The SureLink extension cable is indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. This cable may be reused subject to the cleaning and sterilization restrictions herein.

The TempLink extension cable when used in conjunction with a thermistor configured Stinger/Stinger S catheter is indicated for use during cardiac ablation with set power to 50W.

The TempLink M extension cable when used in conjunction with a thermocouple configured Stinger M/Stinger SM catheter is indicated for use during cardiac ablation with set power to 50W.

These cables may be reused subject to the cleaning and sterilization restrictions herein.

Device Description

The SureLink, TempLink, and TempLink M Extension Cables are accessories that are used in conjunction with the appropriate diagnostic or ablation catheter. Cables, when initially introduced, provided an alternate means of electrically connecting EP catheters to recorders versus the catheter connecting directly to the recorder. The use of cables allows the catheter to remain in the sterile field, the recorder junction box doesn't have to enter the sterile field, and the cable provides more working length. The cables are offered in several lengths ranging from 7 to 10 feet in length.

AI/ML Overview

The provided document is a 510(k) premarket notification for the reuse claim of Bard Electrophysiology's SureLink, TempLink, and TempLink M Extension Cables. It seeks to demonstrate substantial equivalence to previously marketed versions of the same devices, with the primary difference being the addition of a reuse claim.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of specific quantitative acceptance criteria or detailed performance metrics. Instead, it refers to performance data demonstrating that the cables continue to perform as intended after cleaning and sterilization. The "acceptance criteria" are implicitly met by demonstrating that the reused devices are "Substantially Equivalent" to the predicate devices and that the "new characteristics" (the reuse claim) do not affect safety or effectiveness.

Performance Aspect (Implied Acceptance Criteria)	Reported Device Performance
Safety:	The addition of a reuse claim does not affect patient safety. The cables are accessory devices, not placed intravascularly, and have no patient body contact.
Effectiveness:	The cables continue to perform as intended after the specified number of cleanings and resterilizations. Failure of the cable would result in physician inconvenience and have no negative impact on the patient. The reuse claim is supported by performance data in the Appendices.
Functional Equivalence:	The SureLink, TempLink, and TempLink M cables with the reuse claim are "Substantially Equivalent" to their respective predicate devices. The internal tail component was changed from tinsel wrapped kevlar to standard copper wire, and this was found to be equivalent.
Compliance with Sterilization/Cleaning:	Data is provided to support the reuse claim for Ethylene Oxide (EO), steam autoclave, and Sterrad sterilization, subject to cleaning and sterilization restrictions in the Instructions for Use (IFU).

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

The document explicitly states: "Performance data is provided in the Appendices with respect to the reuse claim." However, the specific sample sizes for this performance data (test set) are not provided within the body of this summary.
Data Provenance: Not explicitly stated within this summary. It's highly probable to be internal company testing, but no details like country of origin or whether it was retrospective/prospective are given.

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

Not applicable. This submission is for a medical device (extension cables) and focuses on engineering and performance testing for repeated sterilization cycles rather than diagnostic accuracy or clinical interpretation. Therefore, a "ground truth" derived from expert consensus, as would be common in diagnostic imaging studies, is not relevant to this type of device submission.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this study is not evaluating a diagnostic algorithm where adjudication of expert opinions would be necessary. The evaluation centers on testing the physical and electrical integrity of the cables after repeated sterilization, likely through objective performance tests.

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. This document describes a 510(k) submission for extension cables and does not involve AI or human reader assessment. Therefore, an MRMC study or an effect size for human readers with AI assistance is not relevant or included.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This document pertains to physical medical devices (cables) and does not involve any algorithms or software performing an independent assessment.

7. The Type of Ground Truth Used:

The "ground truth" for this type of device is the expected performance specifications and functional integrity of the cables. The performance data in the Appendices would have compared the cable's electrical and physical properties (e.g., conductivity, insulation, physical damage) after multiple sterilization cycles against pre-defined engineering specifications for a functional cable. This is a form of objective performance data rather than expert consensus, pathology, or outcomes data in the typical sense.

