(42 days)
Not Found
No
The device description focuses on the physical construction and function of a standard electrophysiology catheter for pacing and recording, with no mention of AI or ML capabilities for signal analysis, interpretation, or guidance beyond manual steering. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a diagnostic tool used for evaluating arrhythmias or cardiac mapping, which involves recording and sensing electrical signals rather than treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the catheter is for "evaluation of arrhythmias or cardiac mapping," and the "Device Description" section mentions "reprocessed diagnostic electrophysiology catheters" and "bi-directional transmission of electrical signals (pacing and recording)". The "Predicate Device(s)" section also lists "Diagnostic II Catheter". These phrases clearly indicate its use for diagnostic purposes.
No
The device description clearly outlines a physical catheter with a polymer shaft, electrodes, and a hand piece, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary intracardiac pacing and recording during electrophysiology studies." This involves interacting directly with the patient's heart for diagnostic and therapeutic purposes (pacing).
- Device Description: The description details a catheter that is inserted into the body to transmit electrical signals for pacing and recording. It is a medical device used in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
This device is clearly used within the body for direct interaction with the heart, which is the opposite of an in vitro diagnostic.
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
NLH
Device 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.
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
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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K051043 p. 113
JUN 6 - 2005 510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC
Director of Regulatory Affairs
863-683-8680 [voice]
863-904-2250 [facsimile]
hcrawford@safe-reuse.com [email] |
| Date | April 20, 2005 |
| Device | Trade Name: Vanguard Reprocessed Diagnostic Electrophysiology CathetersCommon Name: Reprocessed Diagnostic Electrophysiology CatheterElectrode Recording CatheterDiagnostic Electrophysiology (EP) Catheter21 CFR Section: 870.1220Classification Name: Catheter, Electrode Recording, or Probe, Electrode RecordingProduct Code: NLH – Class II |
| Predicate
Devices | Trade Name: EP Technologies EPT-Dx™510(k) number: K940168: EP Technologies, Inc., Diagnostic II Catheter |
Continued on next page
1
510(k) Summary of Safety & Effectiveness, Continued
| 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. 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
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. |
.
Continued on next page
2
510(k) Summary of Safety & Effectiveness, Continued
.
| Technological | The Vanguard Reprocessed Diagnostic Electrophysiology Catheters are
Characteristics essentially identical to the currently marketed Original Equipment
Manufacturer (OEM) devices. Device materials, specifications, and
technological characteristics are equivalent. |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 upon the information provided herein and the 510(k) "Substantial
Equivalence" Decision Making Process Chart, we conclude that Vanguard
Reprocessed Diagnostic Electrophysiology Catheters are substantially
equivalent to their predicate devices under the Federal Food, Drug and
Cosmetic Act. |
3
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.
4
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/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
5
Page 3 – Ms. Heather Crawford, RAC
:
.
.
List of Model numbers
| Models found SE: |
|---|
| EPT-Dx |
| 1103 |
| 1101 |
| 1102 |
| 1300 |
| 1301 |
6
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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