(30 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 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
The provided document is a 510(k) summary for the NeuroStar Advanced Therapy System (Version 3.8). This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing clinical study results or acceptance criteria in the comprehensive manner typically found in a clinical study report for an AI/ML device.
However, based on the information provided, we can infer some details relevant to your request, specifically concerning the engineering and human factors testing which serves as the "study" proving the device meets performance criteria, even if not phrased as traditional "acceptance criteria" for an AI/ML algorithm's clinical performance.
Here's an attempt to answer your questions based on the available text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the performance of the new software features, nor does it present device performance in a table with specific metrics. Instead, it states a qualitative conclusion:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Successful recording, saving, and displaying of patient's MT and treatment locations by NeuroSITE and Headrest (equivalent to current Head Support System). | "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." |
| Treatment location equivalence between new components (NeuroSITE/Headrest) and current Head Support System. | "Engineering and Human Factors testing had demonstrated that the treatment location is equivalent whether using the Head Support System or the NeuroSITE" (stated for both MDD and OCD indications). |
| Clinical outcomes will be the same with new components. | "and clinical outcomes will be the same" (stated for both MDD and OCD indications, though this is a prediction based on location equivalence, not a direct clinical outcome measure from this specific submission's testing). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "verification and validation testing" and "Engineering and Human Factors testing." It does not specify the sample size (e.g., number of uses, number of subjects for human factors) used for these tests. It also does not provide details on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full test reports, which are summarized in the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number or qualifications of experts used to establish "ground truth" for the engineering and human factors testing. Given the nature of the change (replacement of physical components for coil positioning), the ground truth for "treatment location equivalence" would likely be based on physical measurements and possibly user observations in human factors studies, rather than expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. This type of process is common in image interpretation studies or clinical trials where subjective assessments are made by multiple readers. For engineering and human factors testing of device mechanics and software functionality, adjudication in this sense is typically not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or mentioned. This submission is for a modification to a Transcranial Magnetic Stimulation (TMS) system, specifically regarding mechanical components and software for coil positioning, not an AI-assisted diagnostic or interpretative device that would typically undergo an MRMC study. The device itself is a treatment device, not primarily an AI-driven interpretive one in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not detail separate standalone algorithm performance. The software change (version 3.8) is explicitly linked to the physical components (NeuroSITE and Headrest) for recording, saving, and displaying patient MT and treatment locations. The testing confirmed the system's ability (software with new hardware) to achieve equivalence, implying an integrated performance evaluation rather than a standalone algorithm assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document doesn't explicitly state the "type of ground truth." However, based on the context of the device modification (coil positioning), the ground truth for "treatment location equivalence" would most likely be established through:
- Engineering measurements: Precise physical measurements of coil placement relative to anatomical landmarks.
- Human factors evaluation: Observation and measurement of user interaction and accuracy in achieving desired coil positions by operators, potentially against a pre-defined target or the performance of the predicate system.
- Absence of new risks: The document emphasizes that the change "does not introduce any new risks" and that "clinical outcomes will be the same," implying that the ground truth for safety and effectiveness is tied to maintaining the established performance of the predicate device.
8. The sample size for the training set
The document does not mention a training set, as this submission is for a hardware and software update to an existing device, not the development or retraining of a new AI/ML algorithm where large training datasets are typically disclosed. The software updates are likely based on engineering design and software development best practices, rather than AI model training.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of AI/ML, this question is not applicable to the information provided. The "ground truth" for the software's functionality would have been established through software requirements, design specifications, and subsequent verification and validation testing against these pre-defined expectations.
Summary of what the document focuses on regarding "proof":
The core of the "proof" in this 510(k) submission, regarding the software and hardware changes, is the demonstration through non-clinical testing (engineering and human factors) that the new components perform equivalently to the existing ones in terms of their intended functions, specifically "recording, saving, and displaying the patient's MT and treatment locations" and achieving "treatment location equivalence." The conclusion is that these changes do not introduce new questions of safety or effectiveness. This is a common approach for minor device modifications where clinical performance has already been established by the predicate device.
