(178 days)
No
The summary describes a transcranial magnetic stimulation device and its components, focusing on the physical delivery of magnetic pulses and the clinical studies supporting its effectiveness. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is intended for the treatment of depressive episodes and decreasing anxiety symptoms in patients with Major Depressive Disorder (MDD), which is a direct therapeutic application.
No
The device is indicated for the treatment of depressive episodes and decreasing anxiety symptoms, and thus is a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the NeuroStar Advanced Therapy System is a "computerized, electromechanical medical device" and lists several hardware components required for its operation, including a Mobile Console, Treatment Chair, Head Support System, and TrakStar PC. While it includes "System Software" and "TrakStar Software," it is clearly a system with significant hardware components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of depressive episodes and anxiety symptoms in adult patients with MDD. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a transcranial magnetic stimulation (TMS) system that delivers magnetic pulses to the brain to induce electrical currents. This is a physical intervention applied to the patient's body, not a test performed on a sample taken from the body.
- Mechanism of Action: TMS works by directly stimulating brain tissue. IVDs work by analyzing samples (like blood, urine, or tissue) to detect substances or characteristics that indicate a disease or condition.
- Performance Studies: The performance studies evaluate the device's effectiveness in treating symptoms (measured by changes in scores on scales like HAMD and GAD-7), not its ability to diagnose a condition.
In summary, the NeuroStar Advanced Therapy System is a therapeutic device that treats a condition by directly interacting with the patient's body. IVDs are diagnostic devices that analyze samples from the body to provide information about a patient's health status.
N/A
Intended Use / Indications for Use
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
Product codes (comma separated list FDA assigned to the subject device)
OBP
Device Description
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, which are required for the operation of the system. The basic configuration includes the following components:
- Mobile Console
- System Software
- Treatment Chair
- Head Support System
- TrakStar PC
- TrakStar Software
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left dorsolateral prefrontal cortex
Indicated Patient Age Range
adult patients, Adults 22-70 years, Adults 18-77 years
Intended User / Care Setting
Inpatient and outpatient settings including physician's offices and clinics, hospitals, and general medical/surgical hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance data was provided to support the safety and effectiveness of the NeuroStar Advanced Therapy System device for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD), as described in the Indications for Use statement. The clinical performance data was based on 2 Randomized Controlled Trials (RCTs) (George et al. (2010), O'Reardon et al. (2007)) in a total of 491patients and on supportive data from a total of 874 patients in one open-label study and four observational studies (retrospective medical chart review), including a large-scale analysis of real-world data (RWD).
The 2007 O'Reardon study was designed to evaluate the safety and efficacy of the NeuroStar Advanced Therapy System for the treatment of adult patients with major depressive disorder (MDD) (N=301) who failed to receive benefit from 1 to 4 prior antidepressant medications verified by the ATHF. The 2010 study by George et al. was a company-independent, NIMH-funded trial designed to evaluate the safety and efficacy of TMS in adult patients (N=190) with moderate to severe MDD who failed to receive benefit from 1 to 4 prior antidepressant medications verified by the ATHF (George, et al, 2010). Clinical data from these two randomized sham-controlled trials were originally used to establish the safety and efficacy effectiveness of NeuroStar Advanced Therapy for the treatment of adult patients with MDD (DEN060153/K061053) and as such, patient demographics and depression outcomes are presented in detail in earlier sections.
For the 2007 O'Reardon study and the 2010 George study, the effect sizes were identical, 0.36 (Cohen's d), representing a low effect size for decreasing anxiety symptoms in this patient population when compared to Sham control. These effect sizes compare favorably to the effect size reported in two of the three RCTs (Levkovitz et al. (2015) – 0.34 and Kaster et al. (2018) – 0.36) which formed the basis for clearance of Brainsway Deep TMS™ System (K210201), the primary predicate device, for the indications for use in section referenced above.
