(30 days)
Not Found
No
The summary describes a transcranial magnetic stimulation device and its components, focusing on the physical delivery of magnetic pulses and system software for control and data management. There is no mention of AI, ML, or related concepts like training/test sets, image processing for analysis, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for the "treatment of depressive episodes" and "treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)," which are therapeutic applications.
No
The device is indicated for treatment of depressive episodes and decreasing anxiety symptoms, and for the treatment of OCD. It is a therapy system that produces and delivers non-invasive magnetic fields to induce electrical currents. This description clearly defines it as a therapeutic device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (Mobile Console, Treatment Chair, Ferromagnetic Treatment Coil, etc.) in addition to the System Software. It is described as a "computerized, electromechanical medical device."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of Major Depressive Disorder and Obsessive-Compulsive Disorder by applying magnetic stimulation to the brain. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description clearly states it's a transcranial magnetic stimulation device that delivers magnetic fields to induce electrical currents in the brain. This is a physical treatment method.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
Therefore, the NeuroStar Advanced Therapy System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Product codes (comma separated list FDA assigned to the subject device)
OBP, QCI
Device Description
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console .
- . System Software
- . Treatment Chair
- Ferromagnetic Treatment Coil .
- . Head Support System or Headrest
- SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- . MDD MT Cap and OCD MT Cap
- . TrakStar™ Patient Data Management System
- . D-Tect™ MT Accessory
- . NeuroSITE
Proposed Change:
The purpose of this 510(k) submission is to introduce the following new features and accessories of the NeuroStar Advanced Therapy System, version 3.8:
-
- A simplified Headrest will replace the patient comfort-related features of the current Head Support System.
-
- The NeuroSITE coil positioning accessory will replace the coil position measuring functions of the current Head Support System. This accessory will be used to navigate to and record the MT and treatment locations.
-
- The NeuroStar System Software, version 3.8 introduces software allows for recording, saving, and displaying the patient's unique MT and treatment location based on the coil position measurements taken using the NeuroSITE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left dorsolateral prefrontal cortex
Bilateral dorsomedial prefrontal cortex
Indicated Patient Age Range
adult patients
Adult patients (ages 22-70)
Intended User / Care Setting
Not Found
Clinical Setting: Inpatient and outpatient settings, including physician's offices and clinics, hospitals, and general medical/surgical 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)
Non-clinical Testing:
The contents of this 510(k) comply with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff."
A biocompatibility risk assessment was performed in accordance with ISO 10993-1 and the FDA Guidance Documents "Use of International Standard ISO 10993-1 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' and revealed no biocompatibility concerns.
Additionally, usability testing was completed in accordance with FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices," using IEC 62366-1 as a guide. Software was designed, and tested in accordance with relevant FDA quidance documents, IEC 62304 and ISO 14971.
To summarize, the results of verification and validation testing confirmed that the NeuroSITE and Headrest can successfully be used with the NeuroStar System software to record, save, and display the patient's MT and treatment locations in a manner that is equivalent to the current Head Support System.
Clinical Testing:
There is no clinical testing required to support this submission.
Conclusion:
The NeuroStar Advanced Therapy System and the predicate device have the same intended uses and technological characteristics. The use of the NeuroSITE, Headrest, or updated NeuroStar System software that supports these features does not raise any different questions regarding safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NeuroStar Advanced Therapy System: K083538, K130233, K133408, K160703, K161519, K201158, K220127, K230029
NeuroStar Advanced Therapy System: K212289 and K230029
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2023
Neuronetics Amanda Pentecost Sr. Regulatory Affairs Specialist 3222 Phoenixville Pike Malvern, Pennsylvania 19355
Re: K233621
Trade/Device Name: NeuroStar Advanced Therapy System (Version 3.8) Regulation Number: 21 CFR 882.5805, 21 CFR 882.5802 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, QCI Dated: November 10, 2023 Received: November 13, 2023
Dear Amanda Pentecost:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Kang -S
for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
NeuroStar Advanced Therapy System (Version 3.8)
Indications for Use (Describe)
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a bold, sans-serif font, with the words "Advanced Therapy for Mental Health" in a smaller font below. To the right of the word "NeuroStar" is a graphic of a star made up of three people holding hands.
