(105 days)
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
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. Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
This document describes the Reprocessed Electrophysiology (EP) Catheters by Alliance Medical Corporation.
Here's a breakdown of the requested information:
Acceptance Criteria and Device Performance
The provided document does not specify quantitative acceptance criteria with numerical targets (e.g., "sensitivity > 90%"). Instead, the acceptance criteria are implicitly defined by the demonstration that the reprocessed catheters perform "as originally intended" and are "safe, effective and substantially equivalent to the predicate devices."
The reported device performance is a categorical assertion of meeting these implied criteria through various tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Technological Characteristics | The design, materials, intended use, mechanism of action, mechanical design, materials, sizes, claims, clinical applications, patient population, performance specifications, and method of operation are identical to the predicate devices. |
| Reprocessing Validation | Reprocessing includes successful removal of adherent visible soil and decontamination. Each individual catheter is tested for appropriate function of its components prior to packaging and labeling. This indicates the reprocessing procedure itself was validated to ensure cleanliness and functionality. |
| Biocompatibility | Bench and laboratory testing demonstrated biocompatibility. |
| Sterilization Validation | Bench and laboratory testing demonstrated sterilization validation. |
| Function Test(s) | Bench and laboratory testing demonstrated appropriate function of the components post-reprocessing. |
| Packaging Validation | Bench and laboratory testing demonstrated packaging validation. |
| Overall Conclusion | Performance testing demonstrates that Reprocessed EP Catheters perform as originally intended. The device is concluded to be safe, effective, and substantially equivalent to the predicate devices in accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807. |
Study Details
The provided information pertains to a 510(k) premarket notification for a reprocessed medical device. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than conducting large-scale clinical trials measuring performance against specific endpoints in a patient population.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify a numerical sample size for the "test set" in the traditional sense of a clinical study. The performance data is based on "Bench and laboratory testing." This would typically involve a sample of reprocessed catheters undergoing the listed tests. The exact number of catheters tested is not provided, which is common for 510(k) submissions focusing on substantial equivalence through engineering and laboratory testing rather than clinical performance data.
- Data Provenance: The testing was conducted by Alliance Medical Corporation, located in Phoenix, Arizona, USA. The data is retrospective in the sense that it evaluates the performance of the reprocessed devices under controlled lab conditions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for this type of submission is not established by human experts interpreting clinical data. Instead, the "ground truth" is adherence to engineering specifications, validated reprocessing procedures, and performance metrics (e.g., electrical conductivity, mechanical integrity, sterility) derived from the original device's specifications and regulatory requirements for reprocessed devices. The expertise involved would be in engineering, microbiology, and quality assurance, rather than clinical specialists establishing a "diagnosis."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials where multiple human readers interpret medical images or patient data to establish a consensus ground truth. This submission relies on objective, measurable laboratory and bench tests, where the results are typically quantitative or pass/fail based on predefined criteria, not subjective interpretation requiring adjudication.
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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. This is a submission for a reprocessed medical device (electrophysiology catheters), not an AI diagnostic or assistance tool. Therefore, an MRMC study and effects on human reader performance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on objective engineering specifications, validated reprocessing parameters, and standardized laboratory tests (e.g., sterility tests, mechanical integrity tests, electrical function tests). It is essentially conformance to established benchmarks for the original device and regulatory standards for reprocessed devices.
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The sample size for the training set:
- Not applicable in the typical sense of machine learning. This is a reprocessed physical device. There isn't a "training set" to develop an algorithm. However, the development of the reprocessing procedures themselves would involve extensive internal testing and refinement, which could be seen as an iterative "training" process for the reprocessing protocol, but not a data set in the AI context.
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How the ground truth for the training set was established:
- Not applicable. As noted above, there isn't a "training set" for an algorithm. The "ground truth" for developing the reprocessing procedure would be successful validation that the reprocessed device consistently meets the performance and safety characteristics of a new equivalent device. This involves engineering design, material science, and regulatory compliance expertise.
§ 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).