Sleep CheckRx is indicated to record a patient's respiratory pattern during sleep for the purpose of pre-screening patients for obstructive sleep apnea (OSA) syndrome.

The device is designed for use in home-screening of adults (≥ 22 years of age) with suspected possible sleep breathing disorders. Results can be used to assist the healthcare professional in determining the need for further diagnosis and evaluation.

The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

Device Description

SleepCheckRx is a software application used by healthcare providers to pre-screen adults at home for the risk of Obstructive Sleep Apnea (OSA). The application is accessed via a compatible smartphone and uses the device's inbuilt microphone to record breathing and snore sounds while the user is asleep, over a minimum duration of 6 hours.

This audio recording, in conjunction with basic information about the user, is analyzed by locked machine learnt software algorithms to provide a risk assessment of the presence of OSA. Prior to use, the patient installs SleepCheckRx on a compatible smartphone and activates the application by entering a code issued to their Healthcare Professional (HCP) through a secure cloud server portal.

The patient enters basic information including date of birth, biological sex, height, weight, and neck circumference. The patient is also required to answer a STOP-Bang questionnaire. The phone is placed on a nightstand as directed, and when the user is ready to go to sleep, they initiate the software that begins a recording.

SleepCheckRx then captures breathing and snore sounds continuously throughout the night until the user stops the recording once they have awoken in the morning (a minimum of 6 hours of recording is required).

In the event of a successful recording, SleepCheckRx provides the user with a binary outcome of either 'Minimal to Mild Risk of OSA' (AHI<15) or 'Moderate to Severe Risk of OSA' (AHI ≥15).

SleepCheckRx requires a healthcare professional (HCP) to access a secure cloud server portal to provide the patient with an access code to use the app downloaded from the Apple App Store.

The results of the patient's recording and the STOP-Bang questionnaire are shared with the patient and the HCP, for the HCP to then determine if further investigation and evaluation is required.

AI/ML Overview

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

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Binary Output: Minimal to Mild Risk of OSA (AHI<15) vs. Moderate to Severe Risk of OSA (AHI ≥15))	Reported Device Performance (SleepCheckRx)
Sensitivity (for Moderate to Severe Risk of OSA, AHI ≥15)	89.3% (109 out of 122 subjects)
Specificity (for Minimal to Mild Risk of OSA, AHI <15)	77.6% (76 out of 98 subjects)

1. Sample Sizes and Data Provenance

Test Set Sample Size: 228 adult analyzable subjects initially, with results reported for n=220.
Data Provenance: Prospective, multi-center study. The text does not explicitly state the country of origin, but the submitter is "ResApp Health" from "Brisbane, Queensland 4000 Australia," implying the study may have been conducted there or involved Australian sites.

2. Number of Experts and Qualifications for Ground Truth

Number of Experts: Two (2) independent PSG scorers.
Qualifications: "Qualified independent sleep scorer." The text does not provide specific details on their years of experience or precise certifications beyond "qualified."

3. Adjudication Method for the Test Set

The text states "PSG diagnosis was established by independent scorers," and "Each sleep study was scored by a qualified independent sleep scorer." It then refers to "clinical diagnosis (using 2 independent PSG scorers)." This implies that both scorers independently scored the PSG studies. However, it doesn't explicitly state an adjudication method (like 2+1 or 3+1) if their scores differed. It simply says the "agreement" between SleepCheckRx and "clinical diagnosis (using 2 independent PSG scorers)." It's possible that if there were discrepancies, they were resolved or averaged, but this is not detailed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The study focused on the standalone performance of the SleepCheckRx algorithm against a gold standard (PSG). The text does not describe human readers using the AI and then comparing their performance to human readers without AI assistance.

5. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The results presented (sensitivity and specificity) are explicitly for the SleepCheckRx algorithm's performance when compared to PSG diagnosis.

6. Type of Ground Truth Used

Expert Consensus / Objective Data: The ground truth was established by independent scoring of Polysomnography (PSG) by qualified sleep scorers, in accordance with the Type II (in-home) American Academy of Sleep Medicine (AASM) 2017 Guidelines. PSG is considered the gold standard for diagnosing sleep apnea.

