(175 days)
No
The summary describes a device that records physiological data. It explicitly states that proprietary software for analysis is under development and will be submitted in a future 510(k). The current submission focuses solely on the data recording capabilities validated against existing polysomnography systems. There is no mention of AI/ML being used for data processing or analysis within the described device.
No.
The device is a physiological data recorder intended for diagnostic purposes (recording data for sleep disorder studies), not for treatment or therapy.
Yes
Explanation: The device is a physiological data recorder that amplifies, digitizes, and records data from multiple physiological channels. This data is then transferred to polysomnography systems for neurophysiology or sleep disorder studies, which are diagnostic purposes. The "Intended Use / Indications for Use" section explicitly states its role in collecting data for these studies.
No
The device description explicitly states it is an "integrated single-use disposable physiological data recorder" and mentions hardware components like EEG channels, PPG (by Maxim), temperature sensor, accelerometer, gyroscope, and audio sensor. It also describes being affixed to the forehead. While it mentions associated software, the core device is a physical hardware product that records physiological data.
Based on the provided information, the SomniCheck device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SomniCheck's Function: SomniCheck is described as a physiological data recorder that measures signals directly from the patient's body (EEG, PPG, temperature, accelerometer, gyroscope, audio). It does not process or analyze specimens taken from the body.
- Intended Use: The intended use is to record physiological data for subsequent transfer to polysomnography systems for neurophysiology or sleep disorder studies. This is a direct measurement of physiological parameters, not an analysis of biological samples.
Therefore, SomniCheck falls under the category of a physiological monitoring or recording device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GWL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
adult patients (18 and older)
Intended User / Care Setting
hospital, clinic, or home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench performance tests included System Requirements Verification, Electromagnetic Compatibility (EMC) Verification, and Device Firmware Verification.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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)
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 (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.
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
K223676 | Primary Predicate Device
K040113 | Secondary Predicate Device
K220631 | Comment |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | SomniCheck | Sandman SD20 Amplifier | NomadAir PMU810 | N/A (differences do not impact
safety or efficacy) |
| Manufacturer | BrainMatterZ, LLC | EB Neuro, S.p.A. | Neurotronics, Inc. | N/A (differences do not impact
safety 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 a
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. | Sandman is intended to be
used by or under the
direction of a physician for
acquisition of EEG,
polygraphy and
polysomnography signals and
transmission of these signals
to a PC during recording of
neurophysiology
examinations. | Intended to record
physiological signals
acquired from a patient for
archival in a sleep study.
Data may be analyzed on
dedicated polysomnography
software running on a
personal computer by a
qualified sleep clinician to
aid in the diagnosis of sleep-
disordered breathing (SDB). | Same intended use |
| Indications for
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) | The SD20 Amplifier is
intended to be used by or
under the direction of a
physician for acquisition of
EEG, polygraphy and
polysomnography signals
and transmission of these
signals to a PC during
recording of neurophysiology
examinations. | The NomadAir PMU810 is
intended to record
physiological signals
acquired from a patient for
archival in a sleep study.
Data may be analyzed on
dedicated
polysomnography software
running on a personal
computer by a qualified
sleep clinician to aid in the
diagnosis of sleep-
disordered breathing (SDB). | Similar; differences do not
introduce a new intended use |
| Aspect | Proposed Device
K223676 | Primary Predicate Device
K040113 | Secondary Predicate Device
K220631 | Comment |
| | • 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. | | intended for use within a
hospital, laboratory, clinic,
nursing home, or patient's
home.
The NomadAir PMU810 is
intended for use on adults
only under the direction of
a physician or qualified
sleep technician.
The NomadAir PMU810, or
any accessory, does not
include or trigger alarms,
and is not intended to be
used alone as, or a critical
component of,
*an alarm or alarm system;
*an apnea monitor or
apnea monitoring system;
or
*a life monitor or life
monitoring system. | |
| Target
Population | Adults | [not publicly specified] | Adults | Adults; Same as Secondary
Predicate |
| Environment of
Use | Hospital, clinic, or patient
home | [not specified] | Hospital, clinic, patient
home, laboratory, or
nursing home | Same as Secondary Predicate |
| Reuse/Single Use | Single use | Reusable | Reusable | Different; this difference does not
raise different questions of safety
and effectiveness; the device
measures the same signals and
functions in the same manner for
patients |
| Sold Sterile or
Non-Sterile | Provided clean, but not
sterile | Provided clean, but not
sterile | Provided clean, but not
sterile | Same as Predicates |
| Aspect | Proposed Device
K223676 | Primary Predicate Device
K040113 | Secondary Predicate Device
K220631 | Comment |
| Functions | Amplification,
Digitization, Storage,
Transmission | Amplification, Digitization,
Transmission | Amplification, Digitization,
Storage, Transmission | Same as Predicates |
| Sensors | The device measures the
following signals:
• EEG (4-channel),
• PPG (by Maxim),
• Temperature,
• 3-axis accelerometer,
• Gyroscope (position),
and
• Audio/ sound for
snoring. | 19-channel cutaneous
electroencephalograph
(EEG), PPG (Nellcor),
temperature sensor input,
position sensor input,
pressure sensor input | 4-channel cutaneous EEG,
PPG, temperature sensor
input, position
/acceleration, pressure | Similar to predicates; differences
do not raise different questions of
safety and effectiveness |
| Power | Internal battery | External IEC 601-1 mains
adapter | Internal battery | Same as secondary predicate |
| Wireless
connectivity | BLE | none (wired network only) | BLE
LTE | 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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