Onera STS measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.

Onera STS is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson. The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders.

The device is intended to be used for adults.

Device Description

Onera STS is a wearable system for measuring (physiological) signals during a sleep study. The device can be used in home (Home Healthcare Environment) as well as Professional Healthcare Facilities, to perform the sleep study.

Onera STS consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area.

The sensors measure EEG, EOG, EMG, ECG, bioimpedance based respiratory effort, bioimpedance based respiratory flow, cannula based respiratory flow, oxygen saturation, activity, position, and sound pressure level.

The study preparation and data retrieval are done in a professional/clinical environment by the trained operator. The device is provided to the user by the trained operator.

The device is not a life supporting physiological monitor.

AI/ML Overview

The provided text is a 510(k) summary for the Onera Sleep Test System (Onera STS). It details the device, its intended use, and a comparison to a previously cleared predicate device (K210593). The primary change in this submission (K223573) is an extension of the device's use time from 8 hours to 16 hours.

It's crucial to understand that this document is a premarket notification asserting substantial equivalence, not a detailed clinical study report proving performance against specific acceptance criteria for diagnostic accuracy. The FDA's review for a 510(k) focuses on safety and effectiveness in comparison to a predicate device, rather than requiring new, full-scale clinical trials for every parameter.

Therefore, the information regarding acceptance criteria and performance studies within this document is limited to demonstrating that the change (extended wear time) does not introduce new safety or effectiveness concerns, and that the device still meets regulatory standards. There is no information provided about a study that assesses the device's diagnostic accuracy or performance against specific, quantifiable "acceptance criteria" for detecting sleep disorders. The device is described as measuring and recording parameters for clinicians to use, not as an automated diagnostic tool itself.

Given this context, I will address your points based on the available information in the provided text.

Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)

The FDA 510(k) summary primarily focuses on demonstrating that the modified device (Onera STS with 16-hour wear time) is substantially equivalent to its predicate device (Onera STS with 8-hour wear time) and that the change does not introduce new safety or effectiveness concerns. There are no explicit "acceptance criteria" for diagnostic accuracy or performance of the device in the context of detecting sleep disorders presented in this document. The "performance testing" mentioned is related to meeting general safety and performance standards, and verifying that the extended wear time does not degrade existing performance or safety.

Table of Comparison (Not "Acceptance Criteria" for Diagnostic Performance):

The table below summarizes the comparison between the proposed device and the predicate, highlighting the only stated difference: extended use time. This is a demonstration of substantial equivalence rather than meeting specific diagnostic acceptance criteria.

Characteristic	Proposed device Onera STS	Currently cleared Onera STS (Predicate)	Result	Implication for "Acceptance"
Recording time	16 hours	8 hours	Extended use time	The primary change, supported by "new skin irritation testing and 16-hour wear time testing as part of design verification and validation activities" to ensure continued safety and performance at extended duration. This is the core "acceptance" point for this 510(k).
Regulation Number	21 CFR 868.2375	21 CFR 868.2375	Identical	Regulatory classification is the same.
Product Code	MNR	MNR	Identical	Product code is the same.
Indications General	Measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders. Intended for patients prescribed a sleep study; applied by layperson under direction of physician/trained technician. Recorded data assists healthcare professional.	Measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders. Intended for patients prescribed a sleep study; applied by layperson under direction of physician/trained technician. Recorded data assists healthcare professional.	Identical	Intended use remains the same.
Indications – Patient population	Adults	Adults	Identical	Target population remains the same.
Indications – Environment	Home and professional environments.	Home and professional environments.	Identical	Usage environment remains the same.
Indications - Limitations	Not intended to monitor or diagnose the patient and does not issue alarms.	Not intended to monitor or diagnose the patient and does not issue alarms.	Identical	Device limitations remain the same.
Operating principle	Measuring of electrophysiological and other (sound, flow, position) signals via a range of sensors. Recording of the data. Making the data available for display on a suitable platform.	Measuring of electrophysiological and other (sound, flow, position) signals via a range of sensors. Recording of the data. Making the data available for display on a suitable platform.	Identical	Core technology and function are unchanged.
Energy	Battery powered devices.	Battery powered devices.	Identical	Power source unchanged.
Materials	Patches are included with the device and found biocompatible.	Patches are included with the device and found biocompatible.	Identical	Materials remain the same, biocompatibility verified.
Measured parameters (EEG, EOG, EMG head, EMG leg, SpO2, ECG, Respiratory effort via bioimpedance, Respiratory flow via nasal cannula, Sound pressure)	All listed as identical. ECG listed as "Similar" for proposed device vs predicate but this appears to be a formatting error in the FDA document as it is then listed as "Identical" across the line. Assuming it is identical.	All listed as identical.	Identical (or similar as noted for ECG, likely formatting error)	The parameters measured are unchanged.
Derived parameters (Position, Activity)	Identical	Identical	Identical	Derived parameters are unchanged.
Operating temperature	10°C - 40°C	10°C - 40°C	Identical	Operating range unchanged.
Operating relative humidity	10% - 90%	10% - 90%	Identical	Operating range unchanged.

