, . ..-. .. .., {. ·..i_ DEPARTMENT OF HEALTH & HUMAN SERVJC£5

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March 28, 2014

Neuronetics, Inc. c/o Judy P. Ways, Ph.D. Vice President, Regulatory Affairs and Quality Assurance 31 General Warren Boulevard Malvern, PA 19355

Re: Kl33408 Trade/Device Name: NeuroStar TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: February26, 2014 Received: February 27,2014

Dear Dr. Ways:

Publil: Health Service

Food and Dnla Admin~011 10903 New Hampshi~ A~nue Oocusnent COIIU'OI Center - W066-<l609 Silver Spri,._ MD 2099J.0002

We have reviewed your Settion 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been retlassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act.

The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate infonnation related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class IJ (Special Controls) or class Ill (PMA), it may be subjett to additional controls. Existing major regulations affecting your device can be found in the Code offederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

Page 2 -Judy P. Ways, Ph.D.

CFR Part 807): labeling (21 CFR Part 80 I); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820}; and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act}; 21 CFR I 000-1050.

lfyou desire specific advice for your device on our labeling regulation (21 CFR Part 801}, please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll­free number (800) 63 8-2041 or (30 1) 796-71 00 or at its Internet address http://www.fda.gov/MedjcaiDevjces/ResourcesforYou/lndustry/default.htm. Also, please note the regulation entitled, nMisbranding by reference to premarket notification" (21 CFR Part 807 .97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803}, please go to · htm://www.fda.gov/MedicaiDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800} 638-204 I or (30 J) 796-7 J 00 or at its Internet address http://www .fdagov/MedicaiPevjcesiResourcesforY ou/lndustry/defay lt.htm.

Enclosure

Sincerely yours,

Carlos L. Pena-S

Carlos L. Pei'la, PhD, MS Director · Division ofNcurological and

Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

510(k) Number (if known} Kl33408

Device Name

Indications for Use

NcuroStar TMS Therapy System

lna1C8tions for Use (DeBCfibe)

Form Approved: OMS No. 091~120

Explrallon Date: January 31,2017

See PRA Stalement on la$1 pege.

The ·NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have fisilcd to receive satisfactory improvement from prior antidepressant medication in the cuncnt episode.

Type of Use (Select OfiB or both, as applicable)

~ Prescription U&e (Part 21 CFR 801 Subpart D) 0 Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological HeaHh (CDRH) (Signature)

Carlos L. Pena -S

FORM FDA 3881 (1/14) Page 1 of2

This section applies only to requirements of the Paperwork Reduction Act of 1995.

•Do NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.•

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instruclions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regan:ling this burden estimate or any other aspecl of this Information collection, including suggestions for reducing this burden, to: ·

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An 8fJflfiCY may not conduct or sponsor, and a pefSOfl is not 18qUired to rvspond to, a collflction of lnfolmatlon unless It displays a currenUy valid OMB number.·

