(266 days)
No
The summary describes a transcranial magnetic stimulation device and its components, but there is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies rely on real-world data analysis and literature review, not on the training or testing of an AI/ML model.
Yes
The device is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD), which is a medical condition, making it a therapeutic device.
No
The NeuroStar Advanced Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD). It functions by delivering magnetic fields to induce electrical currents in the brain, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states that the NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, and lists several hardware components.
Based on the provided information, the NeuroStar Advanced Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder (MDD) in adolescent patients. This is a therapeutic use, not a diagnostic one.
- Device Description: The device description clearly states it is a transcranial magnetic stimulation device that delivers magnetic fields to induce electrical currents in the brain. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) which are characteristic of IVD devices.
Therefore, the NeuroStar Advanced Therapy System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).
Product codes
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
- MT Cap
- D-Tect MT Accessory
- TrakStar Data Management
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
Adolescent patients (age 15-21).
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
A large-scale retrospective analysis of real-world data (RWD) derived from the TrakStar registry data of 1,169 per protocol adolescent patients (age 12-21) who received the standard NeuroStar treatment protocol for MDD over a span of 15 years, beginning in 2008. This RWD was collected from patients across 347 TMS centers in the US. These 1,169 patient records were analyzed to determine the difference in measures of depression (PHQ-9 scores) over a pre-post TMS treatment interval of 6 weeks. (TrakStar (2023) Adolescent Study).
Additionally, a systematic literature search was performed to identify all available published research evaluating use of TMS therapy for the intended patient population of adolescents to enable a thorough descriptive evaluation of findings. The systematic literature search was opened to identification of available published literature inclusive of randomized controlled trials, open-label trials, and retrospective studies.
The parameters for the literature search were:
Study Treatment: NeuroStar Therapy per standard protocol (left DLPFC) or rTMS Therapy with a figure 8 coil over the left DLPFC comparable to NeuroStar Therapy.
Patient/Subject Population: Adolescents covering the age range of 12 to 21 years, inclusive, who received treatment for symptoms of depression and/or anxiety.
Outcome Assessments:
- An outcome measure of depression, any scale (mandatory)
- An outcome measure of anxiety, any scale (preferred)
Review Timeline: November 2008 to January 2024
Search Terms: - Device: transcranial magnetic stimulation, TMS, rTMS, NeuroStar, Neuronetics, Figure 8 coil.
- Condition: depression, depressive disorder, MDD, major depressive disorder, depressive episode.
- Population: adolescent, teen, teenager, child, children, childhood, young adult.
- Indication: antidepressant, antidepressant therapy, antidepressant medication, Escitalopram, Lexapro, Fluoxetine, Prozac, selective serotonin reuptake inhibitors, SSRIs.
Search Sources: - PubMed
- Medline
- Embase
- Central
- Google Scholar
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 use as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (15-21).
The clinical performance data was based on a large-scale analysis of real-world data (RWD) of 1,169 patients, as well as a literature review.
Evidence of Safety and Efficacy in the Use of TMS as an Adjunctive Treatment for Adolescent Patients with MDD: Real-World Data
A large-scale retrospective analysis of real-world data (RWD) derived from the TrakStar registry data of 1,169 per protocol adolescent patients (age 12-21) who received the standard NeuroStar treatment protocol for MDD over a span of 15 years, beginning in 2008. This RWD was collected from patients across 347 TMS centers in the US. These 1,169 patient records were analyzed to determine the difference in measures of depression (PHQ-9 scores) over a pre-post TMS treatment interval of 6 weeks. (TrakStar (2023) Adolescent Study).
The primary endpoint was defined as the proportion of the per protocol population that met the Individual Success Criteria. The primary endpoint was met as 77.8% (95% CI: 72.8%, 83.0%) of the primary per protocol analysis population met the Individual Subject Success Criteria, with the lower limit of the 95% confidence interval exceeding the pre-established Overall Study Success Criteria of a minimum 50% by 22.79%. This proportion was found to be statistically significant at 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.