Study Details (Based on provided 510(k) Summary)

The provided document describes a 510(k) "premarket notification" which asserts substantial equivalence, not a dedicated clinical study for diagnostic accuracy. Therefore, information related to diagnostic performance studies, AI algorithms, human readers, or specific "acceptance criteria" for disease diagnosis is largely absent.

A table of acceptance criteria and the reported device performance:
- As explained above, the "acceptance criteria" discussed are for substantial equivalence and compliance with general safety and performance standards for a medical device (e.g., biocompatibility for extended wear, electrical safety, EMC).
- The reported performance for the primary change (extended wear time) is implied by the statement: "The extension is supported by new skin irritation testing and 16-hour wear time testing as part of design verification and validation activities." This testing demonstrated that the device performs safely and effectively for the increased duration. No quantitative performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity for detecting specific sleep disorders) are provided, as the device records data for clinicians to use for diagnosis, it does not autonomously diagnose.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states: "No clinical data was required to support equivalence." This means a dedicated clinical test set for diagnostic accuracy was not part of this 510(k) submission.
- The extended wear time and skin irritation testing would have involved engineering and biocompatibility testing, likely using a limited number of human subjects or in-vitro/in-vivo models. Specific sample sizes and provenance for these verification/validation activities are not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. Since "No clinical data was required," there was no clinical test set for which ground truth needed to be established by experts for diagnostic performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- Not applicable. The document does not describe the device as incorporating AI for automated diagnosis or interpretation to assist human readers. The device records physiological parameters for clinicians to interpret.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device's stated function is to "measure and record multiple physiological parameters... which are used by clinicians to make a decision on the diagnosis of sleep disorders." It is not presented as a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for diagnostic ground truth. The "ground truth" for this 510(k) was the predicate device's cleared performance and safety standards, combined with verification and validation of the extended wear time not introducing new risks.
The sample size for the training set:
- Not applicable. This device is not described as involving machine learning or AI that would require a "training set" for diagnostic functions.
How the ground truth for the training set was established:
- Not applicable.

Summary

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August 18, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Onera B.V. Ruben de Francisco Martin Managing Director Torenallee 42-54 Eindhoven. NB 5617BD Netherlands

Re: K223573

Trade/Device Name: Onera Sleep Test System (Onera STS) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR. OLV Dated: July 20, 2023 Received: July 21, 2023

Dear Ruben de Francisco Martin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jay R. Gupta -S

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) K223573

Device Name Onera Sleep Test System (STS)

Indications for Use (Describe)

Onera STS measures and records multiple physiological parameters from a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.

The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders.

The device is intended to be used for adults.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Acc. to 807.92

Applicant's Name and Address:	Onera B.V.Torenallee 42-545617BD EindhovenThe Netherlands
Contact Person:	Ruben de Francisco MartinManaging DirectorEmail: ruben@onerahealth.comPhone: +31 (0) 403 082 177
Date submission was prepared:	October 30, 2022
Device Name:
Trade name:	Onera Sleep Test System (STS)
Common Name:	Ventilatory Effort Recorder
Classification:	21 CFR 868.2375, Breathing frequency monitor
Product Codes:	MNR, OLV
Device Class:	2

Product Description:

Onera STS consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area.

The study preparation and data retrieval are done in a professional/clinical environment by the trained operator. The device is provided to the user by the trained operator.

The device is not a life supporting physiological monitor.

Indications for Use:

Onera STS measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.

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assist in the diagnosis of sleep disorders.

The device is intended to be used for adults.

Legally marketed devices to which substantial equivalence is claimed

510(k) Number	Device Name	Type
K210593	Onera STS	Predicate device

Device modifications

The table below provides an overview of the proposed change to the Onera STS device in comparison with the predicate and currently marketed Onera STS device.

#	Scope	Description
1	Labeling	Extend the use time from 8 hours to 16 hours. The extension issupported by new skin irritation testing and 16-hour wear time testing as part ofdesign verification and validation activities

Substantial Equivalence

The table below provides a comparison between the Onera STS device and the predicate device.