7. Sample Size for the Training Set

The text does not explicitly state the sample size used for the training set. It mentions the "locked machine learnt software algorithms" and the clinical study on 228 subjects for performance evaluation, but the training data size is not provided.

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

The text does not explicitly state how the ground truth for the training set was established. It only refers to the algorithm being "machine learnt." Given the nature of the device, it's highly probable that the training data's ground truth was also established using PSG, similar to the test set, but this is not detailed in the provided excerpt.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 5, 2022

ResApp Health Neroli Anderson VP Clinical, Quality And Regulatory Level 12, 100 Creek Street Brisbane, Queensland 4000 Australia

Re: K213360

Trade/Device Name: SleepCheckRx Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: Class II Product Code: MNR Dated: June 9, 2022 Received: June 10, 2022

Dear Neroli Anderson:

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

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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 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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213360

Device Name SleepCheckRx

Indications for Use (Describe)

Sleep CheckRx is indicated to record a patient's respiratory pattern during sleep for the purpose of pre-screening patients for obstructive sleep apnea (OSA) syndrome.

The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

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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K213360 510(k) Summary (As required by section 807.92(c))

SLEEPCHECKRx

I. GENERAL INFORMATION
Submitter:	ResApp HealthLevel 12, 100 Creek StreetBrisbane QLD 4000Australia
Contact Person:	Neroli AndersonVP Clinical, Quality and RegulatoryLevel 12, 100 Creek StreetBrisbane QLD 4000AustraliaPhone: +61 416 220 239Email: neroli@resapphealth.com.au
Date Prepared:	July 02, 2022
II. DEVICE DETAILS
Trade Name:	SleepCheckRx
Common or Usual Name:	Breathing Frequency Monitor
Classification Name:	Device: Ventilatory Effort Recorder
Regulation:	21 CFR 868.2375
Regulatory Class:	II
Product Code:	MNR
Review Panel:	Anesthesiology
III. PREDICATE DEVICE
Predicate Device(s):	DROWZLE (K173974)

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IV. DEVICE DESCRIPTION

In the event of a successful recording, SleepCheckRx provides the user with a binary outcome of either 'Minimal to Mild Risk of OSA' (AHI<15) or 'Moderate to Severe Risk of OSA' (AHI ≥15).

SleepCheckRx requires a healthcare professional (HCP) to access a secure cloud server portal to provide the patient with an access code to use the app downloaded from the Apple App Store.

The results of the patient's recording and the STOP-Bang questionnaire are shared with the patient and the HCP, for the HCP to then determine if further investigation and evaluation is required.

V. INDICATIONS FOR USE

SleepCheckRx is indicated to record a patient's respiratory pattern during sleep for the purpose of pre-screening patients for obstructive sleep apnea (OSA) syndrome.

The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A summary comparison of technological characteristics between the SleepCheckRx and the predicate device is provided below.

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ResApp Health. ResApp Health.

K213360 SleepCheckRx 510(k) Premarket Notification (Traditional)