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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).
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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
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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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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 PikeMalvern, PA 19355 | |
| Contact Person: | Amanda Pentecost, PhDSr. Requlatory Affairs SpecialistEmail: amanda.pentecost@neurostar.com | |
| Secondary Contact: | Robin Fatzinger, RACSr. Director, Requlatory and Medical AffairsEmail: 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: | 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 PredicateDevice: | 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.
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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.
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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.
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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, 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 | Wireless (Wi-fi) andEthernet cable | No Difference |
| Sterility | No parts of the device, accessories orcomponents are required to be sterilized | No parts of the device, accessories orcomponents are required to be sterilized | No Difference |
| Coil Type | FerromagneticIron coreInternal cooling fan | FerromagneticIron coreInternal cooling fan | No Difference |
| Coil Positioning System | NeuroSITE | Integrated into Head Support SystemLaser-aided coil placement | DifferentThe replacement of theHead Support Systemand laser with theHeadrest and NeuroSITEas part of the NeuroStarAdvanced TherapySystem, version 3.8 isthe subject of this510(k). This technologychange does notintroduce any new risks.Engineering and HumanFactors testing haddemonstrated that thetreatment location isequivalent whetherusing the Head SupportSystem or the NeuroSITEand clinical outcomeswill be the same. |
| Treatment Schedule | 5 days per week for 6 weeks with taper over 3weeks (3 sessions first week, 2 sessions second | 5 days per week for 6 weeks with taper over 3weeks (3 sessions first week, 2 sessions second | No Difference |
| week and 1 session third week) for total of 36treatment sessions. | week and 1 session third week) for total of 36treatment sessions. | Different | |
| Device Components | Mobile ConsoleFerromagnetic Coil for deliveringtreatmentHeadrest and NeuroSITE for patientcomfort and coil positioningPositioning cushions and Head Side Padfor patient positioning and comfort (MDD) MT Cap and OCD MT Cap for coilpositioning* D-Tect™ MT Accessory for MT locationand level determination Multi-use disposable for contact sensingand magnetic field quality control Single-use treatment pack includingdisposable hygienic barriers and coilpositioning head strap for use with thestandard 5 cm method TrakStar System for recording patient data | Mobile ConsoleFerromagnetic Coil for deliveringtreatmentHead Support System for patientcomfort and coil positioningPositioning cushions and Head Side Padfor patient positioning and comfort (MDD) MT Cap and OCD MT Cap for coilpositioning* D-Tect™ MT Accessory for MT locationand level determination Multi-use disposable for contact sensingand magnetic field quality control Single-use treatment pack includingdisposable hygienic barriers and coilpositioning head strap for use with thestandard 5 cm method TrakStar System for recording patient data | The replacement of theHead Support Systemand laser with theHeadrest and NeuroSITEas part of the NeuroStarAdvanced TherapySystem, version 3.8 isthe subject of this510(k).This technology changedoes not introduce anynew risks. Engineeringand Human Factorstesting haddemonstrated that thetreatment location isequivalent whetherusing the Head SupportSystem or the NeuroSITEand clinical outcomeswill be the same.*Note: The OCD MT Cap isnot intended to be used inthe MDD MTdetermination process. |
| %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: | 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 allowableadjustments | Level: 80-120% MT with allowableadjustments | ||
| 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: | No Difference |
| 0.22 to 2.08 SMTCalibrated linear output | 0.22 to 2.08 SMTCalibrated linear output | ||
| NeuroBurst Treatment: | NeuroBurst Treatment: | ||
| 0.22 to 1.9 SMT80-120% MT<5% drop | 0.22 to 1.9 SMT80-120% MT<5% drop | ||
| Standard Treatment: | Standard Treatment: | No Difference | |
| 1 PPS: 1 to 600 s | 1 PPS: 1 to 600 s | ||
| Stimulation Time Pulse TrainDuration Range | > 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: 3000Maximum: 5000 | Standard Treatment:Nominal: 3000Maximum: 5000 | No Difference |
