MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE

K990266 · Micromedical Industries, Ltd. · LOS · Feb 2, 1999 · CV

Device Facts

• Record ID: K990266
• Device Name: MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
• Applicant: Micromedical Industries, Ltd.
• Product Code: LOS · CV
• Decision Date: Feb 2, 1999
• Decision: SESE
• Submission Type: Special

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 or software system 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 or to a PC for display.

Device Story

Device is a 12-lead simultaneous cable; connects 10 electrodes to patient chest; acquires ECG signals; converts analog signals to digital format; transmits data via proprietary digital protocol to Micromedical monitor or PC software. Used in clinical settings; operated by healthcare professionals. Output displayed on monitor or PC for clinical review. Facilitates ECG signal acquisition and display for diagnostic monitoring.

Clinical Evidence

Bench testing only. Testing performed to verify compatibility with Cardio View 3000 software.

Technological Characteristics

10-lead cable assembly; proprietary digital data transfer protocol; converts analog ECG signals to digital format; compatible with Micromedical monitors and PC software systems.

Indications for Use

Indicated for patients requiring ECG signal acquisition via 10-lead chest connection for transmission to a Micromedical monitor or PC-based software system.

Predicate Devices

• 12 Lead Simultaneous Cable

Submission Summary (Full Text)

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FEB 2 1999

K990266

## 510(k) SUMMARY

# Submitted by:

Micromedical Industries Limited 11 Technology Drive Labrador Queensland 4215 Australia

## Date Prepared:

January 26, 1999

#### Proposed Device:

Modified 12 Lead Simultaneous Cable

## Predicate Device:

12 Lead Simultaneous Cable

#### Proposed Device Description:

The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical™ monitor or to a software system to display the ECG signal on a personal computer.

## 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 or software system 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 or to a PC for display.

# Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

Nonclinical testing was performed to assure that the device works with the Cardio View 3000 software. Testing supported the proposed labeling change.

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Public Health Service

FEB 2 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Cresswell MicroMedical Industries, Ltd. 11 Technology Drive Labrodor Queensland 4215 Austrailia

Re: K990266 12-Lead Simulataneous Cable Requlatory Class: III (three) Product Code: LOS Dated: January 26, 1999 Received: January 28, 1999

Dear Mr. Cresswell:

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 leqally 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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

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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.

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 requlation (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, 2Misbranding 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, 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:

12 Lead Simultaneous Cable Device Name:

Indication for Use:

The 12 Lead Simultaneous Cable is used to acquire a patient's ECG via 10 leads connected to a patient's chest. It converts the ECG signal into a digital format and transfers this information to a Micromedical monitor or software system using a proprietary digital data transfer protocol.

Prescription Use
(Per 21 CFR 801.109)

V.K. Tiller

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