.

14

Are there essential consumables or accessories associated with

the medical device?

Factors that should be considered include specifications

For such consumables or accessories and any restrictions placed uponusers in their selection of these.

No

15

Is maintenance and /or calibration necessary?

Factors that should be considered include whether maintenance

and/or calibration are to be carried out by the operator or user

or by a specialist, are special substances or equipment

necessary for proper maintenance and /or calibration?

No

16

Does the medical device contain software?

Factors that should be considered include whether software is intended

to be installed, verified, modified or Exchanged by the user and /or

operator.

No

17

Does the medical device have a restricted shelf life? Factors

that should be considered include labeling or indicators and

the disposal of such medical devices.

The expiration date is five

years, which will be

labeled on the package. It

can be handled according

to the law and the

regulation of the country if

it had exceeded the

expiration date.



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18

Are there any delayed and/or long-term use effects? Factors

that should be considered include ergonomic and cumulative

effects.

No

19

To what mechanical forces will the medical device be

subjected?

Factors that should be considered include whether the Forces to

which the medical device will be subjected are under the

control of the user or controlled by interaction Which other

persons

The device depend on

the compression spring

come into suppressing and

sucking the wasted liquid.

20

What determines the lifetime of the medical device?

Factors that should be considered Include ageing and battery

depletion.

The aging of the raw

material has determined

the product’s life

expectancy.

21 Is the medical device intended for Single use? Sign use only.

22

Is safe decommissioning or disposal Of the medical devicenecessary? Factors that should be considered include the waste

products that are Generated during the disposal of the medical

device itself, for example does it contain toxic or hazardous

Material, or is the material recyclable?

The discarded deviceshould be handled

according to the laws or

regulations of that country.

23

Does installation or use of the medical device require special

training? Factors that should be considered include

commissioning and handing Over to the end user and whether it

is Likely/possible that installation can Be carried out by people

without the Necessary skills.

The direction of use is

provided in the packing

label. The user should be

professional doctor or

nursing stuff.

24Will new manufacturing processes need to be established orintroduced. The introduction of new hazard(s)(e.g.new

technology, new scale of production).

No

25

Is successful application of the medical device

critically dependent on human factors such as user

interface? Device control, symbols used ,Ergonomic

features, physical design and layout, hierarchy of

operation, menus for software driven devices,

visibility of warnings, audibility of alarms,

standardized colour coding. these Considerations

include, but are not limited to, the following. Does

the medical device have connecting Parts or

accessories? Differentiation, similarity to other

products’ connections, connection force, feedback on

connection integrity, and over-and under-tightening,

Does the medical device have a control interface?

Visibility, Direction of activation or change, and

Whether the controls are continuous or discrete, and

the reversibility of settings or actions. Does the

medical device display information?Is the medical device controlled by a menu?

The material of the

product selection should

suit for the steady of

production process.

The device controlled by

professional doctor and by

the direction of use.

Entrance Jaw and connecting

tube connecting will fall

of, There are clear method ofuse on the manual


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26

Is the medical device intended to be mobile or portable? Factors thatshould be considered are the necessary grips, handles, wheels,

brakes, mechanical stability and durability.

The hanger of the wounddrainage system should be set

firm enough to bear the weight

of the wasted liquid.

27

Does the device should be cleaned and steriled before use.

How frequency does the clean and sterile do ?

The product is sign use

only, it does need to clean

and sterile before use.

Ensure the endotoxin are

not overweight

prepared： Terry Tan reviewed: Zhu jianxin

4. Definition criterial

4.1 criteria of severity for harm No. Category Description Examples

1 Negligible No hazard occurs or almost

noSkin irritation

2 Marginal Hazard occurs possiblyCoronary arterial spasm

动脉痉挛

3 CriticalPotential of death or serious

injury

Acute myocardial

infarction心肌梗死

4 CatastrophicDeath or injure occurs

possiblyDeath

4.2 Criteria of the probability for harm

No. Class Description Example

1 Incredible Never occurred (1) None

4.3 Criteria for risk acceptability– When Severity ＝4，CAPA should been taken 。


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– When Severity＝3， probability ≥5， CAPA should been taken– When Severity＝2， probability =6， CAPA should been taken– For the residual risk, CAPA should been taken for the top 20﹪risk .