| 510(k) Summary | ||
|---|---|---|
| Date Prepared: | November 10, 2023 | |
| Applicant: | Neuronetics, Inc. | |
| 3222 Phoenixville Pike | ||
| Malvern, PA 19355 | ||
| Contact Person: | Amanda Pentecost, PhD | |
| Sr. Requlatory Affairs Specialist | ||
| Email: amanda.pentecost@neurostar.com | ||
| Secondary Contact: | Robin Fatzinger, RAC | |
| Sr. Director, Requlatory and Medical Affairs | ||
| Email: robin.fatzinger@neurostar.com | ||
| Device Trade Name: | NeuroStar | |
| NeuroStar TMS Therapy System | ||
| NeuroStar Advanced Therapy System | ||
| NeuroStar Advanced Therapy System for Mental Health | ||
| Device Common Name: | Transcranial Magnetic Stimulator | |
| Classifications: | 882.5805, 882.5802 | |
| Product Codes: | OBP, QCI | |
| Primary Predicate Device: | NeuroStar Advanced Therapy System: K083538, K130233, | |
| K133408, K160703, K161519, K201158, K220127, and K230029 | ||
| (Product Code: OBP) | ||
| Secondary Predicate | ||
| Device: | NeuroStar Advanced Therapy System: K212289 and K230029 | |
| (Product Code: QCI) |
Image /page/3/Picture/5 description: The image shows a logo with the letters "NS" in a bold, sans-serif font. The letters are purple. Above the letters is a stylized star shape, also in purple, with four rounded points that resemble people with their arms raised. The overall design is simple and modern.
4
Image /page/4/Picture/1 description: The image shows the logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Above the word "Star" is a star-shaped design with small figures that appear to be people. Below the logo is the text "Advanced Therapy for Mental Health" in a smaller font.
3222 Phoenixville Pike / Malvern, PA 19355
Device Description / Technological Characteristics:
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive maqnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial maqnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console .
- . System Software
- . Treatment Chair
- Ferromagnetic Treatment Coil .
- . Head Support System or Headrest
- SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- . MDD MT Cap and OCD MT Cap
- . TrakStar™ Patient Data Management System
- . D-Tect™ MT Accessory
- . NeuroSITE
Proposed Change:
The purpose of this 510(k) submission is to introduce the following new features and accessories of the NeuroStar Advanced Therapy System, version 3.8:
-
- A simplified Headrest will replace the patient comfort-related features of the current Head Support System.
-
- The NeuroSITE coil positioning accessory will replace the coil position measuring functions of the current Head Support System. This accessory will be used to navigate to and record the MT and treatment locations.
-
- The NeuroStar System Software, version 3.8 introduces software allows for recording, saving, and displaying the patient's unique MT and treatment location based on the coil position measurements taken using the NeuroSITE.
Indications for Use:
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current
Image /page/4/Picture/26 description: The image shows a logo with the letters 'NS' in a stylized font. Above the letters, there are three abstract figures that resemble people with their arms raised, forming a star-like shape. The color of the logo and figures is a shade of purple. The logo appears to represent a group or organization, possibly related to sports or community involvement.
5
Image /page/5/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a stylized font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star shape with small figures at the points.
episode.
The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Performance Standards:
The NeuroStar Advanced Therapy System and accessories have been tested and conform to the following recognized consensus standard:
- · ISO 10993-1
Non-clinical Testing:
The contents of this 510(k) comply with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff."
A biocompatibility risk assessment was performed in accordance with ISO 10993-1 and the FDA Guidance Documents "Use of International Standard ISO 10993-1 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' and revealed no biocompatibility concerns.
Additionally, usability testing was completed in accordance with FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices," using IEC 62366-1 as a guide. Software was designed, and tested in accordance with relevant FDA quidance documents, IEC 62304 and ISO 14971.
