SomniCheck

K223676 · Brainmatterz, LLC · GWL · Jun 1, 2023 · Neurology

Device Facts

• Record ID: K223676
• Device Name: SomniCheck
• Applicant: Brainmatterz, LLC
• Product Code: GWL · Neurology
• Decision Date: Jun 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1835
• Device Class: Class 2

Intended Use

SomniCheck is a prescription-use, single use physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems. The device measures the following signals: • EEG (4-channel), • PPG (by Maxim), • Temperature, • 3-axis accelerometer, • Gyroscope (position), and • Audio/ sound for snoring. It is intended for use on adult patients (18 and older) and can be used in a hospital, clinic, or home.

Device Story

SomniCheck is a single-use, forehead-worn adhesive patch for continuous physiological data recording (up to 10 hours). Device amplifies, digitizes, and stores signals including 4-channel EEG, PPG, temperature, 3-axis acceleration, gyroscope-based position, and audio for snoring. Operated by patients in home, clinic, or hospital settings. Data is transferred to external polysomnography systems for analysis by clinicians to aid in sleep disorder or neurophysiology studies. Device uses internal battery and BLE connectivity. Single-use design eliminates cleaning/sterilization requirements. Output facilitates clinical decision-making by providing raw physiological data for professional review.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included System Requirements Verification, EMC (IEC 60601-1-2), electrical safety (IEC 60601-1), usability (IEC 60601-1-6), home healthcare environment requirements (IEC 60601-1-11), battery safety (IEC 60086-4), and sensor bench testing. Software life cycle processes followed IEC 62304.

Technological Characteristics

Single-use forehead-worn adhesive patch. Sensors: 4-channel EEG, PPG (Maxim), temperature, 3-axis accelerometer, gyroscope, microphone. Power: Internal battery. Connectivity: BLE. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60086-4, IEC 62304, ISO 14971, ISO 13485. Software: Firmware for signal acquisition and digitization.

Indications for Use

Indicated for adult patients (18+) for the amplification, digitization, and recording of physiological signals (EEG, PPG, temperature, 3-axis accelerometer, gyroscope, and audio/snoring) for subsequent transfer to polysomnography systems in hospital, clinic, or home settings.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Predicate Devices

• Sandman SD20 Amplifier (K040113)
• NomadAir PMU810 (K220631)

Reference Devices

• Natus Sleepworks (K090277)

Submission Summary (Full Text)

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June 1, 2023

BrainMatterZ, LLC Kevin Wilson Chief Commercialization Officer 19830 Fm 1093 Richmond, Texas 77407

Re: K223676

Trade/Device Name: SomniCheck Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL Dated: March 3, 2023 Received: March 3, 2023

Dear Kevin 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 (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Patrick Antkowiak -S

Patrick Antkowiak Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic 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) K223676

Device Name SomniCheck

Indications for Use (Describe)

SomniCheck is a prescription-use physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems. The device measures the following signals:

- · EEG (4-channel),
- · PPG (by Maxim),
- · Temperature,
- · 3-axis accelerometer,
- · Gyroscope (position), and
- · Audio/ sound for snoring.

It is intended for use on adult patients (18 and older) and can be used in a hospital, clinic, or home.

| 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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# K223676 Traditional 510(k) Summarv

This 510(k) summary was prepared on 3/21/2023 to provide an understanding of the basis for the determination for a determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.

#### Submitter Information

(a)(1) BrainMatterZ, LLC, 19830 FM 1093, Richmond, TX 77407; contact Mr. Kevin Wilson (phone [phone], email [e-mail]). This summary was prepared 5/31/2023.

#### Subject Device

(a)(2) Device Trade Name: SomniCheck Common Name: Physiological signal amplifier Classification Name: Amplifier, Physiological Signal Regulation Number: 882.1835 Product Code: GWL

#### Predicate Device

(a)(3) Primary Predicate Device: Sandman SD20 Amplifier (K040113, Product Code GWL) Secondary Predicate Device: NomadAir PMU810 (K220631, Product Code GWL)

### Device Description

(a)(4) SomniCheck is an integrated single-use disposable physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems for neurophysiology or sleep disorder studies. It is intended for adult use and can be used in a hospital, clinic, or patient home. The associated software There is proprietary software that is currently under development, but the subject device's signal recording capabilities have been validated using the Natus Sleepworks K090277 via bench testing. The proprietary sleep software will be submitted in a future 510(k) Submission.

