(62 days)
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.
Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text, a 510(k) summary for Reprocessed Electrophysiology Catheters, does not explicitly define quantitative acceptance criteria for device performance in a table format. Instead, it broadly states that "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended."
The closest approximations to "acceptance criteria" are the types of tests performed. Since specific numerical targets for these tests are not provided, I will present the tests as the criteria implied to demonstrate safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Bench and laboratory testing demonstrated satisfactory performance. |
| Validation of reprocessing | Bench and laboratory testing demonstrated satisfactory performance. |
| Sterilization Validation | Bench and laboratory testing demonstrated satisfactory performance. |
| Function test(s) (of components prior to packaging and labeling) | Each individual catheter tested for appropriate function. |
| Packaging Validation | Bench and laboratory testing demonstrated satisfactory performance. |
| Equivalent to predicate devices in design, materials, intended use, mechanism of action, clinical applications, patient population, performance specifications, or method of operation. | "The design, materials, and intended use of Reprocessed Electrophysiology Catheters are identical to the predicate devices." No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets used in biocompatibility, reprocessing validation, sterilization validation, function tests, or packaging validation. It only states that "Bench and laboratory testing was conducted." The data provenance is also not specified beyond being "bench and laboratory testing," implying it was conducted by Ascent Healthcare Solutions, likely in a controlled, prospective manner to demonstrate equivalence. There is no mention of country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described is a series of bench and laboratory tests to demonstrate device performance and equivalence to predicate devices, not a clinical study involving diagnosis or interpretation by human experts to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is focused on bench and laboratory testing of the reprocessed device itself, not on human interpretation or diagnostic accuracy where adjudication would be relevant.
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
An MRMC comparative effectiveness study was not conducted. The device is a reprocessed medical catheter, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used
For the performance testing (biocompatibility, reprocessing, sterilization, function, packaging), the ground truth was established through validated laboratory methods and engineering specifications designed to ensure the reprocessed device meets the original design requirements and safety standards of the new predicate devices. For demonstrating equivalence, the ground truth was the specifications and performance characteristics of the predicate devices.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This document describes the re-processing of medical devices, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set mentioned or implied in the context of this 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).