(293 days)
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Not Found
No
The summary mentions "proprietary software algorithms" and "complex mathematical analysis" for ECG interpretation, but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe training or test sets which are typical for ML-based devices.
No
The device is interpretive software for ECGs, meaning it analyzes and interprets data rather than directly treating a condition. Its function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the software is "intended to interpret electrocardiograms" and "contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal." The "Device Description" also mentions that the software "can also provide an interpretation of the ECG recording." Interpretation of medical signals like ECGs is a diagnostic function.
Yes
The device is described as "computer software" and its function is to receive, display, store, and interpret ECG recordings transmitted from a separate hardware device (Micromedical™ ECG monitor). The 510(k) summary focuses solely on the software's capabilities and performance relative to a predicate device, without mentioning any hardware components included with the submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The CARDIOVIEW™ 3000 interpretive software analyzes and interprets electrocardiograms (ECGs). ECGs are recordings of the electrical activity of the heart, obtained through electrodes placed on the body. This is a non-invasive procedure and does not involve analyzing specimens taken from the body.
Therefore, while it's a medical device used for diagnosis, it falls under the category of devices that analyze physiological signals directly from the patient, rather than analyzing in vitro specimens.
N/A
Intended Use / Indications 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.
Product codes
74 LOS
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MAX 1 Exercise Testing System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.
1
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.
2
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
3
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