The HomeSleepTest is a non-invasive prescription device for home use with patients suspected to have sleep disorders including sleep-related breathing disorders. The HomeSleepTest is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. Using three frontal electrodes and one mastoid electrode, the HomeSleepTest records electrical data. In addition, the device records triaxial accelerometer data, ambient light and acoustic data. With help of the ComfortOxyRing, the device records plethysmographic data, as well as SpO2, heart rate and activity data. The HomeSleepTest calculates and reports to clinicians EEG/EOG/EMG, sleep stages, SpO2, plethysmography, pulse rate and snoring level. Based on this, the HomeSleepTest indices derived parameters, such as autonomic arousal (based on plethysmogram of ring), oxygen desaturation index and hypnogram-derived indices, such as time in each sleep stage, as well as other sleep-related parameters, to aid in determining sleep quality and quantity. HomeSleepTest data is not intended to be used as the sole or primary basis for diagnosing any sleep disorders, or sleep-related breathing disorders, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The HomeSleepTest is not intended for use in life-support and monitoring systems. The HomeSleepTest and its accessories are not intended for patients requiring monitoring and intensive care. The HomeSleepTest is a prescription device indicated for adult patients aged 21 years and over.

Device Description

The HomeSleepTest is used to record vital signs to determine a hypnogram (sleep profile) and sleep parameters that can be helpful in objectively determining sleep quality and quantity. The HomeSleepTest is available in a standard HomeSleepTest (HST) version and a HomeSleepTest REM+ (HST REM+) version. The only difference between the two basic devices is the measuring point of the outer electrodes on the forehead. HomeSleepTest refers to both versions of the device. Furthermore, the HomeSleepTest can be used to detect the patient's activity, head position and snoring. A recording with the HomeSleepTest is initialized in the clinic/practice. For this purpose, the patient is given the HomeSleepTest and a tablet to take home. The recording can thus be carried out independently in the home environment. Immediately after recording, the data is automatically transferred to the HST cloud. The physician has access to this data via the HST cloud where they can analyze the data via the HST cloud in DOMINO and generate a report. A tablet app with video sequences supports the patient in correct application and guides them through the required biocalibration of the system. Once the test is started, all data from the HomeSleepTest is recorded via Bluetooth. The HomeSleepTest records nine signals (3 x frontopolar EEG, 2 x EOG, EMG, snoring, activity and head position). Snoring and snoring rhythm are recorded via the tablet's microphone. Head position, movement and light support information about time in bed (TIB) and other sleep-related parameters. After completion of the measurement the next morning by the patient, the data is automatically uploaded to the HST cloud where it can be analyzed with help of DOMINO software. After the data has been successfully transferred to the cloud, an exchange with the physician is possible via the feed-back function. It is also possible to release a new measurement for this patient, so that recordings can be made over several nights to capture variability. An overview of all measurements is available to the physician in the HST Cloud. A chat area is used for communication between doctor and patient. In the cloud-based evaluation software, both the pre-evaluation and the raw data of the measurement should be analyzed or edited in an AASM compliant manner. A simple report is available immediately after uploading the measurement. However, the recorded data must still be verified by a physician: for the detailed report (standard report), the measurement is opened in the DOMINO software and scored manually. After evaluation, the standard report is also available in the overview and provides additional information on the various sleep parameters.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Metric	Acceptance Criteria	Reported Performance (HomeSleepTest)
Concordance of Manually Scored Sleep Stages (HST vs. PSG)	82.0%	83.0% (Cohen's kappa 0.77)
Concordance of Automated Sleep Stages (HST Pre-evaluation vs. PSG Manual)	50.0%	53.7% (Cohen's kappa 0.40)
Interrater Variability (HST Sleep Stages Scorer 1 vs. Scorer 2)	>70.0%	71.3%
Total Sleep Time (TST)	Not explicitly stated, but "minor differences" implied acceptance	Minor differences in TST between PSG and HST. Sustained sleep efficiency for PSG was 81.85% and for HST was 80.40% (difference of 1.45%).
Sleep Latency, REM Latency, Sleep Period Time, Wake After Sleep Onset	Not explicitly stated, but "minor time differences" implied acceptance	Minor time differences between subject and predicate device.
Different Sleep Stages as % TIB	± 10%	Wake, REM, N1, N2, N3 all meet the acceptance criteria of ± 10%.
Manually Scored Arousal Index	Not explicitly stated, but "met acceptance criteria"	Met acceptance criteria.
Oxygen Desaturation Parameters	Not explicitly stated, but "met acceptance criteria"	Number of Desaturations (total, 90%, <80%), ODI, Minimal and average SpO2, Baseline O2 Saturation, SpO2 time<90%, Largest, average and longest desaturation, Average minimum desaturation, Deepest desaturation, sum of all desaturations, and Artifact all met acceptance criteria.
Average Pulse Rate	Not explicitly stated, but "minimal differences" implied acceptance	Minimal differences between PSG and HST.
Snoring Parameters	Not explicitly stated, but "met acceptance criteria"	Snore number, index, absolute snore, and snore for total sleep time met acceptance criteria.
General Parameters (Subject Position)	Not explicitly stated, but "comparable results" implied acceptance	Provided comparable results.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 30 adult patients.
Data Provenance: The study was designed as a prospective and open validation study. The country of origin is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: At least one trained and certified scorer. For interrater variability, two scorers were used.
Qualifications: "trained and certified scorer". Specific experience level (e.g., "radiologist with 10 years of experience") is not detailed.