To summarize, the results of verification and validation testing confirmed that the NeuroSITE and Headrest can successfully be used with the NeuroStar System software to record, save, and display the patient's MT and treatment locations in a manner that is equivalent to the current Head Support System.
Clinical Testing:
There is no clinical testing required to support this submission.
Conclusion:
The NeuroStar Advanced Therapy System and the predicate device have the same intended uses and technological characteristics. The use of the NeuroSITE, Headrest, or updated NeuroStar System software that supports these features does not raise any different questions regarding safety or effectiveness.
Image /page/5/Picture/18 description: The image shows a logo with the letters 'NS' in a stylized font, colored in purple. Above the letters, there is a star-like shape formed by three figures with raised arms, also in purple. The overall design is simple and modern, suggesting a focus on people or community, possibly related to the organization or brand represented by the logo.
6
Image /page/6/Picture/0 description: The image contains the logo for NeuroStar. The logo is purple and consists of the word "NeuroStar" in a stylized font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star shape.
Technological Comparison with Primary Predicate (Product Code: OBP)
| | NeuroStar Advanced Therapy System
(Subject Device) | NeuroStar Advanced Therapy System
(Primary Predicate Device - K083538, K130233,
K133408, K160703, K161519, K201158, and
K220127) | Explanation of
Differences |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The NeuroStar Advanced Therapy System is
indicated for the treatment of depressive
episodes and for decreasing anxiety symptoms
for those who may exhibit comorbid anxiety
symptoms in adult patients suffering from
Major Depressive Disorder (MDD) and who
failed to achieve satisfactory improvement
from previous antidepressant medication
treatment in the current episode. | The NeuroStar Advanced Therapy System is
indicated for the treatment of depressive episodes
and for decreasing anxiety symptoms for those who
may exhibit comorbid anxiety symptoms in adult
patients suffering from Major Depressive Disorder
(MDD) and who failed to achieve satisfactory
improvement from previous antidepressant
medication treatment in the current episode. | No Difference |
| Intended Use | Major Depressive Disorder (MDD) and
comorbid anxiety symptoms | Major Depressive Disorder (MDD) and comorbid
anxiety symptoms | No Difference |
| Anatomical Sites | Left dorsolateral prefrontal cortex | Left dorsolateral prefrontal cortex | No Difference |
| Target Population | Adult patients | Adult patients | No Difference |
| Clinical Setting | Inpatient and outpatient settings, including
physician's offices and clinics, hospitals, and
general medical/surgical hospitals | Inpatient and outpatient settings, including
physician's offices and clinics, hospitals, and general
medical/surgical hospitals | No Difference |
| Materials | Standard materials commonly used in the
manufacture of electrical medical devices | Standard materials commonly used in the
manufacture of electrical medical devices | No Difference |
| Biocompatibility | Patient-contacting device components use
standard materials compliant with ISO 10993-1
that are commonly used in consumer products
and medical device applications | Patient-contacting device components use standard
materials compliant with ISO 10993-1 that are
commonly used in consumer products and medical
device applications | No Difference |
| Energy Source | Power console with magnetic coil for delivery
for magnetic energy | Power console with magnetic coil for delivery for
magnetic energy | No Difference |
| Electrical Safety & EMC | IEC 60601-1 compliant
IEC 60601-1-2 compliant | IEC 60601-1 compliant
IEC 60601-1-2 compliant | No Difference |
| Communication with
TrakStar | Wireless (Wi-fi) and
Ethernet cable | Wireless (Wi-fi) and
Ethernet cable | No Difference |
| Sterility | No parts of the device, accessories or
components are required to be sterilized | No parts of the device, accessories or
components are required to be sterilized | No Difference |
| Coil Type | Ferromagnetic
Iron core
Internal cooling fan | Ferromagnetic
Iron core
Internal cooling fan | No Difference |
| Coil Positioning System | NeuroSITE | Integrated into Head Support System
Laser-aided coil placement | Different
The replacement of the
Head Support System
and laser with the
Headrest and NeuroSITE
as part of the NeuroStar
Advanced Therapy
System, version 3.8 is
the subject of this
510(k). This technology
change does not
introduce any new risks.