FORM FDA 3881 (1114) Page 2 of2

MAY. 3. 2013 9:01AM NO. 4784 P. 1/3

~~~ _n_BP_A_R_~ __ E_NT __ or __ ~ ___ T_H_&_H_u_~ ___ s_E_Rv_I_~------~--------~~b-~-~---5~--~----------,,~ April 30,2013 ~~a::~m:!n~

Neuronetics, Inc. c/o Judy P. Ways. Ph.D. Vice President, Regulatory Affairs and Quality Assurance 31 General Warren Boulevard Malvern, PA 19355

Re: Kl30233 NeuroStar TMS Therapy System Regulation Number: 21 CFR 882.5805

Dacu111111t Conavl O.W • W066-0GO\l SUver S9till8. MD 20!193.()()02

Regulation Name: Repetitive !l'BJ1$Cranial Magnetic Stjmulator for Treatment ofMajor · Depressive Disorder

Regulatory Class: Class II Product Code: OBP Dated: January 29,2013 Received: Januacy 30, 2013

Deal' Dr. Ways:

We have reviewed your Section 510(k) premarketnotlfication ofinumt to market the device referenced above and have detennined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predjcate devices marketed in interstate commerce prior to May 28, 1976, the enactment date ofthe Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval appHcation (PMA). You may, therefore, market the device, subject to the general controls provisions of the Aet. The general controls provisions of the Act include requirements fOl' annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labelinl must be truthful and not misleading.

If your device is classified (see above) into either class IT (Special Controls) or class III (PMA), it may be subject to additional control$. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish :further announcements concerning your device in the Federal Resister·

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a detemiination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CPR Part 807); labeling {21 CFR Part 801); medical device reporting {reporting of medical . dcvicewrelatcd adverse events) (21 CPR 803); good manufacturing practice requirements as set

MAV. 3. 20!3 9:01AM

NQ 4784 P. 213

Page2 -Judy P. Ways, Ph.D.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-342 oftbe Act); 21 CPR 1000-1050.

Ifyou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the DiVision of Small Manufacturers, Intcrnntional and Consumer Assistance at Its toll­free number (800) 638-2041 or (301) 796-7100 or at its Internet address: http://Www.fda.goy/MedicalDeyjcea/B-eSOJJrcesforYou/Industry/dcfaultJnm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CPR Plllt 807.97). For questions regarding the rcpor.tinJ of adverse events under tho MDR regulation (21 CFR Part 803), please go to:

h'£W:Ilwww.f4a.&Q\!I'Medlca1Deyicea/Safetv!Reporyprohlern/defiru!t.JU:m for the CDRH's Office of Surveillance and Biometrics/Division ofPostmark.ct Surveillance.

You may obtain other general Information on your responsibilities under fhe Act fiom the Division of Small Mannfacturcn, International and Consumer Assistance at Its tolJ.ftee number (800) 638-2041 or (301) 796-7100 or at Its Internet address= http://ww:w.fcJa.,goy/Me<fical'Os!vicesffl,esoyrces{orYou/TndustJYI®fault,htm.

Enclosure

Sincerely yours,

Joyce~ng-S for Victor Krautbamer, Ph.D.

Acting Dlrcotor Division ofNcurolog;ical

and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

MAV. 3. 2013 9:01AM

Indications for Use

SIO(k) Number: Kl30233

Device Name: NeuroStar TMS 'Oterapy SVstem

Indications For Usc:

NO. 4 784 P. 3/3

The NeuroStar TMS Therapy System Is indicated for the treatment ofMajor Depressive Disorder in adult patients who have failed to achieve satisfactory Improvement :from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

Prescription Use _X_ (Part 21 CPR 801 Subpart D)

AND/OR Over-The-Counter Use __ (21 CFR 801 SUbpart C)

(PLEASE DO NOT WRITE BELOW THIS LINB-CONI'INUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce~ng-S (Division Sign Off) Division of Neurological and Physical Medicine Devices (ONPMD)

SlO(k) Number _K1302J3, ____ _.__

Page 1 of_l _

__________________________ ............ .......

('""1_ DEPARTMENT OF HEALTH & HUMAN SERVICES ·· ... J

Neuronetics, Inc. c/o Judy P. Ways, Ph.D. Vice President, Regulatory Affairs and Quality Assurance One Great Valley Parkway, Suite 2 Malvern, PA 19355

Re: K061053; NeuroStar® TMS System Evaluation of Automatic Class Ill Designation Regulation Number: 21 CFR 882.5805 Classification: II Product Code: OBP

Dear Dr. Ways:

This letter corrects our classification letter of October 7, 2008.

l'ublic Health Scn·icc

Food and Drug Adminislr.uion IH'JII3 :>ic\\' Hampshire :\vcnu.: DocumL,ll Conlrol Room- WOM-G609 Sihcr Spring. MD 20993-0002

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your Evaluation of Automatic Class III Designation Petition (de novo) for classification ofthe NeuroStar® TMS System as a prescription device under 21 CFR Part 80 I .I 09 that is indicated for the treatment of Major Depressive Disorder in adult patients who have faiJed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. FDA concludes that this device, and substantially equivalent devices of this generic type, should be classified into class II. This order, therefore, classifies the NeuroStar® TMS System, and substantially equivalent devices of this generic type into class II under the generic name, Repetitive Transcranial Magnetic Stimulation (rTMS) System.

FDA identifies this generic type of device as:

A repetitive transcranial magnetic stimulation (rTMS) system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder (MDD) without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.

