(109 days)
The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® ("Monarch Gen 2") is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
The Monarch Gen 2 eTNS System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:
- . The Monarch® Gen 2 external pulse generator, which controls the electrical stimulation, and
- The Monarch® NS-2 external (cutaneous) electrical patches, which are single-use disposable patches worn on the forehead (Figure 3).
The provided text describes the Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System for treating pediatric Attention Deficit Hyperactivity Disorder (ADHD) and compares it to its predicate device, the first-generation Monarch eTNS System. However, it does not explicitly state acceptance criteria in a table format and does not detail a specific study proving the device meets these criteria in the way requested. Instead, it focuses on demonstrating substantial equivalence to the predicate device through technological comparison and performance data from internal bench tests and external lab testing, along with a reference to the clinical trials that supported the clearance of the first-generation device.
Based on the provided information, here's an attempt to structure the answer, acknowledging the limitations in fully addressing all aspects of the request due to the nature of the text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of "acceptance criteria" and "reported device performance" for the Generation 2.0 Monarch eTNS System in the context of clinical efficacy for ADHD. Instead, it relies on demonstrating substantial equivalence to its predicate device, which had previous regulatory clearance based on clinical trials. The performance data presented for the Generation 2.0 device primarily relate to safety and technical compliance.
| Acceptance Criteria (Inferred from Substantial Equivalence and Testing) | Reported Device Performance (Generation 2.0 Monarch eTNS System) |
|---|---|
| Efficacy for pediatric ADHD (as monotherapy in ages 7-12 not on ADHD meds) | Substantially equivalent to predicate device, which demonstrated statistically significant outcome on primary endpoint in two clinical trials. |
| Maximum output current | 8.0mA (vs. 10.0mA for Gen 1); considered an improvement for user-friendliness and patient safety. |
| Current Increment Control | 0.1 mA (vs. 0.2 mA for Gen 1); considered an improvement for user-friendliness. |
| Electrical Safety | Conforms to IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2:2014 +AMD1:2020; no modifications required. |
| Home Environment Safety | Conforms to IEC 60601-1-11:2015/AMD1:2020; meets safety requirements for uncontrolled home use. |
| Battery Life/Performance | Can perform two therapy sessions per single charge. Cycle life of 300 charge cycles. |
| Nerve and Muscle Stimulator Safety/Performance | Conforms to IEC 60601-2-10:2012+AMD1:2016; met all applicable requirements. |
| Biocompatibility | Gel, foam, and adhesive underwent skin sensitization and histocompatibility studies in animals according to ISO 10993-1. |
| Software and Firmware Testing/Validation | Performed, and device functioned as intended. |
2. Sample size used for the test set and the data provenance
For the Generation 2.0 Monarch eTNS System:
- Test set sample size: Not specified as a clinical test set. The performance data provided are from internal bench tests and external lab testing (e.g., electrical safety, EMC, battery testing, biocompatibility). These tests do not typically involve human subjects or "test sets" in the clinical sense.
- Data provenance: Not specified, but generally from internal company testing and external independent testing laboratories. The document implies these are retrospective for the purpose of demonstrating equivalence, as they are not new clinical trials for the Gen 2 device.
For the first-generation Monarch eTNS System (predicate device) (which the efficacy claims of Gen 2 lean on):
- Test set sample size: Two clinical trials.
- Trial 1: 24 subjects (ages 7-14)
- Trial 2: 62 subjects (ages 8-12)
- Data provenance: Clinical trials. The document does not specify the country of origin, nor whether they were retrospective or prospective, but clinical trials supporting device clearance are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided for either the Generation 2.0 device's testing or the clinical trials of the first-generation predicate device. Clinical trials for ADHD would typically involve assessments by qualified clinicians (e.g., child psychiatrists, developmental pediatricians) using standardized diagnostic and symptom rating scales, but the text does not detail the specific number or qualifications of experts involved in establishing ground truth (e.g., ADHD diagnosis, symptom improvement assessments).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Clinical trials for ADHD often involve multiple raters for symptom scales, with potential for adjudication in cases of disagreement, but the document does not elaborate on these methodologies for the predicate device's studies.
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
An MRMC comparative effectiveness study is not applicable to this device. This type of study usually pertains to diagnostic imaging or AI-assisted diagnostic tools where human readers interpret medical images or data. The Monarch eTNS System is a therapeutic device for ADHD. The document mentions clinical trials showing a "statistically significant outcome on the primary endpoint" for the predicate device, which implies efficacy, but not an MRMC study comparing human performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The Monarch eTNS System is a therapeutic device applied by a caregiver, not an algorithm that performs a task independently or as part of a diagnostic workflow.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the Generation 2.0 Monarch eTNS System:
- The "ground truth" for its performance data is compliance with recognized standards (IEC 60601-x for electrical safety, EMC, home environment, nerve stimulation) and engineering specifications (battery life, output current).