| NeuroBurst Treatment:Nominal: 600Maximum: 2000 | NeuroBurst Treatment:Nominal: 600Maximum: 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 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 thetreatment of adult patients suffering fromObsessive-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, andgeneral medical/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 usestandard materials compliant with ISO 10993-1that are commonly used in consumer productsand medical device applications | No Difference |
| Energy Source | Power console with magnetic coil for deliveryfor magnetic energy | Power console with magnetic coil for deliveryfor magnetic 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 | Wireless (Wi-fi) andEthernet cable | No Difference |
| Sterility | No parts of the device, accessories orcomponents are required to be sterilized | No parts of the device, accessories orcomponents are required to be sterilized | No Difference |
| Coil Type | FerromagneticIron core | FerromagneticIron core | No Difference |
| Internal cooling fan | Internal cooling fan | ||
| Coil Positioning System | NeuroSITE | Integrated into Head Support SystemLaser-aided coil placement | DifferentThe replacement of theHead Support Systemand laser with theHeadrest and NeuroSITEas part of the NeuroStarAdvanced TherapySystem, version 3.8 isthe subject of this510(k).This technology changedoes not introduce anynew risks. Engineeringand Human Factorstesting haddemonstrated that thetreatment location isequivalent whetherusing the Head SupportSystem or the NeuroSITEand clinical outcomeswill be the same |
| Treatment Schedule | Weeks 1-5: 1 treatment session per day for 5daysWeek 6: 1 treatment session per day for 4 daysTotal of 29 treatment sessions | Weeks 1-5: 1 treatment session per day for 5daysWeek 6: 1 treatment session per day for 4 daysTotal of 29 treatment sessions | No Difference |
| DeviceComponents/Accessories | Mobile Console• Ferromagnetic Coil for deliveringtreatment• Headrest and NeuroSITE for patientcomfort and coil positioning• Positioning cushions and Head Side Padfor patient positioning and comfort | Mobile Console• Ferromagnetic Coil for deliveringtreatment• Head Support System for patientcomfort and coil positioning• Positioning cushions and Head Side Padfor patient positioning and comfort | DifferentThe addition of theHeadrest and NeuroSITEas part of the NeuroStarAdvanced TherapySystem, version 3.8 is |
| (MDD) MT Cap and OCD MT Cap for coilpositioning*D-Tect™ MT Accessory for MT locationand level determination*Multi-use disposable for contact sensing•and magnetic field quality controlSingle-use treatment pack including•disposable hygienic barriers and coilpositioning head strap for use with thestandard 5 cm methodTrakStar System for recording patient data | (MDD) MT Cap and OCD MT Cap for coil●positioning*D-Tect™ MT Accessory for MT locationand level determination*Multi-use disposable for contact sensingand magnetic field quality controlSingle-use treatment pack includingdisposable hygienic barriers and coilpositioning head strap for use with thestandard 5 cm methodTrakStar System for recording patient data | the subject of this510(k).This technology changedoes not introduce anynew risks. Engineeringand Human Factorstesting haddemonstrated that thetreatment location isequivalent whetherusing the Head SupportSystem or the NeuroSITEand clinical outcomeswill be the same.*Note: The (MDD) MT Capand D-Tect MT Accessoryare not intended to beused in the OCD MTdetermination process. | |
| %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 | Level: 100% foot motor threshold levelRepetition Rate: 20 PPSStimulation Time: 2 s | Level: 100% foot motor threshold levelRepetition Rate: 20 PPSStimulation 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 |
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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.
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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.
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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'.
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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.
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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.
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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.
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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 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.
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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.
§ 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.