(243 days)
Not Found
110B, 120B, 310B
No
The summary explicitly states the device is "non-interpretive" and there are no mentions of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No.
The device is used to process electrical signals to produce a visual display for diagnostic purposes, not to treat a condition.
Yes
No
The device description explicitly states it is an "electrocardiograph," which is a hardware device that processes electrical signals. While it processes a signal, the core function is tied to a physical sensor (electrodes) and hardware for signal processing and display.
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 function: The description states the device "is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signal produced by the heart." This involves measuring electrical activity directly from the body's surface, not analyzing a sample taken from the body.
- Lack of mention of samples: The description does not mention the analysis of any biological samples.
Therefore, the Dr. LEE ECG-110B, 120B, and 310B are medical devices used for physiological measurement, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Dr. LEE ECG-110B, 120B and 310B (non-interpretive electrocardiographs) is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signal produced by the heart.
The patient population is any patient requiring an electrocardiograph at the direction of a physician.
The product is to be used in a medical professional environment, such as a doctors office, hospital, medical clinic and the like.
Product codes
74 DPS
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
medical professional environment, such as a doctors office, hospital, medical 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)
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
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR | | 1998
Dr. Lee Co., Ltd. c/o Holland and Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K972603 Electrocardiographs Models 110B, 120B, and 310B Regulatory Class: II (two) Product Code: 74 DPS-Dated: December 18, 1997 December 19, 1997 Received:
Dear Dr. Lee:
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 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 requlation (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 requlation 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Dr. LEE Co., Ltd.
Page 1
510(k) Number (if known): K972603
Device Name: Dr. LEE ECG-110B, 120B and 310B
Indications For Use:
Dr. LEE ECG-110B, 120B and 310B (non-interpretive electrocardiographs) is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signal produced by the heart.
The patient population is any patient requiring an electrocardiograph at the direction of a physician.
The product is to be used in a medical professional environment, such as a doctors office, hospital, medical clinic and the like.
(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 K972603
510(k) Number K972603
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use --------
(Optional Format 1-2-96)