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 Ectosense NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") and cloud-based analysis software (the "NightOwl Software").

The NightOwl Sensor is a small biocompatible enclosure with a sensor window made from PMMA (bottom part) and ABS (top part). 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

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly present acceptance criteria in a formal table with pass/fail thresholds. Instead, it describes various tests and their outcomes. The closest information related to "acceptance criteria" and "reported device performance" for the primary function (pAHI accuracy) is derived from the clinical study results.

Derived Acceptance Criteria & Reported Performance for pAHI Accuracy:

Performance Metric	Implied Acceptance Criteria (based on reported results)	Reported Device Performance
pAHI Correlation to PSG	Strong correlation to PSG AHI	Regression line: AHI (Expert PSG) = 0.9981 x pAHI (NightOwl) + 2.235
Sensitivity (AHI cutoff 5)	High sensitivity to detect sleep apnea	0.943 (Belgium study), 0.936 (US study)
Specificity (AHI cutoff 5)	Moderate to high specificity to identify non-apnea cases	0.813 (Belgium study), 0.727 (US study)

Other Performance Data (No explicit criteria given, but compliance is stated):

Biocompatibility: Passed tests (Cytotoxicity, Sensitization, Irritation) in accordance with ISO 10993-1.
Electrical Safety & EMC: Complied with IEC60601-1:2012 and IEC60601-1-2:2014, including bench tests for close-proximity RF emitters.
Software Verification & Validation: Documentation provided as per FDA guidance, considered "moderate" level of concern.
SpO2 Accuracy: Within pass/fail criteria of ISO80601-2-61:2019 Clause 201.12.1.101.1.
Pulse Rate RMS: 2.26 bpm for claimed range of 50 to 118 bpm (within acceptable limits per ISO 80601-2-61:2019 Annex EE.2, implied acceptance).

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

The text mentions "three clinical studies" and then details two "comparison to PSG Sleep Lab Results" studies, one in Belgium and one in the United States, followed by a "pooled analysis." It doesn't explicitly state the sample size for each individual study, nor the combined sample size.

Data Provenance: Belgium and United States (sleep lab settings).
Retrospective or Prospective: Not explicitly stated, but the description of "clinical trials" and "repeat study" suggests prospective data collection for validation.

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

The document refers to the "gold standard analysis of the polysomnography (PSG)" and "AHI (Expert PSG)" in the regression formula. However, it does not specify:

The number of experts involved in establishing the PSG ground truth.
The qualifications of these experts (e.g., board-certified sleep physicians, polysomnography technologists).

4. Adjudication Method for the Test Set

The document states that the ground truth was the "gold standard analysis of the polysomnography (PSG)." It does not mention any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing this PSG ground truth. It implies that the standard clinical PSG analysis was used as the ground truth.

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

The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The studies focused on the standalone performance of the NightOwl device (its pAHI accuracy compared to PSG).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The clinical studies described focused on validating the NightOwl device's accuracy in calculating pAHI against the "gold standard" PSG. This means the device's algorithm output was directly compared to the PSG, indicating a standalone performance evaluation.

7. The Type of Ground Truth Used

The primary ground truth used for the pAHI accuracy validation was:

Polysomnography (PSG) Analysis: Referred to as the "gold standard" and "Expert PSG." This typically involves detailed scoring of sleep stages, respiratory events (apneas, hypopneas), and other physiological parameters by trained personnel following established scoring rules.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set of the NightOwl's algorithms. It only discusses the clinical validation studies (test sets).

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

Since the document does not mention the training set, it does not describe how the ground truth for any training set was established. The clinical studies described are clearly for validation/testing purposes.

Summary

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March 6, 2020

Ectosense nv Bart Van Pee COO Bosbessenlaan 19A Rotselaar, 3110 BE

Re: K191031

Trade/Device Name: NightOwl Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: February 3, 2020 Received: February 3, 2020

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 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

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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 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.

for Michael Ryan Division Director DHT1C: Division of ENT, 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) K191031

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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l. 510(K) SUMMARY

510(k) SUMMARY

Ectosense nv's NightOwl

1. SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED

Ectosense nv Bosbessenlaan 19A Rotselaar Vlaams-Brabant 3110 Belgium

Phone: +32 2 588 9044

Contact Person: Bart Van Pee

Date Prepared: 06 March 2020

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

Itamar Medical Ltd's WatchPAT 200U (K161579) Predicate:

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 Ectosense NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") 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 device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the NightOwl and the predicate WatchPAT 200U are built around fingertip mounted optical plethysmography (PPG) measurements and incorporate an accelerometer for detection of limb movement. The accelerometer is used to estimate when the wearer is asleep by actigraphy methods. The PPG sensor produces a signal that is further analyzed to produce an SpO2 measurement and pulse rate. The variations in the PPG amplitude, SpO2, and pulse rate are then used to determine apnea and hypopnea events and thus indicate the patient's AHI for that night.

