(207 days)
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Reprocessed Electrophysiology (EP) 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.
The provided text is a 510(k) summary for the Alliance Medical Corporation's Reprocessed Electrophysiology (EP) Catheters. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it broadly claims that the reprocessed devices "perform as originally intended" and are "safe, effective and substantially equivalent to the predicate devices."
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Demonstrated through testing |
| Validation of Reprocessing | Demonstrated through testing |
| Sterilization Validation | Demonstrated through testing |
| Function Test(s) | Tested prior to packaging and labeling; deemed to perform "as originally intended" |
| Overall Safety & Effectiveness | Safe, effective, and substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in the performance studies (biocompatibility, reprocessing validation, sterilization validation, function tests).
The data provenance is implied to be prospective bench and laboratory testing conducted by Alliance Medical Corporation. There is no mention of country of origin for the data in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. The nature of the tests (biocompatibility, sterilization, function) suggests objective laboratory measurements rather than expert human interpretation in a clinical setting.
4. Adjudication Method for the Test Set
Not applicable. The tests mentioned (biocompatibility, reprocessing, sterilization, function) are objective laboratory or bench tests, not requiring an adjudication method among experts.
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 510(k) submission for a reprocessed medical device (catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm. The testing focuses on the physical and functional properties of the reprocessed catheter.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be based on:
- Established standards and protocols: for biocompatibility and sterilization.
- Predetermined functional specifications: for the function tests, likely defined by the original manufacturer's specifications for new devices.
- Validated reprocessing procedures: for reprocessing validation.
8. The Sample Size for the Training Set
Not applicable. This is a medical device approval, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning 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).