The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults.

The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing.

The SleepImage System output is not interpreted or clinical action taken without consultation of a qualified healthcare professional.

Device Description

The SleepImage System is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.

The Sleeplmage System automatically analyzes and displays Electrocardiogram (ECG) and Plethysmogram (PLETH) data. When provided in addition to the ECG or PLETH data, the SleepImage System can optionally analyze and display accelerometer and oximeter data.

The results of the processed data are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology for the use by or on the order of physicians, trained technicians, or other healthcare professionals to evaluate sleep disorders where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders for children, adolescents and adults. When oximeter data is available, the Sleeplmage System will generate the Sleeplmage Apnea Hypopnea Index (sAHI) to aid healthcare professionals in diagnosis and management of sleep disordered breathing.

The SleepImage System reports results of the automated data analysis, including expected values for sleep quality, sleep duration and sleep pathology based on published peer-reviewed publications, and guidelines for sleep duration (National Sleep Foundation) and sleep apnea (American Academy of Sleep Medicine).

The clinician can view raw data for interpretation, adjust study duration, write clinical notes in the report and make recommendations to patients for further testing, recommend a referral to another clinician and/or recommendations for therapy.

The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. Due to the intra-night variability of sleep, it is recommended that patients track their sleep over time.

The SleepImage System is a sleep health evaluation application that is indicated for use on a general-purpose computing platform. Like the predicate device, it processes data typically recorded during sleep, using a cloud-based web application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SleepImage System, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) for the modifications. Instead, it states that "All parameters tested exceeded the thresholds set for the tests."

However, we can infer the type of acceptance criteria based on the comparisons made:

Acceptance Criteria Type	Reported Device Performance / Assessment
Modification #1: PLETH vs. ECG input for CPC Analysis
Agreement between automated output from CPC analysis using PLETH input vs. ECG input (compared to predicate device).	"All parameters tested exceeded the thresholds set for the tests." The report references the average agreement for sleep stage scoring among expert scorers using PSG (82.6%) as a contextual benchmark for inter-scorer reliability. The clinical evaluation confirmed that CPC analysis with PLETH input is comparable to ECG input for clinical decisions.
Modification #2: SleepImage Apnea Hypopnea Index (sAHI) vs. Manual AHI
Agreement between sAHI calculated by the device and manual human scoring of AHI using AASM criteria for mild, moderate, severe sleep apnea (pediatric & adult).	"All parameters tested exceeded the thresholds set for the tests." The clinical evaluation confirmed that sAHI auto-scoring algorithms generate comparable output to human manual scoring of AHI from PSG studies.
Sensitivity and Positive Likelihood Ratio (LR+) of sAHI against pre-determined thresholds for Out Of Center (OOC) diagnostic devices (based on AASM guidelines).	"All parameters tested exceeded the thresholds set for the tests." The document states that the sAHI demonstrated agreement levels compared to manually scored AHI from PSG studies to be used to aid clinical diagnosis.
No adverse impact on existing predicate device functionality due to software modifications.	"Validation and verification was performed to verify that the software modifications did not have any adverse impact on the functionality of the SleepImage System." "The verification and validation testing demonstrate that both new feature requirements have been satisfied and safety and effectiveness has not been inadvertently affected by modifications to the system."

Study Details:

2. Sample Size and Data Provenance

Test Set Sample Size: Over 2,000 sleep studies.
- Children: 1334 studies (all based on PSG studies).
- Adults: 761 studies (189 from PSG, 572 from HSAT).
Data Provenance: The records were "obtained from prospective clinical trials," indicating prospective collection. The country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "manual human scoring of Apnea Hypopnea Index (AHI) using American Academy of Sleep Medicine (AASM) scoring criteria" as a comparator for the sAHI. It refers to the "average agreement for sleep stage scoring among expert scorers in accredited sleep centers using PSG" (82.6%) for contextual comparison but does not state the number or specific qualifications of experts who performed the manual scoring for this specific test set's ground truth. It implies that the human scoring adhered to AASM guidelines, suggesting qualified sleep experts/technicians.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It refers to "manual human scoring" which typically implies one qualified scorer, but does not detail if multiple scorers or an adjudication process were used for discrepancies in the AHI ground truth.