For the first-generation Monarch eTNS System (predicate device):
- The ground truth for effectiveness was based on clinical outcomes data from two trials, demonstrating "statistically significant outcome on the primary endpoint." This would typically involve standardized clinical assessment tools for ADHD symptoms and functional impairment.
8. The sample size for the training set
This information is not provided. This term is usually relevant for machine learning algorithms. For regulatory clearance of a medical device, the focus is on verification and validation studies (like bench testing) and clinical trials (for the predicate device's efficacy), not typically on "training sets" in the AI sense.
9. How the ground truth for the training set was established
As the concept of a "training set" in the AI sense is not applicable here, this information is not provided.
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January 16, 2024
NeuroSigma, Inc. % Blake Wilson Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K233293
Trade/Device Name: Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® Regulation Number: 21 CFR 882.5898 Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Regulation Name: Disorder Regulatory Class: Class II Product Code: QGL Dated: October 17, 2023 Received: October 18, 2023
Dear Blake Wilson:
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.
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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 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 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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Pamela D. Scott -S. The date of the signature is 2024.01.16 18:33:34 -05'00'.
Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known)
Device Name
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
Indications for Use (Describe)
The Generation 2.0 Monarch external Nerve Stimulation (eTNS) System® ("Monarch Gen 2") is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
| 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) SUMMARY
NeuroSigma, Inc.'s
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
NeuroSigma, Inc. 10960 Wilshire Blvd., Suite 1910 Los Angeles, CA 90024
Phone: (310) 479-3100 Facsimile: (310) 479-3114 Contact Person: Colin Kealey, M.D. Date Prepared: September 29, 2023
Name of Device
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
Common or Usual Name: Monarch Gen 2
Classification Name: Transcutaneous Nerve Stimulator For ADHD, Neurology
Regulatory Class: Class II
Product Code: QGL
Predicate Device
DEN180041 - NeuroSigma, Inc., Monarch eTNS System
Intended Use / Indications for Use
The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® ("Monarch Gen 2") is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients aged 7 through 12 years old who are not currently taking prescription ADHD medications. The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
Device Description
The Monarch Gen 2 eTNS System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:
- . The Monarch® Gen 2 external pulse generator, which controls the electrical stimulation, and
- The Monarch® NS-2 external (cutaneous) electrical patches, which are single-use disposable patches worn on the forehead (Figure 3).
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Image /page/4/Figure/0 description: The image shows three different views of the Monarch eTNS System. Image A shows the Monarch Gen 2.0 external pulse generator, which has a screen that reads 3.0 and the words "Press O to Go". Image B shows the Gen 2.0 Monarch eTNS System held in a representative human hand for scale. Image C shows the Monarch NS-2 external electrical patch beside the Gen 2.0 Monarch eTNS System, which has a screen that reads 3.2 and the words "Press O to Start".
Figure 3: NeuroSigma's Monarch eTNS System®
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The Monarch External Pulse Generator
The Monarch Gen 2 pulse generator is housed in a sealed protective case and powered by a rechargeable lithium-ion polymer battery. The Monarch Gen 2 stimulation parameters are shown in Table 1 below, and are nearly identical to the first generation Monarch eTNS System. The only differences in output between the two devices are: i) Gen 2 has a maximum output current of 8.0mA, as opposed to 10.0mA in Gen 1, and ii) Patients can adjust the current in increments of 0.1 mA as opposed to 0.2 mA in Gen 1. The sponsor believes that these changes makes the Gen 2 Monarch a more user-friendly device than the Gen 1, and actually improve patient safety. The parameters reported in Table 1 are fixed, except for amplitude. The current amplitude is controlled by the patient's caregiver. Using the device's digital interface, the careqiver is able to set the current amplitude anywhere between 0 and 8 mA, under the physician's supervision.
The Monarch NS-2 Electrical Patch
The Monarch eTNS patch attaches to the skin of the forehead by both hypoallergenic hydrogel and medical grade foam and allows for bilateral stimulation of both the right and left supraorbital (SO) and supratrochlear (ST) branches of the trigeminal nerve (V1), located above the eyebrows in the forehead. The caretaker places the patch in the midline of the patient's forehead and applies the patch to the forehead directly above the eyebrows.
The gel, foam, and adhesive have undergone skin sensitization and histocompatibility studies in animals according to ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing. The electrical patch is connected to the pulse generator via a lead wire.
