BIOLOG 3000 ELECTROCARDIOGRAPH

K974351 · Micromedical, Inc. · DPS · Apr 1, 1998 · Cardiovascular

Device Facts

• Record ID: K974351
• Device Name: BIOLOG 3000 ELECTROCARDIOGRAPH
• Applicant: Micromedical, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

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.

Device Story

Biolog 3000 electrocardiograph records and displays ECG signals; utilizes single lead or 12-lead simultaneous patient cables. Device features built-in LCD for signal visualization; proprietary software algorithms perform signal detection, noise/interference removal, and data storage. Recorded data is downloaded to PC running CardioView 3000 software or Micromedical Printer Interface for clinical review. Used in clinical settings to assist healthcare providers in ECG assessment; facilitates diagnostic decision-making through signal acquisition and transmission.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electrocardiograph with built-in LCD display; supports single lead and 12-lead simultaneous cable inputs. Connectivity via data download to PC (CardioView 3000 software) or printer interface. Proprietary software algorithms for signal detection and interference filtering.

Indications for Use

Indicated for patients requiring ECG monitoring via single lead or 12-lead simultaneous cable acquisition.

Regulatory Classification

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.

Predicate Devices

• MAX 1 Exercise Testing System

Submission Summary (Full Text)

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K974351

# 510(k) SUMMARY

## Submitted by:

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

APR - 1 1998

## Date Prepared:

November 6, 1997

## Proposed Device:

Biolog™ 3000 electrocardiograph

## Predicate Device:

MAX 1 Exercise Testing System

## Proposed 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 CardioView™ 3000 software or to a Micromedical™ monitor to display the ECG signal on a personal computer.

## 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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
Regulatory Class: II (two)
Product Code: 74 DPS
Dated: November 4, 1997
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 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 regulation (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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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:

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. The device includes a Biolog™ 3000 unit, a User’s Manual, and accessories. Additional device description information is presented in Attachment 5.0 – Device Description.