(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.
§ 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).