Device Name	DROWZLE	SleepCheckRx	Comparison
510k number	K173974	K213360	N/A
RegulationNumber	21 CFR§ 868.2375	21 CFR§ 868.2375	Same regulationnumber.
RegulationName	Breathing FrequencyMonitor	Breathing FrequencyMonitor	Same regulation name
Product Code	MNR	MNR	Same product code.
Intended Use	Home-use for screeningpatients with possiblesleep disorders.	Home-use for screeningpatients with possiblesleep disorders.	Equivalent. Bothdevices intended tohome screen patientswith possible sleepdisorders.
Indications forUse	DROWZLE is indicatedto record a patient'srespiratory pattern duringsleep for the purpose ofprescreening patients forobstructive sleep apnea(OSA) syndrome.The device is designedfor use in home-screening of adults withsuspected possible sleepbreathing disorders.Results are used toassist the healthcareprofessional indetermining the need forfurther diagnosis andevaluation.The system is notintended as a substitutefor full polysomnographywhen additionalparameters such assleep stages, limbmovements, or EEGactivity are required.	SleepCheckRx isindicated to record apatient's respiratorypattern during sleep forthe purpose of pre-screening patients forobstructive sleep apnea(OSA) syndrome.The device is designedfor use in home-screening of adults (≥ 22years of age) withsuspected possible sleepbreathing disorders.Results can be used toassist the healthcareprofessional indetermining the need forfurther diagnosis andevaluation.The system is notintended as a substitutefor full polysomnographywhen additionalparameters such assleep stages, limbmovements, or EEGactivity are required.	Equivalent indicationsfor use. Both devicesintended to record apatient's respiratorypattern during sleepfor the purpose of pre-screening patients forobstructive sleepapnea (OSA)syndrome.
TargetPopulation	Adults	Adults	Equivalent. Bothdevices intended foruse on adults.
Intended UseEnvironment	Home Environment	Home Environment	Equivalent. Bothdevices intended forthe home environment
Device Name	DROWZLE	SleepCheckRx	Comparison
Type of Use	Prescription Use (Part 21CFR 801 Subpart D)	Prescription Use (Part 21CFR 801 Subpart D)	Both devices areprescription only use.
Method ofMeasurement	Acoustic analysis ofbreathing and snoringsounds.	Acoustic analysis ofbreathing and snoringsounds.	Equivalent. Bothdevices analyzebreathing and snoringsounds.
Mode of Action	Analyses breathingsounds to identifyrespiratory eventsindicative of OSA or otherdisorders.	Analyses breathingsounds to identifyrespiratory eventsindicative of OSA or otherdisorders.	Equivalent. Bothdevices identifyrespiratory eventsindicative of OSA orother disorders.
SensorPlacement Site	Smartphone placed within24 inches of pillow.	Smartphone placed nextto the bedside (on anightstand).	Equivalent. Bothdevices utilize smartphones placed in closeproximity whilesleeping.
SensorElements	Microphone(s) native tosmartphone.	Microphone(s) native tosmartphone.	Equivalent. Bothdevices utilizemicrophone(s) nativeto the smartphone.
Patient Contact	Software only. No directpatient contact.	Software only. No directpatient contact.	Equivalent. Softwareonly. Neither devicepatient contacting.
Portability	Yes	Yes	Equivalent. Bothdevices downloadedonto a smartphone.
MeasuredVariable	Oral and nasal breathsounds.	Oral and nasal breathsounds.	Equivalent. Bothdevices detect oral andnasal breath sounds.
BreathingEvents	Breath sound gaps >10seconds.	Breathing pauses ofduration ≥ 6s but < 60seconds.	Equivalent. Bothdevices detectbreathing events(however thealgorithms have beentrained to detect eventsof different durations).
SensorAttachment	N/A	N/A	Equivalent. Neitherdevice has a sensorattachment.
Display Type	Smartphone display	Smartphone display	Equivalent. Bothdevices utilize thesmartphone display.
Signal LossIndicator	N/A	N/A	Equivalent. Neitherdevice has a signalloss indicator.
ReportedMetrics	Risk of OSA based on thefollowing AHI estimates:	Risk of OSA based on thefollowing AHI estimates:	Equivalent. Bothdevices report the risk
Device Name	DROWZLE	SleepCheckRx	Comparison
	Minimal to Mild Risk of OSA (AHI<15) Moderate to Severe Risk of OSA (AHI ≥15). Risk classification based on standard questionnaires:a. STOP-Bangb. Epworth Sleepiness Scalec. Calculated Resonea Index	Minimal to Mild Risk of OSA (AHI<15) Moderate to Severe Risk of OSA (AHI ≥15). STOP-Bang questionnaire is also reported.	of OSA based on abinary output, i.e.,either minimal to mild risk of OSA (AHI<15),or moderate to severe risk of OSA (AHI ≥15).Both devices report the STOP-Bang score.SleepCheckRx does not report the Epworthscale, nor does it display a proprietaryindex score.
Reporting ofResults to HCP	Results are available forreview by the clinician viaemail.	Results are available forreview by the clinician viathe portal.	Equivalent. Bothdevices may bereviewed via a clinicianportal.
Sleep Night Use	Can be used multiplenights.	Can be used multiplenights.	Equivalent. Bothdevices may be usedover multiple nights.
Maximum Run-time	No maximum run-time.	No maximum run-time.	Equivalent. Neitherdevice specifies amaximum run-time.
Minimum TimeRequired forresult	2 hours	6 hours	SleepCheckRx isrequired to be used fora longer period of time(6 hours) to ensuremore accurate results.
Controller	Smartphonemicroprocessor.	Smartphonemicroprocessor.	Equivalent. Bothdevices utilize asmartphone.
PhysicalCharacteristics	Software runs on user'ssmartphone.	Software runs on user'ssmartphone.	Equivalent. Bothdevices utilize asmartphone.
Power	Smartphone plugged intowall outlet with built-inbattery back-up.	Smartphone plugged intowall outlet with built-inbattery back-up.	Equivalent. Bothdevices utilize asmartphone.