Severity

Likelihood 1 Negligible 2 Marginal 3 Critical 4 catastrophic

6 Frequent * N/ACC N/ACC N/ACC

5 Probable * * N/ACC N/ACC

4 Occasional * * * N/ACC

3 Remote ACC * * *

2 Unlikely ACC ACC * *

1 Incredible ACC ACC ACC ACC

N/ACC = not acceptable

ACC = acceptable

5. Risk analysis report

Wound drainage system potential hazard

1 Potential hazards are listed below based on the qualitative analysis on the product features

according to ISO14971 Annex D:


Type of Hazard Potential HazardYes No Nor

mal Failure Risk

Factor

If yes (known, foreseen andnot confirmed), describe potential hazard

1．Energy Hazard 1.Pressure (thecontainer breaksand leaks)

√ √ 2The container is likelyto break or leak if the

up cover or bottomcover hit sealingunsteady.

2.Biological hazard

Bio

Contamination

Bio

un-compatibility

Across infect

√

√

√

√

√

3

1.After sterilization, the

SAL for products reach

10-6

to ensure the

thorough sterilization

and reduce the hazard

and risk to acceptable

extent.

2.The material of the barium should be

selected strictly.

3.All parts of the device

are sign use only.

4.Hazard in

Applications of the

device

Improper

Package（the

pollution or

metamorphism of

the medical

equipments）

√

√

√

√

√

√

2

1、The discarded products and the

discharged liquid waste

should be handledaccording to the lawsand regulations of that

country. 2、Leakness

Inspection.


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5．Hazards due to

Function Failure,

improper

Maintenance or

Aging

1、Lack of Proper

Regulation on

End of erviceLife

√ √

3 The device has

exceeds the actual

expiration date and

that lead to the

aging of the product.So the product cannot

be used regularly.

prepared：Terry Tan reviewed： Zhujianxin

2 other risk


Source of Hazard PotentialHazard

Yes No Normal

Failure

RiskFactor

If yes (known, foreseenand not confirmed),

describe potential hazard

Batch inconsistency Different batch

of manufacture√ √

1

Intended usage

failure. Write clear

batch record, make

sure it is traceable.

Common interfering

factor

Different

Environment √ √ 1 Make sure the

environment of the

transportation and

storage are acceptable.

Carry-over effects√ √ 1

Finished good

inspection insure the

product clean and

qualify.

Sample

identification errors√ √

2

Sample validation

Stability problem Package damaged

√ √

2

The proficiency of

workers’ operation

prepared：Terry Tan reviewed： Zhu jianxin

3 Analysis evaluation report

3.1. Risk evaluation：according to criteria

Severity Probability

1=negligible 1=incredible

2=marginal 2=unlikely


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3=critical 3=remote

4=catastrophic 4=occasional

5=probable

6=frequent

Severity

probability

1 2 3 4

6 * N/ACC N/ACC N/ACC

5 * * N/ACC N/ACC

4 * * * N/ACC

3 ACC * * *

2 ACC ACC * *

1 ACC ACC ACC ACC

3 2 Risk estimation and risk evaluation

Risk

estimationEnergyHazards

harms Potential causes

S P

Riskevaluation

R1: Trocar can not punch through the patient

body.

R1.1 residua on

trocar3 4 N/ACC

R1.2 suction tubeblock up

3 5 N/ACC

R1.3 suction failure3 5 N/ACC

Performance

Trocar

sharpness

failure

Barium tube

Rerservoir kit

leakR2: separation of tubing in body

3 3 Risk control of R1

. R1 Hazard Trocar failure, leak

sk evaluation Can cause Acute myocardial infarction, dead. S 3, P 5, N/ACC


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tion selectSafe design and

protective measure

controllable?Yes

unter measures

1. Sharpness ensurance 100% test.

2. risidua inspection

3. Leak test

erification Varification report

esidual risk S 3, P 2, ACC

sk/benefit

alysis

benefit outweighs the risk

plaining The Probability of tubing broke and lefe in patient body and cause patient decease tounlikely level. As the reservoir kit system have been broadly used worldwide for manyyears, and the benefit of reservoir kit is obvious weighting profit against potentialhazards

ew risk No

3.4 Evaluating effectiveness of risk control measure

DHR review.