In both RCT studies, the effectiveness of NeuroStar Advanced Therapy for the treatment of comorbid anxiety symptoms in adult patients with MDD and comorbid anxiety symptoms was assessed using the Hamilton-D anxiety/somatization factor (HAMD – A/S F) Scale. The HAMD – A/S F Scale is a validated scale comprising six anxiety-specific items from the HAMD-17 or the HAMD-24. In O'Reardon et al. (2007), evaluation of change on the HAMD – A/S F was an a priori defined secondary endpoint. In both trials, the between-group difference in the mean change in HAMD – A/S F scores from baseline to the 6-week endpoint evaluation was statistically significant (p= 10
Sample size: 664
Outcome Measures: GAD-7, PHQ-9
Study Results: Response Rate: >= 6 point decrease in end score relative to baseline (6 weeks): PHQ-9: 58.9%
GAD-7: 65.5%
Remission: PHQ-9: = 50% decrease in end score relative to baseline (6 weeks):
HAMD AS/F: 50%
GAD-7: 41.5%
Clinically Significant Change: HAMD AS/F: final score = 6: 41.5%
Mean Change in Scores from Baseline to Endpoint (6 weeks): HAMD AS/F: -3.53, p
§ 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.
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July 14, 2022
Neuronetics, Inc Robin Fatzinger Director, Regulatory Affairs 3222 Phoenixville Pike Malvern, Pennsylvania 19355
Re: K220127
Trade/Device Name: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: June 11, 2022 Received: June 14, 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.
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
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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 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) K220127
Device Name
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy for Mental Health
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 201 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 201 Subpart G) |
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, also in purple, with curved lines that resemble human figures reaching upwards. The overall design is simple and modern, with a focus on the letters and the star-like symbol.
| 510(k) Number: | K220127 |
|---|---|
| Date Prepared: | 14 July 2022 |
| Applicant: | Neuronetics, Inc. |
| 3222 Phoenixville Pike | |
| Malvern, PA 19355 | |
| Primary Contact: | Robin Fatzinger, RAC |
| Sr. Director, Regulatory Affairs | |
| Phone: 610-981-4027 | |
| Email: robin.fatzinger@neurostar.com | |
| Secondary Contact: | Cory Anderson |
| VP, Clinical Affairs & Product Development | |
| Phone: 610-981-4104 | |
| Email: cory.anderson@neurostar.com | |
| Device Trade Names: | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy |
| System, NeuroStar Advanced Therapy for Mental Health | |
| Device Common Name: | Transcranial Magnetic Stimulator |
| Classification: | 21 CFR 882.5805 |
| Product Code: | ОВР |
| Predicate Devices: | Primary Predicate: Brainsway Deep Transcranial Magnetic Stimulation |
| (K210201) | |
| Predicate: NeuroStar Advanced Therapy System (K201158, K161519, | |
| K160703, K133408, K130233, K083538) |
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Device Description
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, which are required for the operation of the system. The basic configuration includes the following components:
- Mobile Console
- System Software
- Treatment Chair
- Head Support System
- TrakStar PC
- TrakStar Software
Indications for Use:
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
The indications for use for the subject device (NeuroStar Advanced Therapy System) is identical to that of the Primary Predicate Device.
Technological Characteristics and Substantial Equivalence:
NeuroStar TMS Therapy system has previously obtained FDA clearance for treatment of major depressive disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode (K061053, K083538, K130233, K133408, K160703, K161519, K201158).
The subject device is substantially equivalent to the primary predicate device that was cleared under K210201. Neuronetics has implemented minor labeling changes to update the indications for use and clinical summaries. None of these changes alter the technical specifications for the subject device. Consistent with the primary predicate and predicate devices, the NeuroStar Advanced Therapy System enables non-invasive activation of brain regions.
The components of, and mechanisms of operation for, the subject device are identical to the
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previously cleared predicate device, NeuroStar Advanced Therapy System (K061053, K083538, K130233, K133408, K160703, K161519, K201158). The performance characteristics, including the Electrical and Magnetic Field Distribution testing are the same as the previously cleared NeuroStar Advanced Therapy System. The subject device has the following similarities to the primary predicate (Brainsway Deep TMS; K210201) and predicate NeuroStar Advanced Therapy System:
- Principles of operation
- Design for delivery of Transcranial Magnetic Stimulation (TMS)
- Materials
The stimulation parameters (frequency, train duration, interval, number of trains, number of pulses, and total duration of treatment) of the subject device are different from those of the primary predicate. Substantial equivalence between the subject device and the primary predicate device was established based on clinical performance data.