Page 2 -Judy P. Ways, Ph.D.

In accordance with section SJJ(f)(l) of the Federal Food, Drug. and Cosmetic Act (21 U.S. C. 360c(f)(l)) (the act), devices that were not in commercial distribution prior to May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976 (the amendments)), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class Ill and require premarket approval, unless and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section S ll(i) of the act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section S I O(k) of the act (21 U.S. C. 360(k)) and Part 807 of the FDA regulations (21 CFR 807).

Section S J 3(t)(2) of the act provides that any person ~ho submits a premarket notification under section S I O(k) for a device may, with in 30 days after receiving an order classifying the device in class III under section S 13( f)( I), request FDA to classify the device under the criteria set forth in section 513(a)(l). FDA shall, within 60 days of receiving such a request classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register classifying the device type.

On May 24, 2007, FDA filed your petition requesting classification of the NeuroStar11 TMS System into class II. The petition was submitted under section S 13(t)(2) of the act. In accordance with section S ll(t)( 1) of the act, FDA issued an order on April 26, 2007 automatically classifying the Neurosrar• TMS System in class III, because it was not within a type of device which was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, nor which was subsequently reclassified into class I or class II. To classify the Neurostar• TMS System into class I or n, it is necessary that the proposed class has sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.

After review of the infonnation submitted in the petition, FDA has detennined that the Neurostar• TMS System indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode can be classified in class II with the establishment of special controls for class n. FDA believes that class II special controls provide reasonable assurance of the safety and effectiveness of the device type.

Page 3 ·Judy P. Ways, Ph.D.

Risks involved with the use of the device and their mitigation include:

Identified Risk Mitiotion Measures Usage outside of labeled patient population Clinical Testing

Labeling Ineffective Treatment Nonclinical Analysis and Testing

Software Life Cycle and Risk Management Animal Testing Clinical Testing Labelin~~:

Seizure Nonclinical Analysis and Testing Animal Testing Clinical Testing Labeling

Scalp discomfort, scalp burn, or other adverse Nonclinical Analysis and Testing effects Software Life Cycle and Risk Management

Animal Testing Clinical Testing Labeling

Magnetic field effects on functioning of other Non-clinical Analysis and Testing medical devices Labeling Adverse Tissue Reaction Biocomoatibility Hazards Associated with Electrical Equipment Electrical Equipment Safety

Labeling Hazards caused by Electromagnetic Interference Electromagnetic Compatibility and Electrostatic Discharge Hazards LabelinR Hearine. Loss Labeline.

In addition to the general controls of the act, the NeuroStar• TMS System is subject to the following categories of special controls: device description. nonclinical analysis and testing, biocompatibility, electrical equipment safety, electromagnetic compatibility, wireless technology, software validation, clinical infonnation and labeling. Section 51 O(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification requirements of the act. Thus, persons who intend to market this device type must submit to FDA a premarket notification submission containing infonnation on the rTMS system they intend to market prior to marketing the device and receive clearance to market from FDA.

Page 4 ·Judy P. Ways, Ph.D.

A notice announcing this classificatiOJJ Older will be published in the Federal Resister. A copy of this order IDd Sllpporting do<umeala!iOJJ are OJ! file in lhe Dockets Manaaemenr Bmnch (HF A-JOS), Food IDd Drug Adminislralion, 5630 Fishers Lane, Room I 061, RocltviUe, MD 20852 IDd are available for inspection between 9 a.m. and 4 p.m., Monday through Friday.

As a resuJr of this order, you may iiDitledialely 11111rker your device as described in rbe de novo, subjecrro lhe genera) COIIIrol pnwisions of the act and the special COD!rols idenrifled in this order.

If you have any questions concerning this classificariOJI order, please conracr AM H. Coslello Ph.D., D.M.D. at 30 J. 776·6493.

Sincerely yours,

~~ Jonette Foy, Ph.D. Acting Deputy Director for Science and Regulatory Policy

Office of Device Evaluation Center for Devices and Radiological Health

Neuronetic:s, lnc. %Judy P. Ways, Ph.D

OCT 7 2011

Vice President, Regulatory Affairs and Quality Assurance One Great Valley Parkway, Suite 2 Malvern, P A 19355

Re: K061 053; NeuroStar8 TMS System Evaluation of Automatic Class III Designation Regulation Number: 21 CFR 882.5805 Classification: II Product Code: OBP

Dear Dr. Ways,

Public Health Service

Food and Drug Administration 9200Corporate Boulevard Rockville MD 20850