Engineering and Human
Factors testing had
demonstrated that the
treatment location is
equivalent whether
using the Head Support
System or the NeuroSITE
and clinical outcomes
will be the same. |
| Treatment Schedule | 5 days per week for 6 weeks with taper over 3
weeks (3 sessions first week, 2 sessions second | 5 days per week for 6 weeks with taper over 3
weeks (3 sessions first week, 2 sessions second | No Difference |
| | week and 1 session third week) for total of 36
treatment sessions. | week and 1 session third week) for total of 36
treatment sessions. | Different |
| Device Components | Mobile Console
Ferromagnetic Coil for delivering
treatment
Headrest and NeuroSITE for patient
comfort and coil positioning
Positioning cushions and Head Side Pad
for patient positioning and comfort (MDD) MT Cap and OCD MT Cap for coil
positioning* D-Tect™ MT Accessory for MT location
and level determination Multi-use disposable for contact sensing
and magnetic field quality control Single-use treatment pack including
disposable hygienic barriers and coil
positioning head strap for use with the
standard 5 cm method TrakStar System for recording patient data | Mobile Console
Ferromagnetic Coil for delivering
treatment
Head Support System for patient
comfort and coil positioning
Positioning cushions and Head Side Pad
for patient positioning and comfort (MDD) MT Cap and OCD MT Cap for coil
positioning* D-Tect™ MT Accessory for MT location
and level determination Multi-use disposable for contact sensing
and magnetic field quality control Single-use treatment pack including
disposable hygienic barriers and coil
positioning head strap for use with the
standard 5 cm method TrakStar System for recording patient data | The replacement of the
Head Support System
and laser with the
Headrest and NeuroSITE
as part of the NeuroStar
Advanced Therapy
System, version 3.8 is
the subject of this
510(k).
This technology change
does not introduce any
new risks. Engineering
and Human Factors
testing had
demonstrated that the
treatment location is
equivalent whether
using the Head Support
System or the NeuroSITE
and clinical outcomes
will be the same.
*Note: The OCD MT Cap is
not intended to be used in
the MDD MT
determination process. |
| %MT Range | 25% to 140% MT | 25% to 140% MT | No Difference |
| Pulses per Second (PPS)
Range | For treatment: 1 to 30 PPS
For MT determination: 0.1-0.3 PPS | For treatment: 1 to 30 PPS
For MT determination: 0.1-0.3 PPS | No Difference |
| Induced Electrical field at 2
cm at 1.0 SMT | 135 V/m (Nominal) | 135 V/m (Nominal) | No Difference |
| Pulse Type | Biphasic Sinusoid | Biphasic Sinusoid | No Difference |
| Pulse Width | 185 µS (Nominal) | 185 µS (Nominal) | No Difference |
| Treatment Protocols | Standard Treatment: | Standard Treatment: | No Difference |
| | Level: 120% MT with allowable adjustments | Level: 120% MT with allowable adjustments | |
| | Repetition Rate: 10 PPS | Repetition Rate: 10 PPS | |
| | Stimulation Time: 4 s | Stimulation Time: 4 s | |
| | Inter-train Interval: As low as 11 s | Inter-train Interval: As low as 11 s | |
| | Session Duration: As low as 18.75 min | Session Duration: As low as 18.75 min | |
| | Pulses per Session: 3000 | Pulses per Session: 3000 | |
| | Sessions per Week: 5 (Acute phase) | Sessions per Week: 5 (Acute phase) | |
| | NeuroBurst Treatment: | NeuroBurst Treatment: | |
| | Level: 80-120% MT with allowable
adjustments | Level: 80-120% MT with allowable
adjustments | |
| | Stimulation Time: 2 s | Stimulation Time: 2 s | |
| | Inter-train Interval: 8 s | Inter-train Interval: 8 s | |
| | Pulses per Burst: 3 | Pulses per Burst: 3 | |
| | Interpulse Interval: 20 ms | Interpulse Interval: 20 ms | |
| | Session Duration: 3.3 min | Session Duration: 3.3 min | |
| | Pulses per Session: 600 | Pulses per Session: 600 | |
| | Bursts per Second: 5 | Bursts per Second: 5 | |