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

No, a formal MRMC comparative effectiveness study involving human readers with and without AI assistance is not explicitly described. The study compared the device's automated output to human manual scoring (for sAHI) and to the predicate device's performance (for CPC with different input). It did not assess human reader improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only) performance study was done for both modifications:
- Modification #1 (PLETH vs. ECG for CPC): The study compared the automated output of CPC analysis using PLETH input directly against the automated output using ECG input (which was the basis of the predicate device).
- Modification #2 (sAHI calculation): The study compared the device's automatically calculated sAHI against manually scored AHI and evaluated its sensitivity and LR+ against AASM guidelines for OOC devices. This is a clear standalone performance evaluation.

7. Type of Ground Truth Used

For Modification #1 (PLETH vs. ECG for CPC): The ground truth implicitly seems to be the performance of the predicate device's ECG-based CPC analysis. The comparison was to show agreement between the two automated methods.
For Modification #2 (sAHI): The ground truth was "manual human scoring of Apnea Hypopnea Index (AHI) using American Academy of Sleep Medicine (AASM) scoring criteria" from Polysomnography (PSG) studies.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. The "over 2,000 sleep studies" are mentioned in the context of "clinical evaluation" which typically refers to validation/test data, not training data.

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

Since the training set size is not provided, the method for establishing its ground truth is also not detailed. However, it can be inferred that if AHI was part of the training, it would likely follow AASM scoring criteria, similar to the test set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 14, 2019

MyCardio, LLC dba SleepImage. Robert Schueppert Manager, Regulatory Affairs 3513 Brighton Blvd, Suite 530 Denver, Colorado 80216

Re: K182618

Trade/Device Name: SleepImage System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: August 5, 2019 Received: August 6, 2019

Dear Mr. Schueppert:

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,

James J. Lee Assistant 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number K182618

Device Name SleepImage System

Indications for Use

The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing.

The SleepImage System output is not interpreted or clinical action taken without consultation of a qualified healthcare professional.

Type of Use	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
-------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

of this information collection, including suggestions for reducing this burden, to:

{3}------------------------------------------------

510(K) SUMMARY

l. SUBMITTER INFORMATION

Contact	Robert SchueppertManager of Regulatory and Qualityregulatory@sleepimage.com
	MyCardio, LLC dba SleepImage3513 Brighton Blvd, Suite 530Denver, CO 80216
	Phone: 720-708-4200
Date of Preparation	August 13, 2019

II. DEVICE IDENTIFICATION

Device Trade Name:	SleepImage System
Device Common Name:	SleepImage
Classification Name:	Breathing frequency monitor
Regulation Number:	21 CFR 868.2375
Product Code:	MNR
Device Classification:	Class II
Classification Panel:	Anesthesiology

lll. PREDICATE DEVICE

SleepImage System (K163696) Device Trade Name:

IV. DEVICE DESCRIPTION

The SleepImage System is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.

{4}------------------------------------------------

The SleepImage System is being updated from the predicate device; the SleepImage System cleared under K163696.

V. INDICATIONS FOR USE

The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The Sleeplmage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults.

{5}------------------------------------------------

The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing.

The Sleeplmage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

VI. COMPARISON TO PREDICATE DEVICE

Like the predicate device (K163696), the SleepImage System subject device (K182618) is Software as a Medical Device (SaMD) designed and intended to establish sleep quality and evaluate sleep disorders. The subject and predicate devices are based on the following same technological elements:

Both are Software as a Medical Device (SaMD). ●
Both are cloud-based web applications, using general-purpose computing platforms.
Both have the same basic software design, control mechanism and operating principle.
Both use the same technology to couple Heart Rate Variability and Respiration.
Both are intended to Inform or Drive Clinical Management of sleep disorders.

