(50 days)
Not Found
No
The summary describes "signal processing algorithms" but does not mention AI, ML, or related terms. There is no description of training or test sets for AI/ML models.
No.
The device is intended for the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders, not for treating them.
Yes
The device is intended to "aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea," directly supporting diagnostic processes.
No
The device description explicitly states that the NightOwl comprises both a sensor (hardware) and cloud-based analysis software. The sensor is a physical component worn on the fingertip with LEDs and an accelerometer.
Based on the provided information, the NightOwl device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The NightOwl is a wearable device that measures biophysical parameters on the body (fingertip). It records signals like PPG and accelerometer data directly from the patient.
- The intended use is for evaluating sleep-related breathing disorders. This is a physiological assessment, not a diagnostic test performed on a biological sample.
- The device description focuses on sensors and signal processing. It doesn't mention any reagents, test strips, or analysis of bodily fluids or tissues, which are characteristic of IVDs.
The NightOwl is a medical device used for physiological monitoring and analysis to aid in the evaluation of a condition, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).
Product codes
MNR
Device Description
The NightOwl is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT).
The NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") over-night whilst the subject is sleeping and cloud-based analysis software (the "NightOwl Software").
The NightOwl Sensor has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is attached to the fingertip by single-use biocompatible adhesive tape, with the sensor window applied against the fingerprint area of the fingertip. The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement.
The data recorded by the NightOwl Sensor can either be stored in on-board memory ("Offline" mode) or streamed via a Bluetooth link to an Ectosense app on a smartphone ("Streaming" mode)
- If the data is stored on the device, the data is retrieved when the NightOwl sensor . is returned to the prescribing HCP and passed up to a cloud-based signal processing suite, the NightOwl Software.
- If the device is used in Streaming mode, the data is stored by the Ectosense app . on the smartphone during the recording. At the end of the recording, it is then passed directly up to the cloud-based signal processing suite.
- The NightOwl Software signal processing algorithms produce a number of sleep . and sleep-disordered breathing related traces and parameters. The trace and parameter information are passed to a company-managed database for storage and access by the prescribing Health Care Professional in the Ectosense Dashboard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
adult patients, 22 years old and older
Intended User / Care Setting
Healthcare Professional (HCP) / clinical and home setting
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
Clinical Study: The clinical validation of the NightOwl performance for Total REM Time determination was compared to the gold standard polysomnography (PSG) in a US population.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software validation: In support of the substantial equivalence determination of the modification made to the device, software validation was performed.
Clinical Study: The clinical validation of the NightOwl performance for Total REM Time determination was compared to the gold standard polysomnography (PSG) in a US population.
Patient population size: 71
Total REM Time root mean square difference: 22.72 minutes
Total REM Time correlation: 0.51
Total REM Time Bias: -1.96 minutes
Total REM Time Upper Limit of Agreement: 42.72 minutes
Total REM Time Lower Limit of Agreement: -46.64 minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Total REM Time root mean square difference: 22.72 minutes
Total REM Time correlation: 0.51
Total REM Time Bias: -1.96 minutes
Total REM Time Upper Limit of Agreement: 42.72 minutes
Total REM Time Lower Limit of Agreement: -46.64 minutes
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
February 24, 2022
Ectosense nv Bart Van Pee Product Manager Bosbessenlaan 19A Rotselaar, Vlaams Brabant 3110 Belgium
Re: K220028
Trade/Device Name: NightOwl Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: January 27, 2022 Received: January 28, 2022
Dear Bart Van Pee:
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
1
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 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 (OS) 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 mediation-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,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220028
Device Name NightOwl
Indications for Use (Describe)
The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).
| 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
NightOwl
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT 1. PERSON AND DATE PREPARED
Ectosense nv Bosbessenlaan 19A Rotselaar Vlaams-Brabant 3110 Belgium
Phone: +32 496 74 46 12
Contact Person: Bart Van Pee
Date Prepared: 23th of February 2022
2. DEVICE
Name of Device
NightOwl
Trade Name
NightOwl
Common or Usual Name
Ventilatory Effort Recorder
Classification Name/Product Code/CFR Reference
Class II, Ventilatory Effort Recorder, Product Code: MNR; 21 CFR 868.2375
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3. PREDICATE DEVICE
Predicate: Ectosense's NightOwl (K213463)
4. DEVICE DESCRIPTION
The NightOwl is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT).
The NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") over-night whilst the subject is sleeping and cloud-based analysis software (the "NightOwl Software").
The NightOwl Sensor has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is attached to the fingertip by single-use biocompatible adhesive tape, with the sensor window applied against the fingerprint area of the fingertip. The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement.
