Onera STS 2 (ONERA STS 2)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION July 3, 2025 Onera B.V. Pieter Ermers Managing Director Torenallee 42-54 Eindhoven, 5617BD Netherlands Re: K243220 Trade/Device Name: Onera STS 2 (ONERA STS 2) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR, OLV Dated: June 3, 2025 Received: June 3, 2025 Dear Pieter Ermers: 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. 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" {1} K243220 - Pieter Ermers Page 2 (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-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). {2} K243220 - Pieter Ermers Page 3 Sincerely,  Patrick Antkowiak -S 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K243220 | | | Device Name Onera STS 2 | | | Indications for Use (Describe) Onera STS 2 measures and records multiple physiological parameters from a patient during a sleep study, which are used by clinicians to decide on the diagnosis of sleep disorders. Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography 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 the healthcare professional to assist in the diagnosis of sleep disorders. The device is intended to be used for adults. The device is not a life supporting physiological monitor. | | | 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) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} Page 1 of 8 # K243220 Traditional 510(k) Summary Prepared in accordance to 21 CFR 807.92 ## Contact Details: Applicant's Name and Address: Onera B.V. Torenallee 42-54 5617BD Eindhoven The Netherlands ## Contact Person: Pieter Ermers VP Q&amp;R, Managing Director Email: Pieter.Ermers@Onerahealth.com Phone: +31 (0) 403 082 177 Date prepared: July 2, 2025 ## Device Name: Trade name: Onera Sleep Test System 2 / Onera STS 2 Common Name: Ventilatory Effort Recorder Classification: 21 CFR 868.2375, Breathing frequency monitor Primary Product Code: MNR Secondary Product Code: OLV Device Class: 2 ## Device Description: Onera Sleep Test System 2 (Onera STS 2) is a hardware, wearable system for measuring physiological signals during a sleep study. The device can be used in the home (Home Healthcare Environment) as well as in Professional Healthcare Facilities. The device measures EEG, EOG, EMG, ECG, respiratory signals, cannula based respiratory flow, oxygen saturation, activity, position, ambient light level and sound pressure level. The ECG signal is not intended for diagnosis of cardiac disorders, except for the manual determination of arrhythmia during polysomnography studies. {5} Page 2 of 8 The Onera STS 2 does not provide any automated output like heart rate, assessments of arrhythmia, heart rate variability, or other related heart rate measurement functions. Onera STS 2 consists of five Sensors applied on the forehead, upper chest area, abdomen and lower leg area (both left and right leg). The Sensors should be placed on intact skin. During the night measurement it is not needed to inspect the application sites. The Sensors encrypt the recorded signals and upload the measurement data during the night to the Patient App installed on the patient's phone via Bluetooth. The Patient App securely transfers the data to the cloud interface for further processing once all data has been uploaded. The output of the system is represented by a file in EDF format which contains the recorded (physiological) signals. EDF files can be read by any application software that accepts such files as input. It is not possible to relocate the Sensors during a sleep study since the Sensor is single-use and for one sleep study only. ## Intended Use: Onera STS 2 measures and records multiple physiological parameters from a patient during a sleep study, which are used by clinicians to decide on the diagnosis of sleep disorders. Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography 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 the healthcare professional to assist in the diagnosis of sleep disorders. The device is intended to be used for adults. The device is not a life supporting physiological monitor. The Onera Analysis Service has the same indications as the predicate device. ## Legally marketed Predicate Device: | 510(k) Number | Device Name | Type | | --- | --- | --- | | K223573 | Onera STS | Predicate device | ## Technological Comparison: The table below provides a comparison between the Onera Analysis Service and the predicate device. | Characteristic | Proposed device Onera STS 2 | Predicate device Onera STS 1 | Discussion | | --- | --- | --- | --- | | General | | | | | Manufacturer | Onera B.V., The Netherlands | Onera B.V., The Netherlands | -- | | 510(k) number | K243220 | K223573 | -- | | Regulation number | 21 CFR 868.2375 | 21 CFR 868.2375 | Same | | Product code | MNR | MNR | Same | {6} Page 3 of 8 | Characteristic | Proposed device Onera STS 2 | Predicate device Onera STS 1 | Discussion | | --- | --- | --- | --- | | Indications for Use Statement | Onera STS 2 measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to decide on the diagnosis of sleep disorders. Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography 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 the healthcare professional to assist in the diagnosis of sleep disorders. The device is intended to be used for adults. | 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. | Identical | | Intended Use Environment | Home and professional environments. | Home and professional environments. | Identical | | Limitations of Use | The device is not a life supporting physiological monitor. The ECG signal is not intended for diagnosis of cardiac disorders, except for the manual determination of arrhythmia during polysomnography studies. The Onera STS 2 does not provide any automated output like heart rate, assessments of arrhythmia, heart rate variability, or other related heart rate measurement functions. | The device is not a life supporting physiological monitor. | Identical | {7} Page 4 of 8 | Characteristic | Proposed device Onera STS 2 | Predicate device Onera STS 1 | Discussion | | --- | --- | --- | --- | | Operating principle | 1. Measuring of electrophysiological and other (sound, flow, position) signals via a range of sensors. 2. Recording of the data. 3. Extracting the data offline via dedicated software 4. Making the data available for display on a suitable platform | 1. Measuring of electrophysiological and other (sound, flow, position) signals via a range of sensors. 2. Recording of the data. 3. Sending data to a cloud platform via a connected smartphone. 4. Making the data available for display on a suitable platform | Similar. The wireless connection instead of wired connection for data extraction does not lead to new questions on safety or effectiveness as supported by the risk analysis. | | Energy | Measuring of electrophysiological signals and other signals (sound, flow, ...). Non-rechargeable battery powered devices. | Measuring of electrophysiological signals and other signals (sound, flow, ...). Rechargeable battery powered devices. | Comparable. The different battery type does not raise new questions on safety or effectiveness as supported by the risk analysis and electrical safety testing. | | Sterility | No sterile parts involved | No sterile parts involved | Identical | | Materials / Biocompatibility | Materials biocompatible conform ISO10933 series including the adhesive patches | Materials biocompatible conform ISO10933 series including the adhesive patches | Identical | | System setup | • 4 wearable disposable sensors: • Head • Chest • Flow • Leg • Smartphone app to transfer data to cloud platform • Cloud platform to make data available to users. | • 4 wearable reusable sensors: • Head • Chest • Flow • Leg • Software to extract data and make available to users. | Comparable. The sensors being disposable reduces risks related to reuse (e.g. cleaning). The app and cloud platform are different technologies to consolidate the sensor data in an output file and make it available to users. This different technology does not raise different questions on safety or effectiveness. | | Generic performance data | | | | | Recording time | 16 hours | 16 hours | Both are sufficient for the intended use. | {8} | Characteristic | Proposed device Onera STS 2 | Predicate device Onera STS 1 | Discussion | | --- | --- | --- | --- | | Data interface | Bluetooth | USB | Similar. The Bluetooth interfaces link the sensors to a connected smartphone. The wireless connection instead of wired connection for data extraction does not raise different questions of safety or effectiveness as supported by the risk analysis. | | Data output file | EDF | EDF | Identical | | Expected service life (reusables) | N/A, single use device | 200 cycles or 5 years | The sensors being disposable reduces risks related to reuse (e.g. cleaning). | | Sensors IP class | IP54 | IP54 | Identical | | Measured parameters (# channels, location, sample rate, resolution, accuracy) | | | | | EEG | • 2 channels • Frontal R, frontal L • Sampling: 256Hz • 16bit | • 2 channels • Frontal R, frontal L • Sampling: 256Hz • 16bit | Identical | | EOG | • 2 channels • EOG R, EOG L • Sampling: 256Hz • 16bit | • 2 channels • EOG1, EOG2 • Sampling: 256Hz • 16bit | Identical | | EMG head | • 2 channels • EMG mas R, EMG mas L • Sampling: 256Hz • 16bit | • 2 channels • EMG mas R, EMG mas L • Sampling: 256Hz • 16bit | Identical | | EMG leg (one leg) | • 1 channel • leg - specific location • Sampling: 256Hz • 16bit | • 1 channel • leg - specific location • Sampling: 256Hz • 16bit | Identical | | SpO2 forehead | • SpO2, PPG red & infrared • forehead • Sampling: 2Hz • 1% resolution • 3% at 70-100%SpO2; Pulse rate 30-200bpm | • SpO2, PPG red & infrared • forehead • Sampling: 2Hz • 1% resolution • 4% at 70-100%SpO2; Pulse rate 30-200bpm | Comparable. The improved accuracy does not raise different questions of safety or effectiveness. | | ECG | • 1 channel • Chest • Sampling: 256Hz • 16bit • Noise < 1 μVRMS, CMRR: >=80dB | • 1 channel • Chest • Sampling: 256Hz • 16bit • Noise < 1 μVRMS, CMRR: >=80dB | Identical | | Respiratory effort | • 1 channel • Chest (derived via measured bioimpedance) • Sampling: 64Hz • 16bit | • 1 channel • Chest (derived via measured bioimpedance) • Sampling: 64Hz • 