Multi-Link Cable and Lead Wire Systems are electrode cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctors offices, emergency vehicles, as well as in home use.

Device Description

Multi-Link Cable and Lead Wire Systems are a reusable electrode cable systems used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. This type of device is common to both the industry and to most medical establishments.

AI/ML Overview

The provided K980582 submission describes a medical device, the "Multi-Link Cable and Lead Wire Systems," which are reusable electrode cable systems used to transmit ECG signals. The study described is a comparison to a predicate device, not a standalone AI device study. Therefore, many of the requested categories are not applicable.

Here's the analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
21CFR Part 898: Performance Standard for Electrode Lead Wire and Patient Cables (effective May 11, 1998)	Meets 21CFR Part 898: Performance Standard for Electrode Lead Wire and Patient Cables
AAMI ECGC-5/83 (Electrical and Mechanical Testing)	Meets equivalent electrical and mechanical testing to AAMI ECGC-5/83
Substantial Equivalence to ConMed 3. Corp. ECG Patient Cables and Leadwires (K933649)	Demonstrated substantial equivalence to the predicate device

Since this is a submission for an ECG lead wire and cable system, and not an AI-powered diagnostic device, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The study involved a "comparison of the predicate device's production and both electrical and mechanical testing to AAMI ECGC-5/83 was made to the equivalent production, electrical and mechanical testing of the Multi-Link Cable and Lead Wire Systems." This suggests product testing rather than a clinical dataset in the traditional sense for an AI device.
Data Provenance: Not applicable in the context of clinical data for AI. The testing would have been performed on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study requiring expert-established clinical ground truth for diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of diagnostic findings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is an ECG cable system, not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For electrical and mechanical testing, the "ground truth" would be the specifications and requirements of the AAMI ECGC-5/83 standard and 21CFR Part 898. For substantial equivalence, it would be a direct comparison of the device's characteristics and performance to the predicate device.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it's not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{0}------------------------------------------------

K980582

Section 2 Summary and Certification 510(k) Summary Date: February 13, 1998

1. Establishment Information	Manufacturer/Submitter: Marquette Medical Systems100 Marquette DriveJupiter, FL 33468
	Registration Number: 1051778
	Contact Name/Phone #: Michael Laughran/ (561) 575-5000
2.	General Device Information
	Common/Usual Name: ECG Lead Wire and Cable System
	Trade/Proprietary Name: Multi-Link Cable and Lead Wire Systems
	Classification Name: Patient transducer and electrode cable (including connector)
	Device Classification: Class II.
	Performance Standards: 21CFR Part 898: Performance Standard for Electrode Lead Wire anPatient Cables. This Standard is effective on May 11, 1998 and was

Substantial Equivalence: Multi-Link Cable and Lead Wire Systems is substantially equivalent to ConMed 3. Corp. ECG Patient Cables and Leadwires which are currently legally marketed under 510(k) 933649.
published in the Friday, May 9, 1997 Federal Register.
Device Description: Multi-Link Cable and Lead Wire Systems are a reusable electrode cable systems used 4. to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. This type of device is common to both the industry and to most medical establishments.
Intended Use: Multi-Link Cable and Lead Wire Systems are reusable electrode cable systems used to transmit ട. signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. Multi-Link Cable and Lead Wire Systems are limited by the indications for use of the connected monitoring or diagnostic equipment is commonly located in hospitals, doctor's offices, and emergency vehicles, as well as in home use.
Technological comparison to legally marketed predicate device: the Multi-Link Cable and Lead Wire 6. Systems technological characteristics are similar in comparison to the ConMed Corp. ECG Patient Cables and Leadwires
1. Test Summary and Conclusion: A comparison of the predicate device's production and both electrical and mechanical testing to AAMI ECGC-5/83 was made to the equivalent production, electrical and mechanical testing of the Multi-Link Cable and Lead Wire Systems. Testing also demonstrated that the Multi-Link Cable and Lead Wire Systems meet 21CFR Part 898: Performance Standard for Electrode Lead Wire and Patient Cables. Marquette Medical Systems has demonstrated that the use of the Multi-Link Cable and Lead Wire Systems is as safe and as effective, and performs substantially equivalent to its predicate device.

MAR 1 6 1998

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the department's name around the perimeter. In the center of the seal is an image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

MAR 16 1998

Mr. Michael Laughran Marquette Medical Systems 100 Marquette Drive Jupiter, FL 33458

Re: K980582 Multi-Link Cable and Lead Wire Systems Requlatory Class: II (two) Product Code: 74 DSA February 13, 1998 Dated: Received: February 17, 1998

Dear Mr. Laughran:

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 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 requlations 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 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 requlatory 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 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. Michael Laughran

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) 594-4649. 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 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 (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

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Section 13 Indication for Use Statement

INDICATIONS FOR USE PAGE

510(K) Number (if known): Unknown - 510(k) filed February 13, 1998

Device Name: Multi-Link Cable and Lead Wire Systems

Indications for use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over- The- Counter Use

(Division Sign-Off)

Regulation Number and Section

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).