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.

Device Description

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.

AI/ML Overview

The provided text describes the predicate device information, applicable standards, and a comparison of the proposed device (SomniCheck) with predicate devices. However, it does not contain details about specific acceptance criteria for performance metrics, nor does it present the results of a study proving the device meets those criteria.

The document states:

"(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: [lists various IEC and ISO standards]."
"(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."
"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."

Based on this, the device's clearance is based on bench testing against established standards and substantial equivalence to predicate devices, rather than a clinical performance study with specific acceptance criteria that would typically involve a test set, ground truth experts, and MRMC studies.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred or stated based on the given document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., sensitivity, specificity) for signal detection or interpretation. The acceptance criteria are implicit in compliance with the listed IEC and ISO standards for electrical safety, EMC, usability, and risk management, and the demonstration of "as safe, as effective, and performs as well as the legally marketed predicate devices."
Reported Device Performance: The document only states that "performance testing demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices," and that "signal recording capabilities have been validated using the Natus Sleepworks K090277 via bench testing." No quantitative performance data (e.g., EEG signal fidelity, PPG accuracy) from these bench tests are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as "Clinical performance testing is not applicable to the device type." The validation was done via bench testing.
Data provenance: Bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for bench testing involves adherence to engineering standards and comparison with predicate device specifications, not expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

No. This device is a physiological data recorder, not an AI-powered diagnostic aide for human readers. It records signals for subsequent transfer to polysomnography systems.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device's signal recording capabilities were validated via bench testing with Natus Sleepworks K090277. This is fundamentally a standalone hardware performance validation. There is no mention of a standalone algorithm performance in the context of interpretation, as the proprietary sleep software is still "under development" and will be "submitted in a future 510(k) Submission."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's validation (signal recording) would be based on engineering specifications, known signal characteristics, and comparison to the performance of the predicate device/system (Natus Sleepworks K090277) under controlled bench conditions. It is not based on clinical "ground truth" such as expert consensus or pathology, as these are related to the interpretation of the collected physiological signals, which is outside the scope of this device's current submission.

8. The sample size for the training set

Not applicable. This is a hardware/firmware device for signal acquisition, not a machine learning model for which a "training set" would be used in the context of this 510(k). The proprietary software is still under development.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

· 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 (469)831-1161, email kwilson@brainmatterz.health). 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.

· 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 DeviceK223676	Primary Predicate DeviceK040113	Secondary Predicate DeviceK220631	Comment
Product Name	SomniCheck	Sandman SD20 Amplifier	NomadAir PMU810	N/A (differences do not impactsafety or efficacy)
Manufacturer	BrainMatterZ, LLC	EB Neuro, S.p.A.	Neurotronics, Inc.	N/A (differences do not impactsafety or efficacy)
Product Code	GWL (21 CFR 882.1835)	GWL (21 CFR 882.1835)	GWL (21 CFR 882.1835),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 aphysiological datarecorder intended toamplify, digitize, andrecord data from multiplephysiological channels forsubsequent transfer topolysomnographysystems forneurophysiology or sleepdisorder studies.	Sandman is intended to beused by or under thedirection of a physician foracquisition of EEG,polygraphy andpolysomnography signals andtransmission of these signalsto a PC during recording ofneurophysiologyexaminations.	Intended to recordphysiological signalsacquired from a patient forarchival in a sleep study.Data may be analyzed ondedicated polysomnographysoftware running on apersonal computer by aqualified sleep clinician toaid in the diagnosis of sleep-disordered breathing (SDB).	Same intended use
Indications forUse	SomniCheck is aprescription-use, singleuse physiological datarecorder intended toamplify, digitize, andrecord data from multiplephysiological channels forsubsequent transfer topolysomnographysystems. The devicemeasures the followingsignals:• EEG (4-channel),• PPG (by Maxim)	The SD20 Amplifier isintended to be used by orunder the direction of aphysician for acquisition ofEEG, polygraphy andpolysomnography signalsand transmission of thesesignals to a PC duringrecording of neurophysiologyexaminations.	The NomadAir PMU810 isintended to recordphysiological signalsacquired from a patient forarchival in a sleep study.Data may be analyzed ondedicatedpolysomnography softwarerunning on a personalcomputer by a qualifiedsleep clinician to aid in thediagnosis of sleep-disordered breathing (SDB).	Similar; differences do notintroduce a new intended use
Aspect	Proposed DeviceK223676	Primary Predicate DeviceK040113	Secondary Predicate DeviceK220631	Comment
	• Temperature,• 3-axis accelerometer,• Gyroscope (position),and• Audio/ sound forsnoring.It is intended for use onadult patients (18 andolder) and can be used ina hospital, clinic, orhome.		intended for use within ahospital, laboratory, clinic,nursing home, or patient'shome.The NomadAir PMU810 isintended for use on adultsonly under the direction ofa physician or qualifiedsleep technician.The NomadAir PMU810, orany accessory, does notinclude or trigger alarms,and is not intended to beused alone as, or a criticalcomponent of,an alarm or alarm system;an apnea monitor orapnea monitoring system;or*a life monitor or lifemonitoring system.
TargetPopulation	Adults	[not publicly specified]	Adults	Adults; Same as SecondaryPredicate
Environment ofUse	Hospital, clinic, or patienthome	[not specified]	Hospital, clinic, patienthome, laboratory, ornursing home	Same as Secondary Predicate
Reuse/Single Use	Single use	Reusable	Reusable	Different; this difference does notraise different questions of safetyand effectiveness; the devicemeasures the same signals andfunctions in the same manner forpatients
Sold Sterile orNon-Sterile	Provided clean, but notsterile	Provided clean, but notsterile	Provided clean, but notsterile	Same as Predicates
Aspect	Proposed DeviceK223676	Primary Predicate DeviceK040113	Secondary Predicate DeviceK220631	Comment
Functions	Amplification,Digitization, Storage,Transmission	Amplification, Digitization,Transmission	Amplification, Digitization,Storage, Transmission	Same as Predicates
Sensors	The device measures thefollowing signals:• EEG (4-channel),• PPG (by Maxim),• Temperature,• 3-axis accelerometer,• Gyroscope (position),and• Audio/ sound forsnoring.	19-channel cutaneouselectroencephalograph(EEG), PPG (Nellcor),temperature sensor input,position sensor input,pressure sensor input	4-channel cutaneous EEG,PPG, temperature sensorinput, position/acceleration, pressure	Similar to predicates; differencesdo not raise different questions ofsafety and effectiveness
Power	Internal battery	External IEC 601-1 mainsadapter	Internal battery	Same as secondary predicate
Wirelessconnectivity	BLE	none (wired network only)	BLELTE	Same as secondary predicate
Form factor	forehead-wearable patch(adhesive)	head-wearable box (strap)amplifier box	wearable box (strap)	Similar to predicates

Appendix A – Substantial Equivalence Comparison

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Regulation Number and Section

§ 882.1835 Physiological signal amplifier.

(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).