4. Adjudication Method for the Test Set

The text states: "The measurements of the PSG device and the HST with ComfortOxyRing were evaluated manually according to the current AASM guidelines in random order by a trained and certified scorer."
For the interrater variability study, "The HST sleep stages were scored by two scorers." The agreement between them was then assessed.
There's no explicit mention of an adjudication method like 2+1 or 3+1 for resolving discrepancies in the primary ground truth establishment. The initial comparison against PSG manually scored by "a scorer" suggests a single-expert scoring for the ground truth, with further inter-rater assessment for the HST device itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described as such. The study focused on validating the HomeSleepTest against a gold standard PSG (SOMNOscreen plus) and assessing inter-rater variability for HST scoring. While multiple readers were involved in assessing inter-rater agreement for HST, this is not presented as a comparative effectiveness study of human readers with and without AI assistance to quantify improvement.
Effect Size: Not applicable, as an MRMC comparative effectiveness study with AI assistance was not reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation was conducted for the automated analysis.
The "pre-evaluation (automated analysis) of the HST sleep stages" was compared to the manually scored measurements of the reference PSG device.
Performance: The concordance for the automated analysis was 53.7%, with a Cohen's kappa of 0.40, meeting a pass criterion of 50.0%.

7. The Type of Ground Truth Used

The primary ground truth used was expert consensus / manual scoring based on the gold standard PSG (SOMNOscreen plus) measurements, according to current AASM guidelines. This is essentially expert consensus against a recognized clinical standard.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set of the HomeSleepTest's algorithm.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. The clinical performance section focuses solely on the validation/test set.

Summary

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Somnomedics GMBH % Cherita James Regulatory Consultant ProPharma Group 1129 20th St NW Suite 600 Washington, District of Columbia 20036

Re: K240700

Trade/Device Name: HomeSleepTest (HST, HST REM+) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV, MNR Dated: March 14, 2024 Received: March 14, 2024

Dear Cherita James:

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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

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for Jay Gupta 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) K240700

Device Name HomeSleepTest (HST, HST REM+)

Indications for Use (Describe)

The HomeSleepTest is a non-invasive prescription device for home use with patients suspected to have sleep disorders including sleep-related breathing disorders.

The HomeSleepTest is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. Using three frontal electrodes and one mastoid electrode, the HomeSleepTest records electrical data. In addition, the device records triaxial accelerometer data, ambient light and acoustic data. With help of the ComfortOxyRing, the device records plethysmographic data, as well as SpO2, heart rate and activity data.

The HomeSleepTest calculates and reports to clinicians EEG/EOG/EMG, sleep stages, SpO2, plethysmography, pulse rate and snoring level. Based on this, the HomeSleepTest indices derived parameters, such as autonomic arousal (based on plethysmogram of ring), oxygen desaturation index and hypnogram-derived indices, such as time in each sleep stage, as well as other sleep-related parameters, to aid in determining sleep quality and quantity.

