(90 days)
Not Found
No
The document describes a transcranial magnetic stimulation device and software for calculating treatment locations based on skull measurements. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the treatment of depressive episodes and for decreasing anxiety symptoms" and "as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)." This directly indicates a therapeutic purpose.
No
The device is indicated for the treatment of depressive episodes and Obsessive-Compulsive Disorder, not for diagnosing these conditions. Its function is to deliver magnetic pulses to induce electrical currents in the brain for therapeutic purposes.
No
The device description explicitly lists multiple hardware components (Mobile Console, Treatment Chair, Ferromagnetic Treatment Coil, etc.) in addition to the System Software. The proposed changes also involve software embedded into the system and single-use measuring accessories, further indicating it is not software-only.
Based on the provided text, the NeuroStar Advanced 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- NeuroStar's Function: The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation (TMS) device. It works by applying magnetic pulses to the brain to induce electrical currents and activate neurons. This is a direct treatment method applied to the patient's body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use is for the treatment of depressive episodes and anxiety symptoms in MDD patients, and as an adjunct for the treatment of OCD. This is a therapeutic use, not a diagnostic use based on analyzing specimens.
- Device Description: The description details the components of a TMS system, including a coil, console, software, and support systems. None of these components are described as being used for the analysis of biological specimens.
Therefore, the NeuroStar Advanced Therapy System falls under the category of 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
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
- SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- MT Cap
- TrakStar™ Patient Data Management System
- D-Tect™ MT Accessory
- Beam F3 Treatment Pack
There are two proposed changes to the NeuroStar Advanced Therapy System that are the subject of this 510(k). The first proposed change introduces the capability to use wireless communication to transfer data between the NeuroStar System software and the TrakStar Patient Data Management System, as an alternative to using an ethernet cable to facilitate this transfer. The second proposed change allows for the alternative use of the Beam F3 treatment location method (herein: "Beam F3 method"), in addition to the current method that utilizes a location 5 cm away from the motor threshold within the dorsolateral prefrontal cortex (DLPFC) reqion of the brain. The Beam F3 method requires measuring different skull dimensions and uses these values to calculate the F3 treatment location, which is also located within the DLPFC. This 510(k) introduces software embedded into the NeuroStar System that performs these calculations as well as single-use measuring accessories. Once the F3 treatment location is determined, the treatment parameters and protocols remain the same as those used in the currently marketed NeuroStar Advanced Therapy System.
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
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 performance testing was performed according to the standards listed above. Additionally, usability testing was completed in accordance with IEC 60601-1-6 and also following FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices." Software was designed, developed, and tested in accordance with relevant FDA quidance documents, IEC 62304, and ISO 14971.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083538, K130233, K133408, K160703, K161519, K201158, K220127, K212289
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
April 4, 2023
Neuronetics Amanda Pentecost, Ph.D. Regulatory Affairs Specialist 3222 Phoenixville Pike Malvern, Pennsylvania 19355
Re: K230029
Trade/Device Name: NeuroStar Advanced Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, QCI Dated: January 4, 2023 Received: January 4, 2023
Dear Dr. 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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding 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 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,
Pamela D. Scott -S
Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine 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
510(k) Number (if known) K230029
Device Name NeuroStar Advanced Therapy System (Version 3.7)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect 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 agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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.
| 510(k) Summary | |||
|---|---|---|---|
| Date Prepared: | April 4, 2023 | ||
| Applicant: | Neuronetics, Inc. | ||
| 3222 Phoenixville Pike | |||
| Malvern, PA 19355 | |||
| Contact Person: | Amanda Pentecost, PhD | ||
| Regulatory Affairs Specialist | |||
| Phone: 610-640-4202, ext. 1132 | |||
| Email: amanda.pentecost@neurostar.com | |||
| Secondary Contact: | Robin Fatzinger | ||
| Sr. Director, Regulatory Affairs | |||
| Phone: 610-640-4202, ext. 1064 | |||
| 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: | 21 CFR 882.5805, 21 CFR 882.5802 | ||
| Product Codes: | OBP, QCI | ||
| Primary Predicate Device: | NeuroStar Advanced Therapy System (K083538, K130233, | ||
| K133408, K160703, K161519, K201158, and K220127) | |||
| (Product Code: OBP) | |||
| Secondary Predicate Device: | NeuroStar Advanced Therapy System (K212289) (Product | ||
| Code: OCI) |
Image /page/3/Picture/5 description: The image shows a logo with the letters "NS" in a bold, sans-serif font, colored in purple. Above the letters, there are three stylized figures that appear to be dancing or reaching upwards, also in purple. The figures are arranged in a semi-circular fashion, suggesting movement and energy. The logo has a clean and modern design, likely representing a company or organization with a focus on people or community.
4
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 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
- SenStar® Connect Treatment Link & SenStar® Treatment Link .
- . Treatment Pack (for use with the SenStar® Connect Treatment Link)
- MT Cap
- TrakStar™ Patient Data Management System .
