K Number
K030114
Device Name
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
Date Cleared
2003-03-21

(67 days)

Product Code
Regulation Number
870.1220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Device Description
Reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 65 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 4 – 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 steerable 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, 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 catheters reprocessed by Vanguard are open to the patient bloodstream. Vanguard collects previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to the healthcare facility for an additional clinical use.
More Information

Not Found

No
The device description focuses on the physical construction and reprocessing of a standard electrophysiology catheter, with no mention of AI or ML capabilities for signal processing, analysis, or guidance beyond standard fluoroscopy.

No
The device is described as a "diagnostic electrophysiology catheter" intended for "temporary intracardiac pacing and recording" and "cardiac mapping," which are diagnostic rather than therapeutic purposes.

Yes

The "Intended Use / Indications for Use" states the catheter is for "evaluation of arrhythmias or cardiac mapping," which are diagnostic activities. Additionally, the device is explicitly referred to as a "diagnostic electrophysiology catheter" and "diagnostic EP catheters" multiple times in the "Device Description" and "Predicate Device(s)" sections.

No

The device is a physical catheter with a polymer shaft, electrodes, and a connector. It is a hardware device used for intracardiac pacing and recording.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing happens outside the body (in vitro).
  • Device Function: The description clearly states this catheter is used for "temporary intracardiac pacing and recording during electrophysiology studies." This involves interacting directly within the body (in vivo) to measure electrical signals and potentially stimulate the heart.
  • No Specimen Analysis: The device description does not mention collecting or analyzing any specimens from the patient. It's focused on electrical signal transmission and recording within the heart.

Therefore, based on the provided information, this device falls under the category of an invasive medical device used for diagnosis and potentially treatment (pacing), but it is not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

NLH, DRF

Device Description

Reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 65 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 4 – 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 steerable 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, 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 catheters reprocessed by Vanguard are open to the patient bloodstream.

Vanguard collects previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to the healthcare facility for an additional clinical use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracardiac

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Cleaning, sterilization, and packaging validations; and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K002976, K012687, K012688, K022316, K023180

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2004 NOV

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

Re: K030114 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: II (two) Product Code: NLH Dated: January 10, 2003 Received: January 13, 2003

Dear Ms. Crawford:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 21, 2003. 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, listing 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.

1

Page 2 - K030114

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 (301) 594-4646. 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/dsma/dsmamain.html.

Sincerely yours,

B.R. Mcmemor for

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

Enclosures

2

Indications for Use

510(k) Number:

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.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

sion of Cardiovascular Devices

510(k) Number K030114

Over-the-Counter Use

(Optional Format 1-2-96)

iv

009

3

K030114

Family (Daig)Catalog #
Supreme™401955
Supreme™401954
Supreme™401893
Supreme™401892
Supreme™401891
Supreme™401890
Supreme™401864
Supreme™401863
Supreme™401859
Supreme™401453
Supreme™401451
Supreme™401445
Supreme™401443
Supreme™401442
Supreme™401441
Supreme™401430
Response™401399
Response™401381
Response™401380
Response™401357
Response™401353
Response™401329
Response™401311
Response™401305
Response™401293
Response™401227
Response™401226
Response™401223
Response™401222
Response™401210
Response™401207

:

Enclosure - List of devices (31 models)

4

K030114

MAR 2 1 2003

510(k) Summary of Safety & Effectiveness

| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mike Sammon, Ph.D.
Director, Research and Development
(863) 904-1628
(801) 327-3339 (facsimile)
msammon@safe-reuse.com |
| Date | January 10, 2002 |
| Device | Trade Names: Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters Common Name: Electrode Recording Catheter, Diagnostic Electrophysiology (EP) Catheter Classification: 21 CFR 870.1220 - Class II - Catheter, Electrode Recording, or Probe, Electrode Recording Product Code DRF |
| Predicate
Devices | Daig™ Response™ Fixed Curve Diagnostic Catheters (K002976) Daig™ Supreme™ Fixed Curve Diagnostic Catheters (K002976) Vanguard Reprocessed Diagnostic EP Catheters (K012687, K012688, K022316, K023180) |
| Indications for
Use | This catheter is intended for temporary 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. Diagnostic EP catheters are not intended for electrical ablation. Diagnostic EP catheters are not intended for coronary artery mapping. |
| Device
Description | Reprocessed diagnostic electrophysiology catheters are constructed of a
hollow polymer shaft approximately 65 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 4 – 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 steerable 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,
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 catheters reprocessed by Vanguard are open to the patient
bloodstream. |
| | Vanguard collects previously used diagnostic EP catheters from healthcare
facilities; cleans, inspects, tests, applies a unique serial number, packages,
labels, and sterilizes each device for return to the healthcare facility for an
additional clinical use. |
| Technological
Characteristics | Vanguard Reprocessed Diagnostic EP Catheters are essentially identical to
the Original Equipment Manufacturer (OEM) devices. No changes are made
to the device materials or specifications and the reprocessed catheters possess
identical technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations; and performance and
biocompatibility testing demonstrate that the reprocessed devices perform as
intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial
Equivalence" Decision Making Process Chart, we conclude that the Vanguard
Reprocessed Diagnostic EP Catheters are substantially equivalent to their
predicate devices under the Federal Food, Drug and Cosmetic Act. |

5

510(k) Summary of Safety & Effectiveness, Continued