The Biolog™ 3000 electrocardiograph detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical™ 12 Lead Simultaneous Cable. The Biolog™ 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView™ 3000 software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices.

Device Description

The proposed device is an electrocardiograph that can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running Cardio View7M 3000 software or to a Micromedical™ monitor to display the ECG signal on a personal computer. The device includes a Biolog™ 3000 unit, a User's Manual, and accessories.

AI/ML Overview

This 510(k) summary for the Biolog™ 3000 electrocardiograph does not contain detailed acceptance criteria or a study proving the device meets those criteria. The provided text is a summary of the 510(k) submission, focusing on establishing substantial equivalence to a predicate device.

Here's an breakdown of the requested information based on the provided text, and where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Specified	Not Specified

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Nonclinical testing was performed to compare the device to the predicate device."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No, an MRMC study is not mentioned as having been performed. The safety and effectiveness are established through substantial equivalence to a predicate device based on nonclinical testing.
Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no MRMC study or AI assistance aspect is mentioned.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: Yes, in a limited sense. The "Nonclinical testing" conducted appears to be a standalone evaluation of the device's technical performance against the predicate. However, detailed metrics of this performance are not provided. The statement "The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices" implies algorithm functionality was tested.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. Given it's an ECG device, the "ground truth" for nonclinical testing would likely be derived from a controlled signal generator or established reference ECG readings, used to confirm the device's ability to accurately detect, process, and display ECG signals compared to the predicate device.

8. Sample Size for the Training Set

Training Set Sample Size: Not specified. The document does not explicitly mention a training set, which would typically be associated with machine learning or AI models undergoing supervised training. While the device contains "proprietary software algorithms," the documentation doesn't detail their development or training methodology.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not specified, as a training set is not explicitly mentioned.

Summary of Information Provided:

The 510(k) summary for the Biolog™ 3000 electrocardiograph primarily focuses on establishing "substantial equivalence" to a predicate device (MAX 1 Exercise Testing System) through "nonclinical testing." It does not provide specific details on acceptance criteria, test set specifics (sample size, data provenance), expert involvement, adjudication methods, or the results of detailed performance studies as would be expected for an AI/ML-based device with comprehensive performance claims. The "proprietary software algorithms" are mentioned for detecting, filtering, storing, and downloading ECG data, but their validation process in terms of statistical metrics or clinical studies is not elaborated upon in this summary.

Summary

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K974351

510(k) SUMMARY

Submitted by:

APR - 1 1998

Malcom Castle, President Micromedical, Inc. 255 Revere Drive Suite 111 Northbrook, IL 60062

Date Prepared:

November 6, 1997

Proposed Device:

Biolog™ 3000 electrocardiograph

Predicate Device:

MAX 1 Exercise Testing System

Proposed Device Description:

Statement of Intended Use:

The Biolog™ 3000 electrocardiograph is intended to detect an ECG using a single lead patient cable or a 12 Lead Simultaneous Cable. The Biolog 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECT data to a PC running CardioView™ software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices.

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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 1998

Mr. Malcom Castle President Micromedical, Inc. 255 Revere Drive, Suite 111 Northbrook, IL 60062

Re : K974351 Biolog™ 3000 Electrocardiograph Requlatory Class: II (two) Product Code: 74 DPS November 4, 1997 Dated: Received: November 19, 1997

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 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 A substantially equivalent determination assumes compliance to 895. 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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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

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Indication for Use

510(k) Number: Not Available

Device Name: Biolog™ 3000 Electrocardiograph

Indication for Use:

Prescription Use
(Per 21 CFR 801.109)

Darlene Heller

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 97435 510(k) Number _

Regulation Number and Section

§ 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).