8. The Sample Size for the Training Set:

Not applicable. This submission is for hardware (cables) and not a machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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Bard Electrophysiology C.R. Bard, Inc. 55 Technology Drive Lowell, MA 01851 (978) 441-6202 BardEP@CRBARD.COM KO 3598 9.115

JAN 1 1 2002

BARD

VI. 510(k) SUMMARY: FOR THE SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990.

A. Submitter's Information

Name:

Address:

Phone: Fax: Email address: Contact Person: Bard electrophysiology Division of C.R. Bard, inc. 55 Technology Drive Lowell, MA 01851 978-323-2216 (Direct Line) 978-323-2222 deborah.herrington@crbard.com Deborah L. Herrington Manager, Regulatory Affairs October 30, 2001

Date of Preparation:

B. Device Name

Trade Name:

Common/Usual Name: Classification Name:

SureLink Extension Cable TempLink Extension Cable TempLink M Extension Cabie Electrode cable (including connector) Patient Transducer and Electrode Cable (including connector)

C. Predicate Device Names(s)

SureLink Extension Cable TempLink Extension Cable TempLink M Extension Cable

510(k) Premarket Notification for the Reuse Claim for the SureLink, TempLink, and TempLink M Extension Cables Bard electrophysiology Division of C.R. Bard, Inc.

Image /page/0/Picture/19 description: The image shows the logo for Bard Electrophysiology. The logo consists of a stylized heart shape enclosed within a square on the left, followed by the word "Bard" in a bold, sans-serif font. Below "Bard" is the word "electrophysiology" in a smaller, italicized font. The logo is black and white.

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Device Description/Indications for Use D.

Description

Indications

SureLink Extension Cables

TempLink/TempLink M Extension Cables

The TempLink extension cable when used in conjunction with a thermistor configured Stinger/Stinger S catheter is indicated for use during cardiac ablation with set power to 50W.

The TempLink M extension cable when used in conjunction with a thermocouple configured Stinger M/Stinger SM catheter is indicated for use during cardiac ablation with set power to 50W.

These cables may be reused subject to the cleaning and sterilization restrictions herein.

510(k) Premarket Notification for the Reuse Claim for the SureLink, TempLink, and TempLink M Extension Cables Bard electrophysiology Division of C.R. Bard, Inc.

(013598

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Technological Characteristics/Performance Data Summary ய்

The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" decision tree (CDRH 510(k) Manual 92-4158) was utilized to make a determination of substantial equivalence. This decision tree is depicted in Figure IV-1 with the decision points relevant to the SureLink, TempLink, and TempLink M cables indicated by highlighting. The answers to the following questions at the indicated decision points in Figure IV-1 lead to a determination of substantial equivalence.

New Device is Compared to a Marketed Device?

Yes. The SureLink, TempLink, and TempLink M Extension cables with the reuse claim are compared to their no reuse claim counterparts. The only change to the indications for use statement is the addition of the reuse claim subject to the cleaning and sterilization restrictions provided in the instructions for use.

Does the New Device have the Same Indications Statement?

No. The indication statement for the SureLink cables, subject of this 510(k), and that of the predicate device are similar. Both are indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. The SureLink cable, subject of this 510(k), is additionally indicated for reuse subject to the cleaning and sterilization restrictions included in the instructions for use (IFU).

The indication statement for the TempLink cables, subject of this 510(k), and that of the predicate device are similar. When used in conjunction with a thermistor configured Stinger / Stinger S catheter the TempLink cable is indicated for use during cardiac ablation with set power to 50W.

The indication statement for the TempLink M cable, subject of this 510(k), and that of the predicate device are similar. When used in conjunction with a thermocouple configured Stinger M catheter the TempLink M cable is indicated for use during cardiac ablation with set power to 50W.

510(k) Premarket Notification for the Reuse Claim for the SureLink, TempLink, and TempLink M Extension Cables Bard electrophysiology Division of C.R. Bard, Inc.

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The TempLink/TempLink M cables, subject of this 510(k), are additionally indicated for reuse subject to the cleaning and sterilization restrictions included in the IFU.

Do the Differences Alter the Intended Therapeutic/Diagnostic/etc. Effect ?

