(261 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or performance metrics indicative of AI/ML processing of the physiological data. The device is described as measuring and recording data for clinicians to use in diagnosis, not as providing automated analysis or interpretation using AI/ML.
No
The device measures and records physiological parameters to assist in the diagnosis of sleep disorders, but it does not treat or cure them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "measures and records multiple physiological parameters... which are used by clinicians to make a decision on the diagnosis of sleep disorders." The recorded data is intended "to assist in the diagnosis of sleep disorders." This directly indicates its role in the diagnostic process.
No
The device description explicitly states that Onera STS consists of four sensors applied to the body, which are hardware components used to measure physiological signals.
Based on the provided information, the Onera STS device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body). The Onera STS measures physiological parameters directly from the patient's body while they are wearing the device.
- The intended use is to measure and record physiological parameters for the diagnosis of sleep disorders. This is a direct measurement of bodily functions, not an analysis of a sample.
- The device description details sensors applied on the body to measure signals. This confirms it's a direct physiological measurement device.
Therefore, the Onera STS falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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 the trained operator. The device is provided to the user by the 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
Designed to be used under the direction of a physician or trained technician but applied by a layperson.
Can be used in home (Home Healthcare Environment) as well as Professional Healthcare Facilities. The study preparation and data retrieval are done in a professional/clinical environment by the trained operator.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing on the changed Onera STS device confirmed that the changed device conforms to the defined requirements.
The proposed Onera STS is found in compliance with the applicable requirements of the following standards:
- IEC 60601-1 Basic safety and essential performance
- IEC 60601-1-2 EMC
- IEC 60601-2-25 Basic safety and essential performance of electrocardiographs
- IEC 80601-2-26 Basic safety and essential performance of electroencephalographs
- IEC 60601-2-40 Basic safety and essential performance of electromyographs and evoked response equipment
- ISO 80601-2-61 Basic safety and essential performance of pulse oximeter equipment
- ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
A risk management process conforming with ISO 14971 was completed for the device. A usability engineering process conforming with IEC 62366-1 was completed for the device. All device software was developed in a process conforming with IEC 62304.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
August 18, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Onera B.V. Ruben de Francisco Martin Managing Director Torenallee 42-54 Eindhoven. NB 5617BD Netherlands
Re: K223573
Trade/Device Name: Onera Sleep Test System (Onera STS) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR. OLV Dated: July 20, 2023 Received: July 21, 2023
Dear Ruben de Francisco Martin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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 R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223573
Device Name Onera Sleep Test System (STS)
Indications for Use (Describe)
Onera STS measures and records multiple physiological parameters from a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.
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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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 |
| Date submission was prepared: | October 30, 2022 |
| Device Name: | |
| Trade name: | Onera Sleep Test System (STS) |
| Common Name: | Ventilatory Effort Recorder |
| Classification: | 21 CFR 868.2375, Breathing frequency monitor |
| Product Codes: | MNR, OLV |
| Device Class: | 2 |
Product Description:
Onera STS is a wearable system for measuring (physiological) signals during a sleep study. The device can be used in home (Home Healthcare Environment) as well as Professional Healthcare Facilities, to perform the sleep study.
Onera STS consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area.
The sensors measure EEG, EOG, EMG, ECG, bioimpedance based respiratory effort, bioimpedance based respiratory flow, cannula based respiratory flow, oxygen saturation, activity, position, and sound pressure level.
The study preparation and data retrieval are done in a professional/clinical environment by the trained operator. The device is provided to the user by the trained operator.
The device is not a life supporting physiological monitor.
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
4
assist in the diagnosis of sleep disorders.
The device is intended to be used for adults.