0
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March 22, 2024
Neuronetics, Inc. Robin Fatzinger, RAC Sr. Director, Regulatory & Medical Affairs 3222 Phoenixville Pike Malvern, PA 19355
Re: K231926
Trade/Device Name: NeuroStar Advanced Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: February 23, 2024 Received: February 23, 2024
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 (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.
1
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).
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).
2
Sincerely,
Robert Kang -S
for Pamela Scott, MS 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)
Device Name NeuroStar Advanced Therapy System
Indications for Use (Describe)
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).
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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| 510(k) Number: | K231926 |
|---|---|
| Date Prepared: | 21 March 2024 |
| Applicant: | Neuronetics, Inc. |
| 3222 Phoenixville Pike | |
| Malvern, PA 19355 | |
| Primary Contact: | Robin Fatzinger, RAC |
| AVP, Regulatory and Medical Affairs | |
| Phone: 610-981-4027 | |
| Email: robin.fatzinger@neurostar.com | |
| Secondary Contact: | Cory Anderson |
| Sr. VP, R&D and Clinical | |
| Phone: | |
| 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: | OBP |
| Predicate Devices: | Primary Predicate - NeuroStar Advanced Therapy System: K230029 |
| Reference Predicates - NeuroStar Advanced Therapy System: K083538, | |
| K130233, K133408, K160703, K161519, K201158, K213543, and K222230 |
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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
- MT Cap
- . D-Tect MT Accessory
- TrakStar Data Management
Indications for Use:
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (15-21).
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 (K083538, K133408, K160703, K161519, K201158, K213543, and K222230).
Neuronetics has provided real-world clinical data that provides evidence that when used as an adjunct, NeuroStar Advanced Therapy has the same safety and efficacy profile in the adolescent population (15-21) as in the adult population and therefore the subject device is substantially equivalent to the predicate device that was cleared under K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K222230. 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.
The components of and mechanisms of operation for the subject device are identical to the previously cleared predicate device, NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K222230). The performance characteristics, including the
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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 predicate NeuroStar Advanced Therapy System:
- Principles of operation
- Design for delivery of Transcranial Magnetic Stimulation (TMS)
- Materials
- Stimulation parameters (frequency, train duration, interval, number of trains, number of pulses, and total duration
The proposed changes for the NeuroStar Advanced Therapy System are limited to labeling updates, specifically for the NeuroStar Advanced Therapy System to be used as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (15-21). The proposed change is supported by information submitted in this premarket notification and with the following rationale:
- The subject device is substantially equivalent to the FDA-cleared Primary Predicate Device, NeuroStar Advanced Therapy System, cleared by FDA under K230029. The subject device is also substantially equivalent to the Reference Predicate Devices previously cleared by FDA under K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K222230.
- The subject device changes remain limited to labeling revisions, in support of the adjunct treatment of adolescent patients (15 -21). No other changes are made to the device or product labeling.
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 patient population. Therefore, the NeuroStar TMS Therapy System with the proposed changes to the product labeling is substantially equivalent to the and predicate device.
Non-Clinical Testing:
There have been no changes to the hardware or software of the subject device and therefore no nonclinical testing was required.
Performance Standards:
The NeuroStar Advanced Therapy System has been previously 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". Prior 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.
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Clinical Performance Data:
Clinical performance data was provided to support the safety and effectiveness of the NeuroStar Advanced Therapy System device for use as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (15-21).
The clinical performance data was based on a large-scale analysis of real-world data (RWD) of 1,169 patients, as well as a literature review.
Evidence of Safety and Efficacy in the Use of TMS as an Adjunctive Treatment for Adolescent Patients with MDD: Real-World Data
A large-scale retrospective analysis of real-world data (RWD) derived from the TrakStar registry data of 1,169 per protocol adolescent patients (age 12-21) who received the standard NeuroStar treatment protocol for MDD over a span of 15 years, beginning in 2008. This RWD was collected from patients across 347 TMS centers in the US. These 1,169 patient records were analyzed to determine the difference in measures of depression (PHQ-9 scores) over a pre-post TMS treatment interval of 6 weeks. (TrakStar (2023) Adolescent Study).
