Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition) and to detect patient presence and body movements.

The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment. The Sleepiz One+ cloud software is intended for use by healthcare professionals.

This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not indicated for use on pregnant women or patients with active implantable devices.

Device Description

Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate from a resting or sleeping patient.

The Sleepiz One+ consists of a hardware unit and cloud-based software The hardware unit can be positioned on a bedside table, mounted on a stand, or attached to the wall behind the patient's bed. It is designed to monitor physiological signals by detecting small body movements, such as those caused by breathing and heartbeat, using Doppler radar. The recorded signals are then transmitted via Wi-Fi to cloud-based software, where they are analyzed to obtain respiration rate, heart rate, and body movement. These outputs can be exposed via the Application Programming Interfaces (APIs) to allow healthcare professionals the review and annotation of the data and compilation of results into reports.

Outputs

Breathing pattern
Instantaneous breathing rate [breaths per minute]
Breathing rate statistics (10th, 50th, and 90th quantiles) [breaths per minute]
Body movement
Time in bed [hours]
Presence detection
Heart rate [beats per minute]
Heart rate statistics (10th, 50th, and 90th quantiles) [beats per minute]

The overall system can be grouped into 4 major components, which are classified on the basis of the logical component interfaces where data exchange is occurring.

Sleepiz Hardware - This is a hardware component serving as primary data acquisition device.
Embedded Software - This encompasses the firmware running of the Sleepiz Hardware. This, together with Sleepiz hardware, is responsible for data acquisition. The embedded software forms the crux of the Sleepiz hardware such that it defines and controls the data acquisition process. The security aspects related to the operation of the device are incorporated in the design and implementation of embedded software.
Sleep Analytics Software - The sleep analytics software is responsible for processing data from the Sleepiz Hardware and returning its analytics (e.g., breathing rate, heart rate), as well as its statistics (e.g., mean breathing rate, total recording time, etc.). This refers to the ML model deployed within the cloud software. By itself, the Sleep Analytics Software does not have an external interface. It is wholly encapsulated by the cloud software component Data Processing Layer.
Cloud Software - The cloud software can be divided into the backend service and the analytics service. The backend service includes modules for data ingestion, a public API, a private API, and a module for sending analysis process requests. The analytics service is responsible for receiving analysis requests and interacting with the sleep analytics software.

AI/ML Overview

The FDA 510(k) clearance letter for Sleepiz One+ (2.5) indicates that the device's substantial equivalence to a predicate device (Sleepiz One+) was established primarily through non-clinical performance testing, focusing on software verification and validation, electrical safety, and electromagnetic compatibility. The document states that the subject device and the predicate device have the same intended use, principle of operation, and similar technological characteristics. The minor modifications (API-based data access instead of web interface and plug-in power instead of battery) were assessed for safety and effectiveness without requiring extensive new clinical studies.

The provided document does not detail specific acceptance criteria for the accuracy of heart rate and respiration rate measurements, nor does it provide a study proving the device meets these specific performance criteria. The clearance is based on the conclusion that "The verification and validation tests performed on the subject device confirm that the device performs as intended in the specified use conditions and comparably to the predicate device. The performance testing conducted shows comparable results between the two models, thereby, demonstrating the safety and performance of the Sleepiz One+ (V.2.5)."

Therefore, based solely on the provided text, a comprehensive table of acceptance criteria and the detailed study proving the device's accuracy against those criteria cannot be constructed. The document infers that the device performs as intended and comparably to the predicate, but it does not present the raw performance data or the specific acceptance thresholds for heart rate and respiration rate accuracy.

Here's a breakdown of the requested information based on the provided text, with clear indications where the information is NOT available.

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

Information NOT available in the provided text. The 510(k) summary states that "performance testing conducted shows comparable results between the two models," but it does not quantify these results or list specific acceptance criteria for heart rate and respiration rate accuracy. The testing primarily focused on software validation, electrical safety, and EMC.