4.Risk and profit analysisFrom results we got upwards, we know that ： 1. the risk management plan has been appropriately implemented;2.by the measures taken all risks are reduced to acceptable level nowadays.3. the overall residual risk is acceptable;

5. SummaryThe main material of the disposable sterile Wound drainage system is trocar, barium tube, connecting tube, the

reservoir body.. The microbes infection and sensitization have been effectively prevented through the control over theincoming examination of raw material and auxiliary material, environment control, the manufacturing process, the finalinspection and sterilization validation. The biocompatibility test and clinical data prove that the products would notcause the harmful stimulation, sensitization and other harmful effects to the mucous membrane of the skin and would

not separate out venomous substance. Meanwhile, every link of the relevant process shall be under controlled status toensure the microbes pollution to the least level, within acceptable scope and in conformance with the requirements of93/42/EEC as amended by 2007/47/EC. All the risk s are describes, evaluated and proved to be within acceptablescope and will not cause the human body to feel unwell, and even death.


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V. Clinical Data

1. Product Profile:

1.1 Wound drainage system, which is used for sucking the wasted liquor

from the patient’s body when pressing the wound drainage cavity with the trocar puncturing the patient’s body andleading the X-ray barium tube. And the product is mainly made of non-toxic PVC and a trocar, so it do no harm to thepatients, nursing staff as well as other relevant or irrelevant people.

1.2 Wound drainage suction tube is widely used in surgical field for suction of waste fluids from a surgical wound.It is mainly made of medical grade PVC and is inert to the body fluid and blood, so it is safe and effective for itsintended use. Beyond’s manufacturing facility of the suction connecting tube has years of experience of making plasticmedical device for single use, and is running under the certified quality management system of ISO13485,as well asCE.

2. Assessment Of Risks And Benefits:

We have managed the risks of the product in four periods: before the designing and developing period, in the stage

of affirmance of the product’s designing and developing, in the production procedure as well as after the collection ofthe feedbacks. And we also adopted a series of efficient controlling measurement to deal with the possible dangerswhich may occur in every stage. Thus, we have minimized the risks to the acceptable range and we assure that thedangers caused by the left risks are much more less than the benefits the product bring to the patients.

3. Product Literature Summarize

The design and the structure of the product have been proved internationally. The steady quality of the productavoids us from any reports about unpleasant medical accidents caused by our equipments during the production andclinical use for these years.

4. The general information of the clinical use:

The wound drainage system manufactured in our company have been sold to overseas market including theOccident and other Asian countries. Since the start of production, the output value has been increasing year by year.Our company has set up perfect after sale services. And according to the statistics, we had sold out more than tenthousand wound drainage system by now. we haven’t received any complaints about unpleasant medical accidents orquality problems caused by our equipment during the clinical use up to now. The result shows that our product is eithersafe or reliable and the product’s quality is excellent.

5 Target market and sales volumeMajor target market is North America, but we are developing Europe market. The sales volume may exceed 1 millionpcs within one or two years.

6.Product safety and effectiveness reviewThis device is made of medical grade PVC, and stainless steel, so from the past experience of other

device, the device is safe.The sterile products are packaged with individual packaging, and sterilized by EtO at SAL 10-6 , thesterility is assured.There are warning words and precautions during condition of use indicated on the label, therefore, toavoid the adverse effect or reduce it to a minimum level.

