(293 days)
CARDIOVIEW™ 3000 interpretive software is a Windows-based program intended to interpret electrocardiograms. CARDIOVIEW™ 3000 interpretive software receives, displays and stores a single or standard 12-lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.
The proposed device is computer software which receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. Using a complex mathematical analysis of a 12 Lead ECG, the software can also provide an interpretation of the ECG recording.
The provided text describes the CARDIOVIEW™ ECG Interpretive Software, K974352. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study comparing the device to acceptance criteria, sample sizes for test or training sets, expert qualifications, or adjudication methods.
The document is a 510(k) summary and an FDA clearance letter. It states that nonclinical testing was performed to compare the proposed device to a predicate device (MAX 1 Exercise Testing System), and concluded that the proposed device is "substantially equivalent" to the predicate device. Substantial equivalence is the basis for 510(k) clearances, implying that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested details are not present in this document.
Here's a summary of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Nonclinical testing showed the proposed device to be substantially equivalent to the predicate device (MAX 1 Exercise Testing System). |
Missing Information: Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets for ECG interpretation) are not detailed in this document.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not specify the sample size of the test set used for nonclinical testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: The document does not mention the number or qualifications of experts used to establish ground truth for any testing.
4. Adjudication method for the test set
Missing Information: No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Missing Information: The document does not describe a multi-reader, multi-case comparative effectiveness study involving human readers with and without AI assistance. The nonclinical testing mentioned was a comparison between the proposed device and a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Answer: Yes, the nonclinical testing section states: "Testing showed the proposed device to be substantially equivalent to the predicate device. Both devices use proprietary algorithms to receive, store, analyze and interpret the ECG signal." This implies a standalone evaluation of the algorithm's performance against the predicate device's algorithm.
7. The type of ground truth used
Missing Information: The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). In the context of ECG interpretation, ground truth is typically established by expert cardiologists reviewing the ECGs and, sometimes, correlating with clinical data or more definitive diagnostic tests.
8. The sample size for the training set
Missing Information: The document does not provide any details about a training set or its size.
9. How the ground truth for the training set was established
Missing Information: As no training set details are provided, the method for establishing its ground truth is also not mentioned.
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8 1098 SEP
510(k) SUMMARY
Submitted by:
Malcom Castle, President Micromedical, Inc. 255 Revere Drive Suite 111 Northbrook, IL 60062
Date Prepared:
November 11, 1997
Proposed Device:
CARDIOVIEW™ ECG Interpretive Software
Predicate Device:
MAX 1 Exercise Testing System
Proposed Device Description:
The proposed device is computer software which receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol.
Statement of Intended Use:
CARDIOVIEW™ ECG Interpretive Software receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. Using a complex mathematical analysis of a 12 Lead ECG, the software can also provide an interpretation of the ECG recording.
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
Nonclinical testing was performed to compare the device to the predicate device. Testing showed the proposed device to be substantially equivalent to the predicate device. Both devices use proprietary algorithms to receive, store, analyze and interpret the ECG signal.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, depicted with flowing lines to suggest movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1398 SEP
Mr. Malcom Castle Micromedical, Inc. 255 Revere Drive, Suite 111 Northbrook, IL 60062
Re: K974352 CardioView™ 3000 Software Regulatory Class: III (three) Product Code: 74 LOS Dated: June 15, 1998 Received: June 16, 1998
Dear Mr. Castle:
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 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). 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 regulation 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.
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Page 2 - Mr. Malocm Castle
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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
allahan, Ph.D. Thomas J. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number: Not Available
CARDIOVIEW™ Interpretive Software Device Name:
Indication for Use:
CARDIOVIEW™ 3000 interpretive software is a Windows-based program intended to interpret electrocardiograms. CARDIOVIEW™ 3000 interpretive software receives, displays and stores a single or standard 12-lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.
Prescription ✓
mark Kramer
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K174352
N/A