The variations in PPG amplitude reflect pulsatile volume changes in the peripheral tissue that reflect changes in Peripheral Arterial Tone ("PAT"). As both devices analyze such changes in peripheral arterial tone from the fingertip, the AHI value is characterized as "peripheral AHI" or "pAHI". The sleep reports presented to the prescribing HCP also contain derived sleep-related parameters such as estimated Total Sleep Time (TST) and maxima and minima of parameters to provide general sleep information to the HCP.

The NightOwl and its predicate are based upon the similar technological elements:

Fingertip optical plethysmography sensor
Accelerometer on the limb ●
External signal processing
. Key output is pAHI

The below table compares NightOwl and WatchPAT devices.

Characteristic	Predicate DeviceWatchPAT 200U	NightOwl	Comparison
Intended Use/Indications forUse	The WatchPAT 200U(WP200U) device is a non-invasive home care device	The NightOwl is awearable device intendedfor use in the recording,	Substantially equivalent.
Characteristic	Predicate DeviceWatchPAT 200U	NightOwl	Comparison
	for use with patientssuspected to have sleeprelated breathing disorders.The WP200U is a diagnosticaid for the detection of sleeprelated breathing disorders,sleep staging (Rapid EyeMovement (REM) Sleep,Light Sleep, Deep Sleep andWake), snoring level andbody position.The WP200U generates aperipheral arterial tonometry("PAT") RespiratoryDisturbance Index ("PRDI"),Apnea-Hypopnea index("PAHI"), Central Apnea-Hypopnea index ("PAHIc"),PAT sleep stagingidentification (PSTAGES)and optional snoring leveland body position discretestates from an externalintegrated snoring and bodyposition sensor.The WP200U's PSTAGESand snoring level and bodyposition providesupplemental information toits PRDI/PAHI/PAHIc. TheWP200U's PSTAGES andsnoring level and bodyposition are not intended tobe used as the sole orprimary basis for diagnosingany sleep related breathingdisorder, prescribingtreatment, or determiningwhether additional diagnosticassessment is warranted.PAHIc is indicated for use inpatients 17 years and older.All other parameters areindicated for 12 years andolder.	analysis, displaying,exporting, and storage ofbiophysical parameters toaid in the evaluation ofsleep-related breathingdisorders of adult patientssuspected of sleep apnea.The device is intended forthe clinical and homesetting use under thedirection of a HealthcareProfessional (HCP).	The NightOwl's IntendedUse and Indications forUse does not includesleep staging, snoringlevel, body position, or thediscrimination betweencentral and obstructivesleep apneic events.The NightOwl is onlyintended for use in anadult patient population.
IntendedEnvironment	Recording in the home environment with the reportinterpretation performed in the clinical setting.		Equivalent.
Characteristic	Predicate DeviceWatchPAT 200U	NightOwl	Comparison
Prescription	Prescription only		Equivalent
TargetPopulation	12 years old and older (forthe main indications)	22 years old and older	Substantially equivalent.NightOwl target patientpopulation is morerestrictive.
Channels	1. PAT2. Pulse rate3. Oximetry4. Actigraphy5.Snoring and BodyPosition (SBP) integratedexternal sensor	1. PAT2. Pulse rate3. Oximetry4. Actigraphy	Substantially equivalent innon-optional channels.The Predicate is providedwith an optional externalsnoring and body positionsensor which NightOwldoes not provide.
Sensors(non-optional)	Optical plethysmography sensor, accelerometer	Optical plethysmography sensor, accelerometer	Substantially Equivalent
Wearablesensor location	Finger probe for PAT andSpO2 sensing componentsare worn on the finger.Embedded actigraphy that islocated in a wrist-mountedenclosure.	The photoplethysmography(PPG) sensor andaccelerometer componentsare worn on the fingertip.	Substantially equivalentThe difference in locationof the actigraphycomponents does notaffect performance insensing movement.
Device size	Wrist-mounted enclosure:3.2" long x 2" wide x 0.8"deep (80x50x20 mm)	0.75" high x 1.1" wide x0.4" thick (19x28x11mm)	Substantially equivalent.
Device weight	4 $^{19}/{32}$ oz (130g) for wrist-mounted enclosure,$^{23}/{32}$ oz (20g) for finger probe	$^{7}/_{32}$ oz (6g)	Substantially equivalent.
SensorSoftware	Firmware is limited to control the recording andcommunications processes. No presentation of test resultsto the patient. Data analyzed and presented in a separatesoftware suite.	Firmware is limited to control the recording andcommunications processes. No presentation of test resultsto the patient. Data analyzed and presented in a separatesoftware suite.	Substantially equivalent
AnalysisSoftware -location	Analysis performed off therecording device, on the PCor cloud-based by thezzzPAT software.	Analysis performed off therecording device,exclusively cloud-based bythe NightOwl software.	Substantially equivalent.The Predicate allows forlocal analysis on a PC,where NightOwl onlyallows for cloud-basedprocessing.
Characteristic	Predicate DeviceWatchPAT 200U	NightOwl	Comparison
Data transfer	Data transfer through a PCby means of USB cable.	Data transfer through asmartphone by wirelessconnection.	Substantially equivalent.The Predicate uses thePC while the NightOwluses the smartphone as adata forwarder.
Memory	Embedded flash memory, 64 MB		Equivalent.
Power Sourcerecorder	Internal rechargeable li-ion battery		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 60601-1-11:2015	IEC 60601-1-11:2010	Substantially equivalent.

