(18 days)
Not Found
No
The document describes a computerized electromechanical device for Transcranial Magnetic Stimulation (TMS) and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as descriptions of training and test sets typically associated with AI/ML development.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the treatment of Major Depressive Disorder."
No
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder by delivering magnetic stimulation to induce electrical currents in the cerebral cortex. Its purpose is therapeutic (treatment), not diagnostic.
No
The device description explicitly states that the NeuroStar TMS System is an "integrated system consisting of a combination of hardware, software, accessories and consumable supplies" and lists several hardware components like a Mobile Console, Treatment Coil, and Head Support System.
Based on the provided information, the NeuroStar TMS Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- NeuroStar TMS System Function: The NeuroStar TMS System is a therapeutic device that delivers magnetic stimulation to the brain for the treatment of Major Depressive Disorder. It does not involve the analysis of biological specimens.
The description clearly states that the device is a "computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation." This aligns with a therapeutic device, not a diagnostic one that analyzes samples.
N/A
Intended Use / Indications for Use
The NeuroStar TMS Therapy System 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.
Product codes
OBP
Device Description
The NeuroStar TMS System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (~200 usec) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. The peak magnetic field strength achieved with each pulse is approximately 1.5 Tesla.
The NeuroStar TMS System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, mechanically supports the ferromagnetic Treatment Coil and includes a software controlled graphical user interface, a ferromagnetic Treatment Coil to deliver TMS Therapy, a Head Support System for accurate coil positioning, and a single use device (SenStar® Treatment Link) placed on the face of the coil to reduce local scalp stimulation, to provide feedback to the operator regarding contact of the coil with the patient's head, and to verify the applied field strength. A separate Practice Data Management System (PDMS) allows and facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS System units.
The NeuroStar TMS Therapy System with Class 1 laser positioning aid utilizes a Class 1 laser for positioning and registration of the patient's head in the Head Support System prior to coil positioning for Motor Threshold (MT) determination and TMS treatment. The Class 1 laser positioning aid provides for ease of use during head positioning and registration as compared to the use of plastic positioning pointers in the predicate device. The use of the Class 1 laser positioning aid does not substantially change the process of patient positioning for NeuroStar TMS Therapy and provides equivalent accuracy in coil placement for MT determination and TMS treatment as shown by verification and validation testing.
The Class 1 laser positioning aid consists of a laser diode, line generating lens, printed circuit board and 1.5V AA battery. The optical components are cemented in place and mechanically captured with a non-removable bezel. The circuitry regulates the laser diode current based on measured output and incorporates a timing circuit that ensures that the laser diode is turned off after a maximum of 45 seconds. There are no user or service adjustable components; the only required maintenance is replacement of the battery on an annual basis during the required system preventative maintenance visit which is performed by a trained service technician. The only laser radiation that is accessible during use or service is the primary output beam which meets Class 1 requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
prescription only under the supervision of a licensed psychiatrist. It can be used in both inpatient and outpatient settings including psychiatrist's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification tests were performed as based on a Failure Modes and Effects Analysis (FMEA). The accuracy of the Class 1 laser positioning aid was verified to meet design specifications (Test Report 80-80095-001). Its utility in treatment coil positioning and equivalence to the predicate device in determination of MT and TMS treatment locations was demonstrated (Test Report 80-80095-000).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NeuroStar TMS Therapy System2 [K061053]
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation 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 without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
0
DEC 1 6 2008
NEURONETICS
510(k) SUMMARY
NEUROSTAR TMS THERAPY® SYSTEM
510(k) Owner:
Neuronetics, Inc. 1 Great Valley Parkway, Suite 2 Malvern, PA 19355 Phone: 610-640-4202 610-640-4206 Fax:
Company Contact:
Judy P. Ways, Ph.D. Vice-President Regulatory Affairs and Quality Assurance Neuronetics, Inc. 1 Great Valley Parkway, Suite 2 Malvern, PA 19355 Phone: 610-640-4202, ext. 1006 Fax: 610-640-4206
Date Prepared:
28 November 2008
Proprietary Name:
Common Name:
Transcranial Magnetic Stimulator
NeuroStar TMS Therapy System2 [K061053]
NeuroStar® TMS Therapy System
Transcranial Magnetic Stimulator for Treatment of Major Depressive Disorder [21 CFR 882.5805, Product Code OBP]
Predicate Device:
Classification Name:
Device Description:
The NeuroStar TMS System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (~200 usec) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. The peak magnetic field strength achieved with each pulse is approximately 1.5 Tesla.
