DynaDx Sleep Quality is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

Device Description

Sleep Quality is a software system, which can probe the dynamical interactions between heart rate and respiratory variability during sleep by using a single lead Electrocardiogram (ECG) recording. It is designed to support FDA approved Holter Monitor devices on the market. Sleep Quality system takes text format ECG recording as input. It requires that supported Holter devices are able to export their recording into ASCII data format. Most of the commencially available Holter Monitors devices have this capability. ECG recording data is first collected by a standard Holter devices na subject's sleep, is converted into ASCII data format, and is then analyzed by the Sleep Quality system. By recognizing episodes of Sleep Disordered Breathing (SDB), the software indicates that apneic events have occurred and estimated the Apnea-Hypopnea Index (AH). To detect SDB, the algorithm derives both RR Interval and ECG-Derived Respiratory (EDR) information from the ECG recording.

AI/ML Overview

The DynaDx Sleep Quality device is intended as a screening tool for sleep apnea in adult patients, determining the need for further clinical diagnosis and evaluation by polysomnography. The ECG recordings can be obtained in various settings (home, hospital, clinic) from subjects with at least 4 hours of sleep and predominantly sinus rhythm in their ECG.

The acceptance criteria for the DynaDx Sleep Quality device and its reported performance are presented below, along with a comparison to its predicate device, Lifescreen Apnea.

1. Table of Acceptance Criteria and Reported Device Performance

Product Parameter	Acceptance Criteria (Predicate: Lifescreen Apnea)	Reported Device Performance (DynaDx Sleep Quality)
Per-subject Sensitivity	85.0%	95.0%
Per-subject Specificity	83.3%	90.0%
Per Subject Accuracy	84.3%	92.9%
Per Subject Positive Predictivity	87.1%	92.7%
Per-minute sensitivity	80.9%	84.5%
Per-minute specificity	78.1%	83.0%
Per-minute Accuracy	79.5%	83.8%
Per-minute Positive Predictivity	78.7%	83.3%
Sleep Length for Test (minutes)	26,100 minutes	26,100 minutes

The DynaDx Sleep Quality device demonstrated performance metrics (Sensitivity, Specificity, Accuracy, Positive Predictivity) that met or exceeded those of the predicate device, Lifescreen Apnea, for both per-subject and per-minute analyses.

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

The document does not explicitly state the sample size used for the test set specifically or data provenance (e.g., country of origin, retrospective/prospective). It does, however, provide "Sleep Length for Test" as 26,100 minutes for both the submission device and the predicate device, suggesting a total duration of ECG recordings used for evaluation. This value alone does not specify the number of individual patients.

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

This information is not provided in the submitted text.

4. Adjudication Method for the Test Set

This information is not provided in the submitted text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The submission focuses on the standalone performance of the algorithm without human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The reported performance metrics (Sensitivity, Specificity, Accuracy, Positive Predictivity) for "DynaDx Sleep Quality (Submission Device)" reflect the performance of the algorithm itself in detecting apneic events and estimating the Apnea-Hypopnea Index (AHI) from ECG recordings. This is evident from the fact that it's a software system analyzing ECG data to produce these metrics.

7. Type of Ground Truth Used

The document states that the device is intended "to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score." This strongly implies that the ground truth for evaluating the device's performance (i.e., whether a patient needs clinical diagnosis and evaluation by polysomnography, or the occurrence of apneic events and AHI) would be established by polysomnography (PSG). PSG is the gold standard for diagnosing sleep disordered breathing, including sleep apnea.

8. Sample Size for the Training Set

This information is not provided in the submitted text. The document focuses on the performance of the device rather than the specifics of its training.

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

This information is not provided in the submitted text. However, similar to the test set, it is highly probable that if a training set were used, its ground truth would also be established by polysomnography.

