(289 days)
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, for adjunctive treatment of OCD, 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 structure. The system consists of: 1. Mobile console 2. System software with GUI 3. Treatment chair 4. Head support system 5. Coil positioning system 6. Same Coil for both MT and treatment 7. Coil fixture 8. Data management system.
The provided text describes the regulatory clearance for the NeuroStar Advanced Therapy System for the
adjunctive treatment of Obsessive-Compulsive Disorder (OCD). The submission is a 510(k) premarket
notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, the study design focuses on proving equivalence rather than meeting pre-defined acceptance
criteria based on clinical efficacy outcomes or standalone algorithm performance.
Here's the breakdown of information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are
primarily focused on demonstrating that the device's technological characteristics, safety, and
performance are equivalent to a predicate device. There aren't traditional clinical efficacy
acceptance criteria (e.g., a specific percentage improvement in OCD symptoms) as would be seen in a
PMA or a clinical trial designed to establish de novo efficacy.
The "acceptance criteria" are therefore implicit in the comparison to the predicate device and the
adherence to recognized standards.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Magnetic and Electric Field Properties Substantially Equivalent to Predicate Device (MagVenture Cool D-B80 coil) (based on Section 4 of FDA's Class II Special Controls Guidance) | Magnetic Field Distribution: Measurements determined that the magnetic spatial distribution is substantially equivalent to the Cool D-B80 coil. Both coils are figure 8 designs, allowing for deep and broad stimulation of the cortex. Information about linearity of output level, magnetic field strength gradients, output waveform, and magnetic field spatial distribution was provided. Electric Field Distribution: Measurements determined that the linearity of the electric field output and the electric field spatial distributions are substantially equivalent to the Cool D-B80 coil. Overall: Performance testing confirmed equivalence in safety and performance based on electric field distribution, stimulation volume, magnetic field distribution, and magnetic flux, pulse timing. No new safety or effectiveness issues introduced. |
| Safety - Sound Pressure Levels (in accordance with IEC60601 Edition 3.1) | Complies with specified permissible sound pressure levels and permissible thresholds for exposure defined by OSHA. Provides evidence that the system does not pose any risk for potential hearing reduction or loss in either patients or operators. |
| Conformity to Performance Standards (ISO 13485:2016, IEC60601-1, IEC60601-1-2) | Successfully tested and conforms to ISO 13485:2016, IEC60601-1 Ed. 3.1, and IEC60601-1-2:2014. |
| Software Verification and Validation | Performed. Subject device functions as intended and meets the same acceptance as the primary predicate and predicate devices. |
| Non-Clinical Performance Testing for Special Controls (per 21 CFRH 882.5802) | Performed as required. |
| Intended Use and Stimulation Parameters Equivalent to Primary Predicate Device (MagVenture TMS Therapy System - K193006) for OCD treatment (specifically regarding intensity, repetition rate, train duration, inter-train-interval, number of trains, pulses, total duration, and treatment area). | The intended use for OCD is identical. The treatment parameters (intensity, repetition rate, train duration, inter-train-interval, number of trains, pulses, total duration, and treatment area - Dorsomedial Prefrontal Cortex) are reported as having "No Difference" compared to the primary predicate. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "This 510(k) does not contain any pivotal clinical trial data related
to the new device. The substantial equivalency is established based on similar technological
characteristics." Therefore, there is no clinical "test set" in the traditional sense of patient
data for efficacy. The "test set" here refers to bench testing data comparing the subject device's
physical characteristics to the predicate device. The provenance of this bench testing data is not
specified (e.g., where the tests were physically conducted), but it refers to well-established
scientific methods using standard scientific instrumentation. The specific sample sizes for these
bench tests (e.g., number of coils tested) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of
those experts
Not applicable. There was no clinical "test set" requiring expert ground truth in the context of this
510(k) submission, which relied on bench testing and comparison to a predicate.
4. Adjudication method for the test set
Not applicable, as there was no clinical "test set" or expert review process for patient outcomes.
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
Not applicable. This device is a Transcranial Magnetic Stimulation (TMS) system, not an AI or imaging
diagnostic device, and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for treatment, not an algorithm. The "device performance"
reported relates to its physical and functional characteristics (e.g., magnetic field, sound levels)
and adherence to safety standards, not an algorithm's standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" was established by measurements using well-established
scientific methods and standard scientific instrumentation, as referenced in Section 4 of the FDA's
Class II Special Controls Guidance document for rTMS systems. This involves physical measurements of
magnetic and electric fields.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML algorithm that undergoes
machine-learning training. The device's design and parameters are established through engineering and
medical principles, not statistical learning from data.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 6, 2022
Neuronetics, Inc Robin Fatzinger Sr. Director, Regulatory Affairs 3222 Phoenixville Pike Malvern, Pennsylvania 19355
Re: K212289
Trade/Device Name: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health Regulation Number: 21 CFR 882.5802 Regulation Name: Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions Regulatory Class: Class II Product Code: QCI Dated: April 6, 2022 Received: April 7, 2022
Dear Robin Fatzinger:
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.