| | Amplitude: 0.22-2.08 SMT ( 1 PPS: 1 to 20 s | > 1 PPS: 1 to 20 s | |
| | NeuroBurst Treatment:
1 to 10 s | NeuroBurst Treatment:
1 to 10 s | |
| Inter-train Interval Range | Standard Treatment:
1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | Standard Treatment:
1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | No Difference |
| | NeuroBurst Treatment:
1 to 60 s | NeuroBurst Treatment:
1 to 60 s | |
| Pulse per Treatment Session | Standard Treatment:
Nominal: 3000
Maximum: 5000 | Standard Treatment:
Nominal: 3000
Maximum: 5000 | No Difference |
| | NeuroBurst Treatment:
Nominal: 600
Maximum: 2000 | NeuroBurst Treatment:
Nominal: 600
Maximum: 2000 | |
| Pulses per Burst (PPB) | NeuroBurst Treatment:
1 to 5 | NeuroBurst Treatment:
1 to 5 | No Difference |
| Interpulse Interval | NeuroBurst Treatment:
20 to 2000 ms | NeuroBurst Treatment:
20 to 2000 ms | No Difference |
| Bursts per Second (BPS) | NeuroBurst Treatment:
0.1 to 20.0 Hz | NeuroBurst Treatment:
0.1 to 20.0 Hz | No Difference |
| | NeuroStar Advanced Therapy System
(Subject Device) | NeuroStar Advanced Therapy System
(Secondary Predicate Device - K212289,
K230029) | Explanation of
Differences |
| Indications for Use | The NeuroStar Advanced Therapy System is
intended to be used as an adjunct for the
treatment of adult patients suffering from
Obsessive-Compulsive Disorder (OCD) | The NeuroStar Advanced Therapy System is
intended to be used as an adjunct for the
treatment of adult patients suffering from
Obsessive-Compulsive Disorder (OCD) | No Difference |
| Intended Use | Obsessive Compulsive Disorder | Obsessive Compulsive Disorder | No Difference |
| Anatomical Sites | Bilateral dorsomedial prefrontal cortex | Bilateral dorsomedial prefrontal cortex | No Difference |
| Target Population | Adult patients (ages 22-70) with Obsessive-
Compulsive Disorder | Adult patients (ages 22-70) with Obsessive-
Compulsive Disorder | No Difference |
| Clinical Setting | Inpatient and outpatient settings including
physician's offices and clinics, hospitals, and
general medical/surgical hospitals. | Inpatient and outpatient settings including
physician's offices and clinics, hospitals, and
general medical/surgical hospitals. | No Difference |
| Materials | Standard materials commonly used in the
manufacture of electrical medical devices | Standard materials commonly used in the
manufacture of electrical medical devices | No Difference |
| Biocompatibility | Patient-contacting device components use
standard materials compliant with ISO 10993-1
that are commonly used in consumer products
and medical device applications | Patient-contacting device components use
standard materials compliant with ISO 10993-1
that are commonly used in consumer products
and medical device applications | No Difference |
| Energy Source | Power console with magnetic coil for delivery
for magnetic energy | Power console with magnetic coil for delivery
for magnetic energy | No Difference |
| Electrical Safety & EMC | IEC 60601-1 compliant
IEC 60601-1-2 compliant | IEC 60601-1 compliant
IEC 60601-1-2 compliant | No Difference |
| Communication with
TrakStar | Wireless (Wi-fi) and
Ethernet cable | Wireless (Wi-fi) and
Ethernet cable | No Difference |
| Sterility | No parts of the device, accessories or
components are required to be sterilized | No parts of the device, accessories or
components are required to be sterilized | No Difference |
| Coil Type | Ferromagnetic
Iron core | Ferromagnetic
Iron core | No Difference |
| | Internal cooling fan | Internal cooling fan | |
| Coil Positioning System | NeuroSITE | Integrated into Head Support System
Laser-aided coil placement | Different
The replacement of the
Head Support System
and laser with the
Headrest and NeuroSITE
as part of the NeuroStar
Advanced Therapy
System, version 3.8 is
the subject of this
510(k).
