(358 days)
No
The description focuses on algorithmic analysis of ECG data (RR Interval and EDR) to detect SDB, without mentioning AI or ML techniques.
No
The device is described as a "screening device to determine the need for clinical diagnosis and evaluation," implying it identifies a condition rather than treating or preventing it.
Yes
The device is intended as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score, and it recognizes episodes of Sleep Disordered Breathing (SDB) and indicates if apneic events have occurred and estimates the Apnea-Hypopnea Index (AH), which are all diagnostic functions.
Yes
The device description explicitly states "Sleep Quality is a software system" and that it takes "text format ECG recording as input" from "standard Holter devices," indicating it is a software application that processes data from external hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The DynaDx Sleep Quality system analyzes ECG recordings, which are electrical signals from the heart. It does not analyze biological samples taken from the body.
- Intended Use: The intended use is to screen for the need for clinical diagnosis of sleep apnea based on the analysis of ECG data during sleep. This is a physiological measurement, not an in vitro test.
Therefore, the DynaDx Sleep Quality system falls under the category of a medical device that analyzes physiological data, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MNR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home, hospital, clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study: Yes
Clinical Trial: No
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Per-subject Sensitivity: 95.0%
Per-subject Specificity: 90.0%
Per Subject Accuracy: 92.9%
Per Subject Positive Predictivity: 92.7%
Per-minute sensitivity: 84.5%
Per-minute specificity: 83.0%
Per-minute Accuracy: 83.8%
Per-minute Positive Predictivity: 83.3%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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:________________________________________________________________________________________________________________________________________________________________