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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 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 medical devices and radiation-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 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K212289
Device Name NeuroStar Advanced Therapy System
Indications for Use (Describe)
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 a logo with the letters "NS" in a bold, purple font. Above the letters, there is a stylized star shape formed by four figures with outstretched arms, also in purple. The figures are arranged around a central point, creating a sense of unity and movement. The overall design is simple yet eye-catching, with the purple color adding a touch of sophistication.
| 510(k) Number: | K212289 |
|---|---|
| Date Prepared: | 06 May 2022 |
| Applicant: | Neuronetics, Inc.3222 Phoenixville PikeMalvern, PA 19355 |
| Primary Contact: | Robin Fatzinger, RACSr. Director, Regulatory AffairsPhone: 610-981-4027Email: robin.fatzinger@neurostar.com |
| Secondary Contact: | Cory AndersonVP, R&D and ClinicalPhone: 610-981-4104Email: cory.anderson@neurostar.com |
| Device Trade Names: | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced TherapySystem, NeuroStar Advanced Therapy for Mental Health |
| Device Common Name: | Transcranial Magnetic Stimulation System for Neurological andPsychiatric Disorders and Conditions |
| Classification: | 21 CFR 882.5802 |
| Product Code: | QCI |
| Predicate Devices: | Primary Predicate: MagVenture TMS Therapy System – for adjunctivetreatment of OCD (K193006)Predicate: NeuroStar Advanced Therapy System (K201158, K161519,K160703, K133408, K130233, K083538, DEN060153/K061053) |
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Image /page/4/Picture/1 description: The image shows a logo with the letters "NS" in a bold, purple font. To the right of the letters, there is a stylized star shape formed by three abstract figures with raised arms. The figures are also purple and appear to be connected at the center, creating the star-like design. The overall design is simple and modern.
Device Description / Technological Characteristics:
The NeuroStar Advanced Therapy System, for adjunctive treatment of OCD, 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. NeuroStar Advanced Therapy System is indicated as an adjunct for the treatment of adult patients who are suffering from Obsessive-Compulsive Disorder (OCD). NeuroStar Advanced Therapy System has previously obtained FDA clearance for treatment of major depressive disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode (K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053).
The subject device is substantially equivalent to the primary predicate device that was cleared under K193006. Neuronetics has implemented minor labeling enhancements to the software user interface and IFU to implement the OCD workflow. While the stimulation parameters have changed for OCD treatment, no changes alter the technical specifications of the subject device.
Consistent with the primary predicate and predicate devices, the proposed NeuroStar Advanced Therapy System, for adjunctive treatment of OCD, enables direct non-invasive activation of brain structures. 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 structure.
Intended 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 intended use is identical to that of the Primary Predicate Device.
Technological Characteristics and Substantial Equivalence:
The subject device, NeuroStar Advanced Therapy System, has the following similarities to the primary predicate (MagVenture TMS Therapy System - K193006) and predicate (NeuroStar Advanced Therapy System - K201158, K161519, K160703, K133408, K130233, K083538, DEN060153/K061053) devices:
- Principles of operation
- Design for delivery of Transcranial Magnetic Stimulation (TMS)
- o Output stimulation parameters (pulse width, frequency range, pulse interval range, etc.)
- Materials
The proposed changes for the NeuroStar Advanced Therapy System, for adjunctive treatment of OCD, are limited to updates to the IFU and software for user interface and treatment stimulation parameters to facilitate safe and effective treatment of patients with OCD. The proposed changes are supported by information submitted in this premarket notification and with the following rationale:
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Image /page/5/Picture/1 description: The image shows a logo with the letters "NS" in a bold, sans-serif font, colored in purple. To the right of the letters, there is a stylized graphic that resembles a star or a stylized human figure with outstretched arms. The graphic is also purple and adds a dynamic element to the logo.
- The subject device is substantially equivalent to the FDA-cleared MagVenture TMS Therapy . System (K193006).
- . The predicate device, NeuroStar Advanced Therapy System, was previously cleared by the FDA under K201158, K161519, K160703, K133408, K130233, K083538, and DEN060153/K061053.
The subject device changes are limited to updates to the IFU and software for user interface and treatment stimulation parameters to facilitate safe and effective treatment of patients with OCD. Therefore, the NeuroStar TMS Therapy System with the proposed changes to the treatment stimulation parameters and labeling is substantially equivalent to the predicate device.