Legally marketed devices to which substantial equivalence is claimed
| 510(k) Number | Device Name | Type |
|---|---|---|
| K210593 | Onera STS | Predicate device |
Device modifications
The table below provides an overview of the proposed change to the Onera STS device in comparison with the predicate and currently marketed Onera STS device.
| # | Scope | Description |
|---|---|---|
| 1 | Labeling | Extend the use time from 8 hours to 16 hours. The extension is |
| supported by new skin irritation testing and 16-hour wear time testing as part of | ||
| design verification and validation activities |
Substantial Equivalence
The table below provides a comparison between the Onera STS device and the predicate device.
| Characteristic | Proposed device
Onera STS | Currently cleared Onera STS | Result |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Manufacturer | Onera B.V., The Netherlands | | -- |
| 510(k) number | K223573 | K210593 | -- |
| Regulation number | 21 CFR 868.2375 | 21 CFR 868.2375 | Identical |
| Product code | MNR | MNR | Identical |
| Indications general | Onera STS measures 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
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 a
healthcare professional to
assist in the diagnosis of
sleep disorders. | 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
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 a
healthcare professional to
assist in the diagnosis of
sleep disorders. | Identical |
| Characteristic | Proposed device
Onera STS | Currently cleared Onera STS | Result |
| Indications – Patient
population | The device is intended to be
used for adults. | The device is intended to be
used for adults. | Identical |
| Indications – Environment | Home and professional
environments. | Home and professional
environments. | Identical |
| Indications - Limitations | The device is not intended to
monitor or diagnose the
patient and does not issue
alarms | The device is not intended to
monitor or diagnose the
patient and does not issue
alarms | Identical |
| 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
devices. | Identical |
| Materials | Patches are included with the
device and found
biocompatible (see summary
below) | Patches are included with the
device and found
biocompatible (see summary
below) | Identical |
| Recording time | 8 hours | 16 hours | Extended use time |
| Measured parameters | EEG (2 channels) | EEG (2 channels) | Identical |
| | EOG (2 channels) | EOG (2 channels) | Identical |
| | EMG head (2 channels) | EMG head (2 channels) | Identical |
| | EMG leg (one leg) | EMG leg (one leg) | Identical |
| | SpO2 forehead | SpO2 forehead | Identical |
| | ECG (1 channel) | ECG (1 channel) | Similar |
| | Respiratory effort (one
channel via bioimpedance) | Respiratory effort (one
channel via bioimpedance) | Identical |
| | Respiratory flow via nasal
cannula | Respiratory flow via nasal
cannula | Identical |
| | Sound pressure | Sound pressure | Identical |
| Derived parameters | Position (1 channel derived
from 3D accelerometer) | Position (1 channel derived
from 3D accelerometer) | Identical |
| | Activity (chest) | Activity (chest) | Identical |
| Operating temperature | 10°C - 40°C | 10°C - 40°C | Identical |
| Operating relative humidity | 10% - 90% | 10% - 90% | Identical |
5
The technology to obtain information on respiratory effort is equivalent to that of the defined reference device.
6
Other than the extended use time described above, there are no differences in technological characteristics between this Onera STS device and the Onera STS device cleared under K210593. The intended use of the device is the same as the predicate device.
None of the indicated changes introduce new questions of safety or effectiveness.
Summary of Performance Testing
Performance testing on the changed Onera STS device confirmed that the changed device conforms to the defined requirements.
The proposed Onera STS is found in compliance with the applicable requirements of the following standards:
- . IEC 60601-1 Basic safety and essential performance
- IEC 60601-1-2 EMC
- IEC 60601-2-25 Basic safety and essential performance of electrocardiographs
- IEC 80601-2-26 Basic safety and essential performance of electroencephalographs
- IEC 60601-2-40 Basic safety and essential performance of electromyographs and evoked response equipment
- ISO 80601-2-61 Basic safety and essential performance of pulse oximeter equipment
- ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
A risk management process conforming with ISO 14971 was completed for the device. A usability engineering process conforming with IEC 62366-1 was completed for the device. All device software was developed in a process conforming with IEC 62304.
Summary of Clinical testing
No clinical data was required to support equivalence.
Conclusion
Based on the information included in this submission, it was concluded that the proposed changed Onera STS device is substantially equivalent to the predicate device.