- . D-Tect™ MT Accessory
- . Beam F3 Treatment Pack
There are two proposed changes to the NeuroStar Advanced Therapy System that are the subject of this 510(k). The first proposed change introduces the capability to use wireless communication to transfer data between the NeuroStar System software and the TrakStar Patient Data Management System, as an alternative to using an ethernet cable to facilitate this transfer. The second proposed change allows for the alternative use of the Beam F3 treatment location method (herein: "Beam F3 method"), in addition to the current method that utilizes a location 5 cm away from the motor threshold within the dorsolateral prefrontal cortex (DLPFC) reqion of the brain. The Beam F3 method requires measuring different skull dimensions and uses these values to calculate the F3 treatment location, which is also located within the DLPFC. This 510(k) introduces software embedded into the NeuroStar System that performs these calculations as well as single-use measuring accessories. Once the F3 treatment location is determined, the treatment parameters and protocols remain the same as those used in the currently marketed NeuroStar Advanced Therapy System.
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 Page 2 of 12
5
Image /page/5/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" written in smaller font below. To the right of the word "NeuroStar" is a stylized star with three people at the top of the star.
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).
Performance Standards:
The NeuroStar Advanced Therapy System has been tested and conforms to the following recognized consensus standards:
- . ISO 10993-1
- . ANSI AAMI ES60601-1 / IEC 60601-1
- IEC 60601-1-2 •
- . IEC 60601-1-6
Non-clinical Testing:
The contents of this 510(k) complies 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." Non-clinical performance testing was performed according to the standards listed above.
Additionally, usability testing was completed in accordance with IEC 60601-1-6 and also following FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices." Software was designed, developed, and tested in accordance with relevant FDA quidance documents, IEC 62304, and ISO 14971.
Clinical Testing:
There is no clinical testing required to support this submission.
Image /page/5/Picture/17 description: The image shows a logo with the letters "NS" in bold, purple font. Above the letters is a stylized graphic of three figures with outstretched arms, also in purple. The figures are arranged in a line, suggesting unity or collaboration. The logo has a clean and modern design.
6
Image /page/6/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 underneath. To the right of the word "NeuroStar" is a stylized star shape with human figures incorporated into the design. The overall design is clean and modern, and the use of purple gives the logo a sense of calm and sophistication.
NeuroStar.com
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 | Ethernet cable | Different
The addition of the
wireless capability is
part of the subject of
this 510(k). |
| 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 | Integrated into Head Support System
Laser-aided coil placement | Integrated into Head Support System
Laser-aided coil placement | No Difference |
| Treatment Schedule | 5 days per week for 6 weeks with taper over 3
weeks (3 sessions first week, 2 sessions second
week and 1 session third week) for total of 36
treatment sessions. | 5 days per week for 6 weeks with taper over 3 weeks
(3 sessions first week, 2 sessions second week and 1
session third week) for total of 36 treatment
sessions. | No Difference |
| Device Components | Mobile Console Ferromagnetic Coil for delivering treatment Head Support System for coil positioning 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 Single-use treatment pack including disposable hygienic barriers and head strap for use with the Beam F3 method for determining treatment location and coil positioning TrakStar System for recording patient data | Mobile Console Ferromagnetic Coil for delivering treatment Head Support System for coil positioning 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 | Different
The addition of the
Beam F3 Treatment
Pack is part of the
subject of this
510(k). |
| %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: | |
| | 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 | Level: 80-120% MT with allowable | No Difference |
| | adjustments | 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 | No Difference |
| | NeuroBurst Treatment: | NeuroBurst Treatment: | |
| | 1 to 10 s | 1 to 10 s | |
| Inter-train Interval Range | Standard Treatment: | Standard Treatment: | No Difference |
| | 1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | 1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | |
| | NeuroBurst Treatment: | NeuroBurst Treatment: | |
| | 1 to 60 s | 1 to 60 s | |
| Pulse per Treatment Session | Standard Treatment: | Standard Treatment: | |
| | Nominal: 3000
Maximum: 5000 | Nominal: 3000
Maximum: 5000 | No Difference |
| | NeuroBurst Treatment: | NeuroBurst Treatment: | |
| | Nominal: 600
Maximum: 2000 | Nominal: 600
Maximum: 2000 | |
| Pulses per Burst (PPB) | NeuroBurst Treatment: | NeuroBurst Treatment: | No Difference |
| | 1 to 5 | 1 to 5 | |
| Interpulse Interval | NeuroBurst Treatment: | NeuroBurst Treatment: | No Difference |
| | 20 to 2000 ms | 20 to 2000 ms | |
| Bursts per Second (BPS) | NeuroBurst Treatment: | NeuroBurst Treatment: | No Difference |
| | 0.1 to 20.0 Hz | 0.1 to 20.0 Hz | |
| | NeuroStar Advanced Therapy System
(Subject Device) | NeuroStar Advanced Therapy System
(Secondary Predicate Device - K212289) | 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 | Ethernet cable | Different
The addition of the
wireless capability is
part of the subject of
this 510(k). |
| 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 | Integrated into Head Support System
Laser-aided coil placement | Integrated into Head Support System
Laser-aided coil placement | No Difference |
| 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 | Mobile Console Ferromagnetic Coil for delivering treatment Head Support System for coil positioning 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 Single-use treatment pack including disposable hygienic barriers and head strap for use with the Beam F3 method for determining treatment location and coil positioning* TrakStar System for recording patient data | Mobile Console Ferromagnetic Coil for delivering treatment Head Support System for coil positioning 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 | Different
The addition of the Beam F3 Treatment Pack is part of the subject of this 510(k) and specific to the MDD indication.
