VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

K051043 · Vanguard Medical Concepts, Inc. · NLH · Jun 6, 2005 · Cardiovascular

Device Facts

• Record ID: K051043
• Device Name: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Jun 6, 2005
• 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 Reprocessed Diagnostic Electrophysiology Catheters are reprocessed OEM diagnostic catheters used for temporary intracardiac pacing and recording. Device consists of 6 French, 110 cm polymer shaft with distal platinum alloy electrodes and proximal connector. Clinician manipulates hand piece to steer distal tip unidirectionally for precise positioning under fluoroscopic guidance. Proximal connector interfaces with standard external sensing, recording, and pacing equipment. Device enables bi-directional electrical signal transmission. Used in clinical electrophysiology studies to evaluate arrhythmias or perform cardiac mapping. Reprocessing includes cleaning, sterilization, and packaging validation to ensure performance equivalent to original device. No lumens open to patient bloodstream.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including cleaning, sterilization, and packaging validation, as well as performance and biocompatibility testing.

Technological Characteristics

6 French, 110 cm polymer shaft with barium sulfate additive for radiopacity. Distal platinum alloy electrodes. Unidirectional steering mechanism via hand piece. Interfaces with standard external pacing/recording equipment. Reprocessed device; sterilization and cleaning protocols applied.

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 patients with acute factors making findings unrepresentative (drug toxicity, electrolyte abnormality, acute ischemia) or high-risk cardiac disease (unstable angina, acute MI, hemodynamic instability). Not intended 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

• EP Technologies EPT-Dx (K940168)

Submission Summary (Full Text)

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K051043 p. 113

## JUN 6 - 2005 510(k) Summary of Safety & Effectiveness

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC<br>Director of Regulatory Affairs<br>863-683-8680 [voice]<br>863-904-2250 [facsimile]<br>[e-mail] [email] |
| Date | April 20, 2005 |
| Device | <ul><li>Trade Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheters</li><li>Common Name: <ul><li>Reprocessed Diagnostic Electrophysiology Catheter</li><li>Electrode Recording Catheter</li><li>Diagnostic Electrophysiology (EP) Catheter</li></ul></li><li>21 CFR Section: 870.1220</li><li>Classification Name: Catheter, Electrode Recording, or Probe, Electrode Recording</li><li>Product Code: NLH – Class II</li></ul> |
| Predicate<br>Devices | <ul><li>Trade Name: <ul><li>EP Technologies EPT-Dx™</li></ul></li><li>510(k) number: <ul><li>K940168: EP Technologies, Inc., Diagnostic II Catheter</li></ul></li></ul> |

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

| Indications<br>for Use | This catheter is intended for temporary intracardiac pacing and recording<br>during electrophysiology studies, e.g., evaluation of arrhythmias or cardiac<br>mapping. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contra-<br>indications | Patients with active systemic infection. Patients with prosthetic valves. Retrograde approach in patients with aortic valve replacement. Transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle patch. Patients with acute factors that make the findings unrepresentative of the patient's usual state (i.e. drug toxicity, electrolyte abnormality, acute ischemia). Patients with underlying cardiac disease that increases risk of being unable to terminate induced arrhythmias and that have a high risk of death (i.e. unstable angina, acute myocardial infarction, hemodynamic instability). Diagnostic EP catheters are not intended for electrical ablation. |
| Device<br>Description | Vanguard reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 6 French in diameter and 110 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector at the end of the hand piece for bi-directional transmission of electrical signals (pacing and recording). The proximal connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment. The distal tip segment of the catheter is capable of unidirectional steering through manipulation of the hand piece. This remote manipulation of the distal tip segment facilitates precise positioning of the electrode array. The catheters are available in a variety of electrode configurations 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. |

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

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| Technological | The Vanguard Reprocessed Diagnostic Electrophysiology Catheters are<br>Characteristics essentially identical to the currently marketed Original Equipment<br>Manufacturer (OEM) devices. Device materials, specifications, and<br>technological characteristics are equivalent. |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Data | Cleaning, sterilization, and packaging validations, and performance and<br>biocompatibility testing demonstrate that the reprocessed devices perform as<br>intended and are safe and effective. |
| Conclusion | Based upon the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that Vanguard<br>Reprocessed Diagnostic Electrophysiology Catheters are substantially<br>equivalent to their predicate devices under the Federal Food, Drug and<br>Cosmetic Act. |

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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.

JUN 6 - 2005

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

Re: K051043

Trade Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: April 25, 2005 Received: April 25, 2005

Dear Ms. Crawford:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nate roviewed your betermined 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, de rices that have been 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. Heather Crawford, RAC

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] 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,

Bhimmer for

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

Enclosure

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## Page 3 – Ms. Heather Crawford, RAC

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#### List of Model numbers

| Models found SE: |
|------------------|
| EPT-Dx |
| 1103 |
| 1101 |
| 1102 |
| 1300 |
| 1301 |

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#### Indications for Use

510(k) Number (if known): K051043

Device Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheter

Indications for Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Ammumo
Sign Off

(Division Sign-Off) (Division of Cardiovascular Devicess
Division of Cardiovascular Devices 05/04 510(k) Number_

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