HomeSleepTest data is not intended to be used as the sole or primary basis for diagnosing any sleep disorders, or sleeprelated breathing disorders, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The HomeSleepTest is not intended for use in life-support and monitoring systems. The HomeSleepTest and its accessories are not intended for patients requiring and intensive care. The HomeSleepTest is a prescription device indicated for adult patients aged 21 years and over.

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- K240700

The following information is provided as required by 21 CFR § 807.87 for HomeSleepTest 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

Sponsor: SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236
Contact: Cherita James ProPharma Group Ph: 347-954-0624 cherita.james@propharmagroup.com

December 6, 2024 Date Prepared: HomeSleepTest (HST, HST REM+) Proprietary Name: Common Name: Standard Polysomnograph with Electroencephalograph Regulatory Class: II 882.1400 Electroencephalograph Regulation Number & Name: Review Panel: Neurology Product Codes: OLV, MNR Predicate Device: SOMNOscreen plus, K201054 Reference Device: Somfit, K231546

Indications for Use: The HomeSleepTest is a non-invasive prescription device for home use with patients suspected to have sleep disorders including sleep-related breathing disorders. The HomeSleepTest is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. Using three frontal electrodes and one mastoid electrode, the HomeSleepTest records electrical data. In addition, the device records triaxial accelerometer data, ambient light and acoustic data. With help of the ComfortOxyRing, the device records plethysmographic data, as well as SpO2, heart rate and activity data.

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desaturation index and hypnogram-derived indices, such as time in each sleep stage, as well as other sleep-related parameters, to aid in determining sleep quality and quantity. HomeSleepTest data is not intended to be used as the sole or primary basis for diagnosing any sleep disorders, or sleep-related breathing disorders, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The HomeSleepTest is not intended for use in life-support and monitoring systems. The HomeSleepTest and its accessories are not intended for patients requiring monitoring and intensive care. The HomeSleepTest is a prescription device indicated for adult patients aged 21 years and over.

Device Description: The HomeSleepTest is used to record vital signs to determine a hypnogram (sleep profile) and sleep parameters that can be helpful in objectively determining sleep quality and quantity.

The HomeSleepTest is available in a standard HomeSleepTest (HST) version and a HomeSleepTest REM+ (HST REM+) version. The only difference between the two basic devices is the measuring point of the outer electrodes on the forehead. HomeSleepTest refers to both versions of the device.

Furthermore, the HomeSleepTest can be used to detect the patient's activity, head position and snoring. A recording with the HomeSleepTest is initialized in the clinic/practice. For this purpose, the patient is given the HomeSleepTest and a tablet to take home. The recording can thus be carried out independently in the home environment. Immediately after recording, the data is automatically transferred to the HST cloud. The physician has access to this data via the HST cloud where they can analyze the data via the HST cloud in DOMINO and generate a report.

A tablet app with video sequences supports the patient in correct application and guides them through the required biocalibration of the system. Once the test is started, all data from the HomeSleepTest is recorded via Bluetooth. The HomeSleepTest records nine signals (3 x frontopolar EEG, 2 x EOG, EMG, snoring, activity and head position). Snoring and snoring rhythm are recorded via the tablet's microphone. Head position, movement and light support information about time in bed (TIB) and other sleep-related parameters.

After completion of the measurement the next morning by the patient, the data is automatically uploaded to the HST cloud where it can be analyzed with help of DOMINO software. After the data has been successfully transferred to the cloud, an exchange with the physician is possible via the feed-back function. It is also possible to release a new

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measurement for this patient, so that recordings can be made over several nights to capture variability.

An overview of all measurements is available to the physician in the HST Cloud. A chat area is used for communication between doctor and patient. In the cloud-based evaluation software, both the pre-evaluation and the raw data of the measurement should be analyzed or edited in an AASM compliant manner. A simple report is available immediately after uploading the measurement.