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

Information NOT available in the provided text. The document mentions "non-clinical performance tests" and "verification and validation tests," but it doesn't specify any sample sizes for a test set related to the accuracy of vital sign measurements, nor the provenance of any data used for such testing.

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

Information NOT available in the provided text. There is no mention of external experts or ground truth establishment in the context of vital sign accuracy, as the clearance seems to rely on comparability to a predicate device and engineering verification/validation. For devices measuring physiological parameters, ground truth is typically established via reference medical devices (e.g., ECG, capnography) rather than expert consensus on subjective data.

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

Information NOT available in the provided text. Since no details on a clinical or performance study involving human subjects and expert review are provided, there is no mention of an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Information NOT available in the provided text. The Sleepiz One+ is a vital signs monitor, not typically an AI-assisted diagnostic imaging device that would undergo MRMC studies. The device primarily measures heart rate and respiration rate via radar and processes this data in cloud software (Sleep Analytics Software contains the ML model). The interaction is between the device and the patient, not a "human reader" interpreting AI outputs in a MRMC context. The cleared device provides raw data and statistics (like quantiles), which healthcare professionals would then interpret.

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

The device's core function, measuring heart rate and respiration rate from radar signals using its Sleep Analytics Software (which contains the ML model), operates in a standalone manner to generate these outputs. The outputs themselves (instantaneous rates, statistics) are generated by the algorithm without human intervention in the loop of the measurement process itself. Healthcare professionals then access and interpret these results via API. The non-clinical performance testing would have validated the output of this standalone algorithm against internal specifications or a reference.

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

Information NOT explicitly stated in the provided text regarding vital sign accuracy. For devices measuring heart rate and respiration rate, ground truth is typically established using established reference medical devices (e.g., synchronously recorded ECG for heart rate, capnography or impedance pneumography for respiration rate). While not stated, it can be inferred that if accuracy was evaluated, it would be against such objective physiological measurements rather than subjective expert consensus or pathology.

8. The sample size for the training set

The device uses an "ML model deployed within the cloud software" for "Sleep Analytics Software." However, the provided 510(k) summary does NOT provide any details about the training set size or methodology for this ML model. The focus of the substantial equivalence claim is on the overall system's safety and performance comparability to the predicate, with modifications primarily linked to data access and power source.

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

Information NOT available in the provided text. As with the training set size, the 510(k) summary does not provide details on how the ground truth for the training set (if any specific to the ML model) was established.

Summary

FDA 510(k) Clearance Letter - Sleepiz One+ (2.5)

Page 1

July 29, 2025

Sleepiz AG
Marta Stepien
Vice-President of Clinical, Regulatory and Quality Affairs
Hornbachstrasse 23
Zurich, Zurich 8008
Switzerland

Re: K251364
Trade/Device Name: Sleepiz One+ (2.5)
Regulation Number: 21 CFR 870.2300
Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm)
Regulatory Class: Class II
Product Code: DRT, BZQ
Dated: July 3, 2025
Received: July 3, 2025

Dear Marta Stepien:

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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K251364 - Marta Stepien Page 2

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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251364 - Marta Stepien Page 3

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,

JENNIFER W. SHIH -S

Jennifer Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K251364

Please provide the device trade name(s).
Sleepiz One+ (2.5)

Please provide your Indications for Use below.
Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition) and to detect patient presence and body movements.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Sleepiz One+ Page 10 of 52

Page 5

510(k) Summary

510(k) #: K251364
Prepared on: 2025-07-03

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Sleepiz AG
Applicant Address	Hornbachstrasse 23 Zurich Zurich 8008 Switzerland
Applicant Contact Telephone	+41 76 783 73 5
Applicant Contact	Ms. Marta Stepien
Applicant Contact Email	marta.stepien@sleepiz.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Sleepiz One+ (2.5)
Common Name	Vital Signs Monitoring System
Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm & Monitor, Breathing Frequency
Regulation Number	21 CFR 870.2300
Product Code(s)	DRT, BZQ

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K223163	Sleepiz One+	DRT

Device Description Summary

21 CFR 807.92(a)(4)

Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate from a resting or sleeping patient.

