(149 days)
Not Found
Unknown
The document mentions a "diagnostic algorithm" but does not provide enough detail to determine if it utilizes AI/ML. The lack of information on training/test sets and specific AI/ML terminology makes it impossible to confirm.
No.
The device is intended for recording electrocardiographic signals and aiding in the diagnosis of acute myocardial infarction, which are diagnostic functions, not therapeutic.
Yes
The PRIME ECG System includes a diagnostic algorithm intended as an aid in diagnosing AMI, and a clinical study confirmed its utility in assisting with the diagnosis of acute myocardial infarction.
No
The device description explicitly mentions hardware components like an 80-lead disposable electrode array (vest) and an 80-channel recording device. While it includes software, it is not solely software.
Based on the provided information, the PRIME ECG System 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.
- PRIME ECG System Function: The PRIME ECG System records electrical signals from the body surface. This is a non-invasive procedure that measures electrical activity directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use is "recording of electrocardiographic signals from the body surface," which aligns with the function of an ECG device, not an IVD.
- Diagnostic Algorithm: While the system includes a diagnostic algorithm as an "aid in diagnosing AMI," this algorithm processes the electrical signals recorded from the body surface, not results from an in vitro test.
Therefore, the PRIME ECG System falls under the category of a medical device that performs a diagnostic function based on physiological measurements from the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The PRIME ECG is indicated for the recording of echocardiographic signals on the body surface.
The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.
Product codes
DPS
Device Description
The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest. The electrodes are screen-printed onto a clear plastic substrate. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored.
The PRIME software also contains a diagnostic algorithm that may be used as an aid in diagnosing AMI. The algorithm provides an explanation of the measurements that were interpreted to reach the suggested diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
In addition, a clinical study was performed that demonstrated that the PRIME ECG System diagnostic algorithm provides information that may assist in the diagnosis of acute myocardial infarction.
The entire system has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard. The biocompatibility testing of the patient contact material showed that the material is safe for use. Performance testing to EC 11 standard demonstrates performance equivalent to marketed ECG systems. This testing demonstrates that the PRIME ECG System meets electrical and environmental safety standards for safe use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
PRIME ECG TM System with Diagnostic Algorithm
Common/Classification Name: Electrocardiograph as classified under 21 CFR 870.2340
Meridian Medical Technologies 10240 Old Columbia Road Columbia, MD 21046
JUN 1 1 2003
Telephone: 410-309-6830 410-309-1475 Fax:
Jamil LaHam Contact: General Manager, Cardiopulmonary Systems
Prepared: July 17, 2001
Legally Marketed Predicate Devices A.
The PRIME ECG System is substantially equivalent to the Hewlett Packard M1700A cleared under K911139. Both systems have the same intended use, which is to record electrocardiographical signals.
B. Device Description
The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest. The electrodes are screen-printed onto a clear plastic substrate. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored.
The PRIME software also contains a diagnostic algorithm that may be used as an aid in diagnosing AMI. The algorithm provides an explanation of the measurements that were interpreted to reach the suggested diagnosis.
C. Indications for Use
The PRIME ECG is indicated for the recording of echocardiographic signals on the body surface.
D. Substantial Equivalence Summary
The PRIME ECG system with diagnostic algorithm is substantially equivalent to the PRIME system cleared under 510(k) K012414. It is also substantially equivalent to
1
marketed ECG systems, some of which also contain diagnostic algorithms.
In addition, a clinical study was performed that demonstrated that the PRIME ECG System diagnostic algorithm provides information that may assist in the diagnosis of acute myocardial infarction.
E. Technological Characteristics
The inclusion of a diagnostic algorithm does not change the technological characteristics of the PRIME ECG system.
F. Testing
The entire system has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard. The biocompatibility testing of the patient contact material showed that the material is safe for use. Performance testing to EC 11 standard demonstrates performance equivalent to marketed ECG systems. This testing demonstrates that the PRIME ECG System meets electrical and environmental safety standards for safe use.
G. Conclusions
Meridian Medical Technologies has demonstrated through its testing that the PRIME ECG with diagnostic algorithm is equivalent to the predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
JUN 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Meridian Medical Technologies c/o Mr. Jamil LaHam Vice President, Business Development 10240 Old Columbia Road Columbia, MD 21046
Re: K030104
Trade Name: PRIME ECG Automated Analysis Software Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: April 10, 2003 Received: April 11, 2003
Dear Mr. LaHam:
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.
3
Page 2 - Mr. Jamil LaHam
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 (301) 594-4646. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Kelle Tule
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):
Device: PRIME TM ECG System
Indications for Use:
The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Ne latim
510(k) Number K030104