An additional 1,006 (45%) adolescent patients in the TrakStar database were not included due to insufficient available data. When compared for average age, gender distribution, type of site at which the patient was treated, and the U.S. geographical location of the sites, there were no statistically significant differences found between the two groups.
Eligible subjects in the TrakStar patient database were selected for analysis according to the following protocol-specified selection criteria.
Inclusion Criteria
- . Primary diagnosis of Major Depressive Disorder (MDD), according to DSM-4/ICD-9 or DSM-5/ICD-19 criteria applicable on the date treatment with NeuroStar Advanced Therapy begins.
- 12 to 21 years of age.
- Male or female.
- Treatment with NeuroStar Advanced Therapy.
- Treatment start-date of November 1, 2008, or later.
- . Treatment end date on or before the date on which the retrospective study sample is extracted from the TrakStar database.
- Per Protocol Subjects: Subject received a course of a minimum of 20 treatments with NeuroStar Advanced Therapy.
- l Intent to Treat (ITT) Subjects: Subject received at least one treatment with NeuroStar Advanced Therapy.
- Treatment with NeuroStar Advanced Therapy to the left dorsolateral prefrontal cortex (DLPFC) only.
- Treatment with NeuroStar Advanced Therapy according to standardized NeuroStar Advanced Therapy treatment protocols of DASH and/or Standard as per the original clinical study that supported FDA clearance of NeuroStar Advanced Therapy to reduce depression in adults suffering from MDD.
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- Each of GAD-7 and PHQ-9 scores available at each of pre-treatment (defined as the closest score available within 7 days prior to administration of the first treatment) and posttreatment (defined as the closest score available within ± 7 days of the date of the last treatment) evaluations for the single NeuroStar Advanced Therapy course.
- . Subjects with moderate or greater depression prior to NeuroStar Advanced Therapy (pretreatment), defined as a score on the Physician Health Questionnaire-9 (PHQ-9) ≥ 10 within 7 days prior to the first treatment.
- Subjects with moderate or greater anxiety symptoms prior to NeuroStar Advanced Therapy . (pre-treatment), defined as a score on the Generalized Anxiety Disorder-7 (GAD-7) ≥ 10 within 7 days prior to the first treatment.
Exclusion Criteria
- Gap in NeuroStar Advanced Therapy treatment due to COVID of > 14 continuous days, where applicable.
- . More than one DLPFC treatment session on the same day.
Patients included in this RWD study had a primary diagnosis of MDD, had received at least 20 treatments with NeuroStar Advanced Therapy to the left dorsolateral prefrontal cortex (DLPFC) and were required to exhibit baseline moderate or greater depression, defined as a score on the Physician Health Questionnaire-9 (PHQ-9) ≥ 10. The mean patient age was 19.2 years (min.12, max. 21), and 60.8% were female.
The primary endpoint was defined as the proportion of the per protocol population that met the Individual Success Criteria. The primary endpoint was met as 77.8% (95% CI: 72.8%, 83.0%) of the primary per protocol analysis population met the Individual Subject Success Criteria, with the lower limit of the 95% confidence interval exceeding the pre-established Overall Study Success Criteria of a minimum 50% by 22.79%. This proportion was found to be statistically significant at pConclusion: HAMD-24 total depression scores decreased significantly for both the active and control treatment groups at week 8 relative to baseline, although the magnitude of the change was greater for the active group relative to control. The finding of a significant decrease for the control group is not surprising; however, given that the subjects in this study were not taking any medication prior to study entry. However, the 4-point difference in depression improvement in favor of the active group clearly demonstrates and supports the enhanced effect of TMS as an adjunct to antidepressant therapy over antidepressant therapy alone. Note there was no sham device to account for a potential device placebo effect. | | | | | | | | | | | | | | | | | | | | | | | | | | | | HAMD-24 -2.01 CI [-2.49, -1.54] |
14
| Study | Study Design and
Treatment | Population | Sample
Size | Outcome
Measure(s) | Study Results | Effect Size
Hedges' g
(between
groups) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------|
| Pan, F. et al.
