(246 days)
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Reprocessed Electrophysiology Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
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 handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.
Alliance Medical Corporation's reprocessing of electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations.
This document is a 510(k) summary for the Alliance Medical Corporation's Reprocessed Electrophysiology (EP) Catheters. As such, it describes the device and its intended use, but it does not detail specific acceptance criteria or a dedicated study that proves the device meets particular performance metrics beyond what is stated in the "Performance data" section.
However, based on the provided text, we can infer some information relating to acceptance criteria and the "study" (validation activities) performed.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it broadly states that "Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters."
The reported areas of performance validation are:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility | Validation performed (implies meeting biocompatibility standards) |
| Reprocessing Effectiveness | Validation performed (implies effective removal of soil & decontamination) |
| Sterilization Effectiveness | Validation performed (implies effective sterilization) |
| Functionality | Each individual reprocessed catheter is tested for appropriate function of its components (implies meeting functional requirements) |
| Overall safety and effectiveness | "Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations." This implies that every reprocessed device undergoes functional testing as part of the quality control process.
For biocompatibility, reprocessing validation, and sterilization validation, the document does not specify the sample size or data provenance. These types of validations are typically prospective studies conducted in a controlled laboratory environment. The country of origin of the data is not specified, but given the company (Alliance Medical Corporation) is based in Phoenix, Arizona, USA, it's highly probable the testing was conducted in the US or by a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The validation activities mentioned (biocompatibility, reprocessing, sterilization, function tests) are primarily objective technical validations and would not typically involve expert "ground truth" establishment in the way it's used for AI/clinical diagnostic studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to the types of technical validations described in the document. Adjudication methods are typically used in clinical studies where subjective interpretation or classification is involved.
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, an MRMC comparative effectiveness study was not done. This document describes the reprocessing of medical devices, not an AI software device.
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 document pertains to physical reprocessed medical devices, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mentioned "Function test(s)," the ground truth is against the original intended function of the new (unreprocessed) device. For biocompatibility, reprocessing, and sterilization, the "ground truth" is established by regulatory standards and industry-accepted test methods that define what constitutes a "biocompatible," "effectively reprocessed," or "sterile" device.
8. The sample size for the training set
This concept is not applicable to this document. "Training set" refers to data used to train an AI algorithm, which is not the subject of this 510(k) summary.
9. How the ground truth for the training set was established
This concept is not applicable to this document.
§ 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).