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your petition for classification of the Neurostar• TMS System as a prescription device under 21 CFR Part 80 l.l 09 that is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. FDA concludes that this device, and substantially equivalent devices of this generic type, should be classified into class II. This order, therefore~ classifies the NeuroStar8 TMS System, and substantially equivalent devices of this generic type into class II under the generic name, Transcnmial magnetic stimulation system. This order also identifies the special controls applicable to this device if put into class II.

FDA identifies this generic type of device as:

21 CFR 882.5805. A transcrania1 magnetic stimulation system is a device intended for the treatment of major depressive disorder (MDD) that non-invasively delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the patient's cerebral cortex to treat the symptoms of MOD without inducing seizure.

Page 2 -Judy P. Ways, Ph.D.

In accordance with section 513(t)( I) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(t)(l)) (the act), devices that were not in commercial distribution prior to May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976 (the amendments)), generally referred to as postamendments devices, are classified automaticaJly by statute into class Ill without any FDA rulemaking process. These devices remain in class Ill and require premarket approval, unless-and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means ofpremarket notification procedures in section SJO(k) of the act (21 U.S.C. 360(k)) and Part 807 of the FDA regulations (21 CFR 807).

Section 513(t)(2) of the act provides that any person who submits a premarket notification under section 51 O(k) for a device may, with in 30 days after receiving an order classifying the device in class Ill under section 5 I 3( f)( I), request FDA to classify the device under the criteria set forth in section 513(a)(l). FDA shall, within 60 days of receiving such a request classify the device. This classification shaH be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register classifying the device.

On May 24,2007, FDA filed your petition requesting classification of the Neurostar• TMS System into class II. The petition was submitted under section Sl3(f)(2) of the act. In accordance with section 513(t)(l) of the act, FDA issued an order on April26, 2007 automatically classifying the NeuroStar8 TMS System in class III, because it was not within a type of device which was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, which was subsequently reclassified into class I or class II. In order to classifY the NeuroStar• TMS System into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance ofthe safety and effectiveness of the device for its intended use.

After review of the infonnation submitted in the petition, FDA has determined that the Neurostar• TMS System indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode can be classified in class II with the establishment of special controls. FDA believes that class II special controls provide reasonable assurance of the safety and effectiveness ofthe device type.

Risks involved with the use of the device type and their mitigation include: .

Page 3- Judy P. Ways, Ph.D.

ldendfled Risk Mltlptloa MeeiUrel

Usage outside of labeled patient population Clinical Testing Labeling

Ineffective Trcaament Nonclin.ieal Analysis and Testing Software Ufe Cycle and Risk Management Animal Testing Clinical Testing Labelin_A

Seizure Nonclinieal Analysis and Testing

Animal Testing

Clinical Testing Labeling

Scalp discomfort. scalp bum. or Nonclinical Analysis and Testing other adverse effects Software Ufe Cycle and Risk Management

Animal T csting

Clinical Testing LabeliDg_

Magnetic field effects on Non-clinical Analysis and Testing fimctioning of other medical Labeling

devices

Adverse Tissue Reaction BioCOIDJ)8tibiliiY

Hazards Associated with Eloctrical Equipment SafelY Electrical. EQ1aiJ)I1lent Label_ing_

Hazards caused by Electromagnetic Compatibility Electromagnetic Interference and Labelin& Electros1atic Discharge Hazards

Hearing Loss

In addition to the general controls of the act. the transcranial magnetic stimulation system for the treatment of major depressive disorder is subject to the following special controls: device description, nonclinical analysis and testing, biocompatibility, electrical equipment safety, electromagnetic compatibility, wireless technology, software validation, clinical infonnation and labeling. Section 510(m) of the act provides that FDA may exempt a class 11 device from the premarket notification requirements under section SIO(k) of the act, if FDA detennines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification requirements. Thus, persons who intend to market this device must submit to FDA a premarket notification submission containing information on the b'anscranial magnetic

Page 4- Judy P. Ways, Ph.D.

stimulation system they intend to market prior to marketing the device and receive clearance to market from FDA.

A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HF A-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday.

As a result of this order, you may immediately market this device, subject to the general control provisions of the act and the special controls identified in this order.

If you have any questions concerning this classification order, please contact Ann H. Costello, Ph.D., D.M.D. at (240) 276-3740.

~y~ Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health