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).

Device Description

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). 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NightOwl device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on the validation of the "Total REM Time" calculation, as this was the new feature introduced by the device modification. The acceptance criteria themselves are not explicitly stated as numerical thresholds (e.g., "correlation must be > X"). Instead, the performance metrics reported serve as the basis for demonstrating substantial equivalence. The implication is that the reported performance is acceptable for the device's intended use, particularly when compared to the established performance of the previously cleared device for Total Sleep Time.

Endpoint Parameter	Reported Device Performance (NightOwl, Current Device)
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

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 71 patients
Data Provenance: The study was conducted in a "US population," implying that the data was collected prospectively for this clinical validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the NightOwl performance for Total REM Time determination was "compared to the gold standard polysomnography (PSG)." PSG is typically scored by trained polysomnographic technologists and/or sleep physicians, but the exact number and qualifications are not detailed here.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The comparison is made against the "gold standard polysomnography (PSG)," which implies that the PSG results were considered the definitive ground truth without a separate adjudication process for the test set scores of the device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. This study focuses on the standalone performance of the device's algorithm for Total REM Time against the PSG gold standard. There is no mention of human readers or AI assistance for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The "Performance of modified device (Subject)" table directly reports algorithm performance metrics (Root Mean Square Difference, Correlation, Bias, Limits of Agreement) when compared to the "gold standard polysomnography (PSG)." This indicates the algorithm's performance without human intervention in the scoring process.

7. The Type of Ground Truth Used

The type of ground truth used was Polysomnography (PSG), which is referred to as the "gold standard." PSG involves comprehensive physiological monitoring during sleep, typically including electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), and respiratory parameters, among others, from which sleep stages (including REM) are scored by trained professionals.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set. The reported study focuses solely on the clinical validation of the modified device's performance for Total REM Time using a test set of 71 patients.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any training set was established. It only details the ground truth used for the validation (test) set (PSG). It states that the "Total REM Time was validated using the identical method and protocol used to validate the TST supporting the previously cleared 510(k)," implying that similar PSG-based ground truth would have been used for any prior training as well, but no specifics are given.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K220028

Device Name NightOwl

Indications for Use (Describe)

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

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 inthe recording, analysis, displaying, exporting, andstorage of biophysical parameters to aid in theevaluation of sleep-related breathing disorders ofadult patients suspected of sleep apnea. The device isintended for the clinical and home setting use underthe direction of a Healthcare Professional (HCP).		Equivalent
IntendedEnvironment	Recording in the home environment with the reportinterpretation performed in the clinical setting.		Equivalent
Prescription	Prescription only		Equivalent
TargetPopulation	22 years old and older		Equivalent
Channels	1. PAT2. Pulse rate3. Oximetry4. Actigraphy		Equivalent
Sensors	Optical plethysmography sensor, accelerometer		Equivalent
Wearable sensorlocation	The photoplethysmography (PPG) sensor and accelerometercomponents are worn on the fingertip.		Equivalent
Sensor Software	Firmware is limited to control the recording andcommunications processes. No presentation of test resultsto the patient. Data analyzed and presented in a separatesoftware suite.		Equivalent
Analysis Software -location	Analysis performed off the recording device, exclusivelycloud-based by the NightOwl software.		Equivalent
Analysis Software -algorithm -pAHI	pAHI calculation tuned to the AASM's '1A Rule' for thescoring of hypopneaANDpAHI calculation tuned to the AASM's '1B Rule' for thescoring of hypopnea		Equivalent
Analysis Software -algorithm -SleepTime	Total Sleep Time (TST)calculation	Total Sleep Time (TST)calculation,and,Total REM Timecalculation	Substantially equivalentThe addition of TotalREM Time does notalter the device'sintended use and doesnot introduce anychange to the safety andeffectiveness of theoriginally cleared device(predicate device). Assuch, the algorithm ofthe altered deviceremains substantiallyequivalent to that of theoriginally cleared device(predicate device)
Data transfer	Data transfer through a smartphone by wirelessconnection.		Equivalent
Power Sourcerecorder	Battery powered by coin cell		Equivalent
Patientisolation	Device has no galvanic connections to mains as it is abattery-operated device.		Equivalent
Sterilization	Non-sterile		Equivalent
Bio-compatibility	Assessed to ISO1099-1:2009 requirements forsensitization, irritation, and cytotoxicity		Equivalent
EMC	IEC 60601-1-2:2014		Equivalent
ElectricalSafety	IEC 60601-1:2005 +AMD1:2012		Equivalent
EnvironmentalTesting	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 squaredifference	22.72 minutes
Total REM Time correlation	0.51
Total REM Time Bias	-1.96 minutes
Total REM Time Upper Limit ofAgreement	42.72 minutes
Total REM Time Lower Limit ofAgreement	-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.

Regulation Number and Section

§ 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).