Outputs

Breathing pattern
Instantaneous breathing rate [breaths per minute]
Breathing rate statistics (10th, 50th, and 90th quantiles) [breaths per minute]
Body movement
Time in bed [hours]
Presence detection
Heart rate [beats per minute]
Heart rate statistics (10th, 50th, and 90th quantiles) [beats per minute]

The overall system can be grouped into 4 major components, which are classified on the basis of the logical component interfaces where data exchange is occurring.

Sleepiz Hardware - This is a hardware component serving as primary data acquisition device.

Page 6

Embedded Software - This encompasses the firmware running of the Sleepiz Hardware. This, together with Sleepiz hardware, is responsible for data acquisition. The embedded software forms the crux of the Sleepiz hardware such that it defines and controls the data acquisition process. The security aspects related to the operation of the device are incorporated in the design and implementation of embedded software.
Sleep Analytics Software - The sleep analytics software is responsible for processing data from the Sleepiz Hardware and returning its analytics (e.g., breathing rate, heart rate), as well as its statistics (e.g., mean breathing rate, total recording time, etc.). This refers to the ML model deployed within the cloud software. By itself, the Sleep Analytics Software does not have an external interface. It is wholly encapsulated by the cloud software component Data Processing Layer.
Cloud Software - The cloud software can be divided into the backend service and the analytics service. The backend service includes modules for data ingestion, a public API, a private API, and a module for sending analysis process requests. The analytics service is responsible for receiving analysis requests and interacting with the sleep analytics software.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indication for use of the subject device and the predicate device are the same; therefore, the intended use environment, intended users, including patient population, and the parameters being monitored, remain unchanged.

Technological Comparison

21 CFR 807.92(a)(6)

The subject device like the predicate uses radar technology to collect patient's physiological signals. The collected data is then transmitted via the internet to the backend server in both devices. The subject and the predicate device differ in how physicians access patient data. While the predicate device provides a dedicated web application to log in and visualize patient data, the subject device provides Application Programming Interface (API) links enabling physicians to access patient data through third-party systems. This transition from a web-based interface to an API-based approach does not introduce new risks or compromise the safety and effectiveness of the subject device as it enhances flexibility while maintaining compliance with security and regulatory requirements.

While the predicate device is battery operated, the subject device has plug-in power, but both essentially require a power source to operate. This difference raises some questions of safety and performance however those risks are well mitigated through various electrical, EMC, thermal testing.

Comprehensive verification, validation, and performance testing have rigorously assessed all differences between the devices, confirming that the subject device remains safe, reliable, and poses no new questions regarding safety or effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Non-clinical Performance Testing

As part of demonstrating substantial equivalence to the predicate device, Sleepiz AG completed a number of non-clinical performance tests. The device meets all the requirements of the overall design. Testing results confirm that the design output meets the design inputs and specifications for the device.

Software Verification and Validation (as per IEC 62304:2006/A1:2015)
Electrical Safety (as per IAN SI AAMI ES60601-1, ANSI AAMI HA60601-1-11)
Electromagnetic Compatibility Testing (as per IEC 60601-1-2:2014 + A1:2020)

Conclusion

Sleepiz AG considers the subject device substantially equivalent to the predicate device. This conclusion is based upon the identical intended use, principle of operation, and similar technological characteristics between the subject and predicate devices. The minor modifications made in the subject device do not alter the intended use of the device, do not impact fundamental scientific technology, or raise new questions of safety or effectiveness. The verification and validation tests performed on the subject device confirm that the device performs as intended in the specified use conditions and comparably to the predicate device. The performance testing conducted shows comparable results between the two models, thereby, demonstrating the safety and performance of the Sleepiz One+ (V.2.5). Hence, it can be concluded that the Sleepiz One+ (V.2.5) is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).