Electrophysiology catheter accessory cables are intended for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment.

Device Description

Vanguard reprocessed electrophysiology catheter accessory cables are accessories to an appropriate diagnostic catheter. The use of the cable provides a means of electrically connecting the EP catheter to recording/pacing equipment while allowing the catheter to remain in the sterile field and also provides additional working length.

Vanguard reprocessed accessory cables are constructed of a hollow polymer shaft approximately 4 to 7 feet in length that terminates with at each end with a connector. One connector couples with the proximal connector of an electrophysiology catheter; the other connector couples with an extension cable or an electrophysiology console. Various connector types are available at each end to match the appropriate electrophysiology catheter and console.

Vanguard receives previously used accessory cables from healthcare facilities and cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to the healthcare facility.

AI/ML Overview

This document describes the acceptance criteria and the study that proves the device meets those criteria for the "Vanguard Reprocessed Electrophysiology (EP) Catheter Accessory Cable" (K030005).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to the concept of substantial equivalence to predicate devices. The study aims to demonstrate that the reprocessed device performs as intended and is safe and effective, similar to the original equipment manufacturer (OEM) devices and the listed predicate devices.

Acceptance Criteria	Reported Device Performance
Functional Equivalence: Device performs as intended, electrically connecting EP catheter to recording/pacing equipment.	Vanguard reprocessed accessory cables are constructed of a hollow polymer shaft approximately 4 to 7 feet in length that terminates with at each end with a connector. One connector couples with the proximal connector of an electrophysiology catheter; the other connector couples with an extension cable or an electrophysiology console. Various connector types are available at each end to match the appropriate electrophysiology catheter and console.
Safety: Device is safe for its intended use.	Cleaning, sterilization, and packaging validations demonstrate that the reprocessed devices are safe.
Effectiveness: Device is effective for its intended use.	Performance testing demonstrates that the reprocessed devices are effective.
Technological Characteristics: Identical to OEM devices.	Vanguard Reprocessed EP Catheter Accessory Cables are essentially identical to the Original Equipment Manufacturer (OEM) devices. No changes are made to the device materials or specifications and the reprocessed catheters possess identical technological characteristics.
Cleaning Validation: Demonstrated effectiveness of cleaning process.	Cleaning validations performed.
Sterilization Validation: Demonstrated effectiveness of sterilization process.	Sterilization validations performed.
Packaging Validation: Demonstrated maintainance of sterility and integrity.	Packaging validations performed.

Summary of Study:

The study conducted to demonstrate that the Vanguard Reprocessed EP Catheter Accessory Cables meet the acceptance criteria is described as follows:

Test Data Performed: "Cleaning, sterilization, and packaging validations and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective."

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

Sample Size: The document does not specify the exact sample size used for the cleaning, sterilization, packaging validations, and performance testing.
Data Provenance: The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that Vanguard receives previously used cables from healthcare facilities for reprocessing, the data would inherently be derived from reprocessed devices.

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

This information is not provided in the given text. The study primarily focuses on technical validations and performance testing rather than expert-based ground truth establishment for a test set.

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

This information is not applicable and not provided in the given text. The type of study described (technical validations and performance testing) typically does not involve adjudication methods like those used in clinical or image-based diagnostic studies.

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 type of study is relevant for diagnostic devices that are interpreted by human readers, often with AI assistance. The Vanguard device is a reprocessed accessory cable, not an AI-powered diagnostic tool.

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

No, a standalone algorithm-only performance study was not done. The device is a physical electrophysiology catheter accessory cable, not an algorithm.

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

The "ground truth" for this study is based on the engineering and performance specifications of the OEM devices and the regulatory standards for safety and effectiveness of medical devices, particularly for reprocessing.
- For cleaning: Efficacy of cleaning procedures (e.g., reduction of bioburden, removal of contaminants).
- For sterilization: Assurance of sterility (e.g., sterility assurance level (SAL)).
- For packaging: Maintenance of sterility and physical integrity.
- For performance: Electrical continuity, impedance, signal integrity, and mechanical integrity matching the OEM device specifications.

