(352 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 92 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 the 5 – 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 deflectable. This allows for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.
In addition to a range of diameters, 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 the catheters reprocessed by Vanguard are open to the patient bloodstream.
Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, repackages and sterilizes the devices; and returns them to the healthcare facility.
This document is a 510(k) summary for Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. The company, Vanguard Medical Concepts, Inc., is seeking to market reprocessed versions of these catheters. The summary states that they are substantially equivalent to currently marketed OEM devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it broadly states that the reprocessed devices are substantially equivalent to the original equipment manufacturer (OEM) devices and perform as intended. The acceptance criteria are implicitly tied to the performance specifications of new, legally marketed diagnostic EP catheters.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functionality | Equivalent to new OEM diagnostic EP catheters | Performs as intended (demonstrated by functional/performance testing) |
| Safety | Equivalent to new OEM diagnostic EP catheters (biocompatibility) | Safe and effective (demonstrated by biocompatibility testing) |
| Cleaning | Effective cleaning of previously used devices | Validated |
| Sterilization | Effective sterilization of reprocessed devices | Validated |
| Packaging | Maintains sterility and device integrity | Validated |
| Technological | Identical to currently marketed OEM devices' specifications | Possesses the same technological characteristics |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set in terms of the number of reprocessed catheters or tests performed. It states "functional/performance and biocompatibility testing," but no numbers are provided.
Regarding data provenance:
- The devices are "previously used diagnostic EP catheters from healthcare facilities," so the source of the reprocessed devices is retrospective in terms of their initial use.
- The testing itself is presumably prospective in nature, conducted by Vanguard Medical Concepts after reprocessing.
- The country of origin for the data is not explicitly stated, but given the submission to the U.S. FDA, it is highly likely to be U.S.-based or at least conducted to U.S. standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts establishing ground truth) is typically relevant for studies involving subjective assessments or interpretation (e.g., image analysis, clinical diagnosis). For device performance testing of a physical medical device like an EP catheter, "ground truth" is typically established by objective measurement against engineering specifications or established standards.
The document does not mention the use of experts to establish a "ground truth" in the way one might for a diagnostic AI algorithm. Device performance is evaluated against predefined functional and safety parameters, which are usually determined by engineering standards and regulatory requirements for predicate devices.
4. Adjudication Method for the Test Set
Not applicable in the context of this device's performance testing as described. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers/experts in subjective assessment tasks. Performance testing of a physical device against objective criteria usually involves direct measurement and comparison, not expert adjudication in this sense.
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
Not applicable. This is a submission for a reprocessed medical device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reprocessed diagnostic EP catheters is implicitly the original design specifications and performance characteristics of the new, legally marketed OEM predicate devices. The testing aims to demonstrate that the reprocessed devices meet these same established performance and safety benchmarks.
- For functional/performance testing: The ground truth would be the expected electrical, mechanical, and physical parameters of a new catheter.
- For biocompatibility testing: The ground truth would be the established biocompatibility profiles for the materials used in such catheters, ensuring no new risks are introduced by reprocessing.
- For cleaning/sterilization: The ground truth would be established microbiological efficacy standards to ensure complete removal of contaminants and pathogens.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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).