Stimulation Parameters
Electrical Stimulation parameters generated by the Monarch eTNS System are summarized in the table below:
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| Parameter | Outcome |
|---|---|
| Waveform | Symmetrical Square Wave |
| Frequency of stimulation | 120 Hz |
| Pulse width | 250 µsec |
| Duration between pulses | 8 msec |
| Maximum stimulus intensity | 8 mA, under patient control |
| Current Increment | 0.1 mA |
| Maximum output voltage | 4.14 V at maximum stimulus intensity |
| Hours of use | 7 - 9 hours, while asleep, as prescribed by treating physician |
| Cycling | 30 sec on : 1 sec ramp down : 30 sec off : 1 sec ramp up |
| Net charge per pulse | 2 microcoulombs per pulse |
| Maximum current density | 1.1 mA/cm² |
| Maximum average power density | 4.5 mW/cm² |
| Maximum average current | 8 mA |
| Anatomical target | Supraorbital (SO) and Supratrochlear (ST) nerves of the V1 division of the Trigeminal Nerve bilaterallyImage: Skull with Supraorbital and Supratrochlear nerves highlighted |
Table 1: Stimulation Parameters and Anatomic Targets for the Monarch eTNS System
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Technological Characteristics
Both the subject device and predicate device function as non-invasive eTENS devices that use electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:
- . The Monarch® Gen 2 external pulse generator, which controls the electrical stimulation, and
- . The Monarch® NS-2 external (cutaneous) electrical patches, which are single-use disposable patches worn on the forehead (Figure 3).
Table 2 provides a comparison between the key functional features of the Monarch® Gen 2 and predicate device.
| Monarch Gen 2(Subject Device) | Monarch eTNS System(DEN180041) | |
|---|---|---|
| Manufacturer | NeuroSigma, Inc. | NeuroSigma, Inc. |
| Regulation Number | N/A - Subject Device | DEN180041 |
| Regulation Description | 21 CFR 882.5898 | 21 CFR 882.5898 |
| Regulatory Class | Class II | Class II |
| Product Code | QGL | QGL |
| Intended Use | Monarch Gen 2 is Transcutaneouselectrical nerve stimulator forAttention Deficit HyperactivityDisorder. | Monarch eTNS System isTranscutaneous electrical nervestimulator for Attention DeficitHyperactivity Disorder. |
| Indications for Use | The Generation 2.0 Monarchexternal Trigeminal NerveStimulation (eTNS) System®("Monarch Gen 2") is indicated fortreatment of pediatric AttentionDeficit Hyperactivity Disorder as amonotherapy in patients ages 7through 12 years old who are notcurrently taking prescription ADHDmedications. The device is used forpatient treatment by prescriptiononly and is intended to be used inthe home under the supervision of acaregiver during periods of sleep. | The Monarch external TrigeminalNerve Stimulation (eTNS) Systemis indicated for treatment ofpediatric Attention DeficitHyperactivity Disorder as amonotherapy in patients ages 7through 12 years old who are notcurrently taking prescription ADHDmedications. The device is usedfor patient treatment byprescription only and is intended tobe used in the home under thesupervision of a caregiver duringperiods of sleep. |
| User Population | Ages 7 through 12 years old who arenot currently taking prescriptionADHD medications. | Ages 7 through 12 years old whoare not currently takingprescription ADHD medications. |
| Physical State | Electrical stimulation unit with leadsand cutaneous electrodes. | Electrical stimulation unit withleads and cutaneous electrodes. |
Table 2: Comparison between subject and predicate devices
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| Monarch Gen 2(Subject Device) | Monarch eTNS System(DEN180041) | |
|---|---|---|
| Technical Method | Applies an electrical current through electrodes on patient's skin. | Applies an electrical current through electrodes on patient's skin. |
| Target Area | Trigeminal nerve | Trigeminal nerve |
| Technological Characteristics | ||
| Waveform | Symmetrical Square Wave | Symmetrical Square Wave |
| Frequency of stimulation | 120 Hz | 120 Hz |
| Pulse width | 250 µsec | 250 µsec |
| Duration between pulses | 8 msec | 8 msec |
| Maximum stimulus intensity | 8 mA, under patient control | 10 mA, under patient control |
| Current Increment | 0.1 mA | 0.2 mA |
| Maximum output voltage | 4.14 V at maximum stimulus intensity | 5.36 V at maximum stimulus intensity |
Performance Data
The Monarch® Gen 2's design elements and performance is similar to that of the predicate device. The subject device presents a few minor upgrades, including a built-in rechargeable battery, amplitude of current controlled in increments of 0.1mA, and the user interface is simplified. The company conducted internal bench tests and external lab testing to verify and validate the battery's safety, software and firmware testing and validation, biocompatibility, and device performance were performed on the Monarch® Gen 2. In all instances, the Monarch® Gen 2 functioned as intended and functions as expected. Conformance to IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-11, IEC 60601-2-10, IEC 62304, and IEC 62133-2 was established.