7.The wound drainage suction reservoir manufactured by our company has been proven to be safe,effective, applicable and be capable of meeting the demands of customer through clinical application inhospital. The results of application are :7.1 Safety: No adverse events or malfunction has been reported.7.2 Effectiveness:a) no adverse event happened, the function of the product, such as suction is effective during the condition ofuse;b) can meet the requirements of clinical application.7.4.3 Applicationa) convenient and applicable for vacuum suctuion;b) no other harm to patients;7.4.4 Othersa) the package is integral;b) the labeling is legible and clear;


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c) instruction for use is clear and fulfills regulation requirements.

8. The effect after use and feedback from our customersWe operated under the operational procedure during production of the product, and conduct quality management

according to ISO13485. For each stage of all processes, i.e. material incoming, assembling, packaging and labeling,sterilization and final release, specifies relevant inspection and control procedures. And it can avoid some adverse

effects to users from unstable factors; therefore, our product can meet the requirements of customers. By application ofpassed years, it has proven that our product is stable in quality, safe and reliable. The feedback fromour customers isgood; the adverse effect of our product is acceptable under normal condition of use.

VI. Label

1.0 Purpose

To give directions for proper operations with the products according to the requirement of MDD.

2.0 Scope of Application:

Applicable to the control procedures for utilization of disposable sterile product label.

3.0 Responsibility

3.1 Technical Development Department is responsible for preparing literal description on the labels.

3.2 The General Manager is responsible for validating the accuracy of the description on the labels.

4.0 Procedures

4.1 Technical Development Department is responsible for preparing specific items on the label, including:

4.1.1 Names and addresses of the Manufacturer, Importer and European Representative

4.1.2 Product name, trade mark, model, size, quantity and bar code;

4.1.3 literal indication of sterilization: “Sterilization” and ETO Sterilization symbols;

4.1.4 Lot number and identification marks:

a) Lot number mark:

LOT

b) The lot number is a 8-digit number, the former 4 for particular year and the latter 4 for serial number.

c) For example: LOT20020001

representing that it is manufactured in the first batch in 2002.

d) The size and location of the lot number and the identification marks are not specified.

4.1.5 “USE BY” indication for service life;

a) “USE BY” mark

STERILE EO


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b) The service life consists of 6 digits, the former 4 for the particular year and the latter 2 for the particular month, with asymbol ”-” going between them.

c) This identification mark indicates the last effective year in the service life of the disposable product

d) For example: 2002-06

representing that the product shall be used before June 2002.

4.1.6 Date of manufacturing

a) Identification mark

b) The date of manufacturing consists of 8 digits, the former 4 for the productive year and the latter 4 for the month anddate respectively;

c) For example: 20050608

representing the date of manufacturing is April 8, 2000;

d) The sizes and locations of the marks and the identifications are not specified.

4.1.7 Identification for disposable product “Disposable (single-use)” and the identification mark

h=1.16a

This mark represents “Disposable (single-use)”

4.1.8 The mark of “SEE INSTRUCTIONS FOR USE” and its application

a) Identification mark:

b) Note:

4.1.9 There shall be a CE mark and code of Proclamation Organization after the product is CE certified.

i. Icon:

0123

b) The vertical height of the icon shall be no less than 5mm and is usually placed at the lower right corner. CE markshall be clear and easy to be caught in eyes.

4.1.10 Symbol for “CATALOGUE NUMBER”

REF ABC123

NO Stipulation for their size and location, to make it if applicable.

4.2 Technical Development Department submits the prepared label description to the General Manager for approval.According to the requirement of MDD, label language must be translated into target market-specific language.

4.3 The reviewed documents for label descriptions are filed together with technical documents.

4.4 The distribution, management and alteration of the label descriptions (technical documents) are in accordance withthe regulations on procedure documents such as “Controlling Procedures for Documents and Data” and “ControllingProcedures for Quality System Document”.


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5.0 Relevant Documents

“Controlling Procedures for Documents and Data”

Section 13 of Annex I, Annex VII (MDD93/42/EEC AS AMENDED BY 2007/47/EC)

EN980: Graphic Symbols for Use in Labeling of Medical Devices

Labels for external package, middle package and inner package of the product are attached.

VIII. Product Quality Assurance:Performance and steadity evaluation

8.1 Product Performance Test Report

Refer to product performance test at inspection record list XSQA008 current version.

