(69 days)
Not Found
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 processing, analysis, or guidance.
No
The device is described as a diagnostic tool for evaluating arrhythmias or cardiac mapping, designed for temporary intracardiac pacing and recording. It is not intended for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "evaluation of arrhythmias or cardiac mapping," and the "Device Description" section states that the device is a "diagnostic electrophysiology catheter" used to record, measure, and compare "the effects of pacing on the conduction system and time intervals between waveforms." These actions are all part of diagnosing a condition.
No
The device description clearly outlines a physical catheter with a polymer shaft, electrodes, and a hand piece, indicating it is a hardware device.
Based on the provided text, 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 is a procedure performed within the body to assess the heart's electrical activity.
- Device Description: The description details a catheter inserted into the heart for electrical signal transmission (pacing and recording). It explicitly states "No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream."
- Mechanism of Action: The device works by directly interacting with the heart's electrical system through pacing and recording, not by analyzing samples taken from the body (like blood, urine, or tissue).
IVD devices are designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the living body) rather than in vitro (in glass, referring to laboratory settings).
N/A
Intended Use / Indications for 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.
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 - 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.
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)
Not Found
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
510(k) Summary of Safety & Effectiveness, Continued
| Indications
for 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. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 - 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 |
| Technological
Characteristics | The Vanguard Reprocessed Diagnostic Electrophysiology Catheters are
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. |
to establish the baseline and current status of the conduction system.
1
.
510(k) Summary of Safety & Effectiveness, Continued
2
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.
3
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
4
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 |
:
.
:
5
Indications for Use
510(k) Number (if known):
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
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