(401 days)
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.
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
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for the Onera Sleep Test System (K210593):
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" in a quantitative table format for all parameters. However, we can infer some key performance metrics and their proven results:
| Measured Parameter / Aspect | Acceptance Criteria (Implied/Stated) | Reported Device Performance | Study Type |
|---|---|---|---|
| Biocompatibility | No cytotoxic potential | Exposure of L929 mammalian cell cultures to test item extracts shows no cytotoxic potential. | Lab Testing (Cytotoxicity) |
| Negligible irritant | Electrode and enclosure did not produce any primary dermal reaction after exposure to the skin of New Zealand White Rabbits. | Lab Testing (Irritation or Intracutaneous reactivity) | |
| No sensitization potential | 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. | Lab Testing (Sensitization) | |
| SpO2 Measurement Accuracy | ±3% in the range 70-100% (as per ISO 80601-2-61:2019) | Onera STS SpO2 showed an accuracy of ±3% in the range 70-100%. | Clinical Study (SpO2 accuracy validation) |
| Sleep Staging Agreement (Kappa) | Substantial agreement (implied for substantial equivalence) | Cohen's kappa = 0.69 (overall agreement with predicate device). When Stage N1 was removed, kappa reached 0.81. This is generally considered "substantial" to "almost perfect" agreement depending on interpretation. | Clinical Study (Comparative sleep study testing) |
| Sleep Staging Accuracy | High accuracy (implied for substantial equivalence) | Wake: Accuracy 94.08 ± 4.34%, Specificity 97.87 ± 2.00%, Sensitivity 61.92 ± 21.70% Stage N1: Accuracy 89.62 ± 4.23%, Specificity 95.25 ± 3.02%, Sensitivity 27.19 ± 12.11% Stage N2: Accuracy 84.69 ± 4.29%, Specificity 81.55 ± 8.05%, Sensitivity 88.32 ± 4.80% Stage N3: Accuracy 95.60 ± 1.80%, Specificity 98.26 ± 2.05%, Sensitivity 76.60 ± 18.58% REM: Accuracy 94.70 ± 3.27%, Specificity 95.95 ± 2.66%, Sensitivity 88.12 ± 14.46% | Clinical Study (Comparative sleep study testing) |
| Sleep Parameter Correlation | High correlation (implied for substantial equivalence) | 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 Wake: 0.64 | Clinical Study (Comparative sleep study testing) |
2. Sample Size Used for the Test Set and Data Provenance
- SpO2 Accuracy Validation:
- Sample Size: 10 healthy volunteers.
- Data Provenance: Not explicitly stated regarding country of origin, but described as a controlled study meeting ISO standards. It is a prospective study as it involved active data collection from subjects for the purpose of validating the device.
- Comparative Sleep Study Testing (Primary Clinical Test Set):
- Sample Size: 32 patients.
- Data Provenance: Not explicitly stated regarding country of origin or if it was retrospective or prospective. However, the description states "concurrently applied to 32 patients undergoing a routine sleep study," which implies a prospective, clinical data collection for the validation purpose.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- SpO2 Accuracy Validation: The ground truth for SpO2 accuracy is typically established using a reference oximeter that has been calibrated and validated according to specific standards (e.g., arterial blood gas measurements). The document does not specify the number or qualifications of experts involved in the direct "ground truth" establishment, as it's a technical parameter validated against a standard reference.
- Comparative Sleep Study Testing:
- Number of Experts: Not explicitly stated. The document mentions "Studies were scored blinded by a qualified sleep professional." This phrasing suggests at least one, but possibly more, qualified sleep professionals were involved.
- Qualifications: "Qualified sleep professional." Specific details like years of experience or board certification (e.g., diplomate of the American Board of Sleep Medicine) are not provided.
4. Adjudication Method for the Test Set
- SpO2 Accuracy Validation: No explicit adjudication method is mentioned, as SpO2 validation against a reference is a direct measurement comparison.
- Comparative Sleep Study Testing: The scoring was done "blinded" by a qualified sleep professional. It's not explicitly stated if multiple professionals scored and then adjudicated differences (e.g., 2+1, 3+1). The wording "a qualified sleep professional" might suggest single-reader scoring relative to the predicate device, or it might be a simplification of a more complex process. More specific adjudication methods (e.g., consensus, expert panel review) are not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
- No explicit MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was described. This study is focused on the device's ability to record and process physiological parameters similarly to a predicate device, and the sleep staging/scoring is done by a human professional based on the device's output. The device itself is not described as providing AI-assisted interpretations that then improve human reader performance. Its purpose is to provide the raw data for such interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The study is essentially a standalone performance evaluation of the device's data collection and preliminary processing capabilities, compared against a predicate device. The "scoring" is done by a human, but the device provides the signals for that scoring. Therefore, the device's performance in generating these signals is evaluated independently of a human's final diagnostic decision. The agreement metrics (Cohen's kappa, accuracy, sensitivity, specificity, correlation) reflect the device's ability to produce data that leads to similar scores as the predicate device.
7. Type of Ground Truth Used
- SpO2 Accuracy Validation: The ground truth for SpO2 was based on a reference standard (likely a co-oximeter or another highly accurate method) as per ISO 80601-2-61:2019, generally derived from arterial blood gas measurements.