The device is affixed to the forehead of the patient and designed for continuous wear (e.g. during sleep) for up to approximately 10 hours. Once activated, the device records data for the duration of the wear period. After the wear period, the device is removed and may be thrown away. The device measures the following signals:

- · EEG (4-channel),
- PPG (by Maxim®),
- · Temperature,
- · 3-axis accelerometer,
- · Gyroscope (position), and
- Audio/ sound for snoring.

#### Intended Use

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(a)(5) SomniCheck is a single use physiological data recorder intended to amplify, digitze, and record data from multiple physiological channels for subsequent transfer to polysomnography systems for neurophysiology or sleep disorder studies. It is intended for adult use (18 years and older) and can be used in a hospital, clinic, or home.

The subject device has the same intended use as the predicate device.

(a)(6) The subject device's technological characteristics are different than those of the predicate devices. However, performance testing adequately accounts for those differences. A comparison of the technological characteristics is available in Appendix A of this Summary.

(b)(1) Non-clinical bench performance tests included System Requirements Verification, Electromagnetic Compatibility (EMC) Verification, and Device Firmware Verification, including applicable clauses from the following standards:

- IEC 60601-1:2020 Medical Electrical Equipment Part 1: General Requirements For . Basic Safety And Essential Performance
- . IEC 60601-1-2:2014+A1:2020 - Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- CISPR 11:2015+A1:2016+A2:2019 - Industrial, scientific and medical equipment -Radio-frequency disturbance characteristics - Limits and methods of measurement
- IEC 60601-1-6:2010+A1:2015 Medical Electrical Equipment Part 1-6: General ● Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- IEC 60601-1-11:2015 Medical Electrical Equipment -- Part 1-11: General Requirements ● For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
- IEC 60086-4:2019 Primary batteries Part 4: Safety of lithium batteries ●
- . IEC 61000-4-2:2008 - Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
- IEC 61000-4-3:2010 Electromagnetic compatibility (EMC) Part 4-3 : Testing and ● measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
- IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) Part 4-8: Testing and ● measurement techniques - Power frequency magnetic field immunity test
- IEC 62304:2006+A1:2015 - Medical device software - Software life cycle processes
- ISO 14971:2019+A11:2021 - Medical Devices -- Application Of Risk Management To Medical Devices
- . ISO 13485:2016+A11:2021 - Medical Devices - Quality Management Systems -Requirements For Regulatory Purposes
- . Sensor bench testing

(b)(2) Clinical performance testing is not applicable to the device type.

(b)(3) The performance testing demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices identified in paragraph (a)(3) of this section and therefore substantially equivalent.