Summary

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K070855

Section 5: 510(k) Summary

MAR 2 0 2008

DynaDx Corporation 213 Houghton Street Mountain View, CA 94041 Phone: 650-386-6369 Fax: 330-734-0004

Contact: Yanhui Liu

Summary Prepared: March 20, 2007

Trade Name: Sleep Ouclity

Common Name: Apnea Examination System

Classification Name: Ventilatory Effort Recorder

Predicate Devices Identification:

CFR21: 868.2375 Product Code: MNR Device Class: II Legally Marketed Device: Lifescreen Apnea Manufacturer: Del Mar Reynolds Medical, Inc. K#: K042745

Description:

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Intended Use:

DynaDx Sleep Quality is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specifical by a physician including home, hospital or clinic. Subjects screened for sleep apneas should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

ProductParameter	Sleep Quality(Submission Device)DynaDx CorporationK070855	Lifescreen Apnea(Predicate Device)Del Mar Reynolds Inc.K042745
Device Class	Class II	Class II
Product Code	MNR	MNR
Device Type	Ventilator Effort Recorder	Ventilator Effort Recorder
Common Name	Apnea Examination Software	Apnea Examination Software
Regulation Number	868.2375	886.2375
Intended Use	Sleep Quality is intended foruse on adult patients only asa screening device todetermine the need forclinical diagnosis andevaluation bypolysomnography based onthe patient's score. The ECGrecording may be obtained atany location specified by aphysician including home,hospital or clinic. Subjectsscreened for sleep apneashould have periods of sleepof at least 4 hours durationduring which the ECG ispredominantly sinus rhythmin nature.	Lifescreen Apnea is intendedfor use on adult patients onlyas a screening device todetermine the need forclinical diagnosis andevaluation bypolysomnography based onthe patient's score. The ECGrecording may be obtained atany location specified by aphysician including home,hospital or clinic. Subjectsscreened for sleep apneashould have periods of sleepof at least 4 hours durationduring which the ECG ispredominantly sinus rhythmin nature.
Target Population	Adults	Adults
Apnea-HypopneaIndex (AHI)determination	Apnea-Hypopnea Index(AHI) derived from ECGsignal through proprietaryalgorithm	Apnea-Hypopnea Index(AHI) derived from ECGsignal through proprietaryalgorithm
Detection of SleepDisorderedBreathing (SDB)	To detect SDB, the algorithmderives both RR Interval andECG-Derived Respiratory(EDR) information from theECG recording.	To detect SDB, the algorithmderives both RR Interval andECG-Derived Respiratory(EDR) information from theECG recording.
Device forcollecting signal	FDA approved HolterMonitor with text formatECG signal output	Del Mar Reynolds Lifescreendigital Holter recorder
Data Collection	Home, hospital, clinic	Home, hospital, clinic
Location
Environment of Use	Hospital and clinic	Hospital and clinic
Software Validation	Yes	Yes
Clinical Study	Yes	Yes
Clinical Trial	No	Yes
Per-subjectSensitivity	95.0%	85.0%
Per-subjectSpecificity	90.0%	83.3%
Per SubjectAccuracy	92.9%	84.3%
Per Subject PositivePredictivity	92.7%	87.1%
Sleep Length forTest (minutes)	26100	26100
Per-minutesensitivity	84.5%	80.9%
Per-minutespecificity	83.0%	78.1%
Per-minuteAccuracy	83.8%	79.5%
Per-minute PositivePredictivity	83.3%	78.7%

Predicate Product Comparison Chart:

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff entwined with a serpent.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2008

DynaDx Corporation C/O Mr. EJ Smith Regulatory Consultant Smith Associates 1676 Village Green, Suite A Crofton, Maryland 21114

Re: K070855

Trade/Device Name: Sleep Quality Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: February 19, 2008 Received: March 10, 2008

Dear Mr. Smith:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Smith

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte Y. Michie Ons.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Sleep Quality

Indications for Use:

Prescription Use イ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C) .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Min Thulal

Page of_________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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).