(2020) | • Prospective, double-
blind RCT.
• Subjects randomized
to escitalopram
oxalate (10mg/d) in
combination with
either active or sham
rTMS.
• Left-sided DLPFC
based on MRI data.
• rTMS treatment for 7
continuous days
• 120 trains of 5 s
duration
• 10 Hz w/ inter-train
intervals of 15 s
• 100% resting MT
• Total 6,000 pulses
per session | • Treatment
naïve MDD
patients with
suicidal
ideation
• Age (yrs)
Active
18.14±3.94
Sham
21.43±6.79
• Gender (M/F)
Active
2/19
Sham
5/16 | 42
Active: 21
Control: 21 | • HAMD-24
• MADRS
• Beck Scale for
Suicide
Ideation (BSI)
• Wisconsin
Card Sorting
Test (WCST)
• Continuous
Performance
Test (CPT)
• Stroop Color-
Word Test
(SCWT) | Mean change in scores on each of the HAMD-24, MADRS, and BSI for each of
the active and sham control study groups from baseline to endpoint (Day 7) is
shown in the table below.
Active TMS +
escitalopram
(n=21) Sham TMS +
escitalopram
(n=21) F p HAMD-24
Baseline mean
scores 38.33±7.93 35.76 ± 8.85 0.992 0.327 Baseline to
Day 7 Change -19.19±8.72 -4.48±6.27 36.682 Adolescents :
• n=42
• Age (yrs):
Mean ± SD: 14.6 ± 2.0
Range: 10-17
- 69% female
Adults :
• n=27
• Age (yrs):
Mean ± SD: 39.3 ± 13.1
Range: 18-59 - 56% male
Older Adults :
• n=48
• Age (yrs):
Mean ± SD: 71.7 ± 7.1
Range: 60-80 - 56% female | 42 | • Hamilton Depression Rating Scale (HAM-D) | Outcome assessments occurred after 2 weeks (mid-treatment) and 4 weeks (end of treatment) relative to baseline for the following, with results shown in the table below:
• HAM-D Treatment Response (TR), defined as ≥ 50% decrease in total score.
• HAM-D Remission Rates (RR), defined as endpoint score Adolescents: n=42 Age (yrs):
Mean ± SD: 15.2 ± 1.6 57% female Adults: n=35 Age (yrs):
Mean ± SD: 44.6 ± 12.6 60% female Older Adults: n=70 Age (yrs):
Mean ± SD: 71.4 ± 6.8 56% female | 42 | HAMD-17 | Primary assessment occurred at 4 weeks post-treatment relative to baseline.
Baseline Week 4 Change HAM-D 14.31 ± 5.60 3.23 ± 1.74 F = 61.470,
p 50% decrease in score: 56%
• HAM-D RR: Endpoint score ≤ 7: 44%
• Mean change in HAM-D from baseline to endpoint: -10.87
(p 50% decrease in score
• Partial response (PR): 25% - 50% decrease in score
• Remission (REM): HAM-D Total score at endpoint 10 days* -26.7±11.2
(p12 weeks* -29.3±14.0
(p1 PPS: 1 to 20 s | Standard Treatment:
1 PPS: 1 to 600 s
1 PPS: 1 to 20 s | No Difference |
| | 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 | |
| Pulses per Treatment
Session | Standard Treatment:
Nominal: 3000
Maximum: 5000 | Standard Treatment:
Nominal: 3000
Maximum: 5000 | No Difference |
| | Subject Device | Primary Predicate Device
NeuroStar Advanced Therapy System
K230029 | Explanation of Differences |
| | NeuroStar Advanced Therapy System
K231926 | Reference Devices
NeuroStar Advanced Therapy System
K083538, K130233, K133408, K160703, K161519,
K201158, K213543, and K222230 | |
| | NeuroBurst Treatment:
Nominal: 600
Maximum: 2000 | NeuroBurst Treatment:
Nominal: 600
Maximum: 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 |
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Image /page/28/Picture/0 description: The image shows a logo with the letters "NS" in a stylized font. The letters are purple and are positioned on top of a star-like shape. The star shape is formed by curved lines that resemble people with their arms raised, creating a sense of community or celebration.
