(406 days)
Not Found
Not Found
Unknown
The summary mentions "interpretive software" which could potentially utilize AI/ML, but there is no explicit mention of AI, ML, or related terms, nor is there information about training or test sets which are common indicators of ML.
No
The device is described as processing electrical signals to produce a visual display of the heart's electrical activity and interpreting ECG waveforms as an aid. It is not intended to replace physician review or provide treatment, but rather to aid in diagnosis. Therapeutic devices are designed to treat or alleviate a medical condition.
Yes
The device processes electrical signals from the heart to produce a visual display and interprets ECG waveforms, which are actions performed for the purpose of diagnosis.
Unknown
The summary does not explicitly state whether the device is software-only. It describes processing an electrical signal and producing a visual display, which could be achieved with either hardware or software components, or a combination. The lack of a "Device Description" section prevents a definitive determination.
Based on the provided information, the Dr.LEE ECG-310A is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Dr.LEE ECG-310A processes electrical signals from the heart, which is a physiological signal, not a specimen derived from the body.
- The intended use describes processing electrical signals and producing a visual display of the heart's electrical activity. This aligns with the function of an electrocardiograph (ECG) machine, which is a medical device used for non-invasive measurement of electrical activity of the heart.
- There is no mention of analyzing biological specimens.
Therefore, the Dr.LEE ECG-310A falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
Dr.LEE ECG-310A (with interpretive software) is to be used to process the electrical signal transmitted through electrodes and to produce a visual display of the electrical signal produced by the heart. While the Dr.LEE ECG-310A is capable of interpreting the ECG waveform as an aid, it is not intended to replace the review and interpretation by the physician. To be used under professional healthcare supervision.
Product codes
74 LOS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare supervision
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 1998
Dr. Lee Co., Ltd. c/o Holland & Associates 3722 Avenue, Sausalito Irvine, CA 92606 Attention: Mr. Greg Holland
Re: K972587 Electrocardiograph, Dr. Lee ECG-310A Requlatory Class: III (three) Product Code: 74 LOS Dated: June 4, 1998 Received: June 8, 1998
Dear Mr. Holland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Dr. Lee Co., Ltd.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. allahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | K972587 |
|---|---|
| --------------------------- | --------- |
Device Namc:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
--
Dr.LEE ECG-310A (with interpretive software) is to be used to process the electrical signal transmitted through electrodes and to produce a visual display of the electrical signal produced by the heart. While the Dr.LEE ECG-310A is capable of interpreting the ECG waveform as an aid, it is not intended to replace the review and interpretation by the physician.
To be used under professional healthcare supervision.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K972587 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)