(149 days)
The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.
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.
Acceptance Criteria and Study Details for PRIME ECG System with Diagnostic Algorithm
The provided 510(k) summary for the PRIME ECG System with Diagnostic Algorithm (K030104) offers limited details on specific acceptance criteria and the comprehensive study that proves the device meets them. However, it does state that a clinical study was performed to demonstrate the algorithm's utility in diagnosing AMI. Based on the available information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device compliance with IEC-601-1 (including subparagraphs) Electro-Medical Equipment Safety Standard. | The entire system has been tested to demonstrate compliance with IEC-601-1. |
| Biocompatibility: Patient contact material shown to be safe for use. | Biocompatibility testing of the patient contact material showed that the material is safe for use. |
| Performance Equivalence: Performance to EC 11 standard demonstrates equivalence to marketed ECG systems. | Performance testing to EC 11 standard demonstrates performance equivalent to marketed ECG systems. |
| Clinical Utility (Diagnostic Algorithm): Algorithm provides information that may assist in the diagnosis of acute myocardial infarction (AMI). | "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." |
Note: The 510(k) summary does not specify quantitative metrics for the "assistance in diagnosis of AMI" nor does it provide a specific performance target or range for this criterion. It merely states that the study "demonstrated" this capability.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the clinical study validating the diagnostic algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The 510(k) summary does not provide details on the number of experts used to establish ground truth or their qualifications for the clinical study.
4. Adjudication Method for the Test Set
The 510(k) summary does not provide details on the adjudication method used for the test set in the clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The study described appears to focus solely on the algorithm's ability to "provide information that may assist in the diagnosis of AMI," rather than a comparative study with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study appears to have been conducted. The description "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" suggests that the algorithm's performance in providing diagnostic information was evaluated. There is no mention of human-in-the-loop performance in the context of this specific clinical study for the diagnostic algorithm.
7. Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used for the clinical study demonstrating the diagnostic algorithm's utility for AMI. Given the nature of AMI diagnosis, it is highly probable that a combination of clinical assessment (symptoms, physical exam), biomarkers (cardiac enzymes), follow-up outcomes, and potentially expert consensus on other diagnostic tests (e.g., echocardiography, coronary angiography) would have been used to establish the ground truth for AMI. However, this is an inference and not explicitly stated in the document.
8. Sample Size for the Training Set
The 510(k) summary does not provide details on the sample size for the training set used for the diagnostic algorithm.
9. How Ground Truth for the Training Set Was Established
The 510(k) summary does not provide details on how the ground truth for the training set was established for the diagnostic algorithm.
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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
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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.
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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.
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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
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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
§ 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).