VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

K012687 · Vanguard Medical Concepts, Inc. · NLH · Aug 1, 2002 · Cardiovascular

Device Facts

• Record ID: K012687
• Device Name: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Aug 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Device Story

Vanguard reprocesses single-use diagnostic electrophysiology (EP) catheters; original devices sourced from healthcare facilities. Process includes cleaning, inspection, testing, refurbishment, repackaging, and sterilization. Catheters feature hollow polymer shafts (92-125 cm) with distal platinum alloy electrodes; fixed or deflectable distal curves; radiopaque additives (barium sulfate). Used by clinicians in clinical settings for intracardiac pacing and recording. Device connects to standard sensing, recording, and stimulation equipment via proximal connector. Output consists of electrical signals for cardiac mapping and arrhythmia evaluation. Reprocessing restores device to original OEM specifications; no changes to technological characteristics.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including cleaning, sterilization, and packaging validations, alongside functional performance and biocompatibility testing to demonstrate equivalence to OEM predicate devices.

Technological Characteristics

Hollow polymer shaft (92-125 cm) with barium sulfate for radiopacity; distal platinum alloy electrodes; fixed or deflectable tip configurations. Bi-directional electrical signal transmission (pacing/recording). Interfaces with standard clinical EP recording/stimulation equipment. Sterilized via validated processes. No lumens open to patient bloodstream.

Indications for Use

Indicated for temporary intracardiac pacing and recording during electrophysiology studies (arrhythmia evaluation, cardiac mapping). Contraindicated in patients with active systemic infection, prosthetic valves, or specific anatomical conditions (aortic valve replacement for retrograde approach; left atrial thrombus, myxoma, or interatrial baffle patch for transseptal approach). Not for electrical ablation.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

• Biosense Webster Diagnostic Electrophysiology Catheters
• Bard Electrophysiology Diagnostic Electrophysiology Catheters

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines above and below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vanguard Medical Concepts, Inc. c/o Ms. Heather Crawford, RAC Director of Regulatory Affairs 5307 Great Oak Drive Lakeland, FL 33815

NOV 1 2004

Re: K012687 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Il (two) Product Code: NLH Dated: August 13, 2001 Received: August 14, 2001

Dear Ms. Crawford:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 1, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

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#### Page 2 - K012687

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), 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 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 yours,

Blymmmer for

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

Enclosures

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#### K012687

F5-OF-005-PS F5-OL-005-PS F5-QA-005-PS F5-OD-005-PS F6-QL-002-TS F6-QA-002-PS F6-QD-002-PS F6-QF-002-TS F6-QF-002-PS F6-QA-005-TS F6-QF-005-TS F6-QL-005-TS F6-QF-005-PS F6-QL-005-PS F6-QA-005-PS F6-OD-005-PS F6-QA-010-PS F6-QD-010-PS F6-QF-010-PS F6-QL-010-PS D6-10DR-P10-FS D7-DR-252-PS D6-DR-252-PS D7-DR-005-PS D7-08DR-002-RT D6-FR-252-PS D6-08DR-002-FS D6-10DR-P10-RT D7-10DR-P10-RT D6-DR-005-PS D6-08DR-002-RT D7-10DR-P10-FS D6-DR-010-PS D7-08DR-002-FS

Enclosure - List of devices (34 models)

(Biosense Webster)

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### Indications for Use -

510(k) Number:

Device Name: Yanguard Reprocessed Diagnostic Electrophysiology Catheters

Indications for Use:

This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012684

iv

.

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## 510(k) Summary of Safety & Effectiveness

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mr. Mike Sammon, Ph.D.<br>Director, Research and Development<br>[phone], extension 228<br>[phone] (facsimile)<br>[e-mail] |
| Date | August 13, 2001 |
| Device | Trade Names: Vanguard Reprocessed Diagnostic Electrophysiology Catheters ⇒ Biosense Webster Diagnostic Electrophysiology Catheters Common Name: Diagnostic Electrophysiology (EP) Catheter Classification: 21 CFR 870.1220 – Class II - Electrode recording catheter or electrode recording probe Product Code DRF |
| Predicate Devices | Biosense Webster and Bard Electrophysiology legally marketed diagnostic EP catheters under various 510(k) premarket notifications. |
| Indications for Use | This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. |
| | Continued on next page |

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# 510(k) Summary of Safety & Effectiveness, Continued

| Contra-<br>indications | <ul><li>Patients with active systemic infection.</li><li>Patients with prosthetic valves.</li><li>Retrograde approach in patients with aortic valve replacement.</li><li>Transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle patch.</li><li>Diagnostic EP catheters are not intended for electrical ablation.</li></ul> |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | Diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 92 to 125 cm in length that terminates with a hand piece or connector. A range of diameters is available; the most clinically utilized sizes are the 5 – 7 French. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various distal curves, either fixed or deflectable. This allows for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array. <p>In addition to a range of diameters, the catheters are also available in a variety of electrode configurations, connector compatibility and torque-transmitting properties that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream.</p> <p>Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, repackages and sterilizes the devices; and returns them to the healthcare facility.</p> |

Continued on next page

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## 510(k) Summary of Safety & Effectiveness, Continued

| Technological<br>Characteristics | The Vanguard reprocessed diagnostic EP catheters are essentially identical to<br>the currently marketed OEM devices. No changes are made to the currently<br>marketed device's specifications and they possess the same technological<br>characteristics. Biocompatibility and performance/functional testing<br>demonstrate that the devices are equivalent and continue to be safe and<br>effective for their intended use. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Data | Cleaning, sterilization and packaging validations; and functional/performance<br>and biocompatibility testing demonstrates that the reprocessed devices<br>perform as intended and are safe and 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 Diagnostic EP Catheters (Biosense Webster Fixed Curve and<br>Deflectable catheters) are substantially equivalent to the predicate devices<br>under the Federal Food, Drug and Cosmetic Act. |