Onera Sleep Test System (Onera STS)

{0}------------------------------------------------ April 6, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Onera B.V. Ruben De Francisco Martin Managing Director Torenallee 42-54 Eindhoven. North Brabant 5617BD Netherlands Re: K210593 Trade/Device Name: Onera Sleep Test System (STS) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR, OLV Dated: March 4, 2022 Received: March 7, 2022 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 {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210593 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. 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. | 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) #### 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." {3}------------------------------------------------ # 510(K) SUMMARY #### Acc. to 807.92 Applicant's Name and Address: Onera B.V. Torenallee 42-54 5617BD Eindhoven The Netherlands Contact Person: Ruben de Francisco Martin Managing Director Email: ruben@onerahealth.com Phone: +31 (0) 403 082 177 February 19, 2021 Date submission was prepared: Device Name: Trade name: Onera Sleep Test System (STS) Ventilatory Effort Recorder Common Name: Classification: 21 CFR 868.2375, Breathing frequency monitor Product Codes: MNR, OLV Device Class: 2 #### Product 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 a dedicated 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. 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. {4}------------------------------------------------ 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. | Legally marketed devices to which substantial equivalence is claimed | | | |----------------------------------------------------------------------|---------------------------------|------------------| | 510(k) Number | Device Name | Type | | k122516 | Embletta MPR | Predicate device | | k161531 | MP50 IntelliVue Patient Monitor | Reference device | # Substantial Equivalence The table below provides a comparison between the Onera STS device and the predicate device. | Characteristic | Proposed device<br>Onera STS | Predicate device<br>Embletta MPR | Result | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation number | 21 CFR 868.2375 | 21 CFR 868.2375 | Same | | Product code | MNR | MNR | Same | | Indications general | Onera STS measures and<br>records multiple physiological<br>parameters from a patient<br>during a sleep study which are<br>used by clinicians to make a<br>decision on the diagnosis of<br>sleep disorders.<br>Onera STS intended to be used<br>on a patient, who has been<br>prescribed a sleep study by a<br>healthcare professional. The<br>device is designed to be used<br>under the direction of a<br>physician or trained technician<br>but applied by a layperson.<br>The recorded data will be made<br>available to a healthcare<br>professional to assist in the<br>diagnosis of sleep disorders. | The Embletta MPR is a digital<br>recording device designed to<br>be used under the direction of<br>a physician or trained<br>technician but may be applied<br>by a layperson. The Embletta<br>MPR records multiple<br>physiological parameters from<br>a sleeping patient for the<br>purpose of simultaneous or<br>subsequent display of the<br>parameters. The displayed data<br>assists in the identification of<br>sleep-related medical disorders<br>by trained personnel. | Substantially equivalent | | Indications — Patient<br>population | The device is intended to be<br>used for adults. | The Embletta MPR is intended<br>to be used for adult and<br>pediatric (excluding infants and<br>neonatal) studies. The device is<br>not equipped with alarms and<br>is not intended to be used as a<br>monitor. | Substantially equivalent | | Characteristic | Proposed device<br>Onera STS | Predicate device<br>Embletta MPR | Result | | Indications - Environment | Home and professional<br>environments. | The intended environments<br>include any clean, dry, dust<br>free environment suitable for a<br>patient's relative comfort. | Substantially equivalent | | Indications - Limitations | The device is not intended to<br>monitor or diagnose the<br>patient and does not issue<br>alarms | The device does not monitor or<br>diagnose the patient and does<br>not issue any alarms. | Substantially equivalent | | Operating principle | Measuring of<br>electrophysiological and other<br>(sound, flow, position) signals<br>via a range of sensors.<br>Recording of the data. Making<br>the data available for display<br>on a suitable platform | Measuring of<br>electrophysiological and other<br>(sound, flow, position) signals<br>via a range of sensors.<br>Recording of the data. Making<br>the data available for display<br>on a suitable platform | Identical | | Energy | Measuring of<br>electrophysiological signals and<br>other signals (sound, flow, ...).<br>Battery powered devices. | Measuring of<br>electrophysiological signals and<br>other signals (sound, flow, ...).