(90 days)
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).
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.
This document does not contain an acceptance criteria table or a detailed study proving the device meets specific performance criteria through clinical testing. Instead, it is a 510(k) premarket notification summary from the FDA, asserting substantial equivalence to previously cleared predicate devices.
The key statement is on page 5: "Clinical Testing: There is no clinical testing required to support this submission."
Therefore, I cannot provide the full response as requested, as the necessary information regarding acceptance criteria, reported performance, test set details, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in the provided document.
The document focuses on demonstrating that the proposed changes (wireless communication and the Beam F3 treatment location method) to the NeuroStar Advanced Therapy System do not raise new questions of safety or effectiveness when compared to its predicate devices. The "Performance Standards" section lists recognized consensus standards (ISO 10993-1, ANSI AAMI ES60601-1 / IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6) and mentions non-clinical performance testing and usability testing were performed according to relevant guidance documents. However, this is related to safety and electrical performance, not clinical efficacy or device performance against specific metrics as would be found in a detailed clinical study report proving accuracy or effectiveness.
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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
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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
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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) |
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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 PikeMalvern, PA 19355 | ||
| Contact Person: | Amanda Pentecost, PhDRegulatory Affairs SpecialistPhone: 610-640-4202, ext. 1132Email: amanda.pentecost@neurostar.com | ||
| Secondary Contact: | Robin FatzingerSr. Director, Regulatory AffairsPhone: 610-640-4202, ext. 1064Email: robin.fatzinger@neurostar.com | ||
| Device Trade Name: | NeuroStarNeuroStar TMS Therapy SystemNeuroStar Advanced Therapy SystemNeuroStar 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) (ProductCode: 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.
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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
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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.
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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, andK220127) | Explanation ofDifferences | |
|---|---|---|---|
| Indications for Use | The NeuroStar Advanced Therapy System isindicated for the treatment of depressiveepisodes and for decreasing anxiety symptomsfor those who may exhibit comorbid anxietysymptoms in adult patients suffering fromMajor Depressive Disorder (MDD) and whofailed to achieve satisfactory improvementfrom previous antidepressant medicationtreatment in the current episode. | The NeuroStar Advanced Therapy System isindicated for the treatment of depressive episodesand for decreasing anxiety symptoms for those whomay exhibit comorbid anxiety symptoms in adultpatients suffering from Major Depressive Disorder(MDD) and who failed to achieve satisfactoryimprovement from previous antidepressantmedication treatment in the current episode. | No Difference |
| Intended Use | Major Depressive Disorder (MDD) andcomorbid anxiety symptoms | Major Depressive Disorder (MDD) and comorbidanxiety 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, includingphysician's offices and clinics, hospitals, andgeneral medical/surgical hospitals | Inpatient and outpatient settings, includingphysician's offices and clinics, hospitals, and generalmedical/surgical hospitals | No Difference |
| Materials | Standard materials commonly used in themanufacture of electrical medical devices | Standard materials commonly used in themanufacture of electrical medical devices | No Difference |
| Biocompatibility | Patient-contacting device components usestandard materials compliant with ISO 10993-1that are commonly used in consumer productsand medical device applications | Patient-contacting device components use standardmaterials compliant with ISO 10993-1 that arecommonly used in consumer products and medicaldevice applications | No Difference |
| Energy Source | Power console with magnetic coil for deliveryfor magnetic energy | Power console with magnetic coil for delivery formagnetic energy | No Difference |
| Electrical Safety & EMC | IEC 60601-1 compliantIEC 60601-1-2 compliant | IEC 60601-1 compliantIEC 60601-1-2 compliant | No Difference |
| Communication withTrakStar | Wireless (Wi-fi) andEthernet cable | Ethernet cable | DifferentThe addition of thewireless capability ispart of the subject ofthis 510(k). |
| Sterility | No parts of the device, accessories orcomponents are required to be sterilized | No parts of the device, accessories or componentsare required to be sterilized | No Difference |
| Coil Type | FerromagneticIron coreInternal cooling fan | FerromagneticIron coreInternal cooling fan | No Difference |
| Coil Positioning System | Integrated into Head Support SystemLaser-aided coil placement | Integrated into Head Support SystemLaser-aided coil placement | No Difference |