8.2 Biocompatibility Test Report (The Tests for irritation and sensitization)

8.2.1 GeneralAccording to the Council Directive 93/42 EEC and ISO 10993-10, The Tests for irritation and

sensitization have been performed to this device, so as to obtain evidence that the product issafe for its intended use.

8.2.2 Tested by ：Cardinal Health

8.2.3 AppendixAppendix I Test report of the Wound Drainage Suction ReservoirAppendix II Retention sample test report

8.3 Aging Test

8.3.1 General

According to the ISO 11137: 2006,The aging test for five years has been performed so as to

obtain evidence that the product is credible for its intended use in it’s expiration date.

8.3.2 Tested by ：Appendix Speed aging test report

8.3.3 The test results showed,the device valid for 5 years shelflife


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IX. Production Process Description

9.1 Production Process

9.1.1 Process flow chart refer to XSPR-SS007, Rev 00 , see attachment 2,9.1.2 Process validation report below list

Process Validation Protocol/Report List

No Document No.

1 FS/QR-7.6-02-01

2 FS/QR-7.6-02-02

3 FS/QR-7.6-02-03

4 FS/QR-7.6-03-01

5 FS/QR-7.6-03-02

6 FS/QR-7.6-04-01

7 FS/QR-7.6-04-02

8 FS/QR-7.6-05-01

9 FS/QR-7.6-05-02

10 FS/QR-7.6-06-01

11 FS/QR-7.6-06-02

12 FS/QR-7.6-07-01

13 FS/QR-7.6-07-02

14 FS/QR-7.6-08-01

15 FS/QR-7.6-08-02

16 FS/QR-7.6-09-01

17 FS/QR-7.6-09-02

18 FS/QR-7.6-10-01

19 FS/QR-7.6-10-02

20 FS/QR-7.6-11-01

21 FS/QR-7.6-11-02

Components Name

IQ BeyondZ001

IQ BeyondZ002

IQ BeyondZ003

OQ-Plate of Cover OQ

PQ-Plate of Cover PQ

OQ-Plate of Bottom OQ

PQ-Plate of Bottom PQ

OQ- Drain Jaws OQPQ- Drain Jaws PQ

OQ- Entrance Jaws OQ

PQ- Entrance Jaws PQ

OQ- Bed Sheet OQ

PQ- Bed Sheet PQ

OQ- Robert Clamp OQ

PQ- Robert Clamp PQ

OQ- Barium Tube OQ

PQ- Barium Tube PQ

OQ- Connection Tube OQPQ- Connection Tube PQ

OQ- Cover for Trocar OQ

PQ- Cover for Trocar PQ


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Changshu Beyond Medical Device Co., Ltd CE Technical File Part

ADocument № BYQA031-00 Revision 1 Issue Date: Mar 20th,2015

9.1.3 Refer to Device Master Records XSQA013.

9.2 Raw materials and packaging materials

9.2.1 Refer to XSQA-038 Rev 00.9.3 Manufacturing Environment

9.3.1This device should be manufactured in class 100,000 clean room.9.3.2 Monitoring scheme of manufacturing environment.

To be decided by the manufacturing facility per Changsu Beyond XSPR-SS003/004.9.3.3 Bioburden of the product.

Clear room bioburden test will perform by Cardinal Health quarterly and test report willkept by Cardinal Healthshanghai.

9.4 Labeling Control

Refer to Changsu Beyond procedure XSLO-PP002, Rev 01.

9.5 Traceability

Refer to Changsu Beyond procedure XSPR-PP001, Rev 01.

9.6 Release

Refer to Changsu Beyond Procedure XSQA-PP007,Rev 01.

X. Process Validation

10.1 Environmental Validation

Refer to the: Waiting for report TBD

10.2 Process Validation

Refer to the extension validation and first article inspection report. (at)

10.3 Packaging Integrity Validation

Refer to the

10.4 Sterilization Validation

Refer to Changsu Beyond Procedure XSQA031-01,Rev A-00