*Note: The Beam F3 Treatment Pack is not intended to be used as part of the OCD treatment protocol. |
| %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
Inter-train Interval: 20 s
Session Duration: As low as 18.3 min
Pulses per Session: 2000
Sessions Per Week: 5 for Weeks 1-5 and 4 for Week 6 | Level: 100% foot motor threshold level
Repetition Rate: 20 PPS
Stimulation Time: 2 s
Inter-train Interval: 20 s
Session Duration: As low as 18.3 min
Pulses per Session: 2000
Sessions Per Week: 5 for Weeks 1-5 and 4 for Week 6 | No Difference |
| Treatment Level Range | 0.22 to 2.08 SMT
Calibrated linear output | 0.22 to 2.08 SMT
Calibrated linear output | No Difference |
| Stimulation Time Pulse Train
Duration Range | 1 PPS: 1 to 600 s
1 PPS: 1 to 20 s | 1 PPS: 1 to 600 s
1 PPS: 1 to 20 s | No Difference |
| Inter-train Interval Range | 1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | 1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | No Difference |
| Pulse per Treatment Session | Nominal: 2000
Maximum: 5000 | Nominal: 2000
Maximum: 5000 | No Difference |
Image /page/6/Picture/6 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 figures connected at the hands, forming the points of the star. The logo appears to represent a company or organization with a focus on people and collaboration.
7
Image /page/7/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and consists of 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 made up of several small circles connected by lines.
t 610 640 4202 / ƒ 610 640 4206
Image /page/7/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized, purple font. Above the letters is a star-like shape formed by three figures with outstretched arms, also in purple. The overall design is simple and modern, suggesting a focus on people and achievement.
8
Image /page/8/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 word "Neuro" in a darker shade of purple than the word "Star". Above the word "Star" is a stylized star shape, also in purple. Below the word "NeuroStar" is the tagline "Advanced Therapy for Mental Health" in a smaller, sans-serif font.
t 610 640 4202 / ƒ 610 640 4206
Image /page/8/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 formed by three figures with outstretched arms, also in purple. A curved, swooping line extends from the bottom right of the "S", adding a dynamic element to the design.
9
t 610 640 4202 / ƒ 610 640 4206
Image /page/9/Picture/4 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and are positioned to the left of a star-like symbol. The star is formed by three curved lines that converge at a central point, with small circles at the ends of the lines, resembling stylized figures. The overall design is simple and modern.
10
Image /page/10/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 tagline "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star shape with human figures incorporated into the design.
t 610 640 4202 / ƒ 610 640 4206
Image /page/10/Picture/5 description: The image shows a logo with the letters "NS" in a stylized font. The letters are purple and are positioned to the left of a star-like shape. The star shape is formed by curved lines that resemble people with outstretched arms, suggesting a sense of community or collaboration. The overall design is simple and modern, with a focus on the letters "NS" as the primary element.
11
Image /page/11/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the company name in a bold, purple font, with the words "Advanced Therapy for Mental Health" in a smaller font underneath. To the right of the name is a stylized star shape, also in purple, with a series of dots and lines extending from it.
NeuroStar.com
Technological Comparison with Primary Predicate (Product Code: QCl):
Page 9 of 12
12
Image /page/12/Picture/0 description: The image shows the logo for NeuroStar. 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, there is a graphic of a star with three people above it.
t 610 640 4202 / ƒ 610 640 4206
Image /page/12/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and are positioned to the left of a star-like symbol. The star symbol is also purple and appears to be formed by abstract human figures with outstretched arms, creating a sense of unity and activity.
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, sans-serif font. To the right of the word "NeuroStar" is a stylized star shape with three figures at the top.
t 610 640 4202 / ƒ 610 640 4206
NeuroStar.com
Image /page/13/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple, and there are three abstract figures above and to the right of the letters. The figures are also purple and appear to be connected, possibly representing people or a group.
Page 11 of 12
14
Image /page/14/Picture/0 description: The image shows the NeuroStar logo. 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 made up of interconnected people.
Conclusion:
The NeuroStar Advanced Therapy System and the primary/secondary predicate devices have the same intended uses and technological characteristics. The use of the optional wireless communication or Beam F3 treatment location features do not raise any different questions regarding safety or effectiveness.
Image /page/14/Picture/6 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 figures connected at the hands, forming the points of the star. The logo appears to represent a community or organization focused on people.