The NeuroStar Advanced Therapy System, for adjunctive treatment of OCD, consists of components that are similar to those of the primary predicate device, with the exception of the treatment coil construction characteristics. The NeuroStar Advanced Therapy System coil is equivalent to the primary predicate device in terms of biocompatibility, design elements, such as cable lengths, coil materials, isolation design and functionalities, however, differs in cooling methods and coil winding configuration / surface area. All coils are subject to high-voltage tests and leakage current tests to ensure safety.
To establish substantial equivalency for the NeuroStar Advanced Therapy System coil, both modeling and performance testing was conducted. Measurements of the magnetic and electric fields of the MagVenture Cool D-B80 coil and NeuroStar coil were taken according to Section 4 of the FDA's Class II Special Controls Guidance document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems.
Measurements of the magnetic field distribution for the Cool D-B80 coil and the NeuroStar Advanced Therapy System coil were performed and determined that the magnetic spatial distribution is substantially equivalent. Both the NeuroStar and MagVenture coils are figure 8 designs, both allowing for deep and broad stimulation of the cortex. Information about magnetic field characteristics, including linearity of output level, magnetic field strength gradients, output waveform and magnetic field spatial distribution according to the Special Controls Guidance document, Section 4 as mentioned above were provided. The coil measurements are based on well-established scientific methods using standard scientific instrumentation.
Measurements of the electric field distribution for the Cool D-B80 coil and the NeuroStar Advanced Therapy System coil were performed and determined that the linearity of the electric field output and the electric field spatial distributions are substantially equivalent. The coil measurements are based on well-established scientific methods using standard scientific instrumentation.
Secondly, performance testing comparing the subject and primary predicate device was conducted to evaluate the equivalence in safety and performance based upon electric field distribution, stimulation volume, magnetic field distribution, and magnetic flux, pulse timing as required in the FDA Special Controls Guidance Document. Results of the testing demonstrate substantial equivalence and confirm that no new safety or effectiveness issues are introduced.
Based on the measurements summarized above, it is therefore concluded, that the magnetic field and electric field properties of the NeuroStar coil are substantially equivalent to the primary predicate device, Cool D-B80.
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Image /page/6/Picture/1 description: The image shows a logo with the letters "NS" in a stylized font, colored in purple. Behind the letters, there is a star-like shape formed by abstract figures that resemble people with outstretched arms. The figures are also purple, and they create a sense of movement and energy around the letters.
Additionally, the subject device has been tested in accordance with IEC60601 Edition 3.1 and verified to comply with the specified permissible sound pressure levels and permissible thresholds for exposure defined by the Occupational Safety and Health Administration (OSHA).
These tests provide evidence that the NeuroStar Advanced Therapy system does not pose any risk for potential hearing reduction or loss in either patients or operators.
Performance Standards:
The NeuroStar Advanced Therapy System, for adjunctive treatment of OCD, has been tested and conforms with the following standards:
- . ISO 13485:2016
- IEC60601-1 .
- . IEC60601-1-2
The following tests were performed to validate the modifications to the device software and indications for use:
- Software verification and validation
- Performance Testing - Bench
In all instances, the subject device functions as intended and meets all the same acceptance as the primary predicate and predicate devices.
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". The non-clinical performance testing of the components of NeuroStar Advanced Therapy System, for treatment of OCD, has been tested as required according to the Special Controls per 21 CFRH 882.5802.
Clinical Testing
This 510(k) does not contain any pivotal clinical trial data related to the new device. The substantial equivalency is established based on similar technological characteristics.
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Image /page/7/Picture/0 description: The image shows a logo with the letters "NS" in a bold, sans-serif font, colored in purple. Above the letters, there is a stylized star shape, also in purple, with rounded points. The star is formed by what appears to be three abstract figures with outstretched arms, suggesting a sense of community or collaboration. The overall design is clean and modern, conveying a sense of unity and purpose.