The proposed changes for the NeuroStar Advanced Therapy System are limited to labeling updates, specifically to include the treatment of adult patients with MDD who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode and may exhibit comorbid anxiety symptoms. The proposed changes are supported by information submitted in this premarket notification and with the following rationale:
- The subject device is substantially equivalent to the FDA-cleared Brainsway Deep TMS (K210201).
- The predicate device, NeuroStar Advanced Therapy System, was previously cleared by the FDA under DEN060153/K061053, K083538, K130233 and K133408, K160703, K161519, and K201158.
- . The subject device changes remain limited to labeling revisions, in support of the reference to treatment of adult patients with MDD who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode and may exhibit comorbid anxiety symptoms. No other changes are made to the device or product labeling.
Supportive clinical data has been provided to support the substantial equivalence of the subject NeuroStar Advanced Therapy System in terms of safety and effectiveness for the expanded indications for use. Therefore, the NeuroStar TMS Therapy System with the proposed changes to the product labeling is substantially equivalent to the primary predicate and predicate devices.
Non-Clinical Testing:
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.
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Performance Standards:
The NeuroStar Advanced Therapy System has been tested and conforms with the following standards:
- . ISO 13485:2016
- IEC60601-1
- IEC60601-1-2
Additionally, 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 was conducted as required according to the standards listed above. All system components have been previously cleared by the FDA.
Clinical Performance Data:
Clinical performance data was provided to support the safety and effectiveness of the NeuroStar Advanced Therapy System device for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD), as described in the Indications for Use statement. The clinical performance data was based on 2 Randomized Controlled Trials (RCTs) (George et al. (2010), O'Reardon et al. (2007)) in a total of 491patients and on supportive data from a total of 874 patients in one open-label study and four observational studies (retrospective medical chart review), including a large-scale analysis of real-world data (RWD).
The 2007 O'Reardon study was designed to evaluate the safety and efficacy of the NeuroStar Advanced Therapy System for the treatment of adult patients with major depressive disorder (MDD) (N=301) who failed to receive benefit from 1 to 4 prior antidepressant medications verified by the ATHF. The 2010 study by George et al. was a company-independent, NIMH-funded trial designed to evaluate the safety and efficacy of TMS in adult patients (N=190) with moderate to severe MDD who failed to receive benefit from 1 to 4 prior antidepressant medications verified by the ATHF (George, et al, 2010). Clinical data from these two randomized sham-controlled trials were originally used to establish the safety and efficacy effectiveness of NeuroStar Advanced Therapy for the treatment of adult patients with MDD (DEN060153/K061053) and as such, patient demographics and depression outcomes are presented in detail in earlier sections.
For the 2007 O'Reardon study and the 2010 George study, the effect sizes were identical, 0.36 (Cohen's d), representing a low effect size for decreasing anxiety symptoms in this patient population when compared to Sham control. These effect sizes compare favorably to the effect size reported in two of the three RCTs (Levkovitz et al. (2015) – 0.34 and Kaster et al. (2018) – 0.36) which formed the basis for clearance of Brainsway Deep TMS™ System (K210201), the primary predicate device, for the indications for use in section referenced above.
In both RCT studies, the effectiveness of NeuroStar Advanced Therapy for the treatment of comorbid anxiety symptoms in adult patients with MDD and comorbid anxiety symptoms was assessed using the Hamilton-D anxiety/somatization factor (HAMD – A/S F) Scale. The HAMD – A/S F Scale is a validated scale comprising six anxiety-specific items from the HAMD-17 or the HAMD-24. In O'Reardon et al. (2007), evaluation of change on the HAMD – A/S F was an a priori defined secondary endpoint. In both trials, the
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between-group difference in the mean change in HAMD – A/S F scores from baseline to the 6-week endpoint evaluation was statistically significant (p