The testing is summarized below:
Electrical Safety
Electrical safety testing was conducted according to FDA-recognized consensus standard IEC 60601-1.
Electromagnetic Compatibility
Electromagnetic compatibility (EMC) testing was conducted according to FDA-recognized consensus standard IEC 60601-1-2:2014 +AMD1:2020. No modifications to the proposed device were required to pass the test. EMC specifications based on the test results were included in the device labeling.
Home Environment Testing
Electrical safety in the home environment was evaluated according to FDA-recognized consensus standard IEC 60601-1-11:2015/AMD1:2020. Testing under this standard demonstrated that the device meets the safety requirements necessary for use in the uncontrolled home environment (e.g., storage temperature, continuous operating conditions, shock temperature, etc.).
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Bench Testing
Bench testing was conducted to evaluate the performance of the subject device according to applicable consensus standards and device characterization testing:
Battery design analysis: Testing was conducted to analyze the number of therapy sessions per single charge of device performed to determine number of consecutive days the battery/device can perform therapy. The test results showed that the device can perform two therapy sessions before needing to charge the device and the cycle life of the battery is 300 charge cycles.
Nerve and muscle stimulator test: The safety and performance of the Monarch® Gen 2 were evaluated per FDA-recognized consensus standard IEC 60601-2-10:2012+AMD1:2016, Medical electrical equipment - Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. The device met all applicable requirements.
Substantial Equivalence
The Monarch® Gen 2 is as safe and effective as the Monarch eTNS System. The Monarch® Gen 2 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Monarch® Gen 2 and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Monarch® Gen 2 is as safe and effective as Monarch eTNS System. Thus, the Monarch® Gen 2 is substantially equivalent.
Clearance of the first-generation Monarch eTNS System as a monotherapy for pediatric ADHD was largely based on results from two clinical trials. The first was an 8-week open label trial of 24 subjects ages 7 - 14 and the second was a 4-week double-blind randomized controlled trial of 62 subjects ages 8 - 12. In both trials subjects underwent stimulation titration during their first clinic visit to find the intensity when stimulation first became perceptible and when the stimulation became too intense for comfort; the resulting range from this exercise was between 2 – 4 mA (i.e., lowest perceptible was 2 mA and the highest setting upon reaching discomfort was 4 mA). While investigators in these two trials did not collect the exact level of stimulation used by patients on a nightly basis, clinical experience shows that pediatric patients are more sensitive to stimulation than adults and tend to use the device between 2 - 4 mA simply because this is comfortable, Importantly, both of these pediatric ADHD studies achieved a statistically significant outcome on the primary endpoint, thereby supporting the effectiveness of nightly stimulation with eTNS administered at settings well below the maximum intensity of 10 mA. Therefore, based on a combination of factors, including, historical development of the Monarch eTNS system, evidence from the clinical trials used to support clearance of the firstgeneration eTNS system, and neuroimaging and electrophysiology findings, we believe the technological differences raise no new issues of safety or effectiveness.
Conclusions
The Monarch® Gen 2 is has the same intended use and indications for use and substantially similar technological characteristics as its predicate device. The modifications to the device and minor changes to user interface, magnitude increments, and to the rechargeable battery do not raise different questions of safety or effectiveness. Performance data demonstrate that the Monarch® Gen 2 is as safe and effective as the predicate device. Thus, the Monarch® Gen 2 is substantially equivalent to its predicate device.
§ 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
(a)
Identification. A transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be performed:
(i) Electrical performance testing must validate electrical output and duration of stimulation;
(ii) Battery performance testing must be performed; and
(iii) Adhesive integrity testing of the electrodes must be conducted.
(4) The technical parameters of the device including waveform, maximum output current and voltage, pulse duration, frequency, net charge per pulse, maximum current density, maximum average current, and maximum average power density must be fully characterized.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Shelf life testing of the electrodes must be performed to demonstrate continued package integrity and component functionality over the labeled shelf life.
(7) Labeling must include the following:
(i) A contraindication for patients with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator;
(ii) A warning that the device is only for use on clean, intact skin;
(iii) Information on how the device operates and the typical sensations experienced during treatment;
(iv) A detailed summary of the device technical parameters;
(v) A shelf life for the electrodes;
(vi) Instructions for use, including placement of the device on the patient; and
(vii) Cleaning instructions.