However, the recorded data must still be verified by a physician: for the detailed report (standard report), the measurement is opened in the DOMINO software and scored manually. After evaluation, the standard report is also available in the overview and provides additional information on the various sleep parameters.

Performance Testing Summary: Performance testing was conducted to confirm compliance to device specifications. All functions were verified to operate as designed. Signals recorded by the HomeSleepTest underwent performance testing demonstrating that all signal types being recorded comply with the performance criteria set forth by SOMNOmedics. Testing according to ISO 10993 Parts 5 and 10 of the HST Electrode adhesive demonstrated biocompatibility for the intended use; additional direct contact components including the snap fastener cable, ComfortOxyRing and NuPrep skin paste have been tested and are marketed by OEM manufacturers.

Basic documentation for software design and validation was provided. Cybersecurity assessment including assessment of impact severity and likelihood were provided. The following FDA guidance were conformed to:

Content of Premarket Submissions for Device Software Functions: June 2023
. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: September 2023

Electrical Safety and EMC testing according to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests, and 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 confirm the HomeSleepTest

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performs as intended in the proposed operating environments.

Standards

SOMNOmedics GmbH has demonstrated compliance with the following standards for the

HomeSleepTest:

Standard	Edition	2020-08
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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
ISO 10993-5	Third edition	2009-06-01
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10	Fourth edition	2021-11
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
EN 60529:1991+A1:2000+A2:2013	Degree of Degrees of Protection Provided by Enclosures
IEC 62304:2006 + A1:2015	Medical device software - Software life cycle processes [Including Amendment 1 (2016)]

Clinical Performance: Design validation of the sleep-staging capabilities of the HomeSleepTest (HST) was performed by comparing performance to SOMNOscreen plus (PSG configuration) in 20 subjects. This confirmed the device is suitable for the intended use.

Additionally, a study of 30 adult patients was conducted with a primary objective for the validation of parameters measured with the HomeSleepTest in combination with ComfortOxyRing against the gold standard PSG (SOMNOscreen plus, K201054). This includes parameters regarding sleep stages, oxygen desaturation, pulse rate, snoring, and general parameters. The study was designed as a prospective and open validation study. The measurements of the PSG device and the HST with ComfortOxyRing were evaluated manually according to the current AASM guidelines in random order by a trained and certified scorer. A total of 24563 epochs (excluding epochs with artefacts) from 30 patients were compared. The concordance of the sleep-stages for manually scored epochs is 83.0%, Cohen's kappa is 0.77. The pass criterion of a concordance of 82.0% is achieved.

Sleep Parameters were evaluated in a comparative analysis of sleep stages and therefore key sleep parameters performance was compared between PSG and HST.

Lights off/on was set equal for both devices based on the video of the PSG recording.

Total Sleep Time (TST) measured with PSG and HST showed only minor differences in TST

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between the devices. The sustained sleep efficiency of 81.85% for PSG and 80.40% for HST showed a difference of 1.45%.

Sleep latency, REM latency, Sleep Period Time and Wake After Sleep Onset also showed only minor time differences between the subject and predicate device.

Comparison of sleep stages in relation to the parameter of Time in Bed (TIB) were evaluated.

Comparison of different sleep stages as % TIB showed that wake, REM, N1, N2, N3 all meet the acceptance criteria of + 10%. Manually scored arousal index for both the subject and predicate devices also met the acceptance criteria.

The following oxygen desaturation parameters also met acceptance criteria:

Number of Desaturations total, 90%, and <80%
ODI
Minimal and average SpO2
Baseline O2 Saturation ●
. SpO2 time<90%
Largest, average and longest desaturation .
Average minimum desaturation ●
. Deepest desaturation, sum of all desaturations
Artifact

Comparison of the average pulse rate obtained for PSG and HST demonstrated minimal differences.

Snoring parameters including snore number, index, absolute snore and snore for total sleep time met acceptance criteria. General parameters for subject position (upright or not upright) provided comparable results.

In the second step the pre-evaluation (automated analysis) of the HST sleep stages is compared to the manually scored measurements of the reference PSG device, A total of 24042 epochs (excluding epochs with artefacts) from 30 patients were compared. The concordance was 53.7%, Cohen's kappa was 0.40. For the pre-evaluation of the HST, the pass criterion of a concordance of 50.0% was achieved.