8. The sample size for the training set:

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning or AI models, which is not what this device is. The "training" for this device would refer to the processes and procedures for reprocessing, which are validated through the described testing.

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

This information is not applicable and not provided for the same reasons as point 8. The "ground truth" for the reprocessing process (if we were to extend the concept) would be established by validated scientific and engineering principles for cleaning, sterilization, and material performance, as well as regulatory standards.

Summary

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K030005

Submitter	Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815
Contact	Mike Sammon, Ph.D.Director, Research and Development(863) 904-1628(801) 327-3339 (facsimile)msammon@safe-reuse.com
Date	December 31, 2002
Device	Trade Names: Vanguard Reprocessed Electrophysiology (EP) Catheter Accessory CableCommon Name: Electrode CableClassification: 21 CFR 870.2900 – Class II – Cable, Transducer and Electrode, Patient, (including connector)Product Code DSA
Predicate Devices	Biosense Webster EP Catheter Accessory Cables (unknown)Daig™ EP Catheter Accessory Cables (K910645)Medtronic EP Catheter Accessory Cables (K894981, K882174)
Indications for Use	Electrophysiology catheter accessory cables are intended for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment.
Contra-indications	None known

Continued on next page## 510(k) Summary of Safety & Effectiveness

MAR 1 8_2003

V - Page 1 ol 1

Biosense Webster® is a registered trademark of Biosense Webster. Daig™ is a trademark of St. Jude Medical, Inc.

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510(k) Summary of Safety & Effectiveness, Continued

DeviceDescription	Vanguard reprocessed electrophysiology catheter accessory cables areaccessories to an appropriate diagnostic catheter. The use of the cableprovides a means of electrically connecting the EP catheter torecording/pacing equipment while allowing the catheter to remain in thesterile field and also provides additional working length.
	Vanguard reprocessed accessory cables are constructed of a hollow polymershaft approximately 4 to 7 feet in length that terminates with at each end witha connector. One connector couples with the proximal connector of anelectrophysiology catheter; the other connector couples with an extensioncable or an electrophysiology console. Various connector types are availableat each end to match the appropriate electrophysiology catheter and console.
	Vanguard receives previously used accessory cables from healthcare facilitiesand cleans, inspects, tests, applies a unique serial number, packages, labels,and sterilizes each device for return to the healthcare facility.
TechnologicalCharacteristics	Vanguard Reprocessed EP Catheter Accessory Cables are essentially identicalto the Original Equipment Manufacturer (OEM) devices. No changes aremade to the device materials or specifications and the reprocessed catheterspossess identical technological characteristics.
Test Data	Cleaning, sterilization, and packaging validations and performance testingdemonstrate that the reprocessed devices perform as intended and are safe andeffective.
Conclusion	Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the VanguardReprocessed EP Catheter Accessory Cables are substantially equivalent totheir predicate devices under the Federal Food, Drug and Cosmetic Act.

V - l'age 2 of 2

Biosense Webster® is a registered trademark of Biosense Webster. Daig™ is a trademark of St. Jude Medical, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

MAR 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vanguard Medical Concepts, Inc. c/o Dr. Mike Sammon, Ph.D. Director, Research and Development 5307 Great Oak Drive Lakeland, FL 33815

Re: K030005

Trade Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Cable, Transducer and Electrode, Patient, (including connector) Regulatory Class: Class II (two) Product Code: DSA Dated: December 31, 2002 Received: January 2, 2003

Dear Dr. Sammon:

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 - Mike Sammon, Ph.D.

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 (QS) 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), 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) you may obtain. 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 vours.

Hobertu

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

Enclosure

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Indications for Use

K030005 510(k) Number:

Device Name: Vanguard Reprocessed Electrophysiology Catheter Accessory Cables

Indications for Use:

Electrophysiology catheter accessory cables are intended for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use___________

(Per 21 CFR 801.109)

Kooooos

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number

(Optional Format 1-2-96)

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).