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

Device Description

Vanguard reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 6 - 8 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 catheters are available with various steerable distal curves for remote manipulation of the distal tip segment to facilitate 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. 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. In clinical use, diagnostic electrophysiology catheters are placed under fluoroscopy within the heart, near major structures of the conduction system. The effects of pacing on the conduction system and time intervals between waveforms are recorded, measured, and compared to baseline and normal values. The electrocardiogram normally has atrial, His, and ventricular components in order to obtain accurate interval measurements which are used to establish the baseline and current status of the conduction system.

AI/ML Overview

This document is a 510(k) Summary of Safety & Effectiveness for Vanguard Reprocessed Diagnostic Electrophysiology Catheters. It describes the device, its indications for use, and a conclusion of substantial equivalence to predicate devices. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria from an AI/ML perspective.

Specifically, the provided text is for a medical device (reprocessed catheters) and not an AI/ML powered device. Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this document.

The "Test Data" section only generally states: "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." It does not provide any specific acceptance criteria or study details.

Since the input document is for a non-AI/ML device, I cannot fill out the requested information.

Summary

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510(k) Summary of Safety & Effectiveness, Continued

Indicationsfor Use	The Reprocessed Diagnostic Electrophysiology Catheter is intended fortemporary intracardiac pacing and recording during electrophysiology studies,e.g. evaluation of arrhythmias or cardiac mapping.
Contra-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.
DeviceDescription	Vanguard reprocessed diagnostic electrophysiology catheters are constructedof a hollow polymer shaft 6 - 8 French in diameter and 110 cm in length thatterminates with a hand piece. Various configurations of distal platinum alloyelectrodes are wired to a proximal connector at the end of the hand piece forbi-directional transmission of electrical signals (pacing and recording). Theproximal connector is attached to an interconnecting cable that interfaces withvarious standard types of sensing, recording, stimulation, and pacingequipment. The catheters are available with various steerable distal curves forremote manipulation of the distal tip segment to facilitate precise positioningof the electrode array. The catheters are also available in a variety ofelectrode configurations that are selected by the clinician based on preferenceand/or indication. The shaft polymer is manufactured with additives(typically barium sulfate) that enhance the catheter's radiopacity to enablepositioning under fluoroscopic guidance. No lumens of the cathetersreprocessed by Vanguard are open to the patient bloodstream.In clinical use, diagnostic electrophysiology catheters are placed underfluoroscopy within the heart, near major structures of the conduction system.The effects of pacing on the conduction system and time intervals betweenwaveforms are recorded, measured, and compared to baseline and normalvalues. The electrocardiogram normally has atrial, His, and ventricularcomponents in order to obtain accurate interval measurements which are used
TechnologicalCharacteristics	The Vanguard Reprocessed Diagnostic Electrophysiology Catheters areessentially identical to the currently marketed Original EquipmentManufacturer (OEM) devices. Device materials, specifications, andtechnological characteristics are equivalent.
Test Data	Cleaning, sterilization, and packaging validations, and performance andbiocompatibility testing demonstrate that the reprocessed devices perform asintended and are safe and effective.
Conclusion	Based upon the information provided herein and the 510(k) “SubstantialEquivalence” Decision Making Process Chart, we conclude that VanguardReprocessed Diagnostic Electrophysiology Catheters are substantiallyequivalent to their predicate devices under the Federal Food, Drug andCosmetic 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 (240) 276-0120 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 (800) 638-2041 or (301) 443-6597 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

Page 1 of 1

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
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.(b)
Classification. Class II (performance standards).