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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the NightOwl device, focusing on a modification that includes a new algorithm tuning (1B rule) for calculating the probable Apnea-Hypopnea Index (pAHI). The document outlines the device's technical characteristics, intended use, and performance data from a clinical study comparing the modified device's 1B rule performance to the predicate device's 1A rule performance against polysomnography (PSG).

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance metrics reported in the "Clinical Study" section, comparing the modified device's 1B rule performance to the predicate device's 1A rule performance. The goal is to demonstrate substantial equivalence, which implies that the 1B rule performance is comparable to or better than the 1A rule performance, and both are clinically acceptable against the gold standard.

Endpoint Parameters	Acceptance Criteria (Implied: Clinically acceptable and comparable to Predicate K191031)	Reported Device Performance (NightOwl K213463 - 1B rule)	Reported Predicate Performance (NightOwl K191031 - 1A rule)
Sensitivity at AHI cutoff 5	N/A (Comparison to predicate is key)	1.000	0.936
Specificity at AHI cutoff 5	N/A (Comparison to predicate is key)	0.823	0.727
Sensitivity at AHI cutoff 15	N/A (Comparison to predicate is key)	0.973	0.978
Specificity at AHI cutoff 15	N/A (Comparison to predicate is key)	0.886	0.704
Sensitivity at AHI cutoff 30	N/A (Comparison to predicate is key)	0.840	0.964
Specificity at AHI cutoff 30	N/A (Comparison to predicate is key)	0.979	0.844
pAHI correlation	N/A (Comparison to predicate is key)	0.946	0.909

Note: The document states that the new 1B rule tuning "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)." The acceptance criteria are therefore implicitly met if the performance characteristics of the 1B algorithm are demonstrated to be clinically acceptable and substantially equivalent to the already cleared 1A algorithm, which the data suggests.

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

The document states, "The clinical validation of the NightOwl performance using 1B rule was compared to the gold standard polysomnography (PSG) in the US population."

Sample Size: The document does not explicitly state the sample size used for the clinical validation test set.
Data Provenance: The data provenance is from the US population. The study type is retrospective, as it describes a "clinical validation" comparing the device's output against established PSG data.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth (e.g., scoring of PSG studies). It only mentions that the comparison was against "gold standard polysomnography (PSG)." Typically, PSG studies are scored by trained polysomnographic technologists and/or interpreted by sleep physicians.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set's ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted as described in the provided text. The study focuses on comparing the algorithmic performance of the device against a gold standard (PSG) and comparing the performance of the new algorithm (1B) to the predicate's algorithm (1A). There is no mention of human readers assisting with the AI or their improved performance with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The reported "Sensitivity," "Specificity," and "pAHI correlation" values are direct measurements of the NightOwl's algorithm (both 1A and 1B tunings) against the PSG gold standard without human intervention or interpretation as part of the performance metrics. The device provides "traces and parameters" to be accessed by a "Healthcare Professional (HCP)," implying the algorithm generates these outputs independently, for the HCP to use in evaluation.

7. Type of Ground Truth Used

The type of ground truth used was expert-scored polysomnography (PSG). PSG is widely considered the gold standard for diagnosing sleep-related breathing disorders. The reference to "AASM's '1A Rule'" and "AASM's '1B Rule'" for hypopnea scoring indicates that the PSG studies would have been scored according to these established clinical criteria.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. The clinical study described appears to be a validation study for the pre-trained algorithm.

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

The document does not provide information on how the ground truth for any potential training set was established. It only discusses the ground truth for the clinical validation test set (PSG).

Summary

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December 16, 2021

Ectosense nv Bart Van Pee Product Manager Bosbessenlaan 19 A Rotselaar, Vlaams Brabant 3110 Belgium

Re: K213463

Trade/Device Name: NightOwl Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: October 26, 2021 Received: October 27, 2021

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) K213463

Device Name NightOwl

Indications for Use (Describe)

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)

	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

1. SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT 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: 15th of December 2021

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 068.2375

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3. PREDICATE DEVICE

Predicate: Ectosense's NightOwl (K191031)

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 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 / 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).

6. DEVICE MODIFICATIONS AND COMPARISON OF TECHNOLOGICAL

CHARACTERSITICS WITH THE PREDICATE DEVICE

We have now incorporated an alternative tuning of the NightOwl algorithm to include hypopnea as scored using the 1B rule. The HCP can now choose to display either the 1A-tuned or the 1B-tuned pAHI (or both) on the NightOwl Examination report. As per the American Academy of Sleep medicine (AASM):

1A rule: a hypopnea is scored when:

1. There is an airflow reduction of 30% for at least 10 seconds
1. There is an oxygen desaturation of at least 3 percent or an arousal.

1B rule: a hypopnea is scored when:

1. There is an airflow reduction of 30% for at least 10 seconds
1. There is an oxygen desaturation of at least 4 percent

Characteristic	NightOwl (K191031)	Comparison
Intended Use/Indications forUse	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 of adultpatients suspected of sleep apnea. The device isintended for the clinical and home setting use under thedirection 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

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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 calculation tuned tothe AASM's '1A Rule' forthe scoring of hypopnea	pAHI calculation tuned tothe AASM's '1A Rule' forthe scoring of hypopneaANDpAHI calculation tuned tothe AASM's '1B Rule' forthe scoring of hypopnea	Substantially equivalentAddition of pAHIcalculation tuned to theAASM's '1B Rule' for thescoring of hypopneaThe addition of the pAHIcalculation tuned to theAASM's '1B Rule' for thescoring of hypopneadoes not alter thedevice's intended useand does not introduceany change to the safetyand effectiveness 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 wireless connection.		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 using 1B rule was compared to the gold standard polysomnography (PSG) in the US population. The following table compares the performance of the subject and predicate devices.

Endpoint Parameters	1A rule performance oforiginally cleared device(Predicate K191031)	1B rule performance ofmodified device(Subject)
Sensitivity at AHI cutoff 5	0.936	1.000
Specificity at AHI cutoff 5	0.727	0.823
Sensitivity at AHI cutoff 15	0.978	0.973
Specificity at AHI cutoff 15	0.704	0.886
Sensitivity at AHI cutoff 30	0.964	0.840
Specificity at AHI cutoff 30	0.844	0.979
pAHI correlation	0.909	0.946

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).