The DOMINO Scorer Manager was used to evaluate the interrater variability. The HST sleep stages were scored by two scorers. The agreement over all 30 HST measurements between scorer 1 and scorer 2 was 71.3%. Therefore, the pass criterion of an agreement above 70.0% was achieved.

The results indicate strong consistency between manually-scored PSG and manually-scored HST recordings across key sleep parameters.

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Substantial Equivalence Comparison

Features / TechnicalInformation	HomeSleepTest (REM+)Subject device	SOMNOscreen®plus Predicatedevice	Somfit® byCompumedics LimitedReference device	Discussion of difference/SubstantialEquivalence
Product Code	OLV, MNR	OLV, MNR	MNR, OMC
K-Number	K240700	K201054	K231546
Indications for Use / IntendedUse	The HomeSleepTest is a non-invasive prescription device forhome use with patients suspected tohave sleep disorders includingsleep-related breathing disorders.The HomeSleepTest is a diagnosticaid for the detection of sleep-relatedbreathing disorders, sleep staging(REM, N1, N2, N3, Wake), andsnoring level. Using three frontalelectrodes and one mastoidelectrode, the HomeSleepTestrecords electrical data. In addition,the device records triaxialaccelerometer data, ambient lightand acoustic data. With help of theComfortOxyRing, the devicerecords plethysmographic data, aswell as SpO2, heart rate andactivity data.The HomeSleepTest calculates andreports to cliniciansEEG/EOG/EMG, sleep stages,SpO2, plethysmography, pulse rateand snoring level. Based on this,the HomeSleepTest indices derivedparameters, such as autonomicarousal (based on plethysmogramof ring), oxygen desaturation indexand hypnogram-derived indices,	The SOMNOscreen® plus isa non-life-supportingportable physiological signalrecording device intended tobe used for testing adults andchildren (age 2 to 12years)/adolescents (age 12and above) suspected ofhaving sleep-relatedbreathing disorders.The SOMNOscreen® plus isindicated for use in therecording, displaying,monitoring, printing, andstorage of biophysicalparameters for the purpose ofassisting in the diagnosis ofNeurological and SleepDisorders.The device is NOT designedto be used in a Life Supportsituation. The device is notdesigned for use on patientswith cardiac pacemakers.	The Somfit® system is a non-invasive prescription devicefor home use with patientssuspected to have sleep-related breathing disorders.The Somfit is a diagnosticaid for the detection of sleeprelated breathing disorders,sleep staging (REM, N1, N2,N3, Wake), and snoringlevel.The Somfit system acquireselectrical data from threefrontal electrodes, tri-axialaccelerometer data,acoustical andplethysmographic data. TheSomfit calculates and reportsto clinicians EEG/EOGchannels, Sleep Stages,SpO2, Peripheral ArterialTonometry (PAT) signal,pulse rate, and snoring level.The Somfit calculates andreports to clinicians derivedparameters such as PAT-derived Apnea HypopneaIndex, ObstructiveDesaturation Index; andhypnogram- derived indices	SOMNOscreen® plus is used as thepredicate device. Both theHomeSleepTest and SOMNOscreen®plus help the physician to diagnosesleep related breathing disorders. Thesame signals are used and the sameDOMINO software for analyzing themeasurement is part of the system.The patient population of the HST isincluded in the patient population ofthe SOMNOscreen® plus.Somfit is used as a reference devicefor the same indication for use. BothHST and Somfit are intended for adultpopulations.