16bit | Identical | {9} Page 6 of 8 | Characteristic | Proposed device Onera STS 2 | Predicate device Onera STS 1 | Discussion | | --- | --- | --- | --- | | Respiratory flow | • 1 channel • Nasal cannula • Sampling 256Hz • 16bit | • 1 channel • Nasal cannula • Sampling 256Hz • 16bit | Identical | | Position | • 1 channel • Chest sensor (derived from 3D accelerometer) • Sampling 1Hz • 1° | • 1 channel • Chest sensor (derived from 3D accelerometer) • Sampling 1Hz • 1° | Identical | | Activity chest | • 1 channel • Chest sensor (derived from 3D accelerometer) • Sampling 16Hz • 15bits • 0 to 6g | • 1 channel • Chest sensor (derived from 3D accelerometer) • Sampling 16Hz • 15bits • 0 to 6g | Identical | | Sound pressure | • 1 channel • Chest – microphone • Sampling 64Hz (3kHz microphone) • 0.1 dB resolution | • 1 channel • Chest – microphone • Sampling 64Hz (3kHz microphone) • 0.1 dB resolution | Identical | | Environmental conditions | | | | | Operating temperature | 5°C - 40°C | 10°C - 40°C | Comparable; the subject device is usable at lower temperatures | | Operating relative humidity | 10% - 90% | 10% - 90% | Identical | | Storage temperature | 12°C - 28°C | 10°C - 40°C | The more limited storage condition is clearly indicated on the labeling and does not raise different questions of safety or effectiveness. | | Transport temperature | -7°C - 50°C | 10°C - 40°C | The more extended transport conditions do not raise different questions of safety or effectiveness. | | Conformance to Standards | | | | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | Identical | | Basic Safety and essential performance | IEC 60601-1 | IEC 60601-1 | Identical | | Safety and essential performance of electrocardiographs | IEC 60601-2-25 | IEC 60601-2-25 | Identical | | Safety and essential performance of Electroencephalographs | IEC 80601-2-26 | IEC 80601-2-26 | Identical | {10} Page 7 of 8 | Characteristic | Proposed device Onera STS 2 | Predicate device Onera STS 1 | Discussion | | --- | --- | --- | --- | | Safety and essential performance of Electromyographs and evoked response equipment | IEC 60601-2-40 | IEC 60601-2-40 | Identical | | Safety and essential performance of pulse oximeter equipment | IEC 80601-2-61 | IEC 80601-2-61 | Identical | The Onera Sleep Test System 2 has the same technological characteristics as the predicate device except for the following features: - The Onera STS 2 has a wireless connection via the cloud for data retrieval, in comparison to the wired/networked connectivity of the predicate device. - The Onera STS 2 system is a single use system in comparison to the re-usable predicate device. These differences do not raise different questions of the safety or effectiveness of the Onera Sleep Test System 2 and valid scientific evidence has been submitted to account for the changes to the device. ## Non-Clinical and/or Clinical Tests Summary &amp; Conclusions: Performance testing on the Onera STS 2 device confirmed that the device conforms to the defined requirements including 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 - ANSI/AAMI EC 12 Disposable Electrodes Biocompatibility testing was performed as listed in the table below: | Test | Results | Conclusions | | --- | --- | --- | | Cytotoxicity | Exposure of L929 mammalian cell cultures to test item extracts shows no cytotoxic potential. | No cytotoxic potential | | Irritation or Intracutaneous reactivity | Electrode and enclosure did not produce any primary dermal reaction after exposure to the skin of New Zealand White Rabbits. | Nonirritating potential | | Sensitization | Electrode and enclosure did not induce any skin reaction scores at the challenge exposure following an induction phase when applied topical to albino guinea pigs. | No sensitization potential | {11} Page 8 of 8 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 ### Spo2 measurement accuracy: $\mathrm{SpO}_2$ accuracy testing was conducted, as recommended by the FDA Guidance for Industry and FDA Staff Pulse Oximeters – Premarket Notification Submissions [510(k)s], during induced hypoxia studies on 12 healthy, light-to-dark-skinned male (9) and female (3) subjects aged between 23 and 46 years old, in a reclined position, in an independent research laboratory. The measured arterial hemoglobin saturation values ($\mathrm{SpO}_2$) of the sensor were compared to the arterial hemoglobin oxygen ($\mathrm{SaO}_2$) values, determined from blood samples with a laboratory co-oximeter. The accuracy of the sensor was calculated using the root-mean-squared difference ($A_{\text{rms}}$ value) between the measured values and the reference values for all subjects over the $\mathrm{SpO}_2$ range of 70 - 100 %. The $\mathrm{SpO}_2$ accuracy testing, and the data analysis were performed as per ISO 80601-2-61. The Onera STS2 SpO2 showed an accuracy of $\pm 2.5\%$ in the range 70-100%, which is within the pass/fail criteria described in ISO80601-2-61:2019 Clause 201.12.1.101.1. Based on the information included in this submission, it was concluded that the Onera Sleep Test System 2 is as safe, as effective and performs as well as the legally marketed device identified above.