VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES

K030005 · Vanguard Medical Concepts, Inc. · DSA · Mar 18, 2003 · Cardiovascular

Device Facts

• Record ID: K030005
• Device Name: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Mar 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

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

Device Story

Vanguard reprocessed electrophysiology (EP) catheter accessory cables serve as electrical interfaces between diagnostic EP catheters and recording/pacing consoles. The device consists of a 4 to 7-foot hollow polymer shaft with connectors at both ends. One end couples to the proximal connector of an EP catheter; the other connects to an extension cable or console. The device provides additional working length and maintains the catheter within the sterile field. Vanguard obtains used cables from healthcare facilities, then cleans, inspects, tests, serializes, packages, and sterilizes them for reuse. The device is used in clinical electrophysiology settings by medical professionals. It facilitates signal transmission for cardiac mapping and pacing, enabling diagnostic procedures.

Clinical Evidence

Bench testing only. Validation included cleaning, sterilization, and packaging processes, alongside performance testing to ensure electrical connectivity and mechanical integrity of the reprocessed cables.

Technological Characteristics

Hollow polymer shaft, 4-7 feet in length, with proximal and distal connectors. Passive electrical cable. No active electronic components. Sterilized via validated processes. Identical to OEM specifications.

Indications for Use

Indicated for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment. No specific patient population or contraindications provided.

Regulatory Classification

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.

Predicate Devices

• Biosense Webster EP Catheter Accessory Cables (unknown)
• Daig™ EP Catheter Accessory Cables (K910645)
• Medtronic EP Catheter Accessory Cables (K894981, K882174)

Submission Summary (Full Text)

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K030005

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mike Sammon, Ph.D.<br>Director, Research and Development<br>[phone]<br>[phone] (facsimile)<br>[e-mail] |
| Date | December 31, 2002 |
| Device | <ul><li>Trade Names: Vanguard Reprocessed Electrophysiology (EP) Catheter Accessory Cable</li><li>Common Name: Electrode Cable</li><li>Classification: 21 CFR 870.2900 – Class II – Cable, Transducer and Electrode, Patient, (including connector)</li><li>Product Code DSA</li></ul> |
| Predicate Devices | <ul><li>Biosense Webster EP Catheter Accessory Cables (unknown)</li><li>Daig™ EP Catheter Accessory Cables (K910645)</li><li>Medtronic EP Catheter Accessory Cables (K894981, K882174)</li></ul> |
| 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

| Device<br>Description | Vanguard reprocessed electrophysiology catheter accessory cables are<br>accessories to an appropriate diagnostic catheter. The use of the cable<br>provides a means of electrically connecting the EP catheter to<br>recording/pacing equipment while allowing the catheter to remain in the<br>sterile field and also provides additional working length. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Vanguard reprocessed accessory cables are constructed of a hollow polymer<br>shaft approximately 4 to 7 feet in length that terminates with at each end with<br>a connector. One connector couples with the proximal connector of an<br>electrophysiology catheter; the other connector couples with an extension<br>cable or an electrophysiology console. Various connector types are available<br>at each end to match the appropriate electrophysiology catheter and console. |
| | Vanguard receives previously used accessory cables from healthcare facilities<br>and cleans, inspects, tests, applies a unique serial number, packages, labels,<br>and sterilizes each device for return to the healthcare facility. |
| Technological<br>Characteristics | Vanguard Reprocessed EP Catheter Accessory Cables are essentially identical<br>to the Original Equipment Manufacturer (OEM) devices. No changes are<br>made to the device materials or specifications and the reprocessed catheters<br>possess identical technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations and performance testing<br>demonstrate that the reprocessed devices perform as intended and are safe and<br>effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that the Vanguard<br>Reprocessed EP Catheter Accessory Cables are substantially equivalent to<br>their 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 [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 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 [phone] or [phone] 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

OR

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)

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