well as other sleep-relatedparameters, to aid in determiningsleep quality and quantity.HomeSleepTest data is not intendedto be used as the sole or primarybasis for diagnosing any sleepdisorders, or sleep-related breathingdisorders, prescribing treatment, ordetermining whether additionaldiagnostic assessment is warranted.The HomeSleepTest is not intendedfor use in life-support andmonitoring systems. TheHomeSleepTest and its accessoriesare not intended for patientsrequiring monitoring and intensivecare. The HomeSleepTest is aprescription device indicated foradult patients aged 21 years andover.	stage. Somfit data is notintended to be used as thesole or primary basis fordiagnosing any sleep- relatedbreathing disorder,prescribing treatment, ordetermining whetheradditional diagnosticassessment is warranted. TheSomfit is not intended foruse as life supportequipment, for example vitalsigns monitoring in intensivecare unit. The Somfit is aprescription device indicatedfor adult patients aged 21years and over.
Type of Use	Prescription Use Only	Prescription Use Only	Prescription Use Only	Equivalent
Patient population	Adults – 21 years and above	Adults and children (age 2to 12 years)/adolescents(age 12 and above)	Adults – 21 years andabove	Equivalent to Somfit predicate device
Usage Environment	Home and further possibleapplications are to be found in	N/A	Home	HomeSleepTest (REM+) andSomfit® are intended for home use.In addition
Features / Technical	HomeSleepTest (REM+)	SOMNOscreen® plus	Somfit® by	Discussion of difference/Substantial
Information	Subject device	Predicate device	Compumedics LimitedReference device	Equivalence
	clinics and physicians' practiceswith relevant diagnostic potential.			the HomeSleepTest (REM+) can beused in physicians' practices.Difference does not affect safety oreffectiveness.
Mass	28 g (with battery)	220 g (with battery)	≤15g (with battery)	The HomeSleepTest (REM+) islighter than the SOMNOscreen plusand slightly heavier than the Somfit®.Difference does not affect safety oreffectiveness.
Dimensions	43 mm x 36,5 mm x 10 mm(Diameter: 56,4)	140 mm x 70 mm x 28 mm	43 mm x 43 mm x 19.7mm(device + charging cradle)	The HomeSleepTest (REM+) isslightly smaller than the predicates.Difference does not affect safety oreffectiveness.
Biocompatibility	Overnight use on intact skin	Overnight use on intact skin	Overnight use on intactskin	Equivalent
Materials	Adhesive (wet/hydrogel)electrodesPC-PBT	N/A	Adhesive (wet) electrodeABS Plastic	The discussion of biocompatibilitycan be found in the SubstantialEquivalence Discussion Document.Difference does not affect safety oreffectiveness.
Portable	Yes	Yes	Yes	Equivalent
Sold Sterile orSterilization Required	No	No	No	Equivalent
Energy Source	1x 240 mAh 3.7 V Li-Ion battery	1 x 2800 mAh 3.7 V Li-Ionbattery	1 x 120 mAh 3.7 V Li-Ionbattery	A more powerful battery is integratedin HomeSleepTest (REM+) thanSomfit. Difference does not affectsafety or effectiveness.
Battery Life	Recording with fully chargedbattery: 36 hours continuousrecording	Recording with fullycharged battery: 23 hourscontinuous recording	On standby/idle mode: 48hours (2 days)Recording: 16 hourscontinuous recording	The HomeSleepTest (REM+) batterylife allows for longer continuousrecording. Difference does not affectsafety or effectiveness.
Electronic Sensors	PhotodiodeAnalog front end for SpO2MicrophoneAccelerometerBiosignal front end incl EEGamplification	PhotodiodeOximeterMicrophoneAccelerometerBiosignal front end inclEEG amplification	PhotodiodeOximeter front end(AFE4404)MicrophoneAccelerometerEEG Amplification	Equivalent sensors are used tomeasure signal in HST andSOMNOscreen® plus.Analog front end for SpO2 is clearedwithin the ComfortOxyRing.
Features / Technical	HomeSleepTest (REM+)	SOMNOscreen® plus	Somfit® by	Discussion of difference/Substantial
Information	Subject device	Predicate device	Compumedics LimitedReference device	Equivalence
	Light sensor	Light sensor(Only relevant electronicsensors for thiscomparison are listed)		Difference does not affect safety oreffectiveness.