The data recorded by the NightOwl Sensor can either be stored in on-board memory ("Offline" mode) or streamed via a Bluetooth link to an Ectosense app on a smartphone ("Streaming" mode)
- If the data is stored on the device, the data is retrieved when the NightOwl sensor . is returned to the prescribing HCP and passed up to a cloud-based signal processing suite, the NightOwl Software.
- If the device is used in Streaming mode, the data is stored by the Ectosense app . on the smartphone during the recording. At the end of the recording, it is then passed directly up to the cloud-based signal processing suite.
- The NightOwl Software signal processing algorithms produce a number of sleep . and sleep-disordered breathing related traces and parameters. The trace and parameter information are passed to a company-managed database for storage and access by the prescribing Health Care Professional in the Ectosense Dashboard.
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5. INTENDED USE
The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).
6. DEVICE MODIFICATIONS
We expanded the sleep time outputs by adding the Total REM Time to the already cleared Total Sleep Time (TST) as output of the device. The Total REM Time was validated using the identical method and protocol used to validate the TST supporting the previously cleared 510(k).
| Characteristic | NightOwl (K213463) | NightOwl (Current Device) | Comparison |
|---|---|---|---|
| Intended Use/ | |||
| Indications for Use | The NightOwl is a wearable device intended for use in | ||
| the recording, analysis, displaying, exporting, and | |||
| storage of biophysical parameters to aid in the | |||
| evaluation of sleep-related breathing disorders of | |||
| adult patients suspected of sleep apnea. The device is | |||
| intended for the clinical and home setting use under | |||
| the direction of a Healthcare Professional (HCP). | Equivalent | ||
| Intended | |||
| Environment | Recording in the home environment with the report | ||
| interpretation performed in the clinical setting. | Equivalent | ||
| Prescription | Prescription only | Equivalent | |
| Target | |||
| Population | 22 years old and older | Equivalent | |
| Channels | 1. PAT |
- Pulse rate
- Oximetry
- Actigraphy | | Equivalent |
| Sensors | Optical plethysmography sensor, accelerometer | | Equivalent |
| Wearable sensor
location | The photoplethysmography (PPG) sensor and accelerometer
components are worn on the fingertip. | | Equivalent |
| Sensor Software | Firmware is limited to control the recording and
communications processes. No presentation of test results
to the patient. Data analyzed and presented in a separate
software suite. | | Equivalent |
| Analysis Software -
location | Analysis performed off the recording device, exclusively
cloud-based by the NightOwl software. | | Equivalent |
| Analysis Software -
algorithm -pAHI | pAHI calculation tuned to the AASM's '1A Rule' for the
scoring of hypopnea
AND
pAHI calculation tuned to the AASM's '1B Rule' for the
scoring of hypopnea | | Equivalent |
| Analysis Software -
algorithm -Sleep
Time | Total Sleep Time (TST)
calculation | Total Sleep Time (TST)
calculation,
and,
Total REM Time
calculation | Substantially equivalent
The addition of Total
REM Time does not
alter the device's
intended use and does
not introduce any
change to the safety and
effectiveness of the
originally cleared device
(predicate device). As
such, the algorithm of
the altered device
remains substantially
equivalent to that of the
originally cleared device
(predicate device) |
| Data transfer | Data transfer through a smartphone by wireless
connection. | | Equivalent |
| Power Source
recorder | Battery powered by coin cell | | Equivalent |
| Patient
isolation | Device has no galvanic connections to mains as it is a
battery-operated device. | | Equivalent |
| Sterilization | Non-sterile | | Equivalent |
| Bio-
compatibility | Assessed to ISO1099-1:2009 requirements for
sensitization, irritation, and cytotoxicity | | Equivalent |
| EMC | IEC 60601-1-2:2014 | | Equivalent |
| Electrical
Safety | IEC 60601-1:2005 +AMD1:2012 | | Equivalent |
| Environmental
Testing | IEC 60601-1-11:2010 | | Equivalent |
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7. PERFORMANCE DATA
Software validation: In support of the substantial equivalence determination of the modification made to the device, software validation was performed.
Clinical Study: The clinical validation of the NightOwl performance for Total REM Time determination was compared to the gold standard polysomnography (PSG) in a US population. The following table highlights the performance of the subject device.
| Endpoint parameters | Performance of modified device
(Subject) |
|-----------------------------------------------|---------------------------------------------|
| Patient population size | 71 |
| Total REM Time root mean square
difference | 22.72 minutes |
| Total REM Time correlation | 0.51 |
| Total REM Time Bias | -1.96 minutes |
| Total REM Time Upper Limit of
Agreement | 42.72 minutes |
| Total REM Time Lower Limit of
Agreement | -46.64 minutes |
8. CONCLUSIONS
Based on (i) the results of the clinical validation testing, (ii) the results of the software validation testing, and (iii) the unchanged product risk analysis, the NightOwl has been demonstrated to be substantially equivalent to the predicate device.