(67 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 65 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 4 – 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 steerable for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.
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 catheters reprocessed by Vanguard are open to the patient bloodstream.
Vanguard collects previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to the healthcare facility for an additional clinical use.
This document describes a 510(k) submission for reprocessed diagnostic electrophysiology (EP) catheters. It concerns the substantial equivalence of reprocessed devices to their original equipment manufacturer (OEM) counterparts. The validation studies focused on demonstrating that the reprocessed devices perform as intended and are safe and effective, upholding the original technological characteristics and intended use.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in a typical AI/software device context. Instead, it states that the reprocessed devices were validated to perform as intended and are safe and effective. The acceptance criteria are implicitly linked to maintaining the original device's safety, effectiveness, and technological characteristics after reprocessing.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Ensuring the devices are adequately cleaned after single use and before reprocessing to remove biological and other contaminants. | Validation studies demonstrated adequate cleaning. |
| Sterilization Validation | Confirming the reprocessed devices achieve appropriate sterility levels for medical use. | Validation studies demonstrated adequate sterilization. |
| Packaging Validation | Verification that the packaging maintains sterility and device integrity until use. | Validation studies demonstrated adequate packaging. |
| Performance Testing | Assessment that the reprocessed devices maintain the functional performance (e.g., electrical signal transmission, mechanical properties, steerability, radiopacity) of the OEM device. | "Performance testing demonstrate[s] that the reprocessed devices perform as intended." "Vanguard Reprocessed Diagnostic EP Catheters are essentially identical to the Original Equipment Manufacturer (OEM) devices. No changes are made to the device materials or specifications and the reprocessed catheters possess identical technological characteristics." |
| Biocompatibility Testing | Ensuring that the reprocessed materials remain biocompatible and do not elicit adverse reactions in patients. | "Biocompatibility testing demonstrate[s] that the reprocessed devices... are safe and effective." |
| Indications for Use | The reprocessed device must meet the same indications for use as the original device: "temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping." | The reprocessed devices were deemed substantially equivalent for the stated indications for use. |
| Contraindications | The reprocessed device must have the same contraindications as the original device. | Same contraindications as the OEM device apply. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/software evaluation. The validation described is for reprocessed physical medical devices (catheters). The "sample size" would refer to the number of reprocessed catheters subjected to cleaning, sterilization, packaging, performance, and biocompatibility testing. This specific number is not provided in the document.
Data provenance (e.g., country of origin, retrospective/prospective) is also not specified for the testing. The catheters are collected from "healthcare facilities" without further geographic detail. The nature of the testing is typically prospective (i.e., newly reprocessed devices are tested under controlled conditions).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and submission. "Ground truth" established by experts is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) in AI/software evaluations. For reprocessed physical devices, "ground truth" relates to objective physical, chemical, and biological measurements and material integrity, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device and submission. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations, which is not the nature of validation for a physical reprocessed medical device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses human performance with and without AI assistance and is irrelevant for the validation of a reprocessed physical catheter.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept applies to AI algorithms, not reprocessed physical medical devices.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established through:
- Objective Measurements: Directly measuring physical properties (e.g., dimensions, flexibility, electrical conductivity, torque), chemical integrity, and sterility of the reprocessed devices.
- Biological Testing: Biocompatibility tests to ensure safety when in contact with biological systems.
- Performance Specifications: Comparison against the known specifications and performance of the OEM, predicate device.
It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic AI systems.
8. The Sample Size for the Training Set
This information is not applicable. This submission concerns a physical medical device, not an AI algorithm utilizing a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" for this type of device.
§ 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).