l
1
NEURONETICS
510(k) SUMMARY NEUROSTAR TMS THERAPY® SYSTEM¹
| | The NeuroStar TMS System is a non-invasive tool for the
stimulation of cortical neurons for the treatment of adult patients
with Major Depressive Disorder (MDD) who have failed to receive
satisfactory improvement from prior antidepressant medication. The
NeuroStar TMS System is used for patient treatment by prescription
only under the supervision of a licensed psychiatrist. It can be used
in both inpatient and outpatient settings including psychiatrist's
offices and clinics, psychiatric hospitals, and general
medical/surgical hospitals with psychiatric units. |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The NeuroStar TMS System is an integrated system consisting of a
combination of hardware, software, accessories and consumable
supplies. It includes a Mobile Console which houses the electronics,
mechanically supports the ferromagnetic Treatment Coil and
includes a software controlled graphical user interface, a
ferromagnetic Treatment Coil to deliver TMS Therapy, a Head
Support System for accurate coil positioning, and a single use device
(SenStar® Treatment Link) placed on the face of the coil to reduce
local scalp stimulation, to provide feedback to the operator regarding
contact of the coil with the patient's head, and to verify the applied
field strength. A separate Practice Data Management System
(PDMS) allows and facilitates recording and retrieval of patient and
treatment information and communication of data among multiple
NeuroStar TMS System units. |
| Intended Use | NeuroStar TMS Therapy 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. |
| Technological
Characteristics
and Substantial
Equivalence | The NeuroStar TMS Therapy System with Class 1 laser positioning
aid utilizes a Class 1 laser for positioning and registration of the
patient's head in the Head Support System prior to coil positioning
for Motor Threshold (MT) determination and TMS treatment. The
Class 1 laser positioning aid provides for ease of use during head
positioning and registration as compared to the use of plastic
positioning pointers in the predicate device. The use of the Class 1
laser positioning aid does not substantially change the process of
patient positioning for NeuroStar TMS Therapy and provides
equivalent accuracy in coil placement for MT determination and
TMS treatment as shown by verification and validation testing. |
| | The Class 1 laser positioning aid consists of a laser diode, line
generating lens, printed circuit board and 1.5V AA battery. The |
2
NEURONETICS
510(k) SUMMARY NEUROSTAR TMS THERAPY® SYSTEM?
optical components are cemented in place and mechanically captured with a non-removable bezel. The circuitry regulates the laser diode current based on measured output and incorporates a timing circuit that ensures that the laser diode is turned off after a maximum of 45 seconds. There are no user or service adjustable components; the only required maintenance is replacement of the battery on an annual basis during the required system preventative maintenance visit which is performed by a trained service technician. The only laser radiation that is accessible during use or service is the primary output beam which meets Class 1 requirements.
Laser certification and identification labels and additional Instructions for Use are provided as required for a Class 1 laser.
Based on risk analysis and performance testing, the NeuroStar TMS Therapy System with Class 1 laser positioning aid raises no new questions of safety and efficacy and is substantially equivalent to the predicate device.
The NeuroStar TMS Therapy System with Class 1 laser positioning aid was designed in conformity with design controls. Design verification tests were performed as based on a Failure Modes and Effects Analysis (FMEA). The accuracy of the Class 1 laser positioning aid was verified to meet design specifications (Test Report 80-80095-001). Its utility in treatment coil positioning and equivalence to the predicate device in determination of MT and TMS treatment locations was demonstrated (Test Report 80-80095-000).
The laser is Class 1 according to IEC 60825-1 and complies with FDA Laser Notice No. 50 (issued 24 June 2007). The NeuroStar TMS Therapy System including the laser assembly complies with all applicable sections of UL/CSA/EN60601-1 for electrical safety.
Based on performance testing, the NeuroStar TMS Therapy System with Class 1 laser positioning aid is as safe, as effective, and performs as well as the predicate device with enhanced ease of use in patient positioning.
0031
The NeuroStar TMS Therapy and SenStar® are registered trademarks of Neuronetics, Inc.
2 Any statement made in conjunction with this submission regarding substantial equivalence to any relates to whether the product can be lawfully market without premarket approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation [42 Fed. Reg. 42,520 et seq. (1977].
Performance Testing
3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, intertwined with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three intertwined snakes and a staff. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neuronetics, Inc. % Judy P. Ways, Ph.D. Vice President Regulatory Affairs and Quality Assurance One Great Valley Parkway, Suite 2 Malvern, Pennsylvania 19355
Re: K083538
Trade/Device Name: NeuroStar TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulator for treatment of major depressive disorder Regulatory Class: II Product Code: OBP Dated: November 28, 2008 Received: November 28, 2008
DEC 1 6 2008
Dear Dr. Ways:
We have reviewed your Section 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 reclassified 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. 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 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 CFR Part 807); labeling (21 CFR Part 801); 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 1000-1050.
4
Page 2 - Judy P. Ways, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800).638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): __
Device Name: NeuroStar TMS Therapy System
Indications for Use:
The NeuroStar TMS Therapy System 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
S. Number.