VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

K042074 · Vanguard Medical Concepts, Inc. · NLH · Mar 9, 2005 · Cardiovascular

Device Facts

• Record ID: K042074
• Device Name: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Mar 9, 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

Reprocessed diagnostic electrophysiology (EP) catheters; used for temporary intracardiac pacing and recording during EP studies. Device consists of 5-7 French, 95-115 cm polymer shaft with distal platinum alloy electrodes and proximal connector. Features steerable distal curves for remote manipulation and precise electrode positioning under fluoroscopic guidance (barium sulfate additive). Interconnects with standard sensing, recording, stimulation, and pacing equipment. Clinician-operated in clinical settings. Reprocessing involves collection of used catheters, cleaning, inspection, testing, serial number assignment, packaging, labeling, and sterilization for subsequent clinical use. Output is electrical signal transmission for cardiac mapping and arrhythmia evaluation; aids clinical decision-making by providing diagnostic electrophysiological data.

Clinical Evidence

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

Technological Characteristics

5-7 French, 95-115 cm polymer shaft; platinum alloy electrodes; barium sulfate additive for radiopacity. Steerable distal tip. Bi-directional electrical signal transmission. No open lumens. Sterilized for reuse.

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 cardiac conditions (unstable angina, acute MI, hemodynamic instability). Transseptal approach contraindicated in patients with left atrial thrombus, myxoma, or interatrial baffle patch. Retrograde approach contraindicated in patients with aortic valve replacement. 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

• St. Jude Medical, Daig Division, Livewire™ Steerable Diagnostic Catheters (K022380)

Submission Summary (Full Text)

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## MAR 9 - 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, Regulatory Affairs<br>[phone] (voice)<br>[phone] (facsimile)<br>[e-mail] |
| Date | July 29, 2004 |
| Device | <ul><li>Trade Names: Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters</li><li>Common Name: Electrode Recording Catheter, Diagnostic Electrophysiology (EP) Catheter</li><li>Classification: 21 CFR 870.1220 - Class II -- Catheter, Electrode Recording, or Probe, Electrode Recording</li><li>Product Code NLH</li></ul> |
| Predicate<br>Devices | St. Jude Medical, Daig Division, Livewire™ Steerable Diagnostic Catheters (K022380) |
| Indications for<br>Use | This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. |
| | <i>Continued on next page</i> |

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

| 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 Livewire diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 5 - 7 French in diameter and 95 to 115 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The hand piece 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 steerable distal curves for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array. The catheters are also available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication.<br><br>The shaft polymer is manufactured with additives (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.<br><br>Vanguard collects previously used diagnostic EP catheters from healthcare facilities, and cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to a healthcare facility for an additional clinical use. |

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

| Technological<br>Characteristics | Vanguard Reprocessed Diagnostic EP Catheters are essentially identical to<br>the Original Equipment Manufacturer (OEM) devices. No changes are made<br>to the device materials or specifications and the reprocessed catheters possess<br>identical technological characteristics. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 are substantially equivalent to their<br>predicate devices under the Federal Food, Drug and Cosmetic Act. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/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 wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle, indicating the department's name and national affiliation.

MAR 9 - 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: K042074

Trade Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLH Dated: January 12, 2005 Received: January 13, 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 10 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 cither 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,

Bzimimorfor

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

| St. Jude Daig LiveWire™ Steerable Diagnostic Catheter - 33<br>Models | | | | |
|----------------------------------------------------------------------|--------|--------|--------|--------|
| 401939 | 401933 | 401578 | 401580 | 401932 |
| 401940 | 401934 | 401586 | 401581 | - |
| 401938 | 401575 | 401587 | 401582 | - |
| 401941 | 401915 | 401588 | 401904 | - |
| 401600 | 401923 | 401583 | 401905 | - |
| 401603 | 401926 | 401584 | 401914 | - |
| 401572 | 401576 | 401585 | 401908 | - |
| 401606 | 401577 | 401579 | 401918 | - |

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### [Indications for Use

510(k) Number (if known): K042074

Device Name: Vanguard 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.

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)

Bimmermo
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042074

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