This technology change
does not introduce any
new risks. Engineering
and Human Factors
testing had
demonstrated that the
treatment location is
equivalent whether
using the Head Support
System or the NeuroSITE
and clinical outcomes
will be the same |
| Treatment Schedule | Weeks 1-5: 1 treatment session per day for 5
days
Week 6: 1 treatment session per day for 4 days
Total of 29 treatment sessions | Weeks 1-5: 1 treatment session per day for 5
days
Week 6: 1 treatment session per day for 4 days
Total of 29 treatment sessions | No Difference |
| Device
Components/Accessories | Mobile Console
• Ferromagnetic Coil for delivering
treatment
• Headrest and NeuroSITE for patient
comfort and coil positioning
• Positioning cushions and Head Side Pad
for patient positioning and comfort | Mobile Console
• Ferromagnetic Coil for delivering
treatment
• Head Support System for patient
comfort and coil positioning
• Positioning cushions and Head Side Pad
for patient positioning and comfort | Different
The addition of the
Headrest and NeuroSITE
as part of the NeuroStar
Advanced Therapy
System, version 3.8 is |
| | (MDD) MT Cap and OCD MT Cap for coil
positioning*
D-Tect™ MT Accessory for MT location
and level determination*
Multi-use disposable for contact sensing
•
and magnetic field quality control
Single-use treatment pack including
•
disposable hygienic barriers and coil
positioning head strap for use with the
standard 5 cm method
TrakStar System for recording patient data | (MDD) MT Cap and OCD MT Cap for coil
●
positioning*
D-Tect™ MT Accessory for MT location
and level determination*
Multi-use disposable for contact sensing
and magnetic field quality control
Single-use treatment pack including
disposable hygienic barriers and coil
positioning head strap for use with the
standard 5 cm method
TrakStar System for recording patient data | the subject of this
510(k).
This technology change
does not introduce any
new risks. Engineering
and Human Factors
testing had
demonstrated that the
treatment location is
equivalent whether
using the Head Support
System or the NeuroSITE
and clinical outcomes
will be the same.
*Note: The (MDD) MT Cap
and D-Tect MT Accessory
are not intended to be
used in the OCD MT
determination process. |
| %MT Range | 25% to 140% MT | 25% to 140% MT | No Difference |
| Pulses per Second (PPS)
Range | For treatment: 1 to 30 PPS
For MT determination: 0.1-0.3 PPS | For treatment: 1 to 30 PPS
For MT determination: 0.1-0.3 PPS | No Difference |
| Induced Electrical field at 2
cm at 1.0 SMT | 135 V/m (Nominal) | 135 V/m (Nominal) | No Difference |
| Pulse Type | Biphasic Sinusoid | Biphasic Sinusoid | No Difference |
| Pulse Width | 185 µS (Nominal) | 185 µS (Nominal) | No Difference |
| Treatment Protocols | Level: 100% foot motor threshold level
Repetition Rate: 20 PPS
Stimulation Time: 2 s | Level: 100% foot motor threshold level
Repetition Rate: 20 PPS
Stimulation Time: 2 s | No Difference |
| | Inter-train Interval: 20 s | Inter-train Interval: 20 s | |
| | Session Duration: As low as 18.3 min | Session Duration: As low as 18.3 min | |
| | Pulses per Session: 2000 | Pulses per Session: 2000 | |
| | Sessions Per Week: 5 for Weeks 1-5 and 4 for | Sessions Per Week: 5 for Weeks 1-5 and 4 for | |
| | Week 6 | Week 6 | |
| Treatment Level Range | 0.22 to 2.08 SMT | 0.22 to 2.08 SMT | No Difference |
| | Calibrated linear output | Calibrated linear output | |
| Stimulation Time Pulse Train | 1 PPS: 1 to 600 s | 1 PPS: 1 to 600 s | |
| | > 1 PPS: 1 to 20 s | > 1 PPS: 1 to 20 s | |
| Inter-train Interval Range | 1 PPS: 0 to 600 s | 1 PPS: 0 to 600 s | No Difference |
| | >1 PPS: 10 to 60 s | >1 PPS: 10 to 60 s | |
| Pulse per Treatment Session | Nominal: 2000 | Nominal: 2000 | No Difference |
| | Maximum: 5000 | Maximum: 5000 | |
7
Image /page/7/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a stylized font, with the words "Advanced Therapy for Mental Health" underneath. To the right of the word "NeuroStar" is a star-shaped design with four figures at each point of the star.
