Who is the manufacturer of SLEEP QUALITY?

Dynadx Corporation filed the 510(k) submission for SLEEP QUALITY (K070855).

What is the FDA product code for SLEEP QUALITY?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for SLEEP QUALITY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SLEEP QUALITY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SLEEP QUALITY

K070855 · Dynadx Corporation · MNR · Mar 20, 2008 · Anesthesiology

Device Facts

Record ID	K070855
Device Name	SLEEP QUALITY
Applicant	Dynadx Corporation
Product Code	MNR · Anesthesiology
Decision Date	Mar 20, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Software as a Medical Device

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 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 Story

Sleep Quality is a software system for screening sleep-disordered breathing (SDB). It processes single-lead ECG recordings exported in ASCII format from FDA-cleared Holter monitors. The system analyzes the ECG to derive RR intervals and ECG-Derived Respiratory (EDR) information. By identifying SDB episodes, the software calculates an Apnea-Hypopnea Index (AHI). Used in clinical or home settings, the software output assists physicians in determining the necessity for formal polysomnography. The device provides a non-invasive screening method to identify patients requiring further diagnostic evaluation, potentially improving access to sleep apnea care.

Clinical Evidence

Clinical study performed on 26,100 minutes of sleep data. Results: 95.0% per-subject sensitivity, 90.0% per-subject specificity, and 92.9% per-subject accuracy. Per-minute metrics: 84.5% sensitivity, 83.0% specificity, and 83.8% accuracy. Comparison against Lifescreen Apnea predicate showed improved performance metrics across all categories.

Technological Characteristics

Software-based system; processes ASCII-formatted ECG data from external Holter monitors. Uses proprietary algorithm to extract RR intervals and ECG-Derived Respiratory (EDR) signals. Operates on standard computing hardware. No specific materials or energy sources as it is a software-only analysis tool.

Indications for Use

Indicated for adult patients as a screening tool for sleep apnea to determine the need for polysomnography. Requires at least 4 hours of sleep duration with predominantly sinus rhythm ECG. Contraindicated for patients without sinus rhythm.

Regulatory Classification

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.

Predicate Devices

Lifescreen Apnea (K042745)

Related Devices

K042745 — LIFESCREEN APNEA · Del Mar Reynolds Medical, Inc. · Jan 19, 2005
K081861 — HOLTER LX ANALYSIS · North East Monitoring, Inc. · Dec 4, 2008
K151433 — AUDICOR CA300/CC100 Analyzer with SDB · Inovise Medical, Inc. · Mar 18, 2016
K163696 — SleepImage System · Mycardio, LLC Dba Sleepimage. · Oct 13, 2017
K070326 — NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM · Widemed, Ltd. · May 5, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ 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: 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. {1}------------------------------------------------ #### 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. | Product Parameter | Sleep Quality (Submission Device) DynaDx Corporation K070855 | 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 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. | Lifescreen Apnea 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. | | Target Population | Adults | Adults | | Apnea-Hypopnea Index (AHI) determination | Apnea-Hypopnea Index (AHI) derived from ECG signal through proprietary algorithm | Apnea-Hypopnea Index (AHI) derived from ECG signal through proprietary algorithm | | Detection of Sleep Disordered Breathing (SDB) | To detect SDB, the algorithm derives both RR Interval and ECG-Derived Respiratory (EDR) information from the ECG recording. | To detect SDB, the algorithm derives both RR Interval and ECG-Derived Respiratory (EDR) information from the ECG recording. | | Device for collecting signal | FDA approved Holter Monitor with text format ECG signal output | Del Mar Reynolds Lifescreen digital 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-subject Sensitivity | 95.0% | 85.0% | | Per-subject Specificity | 90.0% | 83.3% | | Per Subject Accuracy | 92.9% | 84.3% | | Per Subject Positive Predictivity | 92.7% | 87.1% | | Sleep Length for Test (minutes) | 26100 | 26100 | | Per-minute sensitivity | 84.5% | 80.9% | | Per-minute specificity | 83.0% | 78.1% | | Per-minute Accuracy | 83.8% | 79.5% | | Per-minute Positive Predictivity | 83.3% | 78.7% | ### Predicate Product Comparison Chart: {2}------------------------------------------------ {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Sleep Quality Indications for 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 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. 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:________________________________________________________________________________________________________________________________________________________________