(401 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and there is no other language suggesting the use of these technologies. The device measures physiological parameters for clinician interpretation.
No.
The device is used to measure and record physiological parameters to assist in the diagnosis of sleep disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device measures and records physiological parameters "which are used by clinicians to make a decision on the diagnosis of sleep disorders" and that "The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders." These phrases indicate a diagnostic purpose.
No
The device description explicitly states that Onera STS "consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area" and measures various physiological signals. This indicates the device includes hardware components beyond just software.
Based on the provided information, the Onera STS device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Onera STS measures physiological parameters directly from the patient's body (EEG, EOG, EMG, ECG, respiratory effort/flow, oxygen saturation, activity, position, sound pressure level). It does not analyze samples like blood, urine, or tissue.
- The intended use is to measure and record physiological parameters for the diagnosis of sleep disorders. This is a function of a physiological monitoring device, not an IVD.
- The device description details sensors applied to the body. This further confirms it's a device that interacts with the patient directly, not with a specimen.
Therefore, the Onera STS falls under the category of a physiological monitoring device used for diagnostic purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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.
Product codes
MNR, OLV
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 a dedicated trained operator.
The device is not a life supporting physiological monitor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead, upper chest area, abdominal and lower leg area.
Indicated Patient Age Range
adults.
Intended User / Care Setting
Under the direction of a physician or trained technician but applied by a layperson.
Home Healthcare Environment and Professional Healthcare Facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
SpO2 measurement accuracy:
Sample Size: 10 healthy volunteers
Data Source: Not explicitly stated, implied to be laboratory measurements.
Annotation Protocol: 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].
Comparative sleep study testing:
Sample Size: 32 patients
Data Source: Patients undergoing a routine sleep study where Onera STS and Embletta MPR were concurrently applied.
Annotation Protocol: Studies were scored blinded by a qualified sleep professional.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SpO2 measurement accuracy:
Study Type: Biocompatibility and Clinical testing (accuracy validation)
Sample Size: 10 healthy volunteers (for SpO2 accuracy)
Key Results: 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:
Study Type: Clinical validation study to demonstrate equivalence in sleep staging and physiological scoring.
Sample Size: 32 patients.
Key Results: Substantial agreement in scored sleep stages between the Onera STS and Embletta MPR (Cohen's kappa = 0.69). 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| 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 |
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
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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 device
Onera STS | Predicate device
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
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 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 Embletta MPR is a digital
recording device designed to
be used under the direction of
a physician or trained
technician but may be applied
by a layperson. The Embletta
MPR records multiple
physiological parameters from
a sleeping patient for the
purpose of simultaneous or
subsequent display of the
parameters. The displayed data
assists in the identification of
sleep-related medical disorders
by trained personnel. | Substantially equivalent |
| Indications — Patient
population | The device is intended to be
used for adults. | The Embletta MPR is intended
to be used for adult and
pediatric (excluding infants and
neonatal) studies. The device is
not equipped with alarms and
is not intended to be used as a
monitor. | Substantially equivalent |
| Characteristic | Proposed device
Onera STS | Predicate device
Embletta MPR | Result |
| Indications - Environment | Home and professional
environments. | The intended environments
include any clean, dry, dust
free environment suitable for a
patient's relative comfort. | Substantially equivalent |
| Indications - Limitations | The device is not intended to
monitor or diagnose the
patient and does not issue
alarms | The device does not monitor or
diagnose the patient and does
not issue any alarms. | Substantially equivalent |
| 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 |
| Energy | Measuring of
electrophysiological signals and
other signals (sound, flow, ...).
Battery powered devices. | Measuring of
electrophysiological signals and
other signals (sound, flow, ...).
Battery powered and mains
powered devices. | Similar |
| Materials | Patches are included with the
device and found
biocompatible (see summary
below) | Patches are not part of the
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
Leg movement related
sleep disorders can
typically be diagnosed
by one channel EMG leg |
| | SpO2 forehead | SpO2 finger | Different
SpO2 can be measured
in several locations and
clinical data shows
sufficient accuracy for
this location. |
| | ECG (1 channel) | ECG (1 channel) | Similar |
| Characteristic | Proposed device
Onera STS | Predicate device
Embletta MPR | Result |
| | Respiratory effort (one channel
via bioimpedance) | Respiratory effort (2 channels
via belt) | Different but
comparable with
reference device
Measuring respiratory
effort using
bioimpedance is a
common technique
providing information
on relative changes in
lung volume similar to
using inductive
plethysmography on
the chest and the
abdomen. |
| | Respiratory flow via nasal
cannula | Respiratory flow via nasal
cannula | Similar |
| | Sound pressure | Sound pressure | Similar |
| Derived parameters | Position (1 channel derived
from 3D accelerometer) | Position (1 channel derived
from 3D accelerometer) | Similar |
| | Activity (chest) | Activity (Chest) | Similar |
| Operating temperature | 10°C - 40°C | 15°C - 40°C | Similar |
| Operating relative
humidity | 10% - 90% | 0% - 95% | Similar |
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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 | |
| 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. | Negligible irritant | |
| 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 |
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.