- Comparative Sleep Study Testing: The ground truth was established by comparing the Onera STS data to the data from the predicate device (Embletta MPR), with both sets of data scored by a "qualified sleep professional." This means the ground truth for sleep staging and physiological scoring is expert scoring of data from a legally marketed device. It is not stated to be pathology or direct outcomes data, but rather a comparative performance to a widely accepted clinical standard.
8. Sample Size for the Training Set
- The provided document does not mention a specific "training set" or its size for the Onera STS device. This implies that the device's underlying algorithms (if any, separate from standard signal processing) were not developed using a distinct, large, and formally defined training dataset in the way a deep learning AI model would be. The focus is on the device's performance in measuring and recording parameters, and the comparison to an existing predicate device.
9. How the Ground Truth for the Training Set Was Established
- Since a dedicated "training set" is not described, the method for establishing its ground truth is also not applicable or not provided in this document. The device appears to rely on established physiological measurement principles and signal processing, validated against a predicate device and relevant standards.
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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
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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 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) 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)
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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.
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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 deviceOnera STS | Predicate deviceEmbletta MPR | Result |
|---|---|---|---|
| Regulation number | 21 CFR 868.2375 | 21 CFR 868.2375 | Same |
| Product code | MNR | MNR | Same |
| Indications general | Onera STS measures andrecords multiple physiologicalparameters from a patientduring a sleep study which areused by clinicians to make adecision on the diagnosis ofsleep disorders.Onera STS intended to be usedon a patient, who has beenprescribed a sleep study by ahealthcare professional. Thedevice is designed to be usedunder the direction of aphysician or trained technicianbut applied by a layperson.The recorded data will be madeavailable to a healthcareprofessional to assist in thediagnosis of sleep disorders. | The Embletta MPR is a digitalrecording device designed tobe used under the direction ofa physician or trainedtechnician but may be appliedby a layperson. The EmblettaMPR records multiplephysiological parameters froma sleeping patient for thepurpose of simultaneous orsubsequent display of theparameters. The displayed dataassists in the identification ofsleep-related medical disordersby trained personnel. | Substantially equivalent |
| Indications — Patientpopulation | The device is intended to beused for adults. | The Embletta MPR is intendedto be used for adult andpediatric (excluding infants andneonatal) studies. The device isnot equipped with alarms andis not intended to be used as amonitor. | Substantially equivalent |
| Characteristic | Proposed deviceOnera STS | Predicate deviceEmbletta MPR | Result |
| Indications - Environment | Home and professionalenvironments. | The intended environmentsinclude any clean, dry, dustfree environment suitable for apatient's relative comfort. | Substantially equivalent |
| Indications - Limitations | The device is not intended tomonitor or diagnose thepatient and does not issuealarms | The device does not monitor ordiagnose the patient and doesnot issue any alarms. | Substantially equivalent |
| Operating principle | Measuring ofelectrophysiological and other(sound, flow, position) signalsvia a range of sensors.Recording of the data. Makingthe data available for displayon a suitable platform | Measuring ofelectrophysiological and other(sound, flow, position) signalsvia a range of sensors.Recording of the data. Makingthe data available for displayon a suitable platform | Identical |
| Energy | Measuring ofelectrophysiological signals andother signals (sound, flow, ...).Battery powered devices. | Measuring ofelectrophysiological signals andother signals (sound, flow, ...).Battery powered and mainspowered devices. | Similar |
| Materials | Patches are included with thedevice and foundbiocompatible (see summarybelow) | Patches are not part of thedevice | 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) | DifferentLeg movement relatedsleep disorders cantypically be diagnosedby one channel EMG leg | |
| SpO2 forehead | SpO2 finger | DifferentSpO2 can be measuredin several locations andclinical data showssufficient accuracy forthis location. | |
| ECG (1 channel) | ECG (1 channel) | Similar | |
| Characteristic | Proposed deviceOnera STS | Predicate deviceEmbletta MPR | Result |
| Respiratory effort (one channelvia bioimpedance) | Respiratory effort (2 channelsvia belt) | Different butcomparable withreference deviceMeasuring respiratoryeffort usingbioimpedance is acommon techniqueproviding informationon relative changes inlung volume similar tousing inductiveplethysmography onthe chest and theabdomen. | |
| Respiratory flow via nasalcannula | Respiratory flow via nasalcannula | Similar | |
| Sound pressure | Sound pressure | Similar | |
| Derived parameters | Position (1 channel derivedfrom 3D accelerometer) | Position (1 channel derivedfrom 3D accelerometer) | Similar |
| Activity (chest) | Activity (Chest) | Similar | |
| Operating temperature | 10°C - 40°C | 15°C - 40°C | Similar |
| Operating relativehumidity | 10% - 90% | 0% - 95% | Similar |
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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.
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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 totest item extracts shows no cytotoxic potential. | No cytotoxic potential |
| Irritation or Intracutaneousreactivity | Electrode and enclosure did not produce anyprimary dermal reaction after exposure to theskin of New Zealand White Rabbits. | Negligible irritant |
| Sensitization | Electrode and enclosure did not induce any skinreaction scores at the challenge exposurefollowing an induction phase when appliedtopical 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 ±
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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.
§ 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).