(107 days)
Not Found
Unknown
While the summary mentions "training group" and "diagnostic criteria were established using a separate training group," it does not explicitly state that AI or ML algorithms were used in this process. The description focuses on software options and ECG analysis, which could be based on traditional signal processing techniques rather than AI/ML.
No
The device is described as a "screening device to determine the need for clinical diagnosis and evaluation," which indicates it is used for identification rather than treatment or therapy.
No
The device is described as a "screening device to determine the need for clinical diagnosis and evaluation by polysomnography," not a diagnostic device itself.
Yes
The device description explicitly states that "The Lifescreen Apnea option is a software addition only - no hardware changes are involved." This confirms it is a software-only component added to existing ECG Holter scanning software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes ECG recordings, which are electrical signals measured on the body, not a sample taken from the body.
- The intended use is based on analyzing physiological signals (ECG) to screen for a condition (sleep apnea). This falls under the category of devices that analyze physiological data, not biological samples.
Therefore, while it's a medical device used for diagnosis-related purposes, it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device 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 (comma separated list FDA assigned to the subject device)
MNR
Device Description
Lifescreen Apnea is a software option for the LifeScreen ECG Holter scanning software. The Lifescreen Apnea option is a software addition only - no hardware changes are involved.
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
adult patients only
Intended User / Care Setting
physician including home, hospital or clinic.
Description of the training set, sample size, data source, and annotation protocol
Diagnostic criteria were established using a separate training group.
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)
- Non-clinical tests
- Tests with input data from data bases
- Validation tests
- Tests to check the operation of the algorithms
- Clinical tests
Lifescreen Apnea has been extensively tested in a clinical trial.
The results of the tests were:
Accuracy: 89.1% (95% C.I. 88.58-89.52)
Sensitivity: 87.0% (95% C.I. 86.19-87.82)
Specificity: 90.3% (95% C.I. 89.74-90.88)
Positive predictivity: 84.9%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 89.1% (95% C.I. 88.58-89.52)
Sensitivity: 87.0% (95% C.I. 86.19-87.82)
Specificity: 90.3% (95% C.I. 89.74-90.88)
Positive predictivity: 84.9%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
JAN 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Del Mar Reynolds Medical, Incorporated C/O Dr. George Myers Official Correspondent Medsys, Incorporated 377 Route 17S Hasbrouck Heights, New Jersey 07604
Re: K042745
Trade/Device Name: Lifescreen Apnea Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: December 13, 2004 Received: December 16, 2004
Dear Dr. Myers:
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.
1
Page 2 - Dr. Myers
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 vours.
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
2
Indications for Use
510(k) Number (if known): K042745
Device Name: Lifescreen Apnea
Indications for Use:
The device 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aeen Suliom
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042745
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K042745 Lifescreen Apnea
Del Mar Reynolds Inc. 510(k) Submission Lifescreen Apnea September 7, 2004
510(k) Summary
Submitter Information 1.
Name: Del Mar Reynolds Medical Inc.
Address:
Del Mar Reynolds Inc. 13 Whatney Irvine, CA 92618
Telephone Number: 949-699-3300 Fax Number: 949-699-3380
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: September 7, 2004
2. Name of Device
Trade Name: Lifescreen Apnea Common Name: Apnea Examination System Classification name: Ventilatory Effort Recorder
3. Equivalent legally-marketed devices.
Silent Night V, K000253, manufactured by Sleep Solutions
4. Description
Lifescreen Apnea is a software option for the LifeScreen ECG Holter scanning software. The Lifescreen Apnea option is a software addition only - no hardware changes are involved.
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K042745 Lifescreen Apnea
Page A 8
operation, electrocardiogram (ECG) data is collected by a standard Del Mar Reynolds Holter system and is operation, clock out a graming system with the Lifescreen Apnea option added. By recognizing episodes ment and from thing (SDB), the program indicates the probability that apneic events have occurred or breep Disodered Dreaming onea (AHI) Index. To detect SDB, the algorithm derives both RR Interval and ECG-Derived Respiratory (EDR) information from the ECG.
Intended Use ડ.
"Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the necessity for a polysomonographic examination. 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."
6. Performance Data
- Non-clinical tests (a)
- 4. Tests with input data from data bases
-
- Validation tests
-
- Tests to check the operation of the algorithms
- '५) Clinical tests
Lifescreen Apnea has been extensively tested in a clinical trial. The diagnostic criteria have also been established with a separate training group. Diagnostic criteria were established using a separate training group.
The results of the tests were:
Per-minute statistics
| Algorithm | Expert | ||
|---|---|---|---|
| N | P | ||
| n | 9449 | 845 | |
| p | 1012 | 5669 | |
| mean | 95% C.I. | ||
| Accuracy | 89.1 | 88.58-89.52 | |
| Sensitivity | 87.0 | 86.19-87.82 | |
| Specificity | 90.3 | 89.74-90.88 | |
| Positive predictivity | 84.9 |
Where:
N or n = negative (non-SDB)
upper case: expert classification
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K042745 Lifescreen Apnea
Page A 9
P or p = positive (SDB detected) lower case: algorithm classification
| Accuracy | $[(Nn + Pp) / Total] * 100 %$ |
|---|---|
| Sensitivity | $[Pp / (Pn + Pp)] * 100 %$ |
| Specificity | $[Nn / (Nn + Np)] * 100 %$ |
| Positive Predictivity | $[Pp / (Pp + Np)] * 100 %$ |
(c) Conclusions
Lifescreen Apnea is equivalent in safety and efficacy to the legally marketed predicate devices.