<br>Battery powered and mains<br>powered devices. | Similar | | Materials | Patches are included with the<br>device and found<br>biocompatible (see summary<br>below) | Patches are not part of the<br>device | Comparable | | Duration of Use | 8 hours | 24 hours | Similar | | Measured parameters | EEG (2 channels) | EEG (8 channels) | Comparable | | | EOG (2 channels) | EOG (2 channels) | Same | | | EMG head (2 channels) | EMG head (3 channels) | Similar | | | EMG leg (one leg) | EMG leg (2 legs) | Different<br>Leg movement related<br>sleep disorders can<br>typically be diagnosed<br>by one channel EMG leg | | | SpO2 forehead | SpO2 finger | Different<br>SpO2 can be measured<br>in several locations and<br>clinical data shows<br>sufficient accuracy for<br>this location. | | | ECG (1 channel) | ECG (1 channel) | Similar | | Characteristic | Proposed device<br>Onera STS | Predicate device<br>Embletta MPR | Result | | | Respiratory effort (one channel<br>via bioimpedance) | Respiratory effort (2 channels<br>via belt) | Different but<br>comparable with<br>reference device<br>Measuring respiratory<br>effort using<br>bioimpedance is a<br>common technique<br>providing information<br>on relative changes in<br>lung volume similar to<br>using inductive<br>plethysmography on<br>the chest and the<br>abdomen. | | | Respiratory flow via nasal<br>cannula | Respiratory flow via nasal<br>cannula | Similar | | | Sound pressure | Sound pressure | Similar | | Derived parameters | Position (1 channel derived<br>from 3D accelerometer) | Position (1 channel derived<br>from 3D accelerometer) | Similar | | | Activity (chest) | Activity (Chest) | Similar | | Operating temperature | 10°C - 40°C | 15°C - 40°C | Similar | | Operating relative<br>humidity | 10% - 90% | 0% - 95% | Similar | {5}------------------------------------------------ {6}------------------------------------------------ The technology to obtain information on respiratory effort is equivalent to that of the defined reference device. None of the indicated differences introduces new questions on safety or effectiveness. {7}------------------------------------------------ # Summary of Performance Testing Performance testing on the Onera STS 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 | Test | Results | Conclusions | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Cytotoxicity | Exposure of L929 mammalian cell cultures to<br>test item extracts shows no cytotoxic potential. | No cytotoxic potential | | Irritation or Intracutaneous<br>reactivity | Electrode and enclosure did not produce any<br>primary dermal reaction after exposure to the<br>skin of New Zealand White Rabbits. | Negligible irritant | | Sensitization | Electrode and enclosure did not induce any skin<br>reaction scores at the challenge exposure<br>following an induction phase when applied<br>topical to albino guinea pigs. | No sensitization potential | Biocompatibility testing was performed as listed in the table below: 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: To validate the accuracy of the Onera STS SpO2 sensor, a study was performed using 10 healthy volunteers in a reclined position, in accordance with ISO 80601-2-61:2019 201.12.1.101.2 and Annex EE.2, as recommended by the FDA Guidance for Industry and FDA Staff Pulse Oximeters – Premarket Notification Submissions [510(k)s] . The population sample was middle-aged (21 - 49), light-to-dark-skinned (Fitzpatrick skin tone type II-VI), and balanced in gender (50% male). The Onera STS SpO2 showed an accuracy of ±3% in the range 70-100%, which is within the pass/fail criteria described in ISO80601-2-61:2019 Clause 201.12.1.101.1. # Comparative sleep study testing: A clinical validation study was performed to demonstrate equivalence to the Embletta MPR in sleep staging and physiological scoring. The Onera STS and Embletta MPR were concurrently applied to 32 patients undergoing a routine sleep study. The sample population had a well-distributed range of age (23-80 years) and BMI (21 - 37.2), a predominance of males (90.6%), and several common comorbidities (15.6% Hypertension; 12.5% Cardiac Arrythmia; 9.4% Pulmonary diagnosis). Studies were scored blinded by a qualified sleep professional. There was substantial agreement in scored sleep stages between the Onera STS and Embletta MPR (Cohen's kappa = 0.69). The accuracy, specificity and sensitivity are reported in Table 1, (mean ± {8}------------------------------------------------ standard deviation). When Stage N1 was removed from the analysis, kappa reached 0.81. Sleep parameters showed a high correlation between the Onera STS and Embletta MPR (Total sleep time 0.77; Sleep efficiency 0.65; Sleep latency 0.95; REM onset latency 0.58; Wake after sleep onset 0.55; Minutes in Stage N1 0.67, N2 0.69, N3 0.65, REM 0.91, and Wake 0.64). | | Accuracy (%) | Specificity (%) | Sensitivity (%) | |----------|--------------|-----------------|-----------------| | Wake | 94.08 ± 4.34 | 97.87 ± 2.00 | 61.92 ± 21.70 | | Stage N1 | 89.62 ± 4.23 | 95.25 ± 3.02 | 27.19 ± 12.11 | | Stage N2 | 84.69 ± 4.29 | 81.55 ± 8.05 | 88.32 ± 4.80 | | Stage N3 | 95.60 ± 1.80 | 98.26 ± 2.05 | 76.60 ± 18.58 | | REM | 94.70 ± 3.27 | 95.95 ± 2.66 | 88.12 ± 14.46 | Table 1: Sleep staging accuracy, specificity, and sensitivity between Onera STS and the in-lab PSG. ### Conclusion Based on the information included in this submission, it was concluded that the Onera STS device is substantially equivalent to the identified predicate device.