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ResApp Health. ResApp Health.

K213360 SleepCheckRx 510(k) Premarket Notification (Traditional)

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ResApp Health. ResApp Health.

K213360 SleepCheckRx 510(k) Premarket Notification (Traditional)

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VII. NON-CLINICAL PERFORMANCE DATA

SleepCheckRx performance data included various verification and validation activities to demonstrate compliance with the applicable FDA guidance documents, including:

· Software verification and validation testing was performed in accordance with the applicable requirements outlined in the FDA quidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005).
· Cybersecurity verification and validation testing in accordance with the applicable requirements outlined in the FDA guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (2014).
· Device Compatibility testing was performed to ensure that compatible smartphones support equivalent performance.
An evaluation of performance of SleepCheckRx under conditions part of intended use environment (noise, distances, direction, etc.) to verify device effectiveness.
· Human Factors Engineering (HFE) / Usability evaluation was performed in accordance with the applicable requirements of FDA Guidance. Applying Human Factors and Usability Engineering to Medical Devices. Guidance for Industry and Food and Drug Administration Staff. February 3, 2016.

VIII. CLINICAL DATA

A prospective, multi-center, single-staged study on the SleepCheckRx algorithm was conducted on 228 adult analyzable subjects.

The clinical study used a binomial endpoint comparing the presence and severity of OSA, by using sleep sounds captured and analyzed by the SleepCheckRx algorithm and comparing them to a simultaneous PSG diagnosis (gold standard). PSG diagnosis was established by independent scorers, in accordance with the Type II (in-home) American Academy of Sleep Medicine (AASM) 2017 Guidelines.

Sleep sound recordings were captured by the SleepCheckRx algorithm throughout the night (minimum of 6 hours) according to the overnight sleep study protocol. Sleep sounds were recorded by a compatible smartphone (loaded with the SleepCheckRx sound recording algorithm) placed on the nightstand, simultaneously with PSG. Each sleep study was scored by a qualified independent sleep scorer.

The mean age of all subjects was 50 years, with a higher percentage of males in the study (63%). The mean BMI was 29.8 and the mean neck circumference of 39.4.

Results of the study (n=220) demonstrated an agreement between SleepCheckRx and clinical diagnosis (using 2 independent PSG scorers) of 109 from 122 subjects (sensitivity 89.3%) with moderate to severe risk of OSA (AHI ≥15), and an agreement of 76 from 98 subjects (specificity 77.6%) with minimal to mild risk of OSA (AHI<15).

There were no adverse events or adverse device effects reported during the study.

IX. Substantial Equivalence discussion

SleepCheckRx has the same intended use as the predicate DROWZLE. Both software platforms are intended to record a patient's respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome.

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Both devices are designed for use in home-screening adults with suspected possible sleep breathing disorders. The results of both devices are used to assist the healthcare professional in determining the need for further diagnosis and evaluation.

Both devices report the risk of OSA based on a binary output, i.e., either minimal to mild risk of OSA (AHI<15), or moderate to severe risk of OSA (AHI ≥15).

SleepCheckRx is supported by clinical data demonstrating a sensitivity and specificity at the AHI ≥ 15 threshold of 89.3% and 77.6% respectively (n=220) when compared to clinical diagnosis. These results are comparable to the DROWZLE device which reported a sensitivity of 93.7% and specificity of 63% (AHI>15).

CONCLUSIONS X.

Based on the information provided in this submission, the SleepCheckRx is substantially equivalent to the predicate DROWZLE 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).