(42 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g., evaluation of arrhythmias or cardiac mapping.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vanguard Reprocessed Diagnostic Electrophysiology Catheters:
The provided text (510(k) summary) describes a device undergoing FDA clearance, specifically a reprocessed medical device. For such devices, the primary focus of the regulatory submission is to demonstrate that the reprocessed device is substantially equivalent to its original, new counterpart (the predicate device). This often means demonstrating that the reprocessing does not negatively impact the device's original performance, safety, or effectiveness.
It is important to note that this document does not describe a study involving AI or machine learning. Therefore, many of the requested points related to AI-specific evaluation (multi-reader multi-case studies, standalone algorithm performance, AI specific ground truth, training data) are not applicable.
Here's the information extracted and interpreted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reprocessed devices perform as intended (equivalent to predicate) | "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." |
| Reprocessed devices are safe and effective | "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." |
| Device materials, specifications, and technological characteristics are equivalent to the OEM device | "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." |
Explanation of Implied Criteria: For reprocessed devices, the acceptance criteria are generally to demonstrate equivalence to the predicate device in terms of safety, effectiveness, and functional performance after reprocessing. The specific quantitative criteria for each performance aspect (e.g., electrical impedance within a certain range, mechanical durability) are typically detailed in the underlying test reports, but only a summary statement is presented in the 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size for the performance and biocompatibility testing. It only states that "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing" were conducted.
- Data Provenance: The studies were internal company validations and testing. The document doesn't specify if clinical data (e.g., from human patients) was used, but implies lab-based performance and biocompatibility testing relevant to the device itself. Given it's a reprocessed medical device, the focus is typically on whether the reprocessing impacts the device's physical and functional properties, rather than new clinical trials with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable in the context of this 510(k) summary. The "ground truth" for demonstrating substantial equivalence of a reprocessed device typically relies on validated laboratory testing methods and engineering analyses compared against the specifications of the original device, rather than expert consensus on diagnostic interpretations. The "experts" involved would be engineers, microbiologists, and other technical professionals specializing in sterilization, material science, and device performance testing. Their qualifications are not listed.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of diagnostic findings. Adjudication would not be a relevant concept for the performance testing of a reprocessed medical device's physical and functional characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-powered diagnostic tool, but rather a reprocessed diagnostic electrophysiology catheter. The concept of human readers improving with AI assistance is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" implicitly used is the original design specifications and performance characteristics of the predicate device (EP Technologies EPT-Dx™). The reprocessed device must demonstrate that its performance (e.g., electrical properties, mechanical integrity, biocompatibility, sterility) meets these original specifications after reprocessing. The types of ground truth involved would be:
- Instrumental measurements: For performance characteristics like electrical conductivity, mechanical strength, dimensional accuracy.
- Chemical analysis: For material composition and degradation.
- Microbiological testing: For sterility and endotoxin levels.
- Biocompatibility testing: According to ISO standards.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being "trained" for this device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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K051043 p. 113
JUN 6 - 2005 510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Heather Crawford, RACDirector of Regulatory Affairs863-683-8680 [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 |
| PredicateDevices | Trade Name: EP Technologies EPT-Dx™510(k) number: K940168: EP Technologies, Inc., Diagnostic II Catheter |
Continued on next page
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510(k) Summary of Safety & Effectiveness, Continued
| Indicationsfor Use | This catheter is intended for temporary intracardiac pacing and recordingduring electrophysiology studies, e.g., evaluation of arrhythmias or cardiacmapping. |
|---|---|
| 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 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
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510(k) Summary of Safety & Effectiveness, Continued
.
| Technological | The Vanguard Reprocessed Diagnostic Electrophysiology Catheters areCharacteristics essentially 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. |
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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.
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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/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
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Page 3 – Ms. Heather Crawford, RAC
:
.
.
List of Model numbers
| Models found SE: |
|---|
| EPT-Dx |
| 1103 |
| 1101 |
| 1102 |
| 1300 |
| 1301 |
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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_
Page 1 of 1
iv
§ 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).