(90 days)
No
The description focuses on electromechanical components, magnetic stimulation, and data management software, with no mention of AI or ML algorithms for treatment planning, analysis, or delivery.
Yes
The device is indicated for the treatment of Major Depressive Disorder, which is a therapeutic purpose.
No.
The device is indicated for the treatment of Major Depressive Disorder, not for diagnosing it.
No
The device description explicitly states that the NeuroStar TMS Therapy System is an "integrated system consisting of a combination of hardware, software, accessories and consumable supplies." It details various hardware components like a Mobile Console, gantry, Treatment Coil, Head Support System, and SenStar® Treatment Link. While it includes software, it is not a software-only device.
Based on the provided information, the NeuroStar TMS Therapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- NeuroStar TMS Therapy System Function: The NeuroStar TMS Therapy System is a device that treats a condition (Major Depressive Disorder) by applying magnetic stimulation to the cerebral cortex. It does not examine specimens from the human body to provide diagnostic information.
The device description clearly states it's a "computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation." This is a therapeutic device, not a diagnostic one.
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 Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (~200 µsec) 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 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 as described under Intended Use. The NeuroStar TMS System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
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, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers the TMS TherapyTM. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. A singleuse device, the SenStar® Treatment Link, which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment, surface field cancellation to reduce stimulation of the scalp, and acts as a hygiene barrier from patient to patient. The TMS TrakStar (previously known as Practice Data Management System - PDMS) consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.
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
Licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NeuroStar TMS Therapy® System [K061053/K083538]
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
NEUR®NETICS
510(k) Summary NeuroStar® TMS Therapy System
APR 3 0 2013
| 510(k) Owner: | Neuronetics, Inc.
31 General Warren Blvd
Malvern, PA 19355
Phone: 610-640-4202
Fax: 610-640-4206 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Judy P. Ways, Ph.D.
Vice President,
Regulatory Affairs and Quality Assurance
Neuronetics, Inc.
31 General Warren Blvd
Malvern, PA 19355
Phone: 610-981-4107
Fax: 610-640-4206 |
| Date Prepared: | 30 April 2013 |
| Proprietary Name: | NeuroStar® TMS Therapy System |
| Common Name: | Transcranial Magnetic Stimulator |
| Classification Name: | Transcranial Magnetic Stimulator for Treatment of Major
Depressive Disorder [21 CFR 882.5805, Product Code OBP] |
| Predicate Device: | NeuroStar TMS Therapy® System [K061053/K083538] |
| Device Description: | The NeuroStar TMS Therapy System is a computerized,
electromechanical medical device that produces and delivers non-
invasive, magnetic stimulation using brief duration (~200 µsec)
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 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 as described under Intended Use. The NeuroStar TMS
System is used for patient treatment by prescription only under the
supervision of a licensed physician. It can be used in both
inpatient and outpatient settings including physician's offices and
clinics, and hospitals.
The NeuroStar TMS System is an integrated system consisting of
a combination of hardware, software, accessories and consumable |
APR 30 2031 General Warren Boulevard / Malven, PA 19355 / 610-640-4202 / 6 10-640-4206 / www.neuronetics.com
·
1
NEUR®NETICS
supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers the TMS TherapyTM. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. A singleuse device, the SenStar® Treatment Link, which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment, surface field cancellation to reduce stimulation of the scalp, and acts as a hygiene barrier from patient to patient. The TMS TrakStar (previously known as Practice Data Management System - PDMS) consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.
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.
The subject device, NeuroStar TMS System, has the following similarities to the predicate TMS device (NeuroStar TMS Therapy System, K061053/K083538):
- Indications for use ●
- . Principles of operation
- Design for delivery of Transcranial Magnetic . Stimulation (TMS)
- . Materials
- . Shelf life, and packaged using the same materials and processes.
The proposed change, which is the subject of this 510(k), is a labeling change to the prescribing statement to comply with the FDA's Class II Special Controls Guidance for Repetitive Transcranial Magnetic Stimulation (rTMS) Devices (26 July 2011). No other changes are made to the device or labeling. Therefore, the NeuroStar TMS Therapy System with the change proposed in the 510(k) is substantially equivalent to the predicate · device.
"The NeuroStar @ and NeuroStar TMS Therapy® are registered trademarks of Neuronetics, Inc. TMS Therapy™ is a trademark of Neuronetics, Inc.
1-2 31 General Warren Boulevard / Malvem, PA 19355 / t 610-640-4202 / f 610-640-4206 / www.neuronetics.com
Intended Use
Technological Characteristics and Substantial Equivalence
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
April 30,2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Neuronetics. Inc. c/o Judy P. Ways, Ph.D. Vice President, Regulatory Affairs and Quality Assurance 31 General Warren Boulevard Malvern, PA 19355
Re: K130233 NeuroStar TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulator for Treatment of Major Depressive Disorder Regulatory Class: Class II Product Code: OBP Dated: January 29, 2013 Received: January 30, 2013
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. Ilsting 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 labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Judy P. Ways, Ph.D.
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you 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) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to:
http://www.fda.gov/MedicalDevices/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) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K130233
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whanq -S
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K130233
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