(269 days)
SOMNOscreen® plus, K201054
Yes
The document mentions "pre-evaluation (automated analysis) of the HST sleep stages" and provides performance metrics for this automated analysis, suggesting the use of an algorithm to process the data and determine sleep stages without manual scoring. While the specific term "AI" or "ML" is not used, automated analysis of complex physiological signals like EEG, EOG, and EMG for sleep staging is a common application of ML algorithms. The comparison of this automated analysis to manual scoring further supports the presence of an automated, likely ML-based, process.
No
The device is a diagnostic aid for detecting sleep disorders, not a device used to provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The HomeSleepTest is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level."
No
The device description explicitly states that the HomeSleepTest includes physical components such as electrodes, a ComfortOxyRing, and a tablet, which are used to record various physiological data. While software is used for data analysis and reporting, the device is not solely software.
Based on the provided information, the HomeSleepTest is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- HomeSleepTest Function: The HomeSleepTest is a non-invasive device that records physiological signals directly from the patient's body (electrical data from electrodes, accelerometer data, ambient light, acoustic data, plethysmographic data, SpO2, heart rate, activity). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to aid in the diagnosis of sleep disorders by recording and analyzing physiological data, not by analyzing biological samples.
Therefore, the HomeSleepTest falls under the category of a medical device, specifically a diagnostic aid for sleep disorders, but not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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.
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.
Product codes
OLV, MNR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead (for electrodes)
Index finger (for ComfortOxyRing)
Indicated Patient Age Range
Adults aged 21 years and over.
Intended User / Care Setting
Home use with patients suspected to have sleep disorders, as well as in clinics and physicians' practices with relevant diagnostic potential. The data is analyzed by clinicians/physicians.
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
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.
For the second step, the pre-evaluation (automated analysis) of the HST sleep stages was 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 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%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Design validation, comparative analysis, interrater variability study.
Sample Size: 20 subjects for initial design validation, 30 adult patients for the main validation study.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not explicitly stated as standalone, but 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.
Key Results:
- Sleep Staging (manual scoring HST vs. manual scoring PSG): 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 (manual scoring HST vs. manual scoring PSG):
- Total Sleep Time (TST) measured with PSG and HST showed only minor differences. 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.
- Comparison of sleep stages in relation to the parameter of Time in Bed (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.
- Oxygen Desaturation Parameters: The following parameters met acceptance criteria: Number of Desaturations total, 90%, and
§ 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).
0
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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.
1
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
2
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
3
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.
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
5
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
6
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
7
performs as intended in the proposed operating environments.
Standards
SOMNOmedics GmbH has demonstrated compliance with the following standards for the
HomeSleepTest:
| Standard | Edition | 3.2 | 2020-08 | CONSOLIDATED | VERSION |
|---|---|---|---|---|---|
| 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
8
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