The following similarities / differences exist between the subject and predicate devices:

Modification #1: Plethysmography (PLETH) is added as valid input signal for Cardiopulmonary Coupling (CPC) analysis. This modification required a change in the software to add PLETH as an alternative to electrocardiogram (ECG) as valid input signal.

CPC processing remains unchanged and is the same for both input signals using peak-topeak intervals of heart (pulse) rate variability coupled with respiration.

Report output and user instructions are expanded to accommodate this change.

Modification #2: Calculation of a SleepImage Apnea Hypopnea Index (sAHI) is added to aid healthcare professionals in diagnosis of sleep disordered breathing. This modification required a change in the software to automatically calculate the sAHI output, using SpO2 data input already cleared in the predicate device.

sAHI calculations are performed and presented using American Academy of Sleep Medicine (AASM) guidelines and thresholds to categorize sleep apnea as mild; moderate and severe, both in adults and children. The sAHI output is based on calculating desaturations from SpO2 data and based on sleep time.

Report output and user instructions are expanded to accommodate this change.

{6}------------------------------------------------

VII. SUBSTANTIAL EQUIVALENCE

Substantial equivalence is established through a phased clinical evaluation process and performance testing, referencing American Academy of Sleep Medicine (AASM) published guidelines and recommendations.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided based on Guidance Documents for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Software as a Medical Device (SaMD): Clinical Evaluation".

Clinical Evaluation

In accordance with FDA Guideline for clinical evaluation of Software as a Medical Device (SaMD), reference data from over 2,000 sleep studies obtained from prospective clinical trials in children and adults that were conducted for the same intended use as the subject device were analyzed.

Each sleep recording obtained and utilized for this clinical evaluation contained ECG, PLETH and SpO2 signals, collected simultaneously. Study results from children (n=1334) are all based on PSG studies and study results from adults (n=761) are reported separately from PSG (n=189) and HSAT (n=572) in the labeling.

Tests for modification #1 were performed to compare agreement of the automated output from CPC analysis using the predicate device to compare PLETH vs ECG as the input signals for the test. The tests were performed based on pre-determined agreement in outcomes. All parameters tested exceeded the thresholds set for the tests. Reference is made to published results from the American Academy of Sleep Medicine (AASM) Interscorer Reliability Program: Sleep Scoring, published in the Journal of Clinical Sleep Medicine reporting the average agreement for sleep stage scoring among expert scorers in accredited sleep centers using PSG, which is on average 82.6%. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3525994/

Tests for modification #2 were performed (1) to compare agreement from SleepImage Apnea Hypopnea Index (sAHI) vs. manual human scoring of Apnea Hypopnea Index (AHI) using American Academy of Sleep Medicine (AASM) scoring criteria for mild, moderate and severe sleep apnea in pediatric and adult patients and (2) to evaluate sAHI using guidelines issued by the AASM to compare sensitivity and Positive Likelihood Ratio (LR+) against pre-determined thresholds for use in Out Of Center (OOC) sleep diagnostic devices. Guidelines were published in the Journal of Clinical Sleep Medicine. https://www.ncbi.nlm.nih.gov/pubmed/22003351

{7}------------------------------------------------

All parameters tested exceeded the thresholds set for the tests.

ECG signal processing and CPC analysis in the subject device is unchanged, the output of CPC analysis from ECG signal therefore remains identical to the predicate device.

Labeling and Instructions for Use have been updated with information on performance results and references to academic guidelines from the American Academy of Pediatrics stating that clinicians should familiarize themselves with the sensitivity and specificity of the test against a full polysomnography test to determine if it is conclusive to be reliable for clinical diagnosis.

Validation and verification was performed to verify that the software modifications did not have any adverse impact on the functionality of the SleepImage System. Software verification and validation included software code reviews as well as labeling and user manual review.

The verification and validation testing demonstrate that both new feature requirements have been satisfied and safety and effectiveness has not been inadvertently affected by modifications to the system.