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| Aspect | Proposed Device<br>K223676 | Primary Predicate Device<br>K040113 | Secondary Predicate Device<br>K220631 | Comment |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | SomniCheck | Sandman SD20 Amplifier | NomadAir PMU810 | N/A (differences do not impact<br>safety or efficacy) |
| Manufacturer | BrainMatterZ, LLC | EB Neuro, S.p.A. | Neurotronics, Inc. | N/A (differences do not impact<br>safety or efficacy) |
| Product Code | GWL (21 CFR 882.1835) | GWL (21 CFR 882.1835) | GWL (21 CFR 882.1835),<br>MNR, DQA | Same as Predicates |
| Device Class | II | II | II | Same as Predicates and Reference |
| Prescribe/OTC | Prescription Only | Prescription Only | Prescription Only | Same as Predicates and Reference |
| Intended Use | SomniCheck is a<br>physiological data<br>recorder intended to<br>amplify, digitize, and<br>record data from multiple<br>physiological channels for<br>subsequent transfer to<br>polysomnography<br>systems for<br>neurophysiology or sleep<br>disorder studies. | Sandman is intended to be<br>used by or under the<br>direction of a physician for<br>acquisition of EEG,<br>polygraphy and<br>polysomnography signals and<br>transmission of these signals<br>to a PC during recording of<br>neurophysiology<br>examinations. | Intended to record<br>physiological signals<br>acquired from a patient for<br>archival in a sleep study.<br>Data may be analyzed on<br>dedicated polysomnography<br>software running on a<br>personal computer by a<br>qualified sleep clinician to<br>aid in the diagnosis of sleep-<br>disordered breathing (SDB). | Same intended use |
| Indications for<br>Use | SomniCheck is a<br>prescription-use, single<br>use physiological data<br>recorder intended to<br>amplify, digitize, and<br>record data from multiple<br>physiological channels for<br>subsequent transfer to<br>polysomnography<br>systems. The device<br>measures the following<br>signals:<br>• EEG (4-channel),<br>• PPG (by Maxim) | The SD20 Amplifier is<br>intended to be used by or<br>under the direction of a<br>physician for acquisition of<br>EEG, polygraphy and<br>polysomnography signals<br>and transmission of these<br>signals to a PC during<br>recording of neurophysiology<br>examinations. | The NomadAir PMU810 is<br>intended to record<br>physiological signals<br>acquired from a patient for<br>archival in a sleep study.<br>Data may be analyzed on<br>dedicated<br>polysomnography software<br>running on a personal<br>computer by a qualified<br>sleep clinician to aid in the<br>diagnosis of sleep-<br>disordered breathing (SDB). | Similar; differences do not<br>introduce a new intended use |
| Aspect | Proposed Device<br>K223676 | Primary Predicate Device<br>K040113 | Secondary Predicate Device<br>K220631 | Comment |
| | • Temperature,<br>• 3-axis accelerometer,<br>• Gyroscope (position),<br>and<br>• Audio/ sound for<br>snoring.<br><br>It is intended for use on<br>adult patients (18 and<br>older) and can be used in<br>a hospital, clinic, or<br>home. | | intended for use within a<br>hospital, laboratory, clinic,<br>nursing home, or patient's<br>home.<br><br>The NomadAir PMU810 is<br>intended for use on adults<br>only under the direction of<br>a physician or qualified<br>sleep technician.<br><br>The NomadAir PMU810, or<br>any accessory, does not<br>include or trigger alarms,<br>and is not intended to be<br>used alone as, or a critical<br>component of,<br>*an alarm or alarm system;<br>*an apnea monitor or<br>apnea monitoring system;<br>or<br>*a life monitor or life<br>monitoring system. | |
| Target<br>Population | Adults | [not publicly specified] | Adults | Adults; Same as Secondary<br>Predicate |
| Environment of<br>Use | Hospital, clinic, or patient<br>home | [not specified] | Hospital, clinic, patient<br>home, laboratory, or<br>nursing home | Same as Secondary Predicate |
| Reuse/Single Use | Single use | Reusable | Reusable | Different; this difference does not<br>raise different questions of safety<br>and effectiveness; the device<br>measures the same signals and<br>functions in the same manner for<br>patients |
| Sold Sterile or<br>Non-Sterile | Provided clean, but not<br>sterile | Provided clean, but not<br>sterile | Provided clean, but not<br>sterile | Same as Predicates |
| Aspect | Proposed Device<br>K223676 | Primary Predicate Device<br>K040113 | Secondary Predicate Device<br>K220631 | Comment |
| Functions | Amplification,<br>Digitization, Storage,<br>Transmission | Amplification, Digitization,<br>Transmission | Amplification, Digitization,<br>Storage, Transmission | Same as Predicates |
| Sensors | The device measures the<br>following signals:<br>• EEG (4-channel),<br>• PPG (by Maxim),<br>• Temperature,<br>• 3-axis accelerometer,<br>• Gyroscope (position),<br>and<br>• Audio/ sound for<br>snoring. | 19-channel cutaneous<br>electroencephalograph<br>(EEG), PPG (Nellcor),<br>temperature sensor input,<br>position sensor input,<br>pressure sensor input | 4-channel cutaneous EEG,<br>PPG, temperature sensor<br>input, position<br>/acceleration, pressure | Similar to predicates; differences<br>do not raise different questions of<br>safety and effectiveness |
| Power | Internal battery | External IEC 601-1 mains<br>adapter | Internal battery | Same as secondary predicate |
| Wireless<br>connectivity | BLE | none (wired network only) | BLE<br>LTE | Same as secondary predicate |
| Form factor | forehead-wearable patch<br>(adhesive) | head-wearable box (strap)<br>amplifier box | wearable box (strap) | Similar to predicates |

Appendix A – Substantial Equivalence Comparison

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