Image /page/7/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and slightly overlapping. Above the letters is a star-like shape formed by four stylized figures with outstretched arms, also in purple. The overall design is simple and modern.
8
Image /page/8/Picture/0 description: The image shows the logo for NeuroStar Advanced Therapy for Mental Health. The logo is purple and features the word "NeuroStar" in a stylized font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star shape.
9
Image /page/9/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a stylized font, with the word "Neuro" in a darker shade of purple than the word "Star". Above the word "Star" is a star-shaped design with three figures at the top. Below the word "NeuroStar" is the tagline "Advanced Therapy for Mental Health" in a smaller font.
Image /page/9/Picture/5 description: The image shows a logo with the letters 'NS' in a bold, purple font. Above the letters, there is a stylized star shape, also in purple, with three small figures connected to the top points of the star. The overall design is simple and modern, likely representing an organization or company with the initials 'NS'.
10
Image /page/10/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the tagline "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star shape.
Image /page/10/Picture/5 description: The image shows a logo with the letters "NS" in a bold, sans-serif font, colored in purple. Above and to the right of the letters is a stylized star shape, also in purple, with abstract figures incorporated into its design. The figures appear to be reaching upwards, adding a sense of dynamism and community to the logo.
11
Image /page/11/Picture/0 description: The image contains the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a bold, sans-serif font, with the words "Advanced Therapy for Mental Health" in a smaller font underneath. Above the word "NeuroStar" is a stylized star shape, which is made up of several interconnected lines and dots. The logo is purple.
Technological Comparison with Secondary Predicate (Product Code: QCl)
Image /page/11/Picture/6 description: The image shows a logo with the letters 'NS' in purple, with a stylized starburst shape behind them. The starburst is also purple and appears to be made up of abstract human figures. The logo is simple and modern, with a focus on the letters 'NS' as the primary element.
12
Image /page/12/Picture/0 description: The image is a logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a stylized font, with the words "Advanced Therapy for Mental Health" written in a smaller font underneath. To the right of the word "NeuroStar" is a star-shaped design with three small circles above it.
Image /page/12/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple, and there is a star-like shape above and to the right of the letters. The star shape is also purple and appears to be made up of several figures with outstretched arms.
13
Image /page/13/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star with three figures at the points of the star.
Image /page/13/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and slightly overlapping. Above the letters is a graphic that resembles a star with three figures connected at the center, also in purple. The overall design is simple and modern.
14
Image /page/14/Picture/0 description: The image shows the logo for NeuroStar. The logo features the word "NeuroStar" in a bold, sans-serif font, with the first letter "N" in uppercase and the rest of the letters in lowercase. Below the word "NeuroStar" is the tagline "Advanced Therapy for Mental Health" in a smaller, sans-serif font. To the right of the word "NeuroStar" is a stylized star shape made up of interconnected human figures.
Image /page/14/Picture/5 description: The image shows a logo with the letters 'NS' in bold, purple font. Above the letters is a stylized star shape, also in purple, with three small circles at the points, resembling people holding hands. The overall design is simple and clean, suggesting a focus on community or connection.