Comparison of Technological Characteristics
| Subject Device | Predicate Device | Primary Predicate Device | Justification ofDifferences | |
|---|---|---|---|---|
| Specification | NeuroStar Advanced Therapy System(for adjunctive treatment of OCD) | NeuroStar Advanced Therapy system(K201158, K161519, K160703,K133408, K130233, K083538,DEN060153/K061053) | MagVenture TMS TherapySystem (K193006)Tonica Elektronik A/S, Denmark | |
| Indicationsfor use | The NeuroStar Advanced TherapySystem is intended to be used as anadjunct for the treatment of adultpatients suffering from Obsessive-Compulsive Disorder (OCD) | Not Applicable | The MagVenture TMSTherapy System is intendedto be used as an adjunct forthe treatment of adultpatients suffering fromObsessive- CompulsiveDisorder (OCD) | No Difference |
| EnergyDeliveredandPerformance | Treatment parameters:Intensity:of Leg MT (Leg MotorThreshold) | Not Applicable | Treatment parameters:Intensity:of Leg MT(Leg Motor | No Difference |
| 100% | 100% | |||
| Repetition Rate: | Repetition Rate: | No Difference | ||
| 20 Hz | 20 Hz | |||
| Train Duration: | Train Duration: | No Difference | ||
| 2 sec | 2 sec | |||
| Inter-train-Interval: | Inter-train- | No Difference | ||
| 20 secs | 20 secs | |||
| Number of trains: | Number of | No Difference | ||
| 50 | 50 | |||
| Number of pulses: | Number of | No Difference | ||
| 2000 | 2000 | |||
| Total duration: | Total duration: | No Difference | ||
| 18.3 min | 18.3 min | |||
| Treatment area:Area of brain to be stimulated:Dorsomedial Prefrontal Cortex | Not Applicable | Treatment area:Area of brain to bestimulated: | No Difference | |
| Output Stimulation Parameters:Available Stimulation Intensity in termsof Standard Motor Threshold(SMT) unitsRange: 0.22 - 2.08 SMTWaveform: Biphasic | Output Stimulation Parameters:Available Stimulation Intensity in termsof Standard Motor Threshold (SMT)unitsRange: 0.22 - 2.08 SMTWaveform: Biphasic | Output StimulationParameters: AvailableStimulation Intensity in termsof Standard Motor Threshold(SMT) unitsRange: 0 – 2.6 SMTWaveform: Biphasic | Similar | |
| Design | The system consists of:1. Mobile console2. System software with GUI3. Treatment chair4. Head support system5. Coil positioning system6. Same Coil for both MT and treatment7. Coil fixture8. Data management system | The system consists of:1. Mobile console2. System software with GUI3. Treatment chair4. Head support system5. Coil positioning system6. Same Coil for both MT and treatment7. Coil fixture8. Data management system | The system consists of:1. Mobile console2. System software with GUI3. Treatment chair*4. Head support system*5. Coil positioning system6. Same Coil for both MT andtreatment7. Coil fixture8. Data management system*optional | No Difference |
| Coil | Bent figure 8 coil with ferromagneticcore | Bent figure 8 coil with ferromagneticcore | Figure 8 double-cone coil, AirCore | Both provide effectivestimulation for targetedregion based onperformance testing. |
| Cooling | Air cooled.Used for both MT determinationand treatment | Air cooled.Used for both MT determinationand treatment | Liquid cooledUsed for both MTdetermination and treatment. | Both sufficient for safetywith treatment duty cyclebased on performancetesting. |
| Standards | Company complies with EN ISO13485:2016. | Company complies with EN ISO13485:2016. | Company complies with ISO13485:2016. | No Difference |
| Electricalsafety | Complies with IEC60601-1 Edition 3.1,and IEC60601-1-2:2014. | Complies with IEC60601-1 Edition 3.1,and IEC60601-1-2:2014. | Complies with IEC60601-1 v.3.1, and IEC60601-1-2 | No Difference |
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Image /page/8/Picture/0 description: The image shows a logo with the letters "NS" in a bold, purple font. Behind the letters is a stylized star shape, also in purple. The star is formed by three abstract figures with outstretched arms, suggesting movement or celebration. The overall design is simple yet dynamic, conveying a sense of energy and collaboration.
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Image /page/9/Picture/0 description: The image shows a partial view of a logo or emblem, focusing on the right side. The visible portion includes a stylized, abstract figure in purple, possibly representing a person or a group of people with arms raised or connected. The figure is positioned next to a large, bold letter 'S', also in purple. The overall design suggests a symbol for an organization or brand, potentially related to community, support, or a similar concept.
Conclusion:
The NeuroStar Advanced Therapy System has the same intended use and indications, principles of operation, and similar technological characteristics as the previously cleared primary predicate device. The minor differences noted in the technical characteristics between the coil assemblies do not raise any new or different questions of safety or effectiveness. Performance data demonstrates that the subject device is safe and effective for its intended use. Thus, the NeuroStar Advanced Therapy System, for adjunctive treatment of OCD, is substantially equivalent to the MagVenture TMS Therapy System - for adjunctive treatment of OCD.
§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
(a)
Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic pulse output testing;
(ii) Magnetic and electrical field testing;
(iii) Testing of the safety features built into the device; and
(iv) Testing of the sound levels patients are exposed to during device use.
(5) The physician and patient labeling must include the following:
(i) The risks and benefits associated with use of the device;
(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and
(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.