MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE

K974220 · Micromedical, Inc. · DPS · Aug 25, 1998 · Cardiovascular

Device Facts

• Record ID: K974220
• Device Name: MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
• Applicant: Micromedical, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Micromedical™ 12 Lead Simultaneous Cable is intended for use in acquiring a patient ECG signal via 10 leads connected to the patient's chest, converting the ECG patient DOO siguir 11-2-2, and transferring this information to a Micromedical™ monitor using a proprietary digital data transfer protocol.

Device Story

Device is a 12-lead simultaneous cable; connects electrodes to patient chest; acquires ECG signals via 10 leads; converts analog ECG signals to digital format; transfers data to Micromedical monitor via proprietary digital protocol. Used in clinical settings; operated by healthcare professionals. Facilitates ECG monitoring by enabling signal transmission from patient to monitor.

Clinical Evidence

Bench testing only.

Technological Characteristics

10-lead cable assembly; proprietary digital data transfer protocol; converts analog ECG signals to digital format for monitor interface.

Indications for Use

Indicated for patients requiring ECG signal acquisition via 10-lead chest connection for transmission to a Micromedical monitor. Prescription use only.

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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K97430

# AUG 25 1998 -

#### 510(k) SUMMARY

#### Submitted by:

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

#### Date Prepared:

October 19, 1997

Proposed Device:

12 Lead Simultaneous Cable

# Predicate Device:

MAX 1 Exercise Testing System

# Proposed Device Description:

The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical™ monitor.

# Statement of Intended Use;

The 12 Lead Simultaneous Cable acquires a patient's ECG via 10 leads connected to a patient's chest, converts the ECG signal into a digital format, and transfers this information to a Micromedical™ monitor using a proprietary digital data transfer protocol.

The proposed device is intended to be used to acquire a patient's ECG signal and transmit it to a Micromedical™ monitor.

# Discussion of Non-Clinical Tests; Conclusions Drawn from Non-Clinical Tests

Non-clinical 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

AUG 25 1998

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

Re: K974220 12-Lead Simultaneous Cable Requlatory Class: II (two) Product Code: DPS Dated: August 13, 1998 Received: August 19, 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 Requlations, 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 Druq 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 Reqister. Please note: this response to your premarket notification submission does not affect any

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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 requlations.

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? (21CFR 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/dsma/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

K974220 510(k) Number:

Device Name:

Micromedical™ 12 Lead Simultaneous Cable

Indication for Use:

The Micromedical™ 12 Lead Simultaneous Cable is intended for use in acquiring a patient ECG signal via 10 leads connected to the patient's chest, converting the ECG patient DOO siguir 11-2-2, and transferring this information to a Micromedical™ monitor using a proprietary digital data transfer protocol.

**Prescription Use**
**(Per 21 CFR 801.109)**

V. Dale Tull

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