(85 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Explorer 360™ diagnostic electrophysiology catheters are constructed of a 6 French hollow polymer shaft 100 cm in length. The quadripolar catheters are available with various fixed distal curves and electrode spacing configurations. The polymer shaft is manufactured with additives (typically barium sulfate) that enhance its radiopacity during fluoroscopic positioning of the catheter. The platinum alloy electrodes are sealed to the distal catheter and internally wired to a proximal shielded Nexus connector for bi-directional transmission of electrical signals (pacing and recording). The connector is designed to be attached to a compatible instrument cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment.
Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, applies a unique serial number, repackages, and sterilizes the devices; and returns them to the healthcare facility.
This document is a 510(k) summary for the Vanguard Reprocessed Diagnostic Electrophysiology Catheters. It details the reprocessing of single-use devices, specifically EP Technologies™ Explorer 360™ Diagnostic Electrophysiology Catheters. The core of the submission is to demonstrate that the reprocessed devices are substantially equivalent to the original, legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance:
The document broadly discusses "functional/performance and biocompatibility testing" demonstrating that the reprocessed devices "perform as intended and are safe and effective." However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum electrical resistance, etc.) and their corresponding reported device performance values are not provided in this 510(k) summary. It states that "No changes are made to the currently marketed device's specifications and they possess the same technological characteristics." This implies that the acceptance criteria are essentially those of the original device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance as intended (e.g., electrical signal transmission, pacing capability, navigation, structural integrity, biocompatibility post-reprocessing) | "Functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." |
| "Essentially identical to the currently marketed OEM devices" | "Essentially identical to the currently marketed OEM devices. No changes are made to the currently marketed device's specifications and they possess the same technological characteristics." |
| Maintenance of original device specifications | Met (implied by "No changes are made") |
2. Sample sizes used for the test set and the data provenance:
The document mentions "cleaning, sterilization, and packaging validations; and functional/performance and biocompatibility testing." However, it does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document is for a medical device (catheter) and focuses on its functional and safety aspects after reprocessing, not on diagnostic accuracy based on expert interpretation like an AI imaging device. Therefore, the concept of "experts used to establish ground truth for the test set" is not applicable in the same way. The evaluation would have been performed by engineers and scientists with expertise in medical device testing, manufacturing, microbiology, and biocompatibility.
4. Adjudication method for the test set:
Not applicable, as this is not a study involving human reader interpretation or diagnostic consensus.
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 medical device submission, not an AI or imaging diagnostic study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device submission, not an AI or algorithm-only study. The "standalone" performance here refers to the device itself performing its intended function.
7. The type of ground truth used:
For medical device performance testing, the "ground truth" is typically established through:
- Engineering specifications and standards: The original device's established performance parameters serve as the benchmark.
- Bench testing: Direct measurements of physical, mechanical, and electrical properties.
- Biocompatibility testing: Standardized assays (e.g., cytotoxicity, sensitization, irritation) to ensure no adverse biological reactions.
- Sterilization validation: Ensuring the device meets sterility assurance levels.
- Cleaning validation: Ensuring all biological and chemical contaminants are removed to acceptable levels.
8. The sample size for the training set:
Not applicable. This is a medical device (catheter) submission. There is no AI model being trained, so no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model.
§ 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).