Characteristic	Proposed deviceOnera STS	Currently cleared Onera STS	Result
Manufacturer	Onera B.V., The Netherlands		--
510(k) number	K223573	K210593	--
Regulation number	21 CFR 868.2375	21 CFR 868.2375	Identical
Product code	MNR	MNR	Identical
Indications general	Onera STS measures andrecords multiple physiologicalparameters from a patientduring a sleep study whichare used by clinicians to makea decision on the diagnosis ofsleep disorders.Onera STS intended to beused on a patient, who hasbeen prescribed apolysomnography study by ahealthcare professional. Thedevice is designed to be usedunder the direction of aphysician or trainedtechnician but applied by alayperson.The recorded data will bemade available to ahealthcare professional toassist in the diagnosis ofsleep disorders.	Onera STS measures andrecords multiple physiologicalparameters from a patientduring a sleep study whichare used by clinicians to makea decision on the diagnosis ofsleep disorders.Onera STS intended to beused on a patient, who hasbeen prescribed apolysomnography study by ahealthcare professional. Thedevice is designed to be usedunder the direction of aphysician or trainedtechnician but applied by alayperson.The recorded data will bemade available to ahealthcare professional toassist in the diagnosis ofsleep disorders.	Identical
Characteristic	Proposed deviceOnera STS	Currently cleared Onera STS	Result
Indications – Patientpopulation	The device is intended to beused for adults.	The device is intended to beused for adults.	Identical
Indications – Environment	Home and professionalenvironments.	Home and professionalenvironments.	Identical
Indications - Limitations	The device is not intended tomonitor or diagnose thepatient and does not issuealarms	The device is not intended tomonitor or diagnose thepatient and does not issuealarms	Identical
Operating principle	Measuring ofelectrophysiological andother (sound, flow, position)signals via a range of sensors.Recording of the data.Making the data available fordisplay on a suitable platform	Measuring ofelectrophysiological andother (sound, flow, position)signals via a range of sensors.Recording of the data.Making the data available fordisplay on a suitable platform	Identical
Energy	Measuring ofelectrophysiological signalsand other signals (sound,flow, ...). Battery powereddevices.	Measuring ofelectrophysiological signalsand other signals (sound,flow, ...). Battery powereddevices.	Identical
Materials	Patches are included with thedevice and foundbiocompatible (see summarybelow)	Patches are included with thedevice and foundbiocompatible (see summarybelow)	Identical
Recording time	8 hours	16 hours	Extended use time
Measured parameters	EEG (2 channels)	EEG (2 channels)	Identical
	EOG (2 channels)	EOG (2 channels)	Identical
	EMG head (2 channels)	EMG head (2 channels)	Identical
	EMG leg (one leg)	EMG leg (one leg)	Identical
	SpO2 forehead	SpO2 forehead	Identical
	ECG (1 channel)	ECG (1 channel)	Similar
	Respiratory effort (onechannel via bioimpedance)	Respiratory effort (onechannel via bioimpedance)	Identical
	Respiratory flow via nasalcannula	Respiratory flow via nasalcannula	Identical
	Sound pressure	Sound pressure	Identical
Derived parameters	Position (1 channel derivedfrom 3D accelerometer)	Position (1 channel derivedfrom 3D accelerometer)	Identical
	Activity (chest)	Activity (chest)	Identical
Operating temperature	10°C - 40°C	10°C - 40°C	Identical
Operating relative humidity	10% - 90%	10% - 90%	Identical

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The technology to obtain information on respiratory effort is equivalent to that of the defined reference device.

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Other than the extended use time described above, there are no differences in technological characteristics between this Onera STS device and the Onera STS device cleared under K210593. The intended use of the device is the same as the predicate device.

None of the indicated changes introduce new questions of safety or effectiveness.

Summary of Performance Testing

Performance testing on the changed Onera STS device confirmed that the changed device conforms to the defined requirements.

The proposed Onera STS is found in compliance with the applicable requirements of the following standards:

. IEC 60601-1 Basic safety and essential performance
IEC 60601-1-2 EMC
IEC 60601-2-25 Basic safety and essential performance of electrocardiographs
IEC 80601-2-26 Basic safety and essential performance of electroencephalographs
IEC 60601-2-40 Basic safety and essential performance of electromyographs and evoked response equipment
ISO 80601-2-61 Basic safety and essential performance of pulse oximeter equipment
ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

A risk management process conforming with ISO 14971 was completed for the device. A usability engineering process conforming with IEC 62366-1 was completed for the device. All device software was developed in a process conforming with IEC 62304.

Summary of Clinical testing

No clinical data was required to support equivalence.

Conclusion

Based on the information included in this submission, it was concluded that the proposed changed Onera STS device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).