Pulse Oximeter	ComfortOxyRing(K221361)	Soft Silicone Finger Sensorfor Pulse Oximeter forpediatric / adults	Pulse rate data wasobtained from Nonin andMasimo referenceoximeters during acontrolled desaturationstudy. Two hundred andthirty-seven pulse ratesamples were obtainedfrom 12 healthy patients,and analysed using thestatistical methodsmandated by ISO 80601-2-61. The root-mean squareerror was found to be 1.91BPM with a meandifference of 0.017 BPMbetween the Somfit andMasimo oximeters. Theroot-mean square error wasfound to be 1.81 BPM witha mean difference of 0.00BPM between the Somfitand Nellcor oximeters.Potential sources of errormay include inadequatesynchronization betweendevices.since oximeters provide arange of data update rates,and were placed atdiffering anatomicallocations, as well asadditional patient motion	Other method, same signals.ComfortOxyRing (The circul™ proRing) has the appropriate intended usefor use with the HST.K221361: The circul™ pro Ring is awireless, non-invasive, and stand-alone pulse oximeter intended to beused for spot-check and/ orcontinuous data collection of oxygensaturation of arterial hemoglobin(Sp02) and pulse rate (PR) through theindex finger in adult patients. It can beused in hospitals and homeenvironments for up to twelve hoursin non-motion and well perfusedconditions. It is not intended forsingle-use and out-of-hospitaltransport use and does not havealarms.Difference does not affect safety oreffectiveness.
Features / TechnicalInformation	HomeSleepTest (REM+)Subject device	SOMNOscreen® plusPredicate device	Somfit® byCompumedics LimitedReference device	Discussion of difference/SubstantialEquivalence
Analysis Software	DOMINO	DOMINO	Sleep Profiler	Equivalent to primary predicatedevice
Channel	PlethysmographyOxygen saturationEEG/EOG/EMGSound for snore detectionActivityPosition	PlethysmogramOxygen saturationEEG/EOG/EMGSound for snoredetectionActivityPosition(Only relevant channelsfor this comparison arelisted)	PATOximetryEEGSnoringMotion	Same channels already used withinSOMNOscreen® plus.
Analysis Output	Sleep stagesSnoringODIPulse ratePosition	Sleep stagesSnoringODIPulse ratePosition(Only relevant analysisoutput for thiscomparison is listed)	Sleep stagesSnoring LevelODIpAHI	Uses same output than SOMNOscreenplus. The analysis output is scored andevaluated within the analysis SoftwareDOMINO of the SOMNOscreen®plus.Substantially Equivalent
Application Site	Forehead	N/A	Forehead	Equivalent to predicate device
Device Visual Indicator	LED on Device, mobileapplication	Alphanumeric display	Green and blue LEDs ondevice, mobile application	Equivalent to predicate device
User Control	Start/stop button on mobileapplication	Start/Stop via menu ondisplay or pre-initializedautomatic start	Start/stop button on mobileapplication	Equivalent to predicate device
Features / TechnicalInformation	HomeSleepTest (REM+)Subject device	SOMNOscreen® plusPredicate device	Somfit® byCompumedics LimitedReference device	Discussion of difference/SubstantialEquivalence
Data Collection	Data is transferred from the deviceto the tablet via Bluetooth. Afterthe measurement is completed, thedata is securely uploaded to theHST Cloud. Furthermore, the HSTCloud preprocesses the data withDOMINO and the results arestored in a secure database insidethe Cloud. The user can laterfurther analyze the data with	Data is via a Dockingstation transferred to thephysicians PC for storageand analysis.	Study data is wirelesslytransferred throughBluetooth from the deviceto a mobile application.Data is then uploaded intoa secure Cloud and toNexus360 web server forstorage and analysis.	HST uses the same Data Collectionand transfer as the Somfit®. Only theStorage Device is different.Difference does not affect safety oreffectiveness.

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Conclusion: The subject and primary predicate device are both non-invasive prescription devices for home use with measuring system for recording of physiological signals. They assist the physician in diagnosing sleep disorders, including sleep-related breathing disorders.

There is no relevant difference in the indications for use or the intended use of the subject device and the primary predicate device. The subject device has the similar principles of operation and technical characteristics as the previously cleared primary and reference predicates. The subject device fulfils the requirements of IEC 60601-1-11 for home use. Patient contacting components have been evaluated for biocompatibility.

The differences do not raise new issues regarding safety or effectiveness.

The HomeSleepTest is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).