| Treatment Schedule | 5 days per week for 6 weeks with taper over 3weeks (3 sessions first week, 2 sessions secondweek and 1 session third week) for total of 36treatment sessions. | 5 days per week for 6 weeks with taper over 3 weeks(3 sessions first week, 2 sessions second week and 1session third week) for total of 36 treatmentsessions. | 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 | DifferentThe addition of theBeam F3 TreatmentPack is part of thesubject of this510(k). |
| %MT Range | 25% to 140% MT | 25% to 140% MT | No Difference |
| Pulses per Second (PPS)Range | For treatment: 1 to 30 PPSFor MT determination: 0.1-0.3 PPS | For treatment: 1 to 30 PPSFor MT determination: 0.1-0.3 PPS | No Difference |
| Induced Electrical field at 2cm 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 (<5% drop) | Amplitude: 0.22-2.08 SMT (<5% drop) | ||
| Treatment Level Range | Standard Treatment: | Standard Treatment: | |
| 0.22 to 2.08 SMT | 0.22 to 2.08 SMT | ||
| Calibrated linear output | Calibrated linear output | ||
| NeuroBurst Treatment: | NeuroBurst Treatment: | No Difference | |
| 0.22 to 1.9 SMT | 0.22 to 1.9 SMT | ||
| 80-120% MT | 80-120% MT | ||
| <5% drop | <5% drop | ||
| Stimulation Time Pulse Train | Standard Treatment: | Standard Treatment: | |
| Duration Range | 1 PPS: 1 to 600 s | 1 PPS: 1 to 600 s | |
| > 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: 3000Maximum: 5000 | Nominal: 3000Maximum: 5000 | No Difference | |
| NeuroBurst Treatment: | NeuroBurst Treatment: | ||
| Nominal: 600Maximum: 2000 | Nominal: 600Maximum: 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 ofDifferences | |
| Indications for Use | The NeuroStar Advanced Therapy System isintended to be used as an adjunct for thetreatment of adult patients suffering fromObsessive-Compulsive Disorder (OCD) | The NeuroStar Advanced Therapy System isintended to be used as an adjunct for the treatmentof 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 includingphysician's offices and clinics, hospitals, andgeneral medical/surgical hospitals. | Inpatient and outpatient settings includingphysician's offices and clinics, hospitals, and generalmedical/surgical hospitals. | No Difference |
| Materials | Standard materials commonly used in themanufacture of electrical medical devices | Standard materials commonly used in themanufacture of electrical medical devices | No Difference |
| Biocompatibility | Patient-contacting device components usestandard materials compliant with ISO 10993-1that are commonly used in consumer productsand medical device applications | Patient-contacting device components use standardmaterials compliant with ISO 10993-1 that arecommonly used in consumer products and medicaldevice applications | No Difference |
| Energy Source | Power console with magnetic coil for deliveryfor magnetic energy | Power console with magnetic coil for delivery formagnetic energy | No Difference |
| Electrical Safety & EMC | IEC 60601-1 compliantIEC 60601-1-2 compliant | IEC 60601-1 compliantIEC 60601-1-2 compliant | No Difference |
| Communication withTrakStar | Wireless (Wi-fi) andEthernet cable | Ethernet cable | DifferentThe addition of thewireless capability ispart of the subject ofthis 510(k). |
| Sterility | No parts of the device, accessories orcomponents are required to be sterilized | No parts of the device, accessories or componentsare required to be sterilized | No Difference |
| Coil Type | FerromagneticIron coreInternal cooling fan | FerromagneticIron coreInternal cooling fan | No Difference |
| Coil Positioning System | Integrated into Head Support SystemLaser-aided coil placement | Integrated into Head Support SystemLaser-aided coil placement | No Difference |
| Treatment Schedule | Weeks 1-5: 1 treatment session per day for 5 daysWeek 6: 1 treatment session per day for 4 daysTotal of 29 treatment sessions | Weeks 1-5: 1 treatment session per day for 5 daysWeek 6: 1 treatment session per day for 4 daysTotal 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 | DifferentThe 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 PPSFor MT determination: 0.1-0.3 PPS | For treatment: 1 to 30 PPSFor 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 levelRepetition Rate: 20 PPSStimulation Time: 2 sInter-train Interval: 20 sSession Duration: As low as 18.3 minPulses per Session: 2000Sessions Per Week: 5 for Weeks 1-5 and 4 for Week 6 | Level: 100% foot motor threshold levelRepetition Rate: 20 PPSStimulation Time: 2 sInter-train Interval: 20 sSession Duration: As low as 18.3 minPulses per Session: 2000Sessions Per Week: 5 for Weeks 1-5 and 4 for Week 6 | No Difference |
| Treatment Level Range | 0.22 to 2.08 SMTCalibrated linear output | 0.22 to 2.08 SMTCalibrated linear output | No Difference |
| Stimulation Time Pulse TrainDuration 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: 2000Maximum: 5000 | Nominal: 2000Maximum: 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.
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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.
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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.
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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.
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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.
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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):
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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.
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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
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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.
§ 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.