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Image /page/29/Picture/0 description: The image shows a logo with the letters "NS" in purple. The letters are stylized and connected, with the "N" slightly larger than the "S". Above and to the right of the letters, there is a stylized star shape formed by three figures with outstretched arms, also in purple. The overall design is simple and modern.
| Treatment parameters | Treatment parameters | ||||
|---|---|---|---|---|---|
| Magnetic Field Intensity | 120% | Magnetic Field Intensity | 120% | No Difference | |
| Repetition Rate | 10 Hz | Repetition Rate | 10 Hz | No Difference | |
| Train Duration | 4 sec | Train Duration | 4 sec | No Difference | |
| Inter-Train-Interval | 11-26 secs | Inter-Train-Interval | 11-26 secs | No Difference | |
| Energy Delivered and | |||||
| Performance | Number of Trains | 75 | Number of Trains | 75 | No Difference |
| Number of Pulses | 3000 | Number of Pulses | 3000 | No Difference | |
| Treatment Duration | 18.75 min | Treatment Duration | 18.75 min | No Difference | |
| Treatment area of brain to be stimulated: | Treatment area of brain to be stimulated: | No Difference | |||
| Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | No Difference | |||
| Output Stimulation Parameters: | |||||
| Available Stimulation Intensity in terms of Standard | |||||
| Motor Threshold (SMT) units | Output Stimulation Parameters: | ||||
| Available Stimulation Intensity in terms of Standard | |||||
| Motor Threshold (SMT) units | No Difference | ||||
| Range: .22 - 2.08 | Range: .22 - 2.08 | No Difference | |||
| Waveform: Biphasic | Waveform: Biphasic | No Difference |
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Image /page/30/Picture/0 description: The image shows a logo with the letters "NS" in a stylized font. The letters are purple and are positioned on the left side of the logo. To the right of the letters, there is a graphic of three figures with outstretched arms, also in purple. The figures are arranged in a semi-circle above the letters, creating a sense of movement and energy.
| Design | The system consists of:
- Mobile console
- System software with GUI
- Treatment chair
- Head support system
- Coil positioning system
- Same Coil for both MT and treatment
- Coil fixture
- Data management system | The system consists of:
- Mobile console
- System software with GUI
- Treatment chair
- Head support system
- Coil positioning system
- Same Coil for both MT and treatment
- Coil fixture
- Data management system | No Difference |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Coil | Biphasic Figure 8 Coil with Ferromagnetic Core | Biphasic Figure 8 Coil with Ferromagnetic Core | No Difference |
| Cooling | Air cooled.
Used for both MT determination and treatment | Air cooled.
Used for both MT determination and treatment | No Difference |
| Quality & Risk Standards | Company complies with ISO 13485:2016 and ISO
14971 | Company complies with ISO 13485:2016 and ISO
14971 | No Difference |
| Electrical Safety & Electromagnetic
Compatibility | Complies with IEC60601-1 and IEC60601-1-2 | Complies with IEC60601-1 v. 3.1, and IEC60601-1-2 | No Difference |
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Image /page/31/Picture/5 description: The image shows a logo with the letters "NS" in purple. Above the letters are three stylized figures with outstretched arms, also in purple, arranged in a star-like formation. The figures appear to be connected at the hands, creating a sense of unity or collaboration. The logo is simple and clean, with a focus on the letters and the figures.
Conclusion:
The NeuroStar Advanced Therapy System has the same intended use, principles of operation, and technological characteristics as the predicate device. Clinical performance data demonstrates that the subject device is as safe and effective as the predicate device when used for its intended purpose as an adjunct to treat major depressive disorder in adolescents (15-21). Thus, the NeuroStar Advanced Therapy System is substantially equivalent to the predicate device.