VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

K050763 · Vanguard Medical Concepts, Inc. · NLH · Jun 1, 2005 · Cardiovascular

Device Facts

• Record ID: K050763
• Device Name: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Reprocessed Diagnostic Electrophysiology Catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Device Story

Reprocessed diagnostic electrophysiology catheter; hollow polymer shaft (6-8 French, 110 cm); distal platinum alloy electrodes; proximal connector. Used in clinical electrophysiology studies; placed under fluoroscopic guidance within heart near conduction system. Bi-directional transmission of electrical signals (pacing/recording) via interconnecting cable to external sensing/recording/stimulation equipment. Clinician manipulates steerable distal tip for precise positioning. Radiopaque additives (barium sulfate) enable fluoroscopic visualization. Output consists of electrical waveforms (atrial, His, ventricular) recorded and measured by external equipment; used by clinicians to assess conduction system status, identify arrhythmias, and perform cardiac mapping. Benefits include diagnostic insight into cardiac conduction.

Clinical Evidence

No clinical data. Safety and effectiveness established via bench testing, including cleaning, sterilization, and packaging validations, as well as performance and biocompatibility testing.

Technological Characteristics

Hollow polymer shaft (6-8 French, 110 cm) with barium sulfate for radiopacity. Distal platinum alloy electrodes. Steerable distal curves. Proximal connector for interface with external pacing/recording equipment. Passive device; no internal energy source. Sterilized via validated processes.

Indications for Use

Indicated for temporary intracardiac pacing and recording during electrophysiology studies, including arrhythmia evaluation and cardiac mapping. Contraindicated in patients with active systemic infection, prosthetic valves, aortic valve replacement (retrograde approach), left atrial thrombus/myxoma or interatrial baffle patch (transseptal approach), acute drug toxicity, electrolyte abnormality, acute ischemia, or unstable cardiac conditions (unstable angina, acute MI, hemodynamic instability). 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.

Submission Summary (Full Text)

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

| Indications<br>for Use | The Reprocessed Diagnostic Electrophysiology Catheter is intended for<br>temporary intracardiac pacing and recording during electrophysiology studies,<br>e.g. evaluation of arrhythmias or cardiac 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<br>of a hollow polymer shaft 6 - 8 French in diameter and 110 cm in length that<br>terminates with a hand piece. Various configurations of distal platinum alloy<br>electrodes are wired to a proximal connector at the end of the hand piece for<br>bi-directional transmission of electrical signals (pacing and recording). The<br>proximal connector is attached to an interconnecting cable that interfaces with<br>various standard types of sensing, recording, stimulation, and pacing<br>equipment. The catheters are available with various steerable distal curves for<br>remote manipulation of the distal tip segment to facilitate precise positioning<br>of the electrode array. The catheters are also available in a variety of<br>electrode configurations that are selected by the clinician based on preference<br>and/or indication. The shaft polymer is manufactured with additives<br>(typically barium sulfate) that enhance the catheter's radiopacity to enable<br>positioning under fluoroscopic guidance. No lumens of the catheters<br>reprocessed by Vanguard are open to the patient bloodstream.<br>In clinical use, diagnostic electrophysiology catheters are placed under<br>fluoroscopy within the heart, near major structures of the conduction system.<br>The effects of pacing on the conduction system and time intervals between<br>waveforms are recorded, measured, and compared to baseline and normal<br>values. The electrocardiogram normally has atrial, His, and ventricular<br>components in order to obtain accurate interval measurements which are used |
| Technological<br>Characteristics | The Vanguard Reprocessed Diagnostic Electrophysiology Catheters are<br>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. |

to establish the baseline and current status of the conduction system.

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

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 - 2005

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

Re: K050763

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: March 23, 2005 Received: March 24 , 2005

Dear Ms. Crawford:

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. 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/dsmamain.html

Sincerely yours,

Brimmer 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

#### List of Model numbers

| Models Found SE |
|--------------------------------------------|
| Valve Mapper SteeroCath-Dx & SteeroCath-Dx |
| 2001 |
| 2031L |
| 2200 |
| 2270 |
| 2270K2 |
| 2270N4 |
| 2270L |
| 2028BL |
| 2027BL |

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### Indications for Use

510(k) Number (if known):

K050763

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 X (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)

Blummenstiel

Ivision Slan-Off Division of Cardlovascular Devices 510(k) Number

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