No. The cables with the reuse claim continue to be used as originally described. These cables, like their respective predicate devices, are not placed intravascularly and have no patient body contact. These cables are accessory devices that continue to be used in conjunction with their respective therapeutic or diagnostic catheters.

New Device Has Same Intended Use and May Be "Substantialy Equivalent"

Does New Device Have the Same Technological Characteristics, e.g., Design, Materials, etc.?

No. The SureLink, TempLink, and TempLink M cables are similar to their predicate devices. The design of each cable remains unchanged. The internal tail component was originally made from tinsel wrapped kevlar, but was replaced with standard copper wire that is easier to work with in manufacturing, more readily available, and found equivalent to the kevlar material. With respect to the reuse claim for EO, steam autoclave, and Sterrad sterilization, data to support this claim is provided in the Appendices.

Could the New Characteristics Affect Safety or Effectiveness?

No. The addition of a reuse claim could effect safety and/or effectiveness for a number of devices. However, these cables are accessories to their respective catheters and are not placed intravascularly, nor do they have patient body contact. Regarding effectiveness, failure of the cable to not perform as intended would result in physician inconvenience and have no negative impact on the patient.

Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?

No. Although the design of the cables has not changed, and the materials of construction are similar (change in intemal tail component from tinsel wrapped kevlar to copper wire ), data are required to support the reuse claim.

510(k) Premarket Notification for the Reuse Claim for the SureLink, TempLink, and TempLink M Extension Cables Bard electrophysiology Division of C.R. Bard, Inc.

ી 3598

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Are Performance Data Available to Assess Equivalence?

Yes. Performance data is provided in the Appendices with respect to the reuse claim.

Performance Data Demonstrate Equivalence?

Yes. The performance data demonstrates that the SureLink, TempLink, and TempLink M cables continue to perform as intended after the specified number of cleanings and resterilizations as described in the instructions for use.

Therefore, the SureLink, TempLink, and TempLink M cables with the reuse claim are "Substantially Equivalent" to their respective predicate devices.

SUBSTANTIALLY EQUIVALENT DETERMINATION:

The determination of substantial equivalence is based on the decision tree found in Figure IV-1, the safety information provided in Section IV.C, the effectiveness results regarding cable performance summarized in Section IV, and the actual data provided in the Appendices. Refer to the table under the tab "Appendices" for the actual information provided.

510(k) Premarket Notification for the Reuse Claim for the SureLink, TempLink, and TempLink M Extension Cables Bard electrophysiology Division of C.R. Bard, Inc.

KO13598

9.5/5

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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2002

Ms. Deborah L. Herrington Manager. Regulatory Affairs C.R. Bard, Inc. Bard Electrophysiology 55 Technology Drive Lowell, MA 01851

Re: K013598

Trade Name: Reuse Claim for the Bard Electrophysiology SureLink, TempLink, and TempLink M Extension Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable Regulatory Class: Class II (two) Product Code: DSA Dated: October 30, 2001 Received: October 31, 2001

Dear Ms. Herrington:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Deborah L. Herrington

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

hs. X. O'Dell

ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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D. INDICATIONS FOR USE

K013598

SureLink Extension Cables Device Name:

Indications for Use:

indications for USC.
The SureLink extension cable is indicated for use during electrophysiology studies in The Sulecins extension cable is indicator for ass authig cross in process project to the cleaning and sterilization restrictions herein.

TempLink/TempLink M Extension Cables Device Name:

Indications for Use:

indications for Osc.
The TempLink extension cable when used in conjunction with a thermistor configured The Tempelline exceller cable when as a se during cardiac ablation with set power to 50W.

The TempLink M extension cable when used in conjunction with a thermocouple configured The TempEllik in Oxlondon Cable Wee during cardiac ablation with set power to 50W.

These cables may be reused subject to the cleaning and sterilization restrictions herein.

Contraindications: Contraindications for the SureLink, TempLink, and TempLink M Extension cables.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use _

Division of Cardiovascular & Regulatory Devices
510(k) Number K013398

510(k) Premarket Notification for the Reuse Claim for the SureLink, TempLink, and TempLink M Extension Cables Bard electrophysiology Division of C.R. Bard, Inc.

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).