(119 days)
Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
Reprocessed diagnostic 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.
The provided document describes the premarket notification (510(k)) for Alliance Medical Corporation's reprocessed Electrophysiology (EP) Catheters and Cables. The FDA has determined the device is substantially equivalent to legally marketed predicate devices. The document highlights the indications for use, technological characteristics, and performance data used to support this determination.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical "acceptance criteria" for performance metrics in a table. Instead, it relies on demonstrating that the reprocessed devices perform as originally intended and are substantially equivalent to predicate devices. The performance attributes evaluated are listed as types of testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Biocompatibility testing conducted |
| Effectiveness: Proper Reprocessing | Validation of reprocessing conducted |
| Safety: Sterility | Sterilization Validation conducted |
| Effectiveness: Appropriate Function of Components (mechanical, electrical) | Function test(s) conducted for each individual catheter prior to packaging |
| Overall Performance: As originally intended | Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended. |
| Overall Equivalence: Substantially equivalent to predicate devices | Alliance Medical Corporation concludes that the modified device (the Reprocessed Electrophysiology (EP) Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein. |
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly mentions "Bench and laboratory testing was conducted," but it does not specify the sample size for the test set used for performance validation.
The data provenance is implicitly from Alliance Medical Corporation's internal testing ("Bench and laboratory testing was conducted"). The document does not specify the country of origin, but given the company's address in Phoenix, Arizona, and the FDA submission, it can be inferred that the testing was likely conducted in the USA or supervised under US regulatory standards. It's a retrospective evaluation of the reprocessed devices against established performance criteria, rather than a prospective clinical study with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the device's performance. The "ground truth" here seems to be inherent in the established performance specifications for new EP catheters and the successful completion of the described laboratory tests.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method. For laboratory and bench testing, adjudication as seen in clinical studies (e.g., 2+1 physician review) is typically not applicable. The results of the tests (e.g., sterilization efficacy, biocompatibility, functional integrity) are generally objective measurements directly compared against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
An MRMC comparative effectiveness study is not applicable to this device. This document concerns the reprocessing of an electrophysiology catheter, which is a physical medical device, not an AI-driven diagnostic tool that assists human readers. Therefore, there is no discussion of radiologists, AI, or human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is also not applicable as the device is not an algorithm or an AI system. It is a reprocessed physical medical device.
7. The Type of Ground Truth Used:
The ground truth used for assessing the reprocessed catheters is based on engineering specifications and established performance standards for new, legally marketed electrophysiology catheters. This includes:
- Biocompatibility standards: Ensuring the reprocessed device is safe for contact with human tissue.
- Reprocessing validation criteria: Demonstrating that the reprocessing procedures effectively clean and prepare the device for reuse.
- Sterilization validation criteria: Confirming the device is sterile after reprocessing.
- Functional performance specifications: Verifying that the electrical and mechanical functions of the reprocessed catheter meet the original design specifications of new devices.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here. This device is a reprocessed physical medical device, not an AI algorithm that undergoes machine learning training.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as 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).