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7. PERFORMANCE DATA

The following performance data has been provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the NightOwl device was conducted in accordance with the FDA guidance document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1 : Evaluation and testing within a risk management process", as recognized by FDA, with passing results. The tests conducted were:

Cytotoxicity ●
Sensitization ●
Irritation ●

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Electrical Safety and Electromagnetic Compatibility (EMC)

The Ectosense NightOwl has been tested to the relevant parts of the following recognized performance standards:

IEC60601-1:2012 Medical electrical equipment Part 1: General requirements . for basic safety and essential performance.
IEC60601-1-2:2014 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

The NightOwl complied with all of the requirements of the performance standards for use in the home environment.

The following additional testing was carried out:

. RF immunity in the presence of Home RF emitters: A cell phone, when it is closer than 10 feet away, may emit RF fields in excess of those tested by IEC60601-1-2. A bench test was carried out to demonstrate that the NightOwl was unaffected by common household RF emitters that were within 3 feet of it.

Software Verification and Validation Testing

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Clinical Studies

The three clinical studies of the NightOwl consisted of:

SpO2 measurement accuracy: To validate the accuracy of the NightOwl derived SpO2 values and the pulse rate (PR) trace 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 NightOwl's pulse oximeter function was within the pass/fail criteria as described in ISO80601-2-61:2019 Clause 201.12.1.101.1. The pulse rate root mean square (RMS) value was found to be 2.26 beats per minute (bpm) for a claimed range of 50 to 118 bpm.

Comparison to PSG Sleep Lab Results: The clinical validation of the NightOwl accuracy in the calculation of pAHI when compared to the gold standard analysis of the polysomnography (PSG). This trial was conducted in Belgium. It was evidenced that the NightOwl sensitivity and specificity at an AHI cutoff 5 were 0.943 and 0.813, respectively.

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Comparison to United States PSG Sleep Lab Results: A repeat study of the PSG comparison trial conduced in the United States to confirm that the NightOwl's pAHI accuracy is similar when the device is used in a US population. It was evidenced that the NightOwl sensitivity and specificity at an AHI cutoff 5 were 0.936 and 0.727, respectively.

Summary of AHI accuracy results: The AHI accuracy results of the pooled analysis containing the patients from the clinical trials in the United States and Belgium can be summarized as follows:

. Regression line with AHI (Expert PSG) = 0.9981 x pAHI (NightOwi) + 2.235

8. CONCLUSIONS

Based on the performance data and testing in conformance to consensus standards, 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).