Product Information	Subject Device	Predicate Device
Device	Medical Software (SaMD)	Medical Software (SaMD)
510(k) #	K182618	K163696
Trade / Product Name	SleepImage System	SleepImage System
Regulation No.	21 CFR 868.2375	21 CFR 868.2375
Product Code	MNR	MNR
Classification	II	II
Panel	Anesthesiology	Anesthesiology
Manufacturer	MyCardio LLC	MyCardio LLC
Environment of Use	N/A (Software)	N/A (Software)
Indications for Use	The SleepImage System isSoftware as a Medical Device(SaMD) that establishes sleepquality. The SleepImageSystem analyzes, displays andsummarizes Electrocardiogram(ECG) or Plethysmogram(PLETH) data, typically collectedduring sleep, that is intendedfor use by or on the order of aHealthcare Professional to aidin the evaluation of sleepdisorders, where it may inform	The SleepImage System ismedical software thatestablishes sleep quality. TheSleepImage System analyzes,displays and summarizes ECGdata, typically collected duringsleep that is intended for useby or on the order of aHealthcare Professional to aidin the evaluation of sleepdisorders, where it may informor drive clinical management.
Intended Use	for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.	The SleepImage System is medical software that establishes sleep quality, intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders based on Electrocardiogram (ECG) recordings, typically collected during sleep. The results of these analyses are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology. These presentations and reports are intended to inform or drive clinical management. The SleepImage System is intended for use on a general-purpose computing platform, it is not a monitor and does not issue any alarms.
	The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality, intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders based on Electrocardiogram (ECG) or Plethysmogram (PLETH) recordings, typically collected during sleep.The results of these analyses are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology. These presentations and reports are intended to inform or drive clinical management for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. The SleepImage System is intended for use on a general-purpose computing

	Principle of Operation	platform, it is not a monitorand does not issue any alarms.The SleepImage System is acloud-based web applicationSoftware as a Medical Device(SaMD).	The SleepImage System is acloud-based web applicationSoftware as a Medical Device(SaMD).
	Computer Requirements	General-purpose computingplatform with internetconnection	General-purpose computingplatform with internetconnection
	Software	Cloud-based softwareapplication that analyzes anddisplays ECG, PLETH andoximeter data	Cloud-based softwareapplication that analyzes anddisplays ECG and oximeter data
	Data Transfer	Data is transferred betweenuser's general-purposecomputing platform and cloud-based server, utilizing secureauthentication protocols overthe Internet	Data is transferred betweenuser's general-purposecomputing platform and cloud-based server, utilizing secureauthentication protocols overthe Internet
	Computer Security	Use of secure authenticationprotocols	Use of secure authenticationprotocols
	Target Population	Children, Adolescents andAdults	Unspecified

VIII. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

{8}------------------------------------------------

{9}------------------------------------------------

IX. CONCLUSION

Clinical evaluation has confirmed that the output of Cardiopulmonary Coupling (CPC) analysis PLETH signal input of the subject device when compared to the ECG signal input of the predicate device are comparable for clinical decisions.

Clinical evaluation has confirmed that the SleepImage System auto-scoring algorithms calculating the Sleeplmage Apnea Hypopnea Index (sAHI) generate comparable output to human manual scoring of an Apnea Hypopnea Index (AHI) from Polysomnography (PSG) studies, using American Academy of Sleep Medicine (AASM) scoring guidelines for children and adult patients.

The conclusions of these performance tests support the same intended use of the subject device as the predicate device and do not raise any new concerns about safety and effectiveness. It is concluded that the Sleeplmage System subject device, using either ECG or PLETH for Cardiopulmonary Coupling is substantially equivalent to the predicate device. It is further concluded that despite differences in how the SleepImage Apnea Hypopnea Index (SAHI) is automatically calculated compared to how the Apnea Hypopnea Index (AHI) is manually scored from PSG studies, that the sAHI has demonstrated agreement levels compared to manually scored AHI from PSG studies to be used to aid clinical diagnosis of sleep apnea in children and adults.

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).