(58 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 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. Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
The provided document is a 510(k) Summary for a reprocessed medical device, specifically Electrophysiology Catheters. This type of submission focuses on proving "substantial equivalence" to existing legally marketed devices (predicates) rather than establishing new performance claims or conducting clinical efficacy studies.
Therefore, the acceptance criteria and study information requested, which are typically associated with demonstrating novel performance or clinical superiority of a device, are not directly applicable in the context of this 510(k) submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or detailed device performance metrics in the way one would see for a new device's clinical trial or performance study. Instead, the performance demonstration focuses on showing that the reprocessed devices function identically to their predicate devices and meet safety standards after reprocessing.
The "Performance data" section states:
- "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Electrophysiology Catheters."
- This included:
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation
- "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended."
Since there are no specific numeric acceptance criteria or quantitative performance results provided in the summary, a table cannot be populated as requested. The "acceptance criteria" here are implied to be adherence to the original device specifications and established reprocessing standards. The "reported device performance" is a general statement that they "perform as originally intended."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the bench and laboratory testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests. This information is typically found in the detailed test protocols and reports, which are not part of this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This is not applicable to the type of testing described (bench and laboratory). Bench testing for medical devices typically relies on engineering specifications and measurement against those specifications, not expert consensus on interpretations of qualitative data.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or experts when establishing ground truth, typically in image interpretation or diagnostic studies. The tests mentioned (biocompatibility, sterilization, function, packaging) are objective, quantitative, or qualitative assessments against predefined standards, not subjective interpretations requiring adjudication.
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
This is not applicable. The device described is a reprocessed electrophysiology catheter, which is a physical medical device, not an AI or software algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI.
7. The Type of Ground Truth Used
For the bench and laboratory testing:
- Biocompatibility: Ground truth would be adherence to established biocompatibility standards (e.g., ISO 10993).
- Validation of reprocessing: Ground truth would be the successful removal of soil, decontamination, and functionality post-reprocessing, verified by established protocols and measurable criteria.
- Sterilization Validation: Ground truth would be a Sterility Assurance Level (SAL) meeting an accepted standard (e.g., 10^-6), confirmed by established sterilization validation methods.
- Function test(s): Ground truth would be that the reprocessed catheter performs according to the original manufacturer's specifications for function (e.g., electrical conductivity, deflection, structural integrity).
- Packaging Validation: Ground truth would be that the packaging maintains sterility and integrity, confirmed by established packaging validation methods.
8. The Sample Size for the Training Set
This is not applicable. The device is a reprocessed physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for a physical reprocessed device.
In Summary:
The provided document describes a 510(k) submission for a reprocessed electrophysiology catheter. The "acceptance criteria" and "study" described are fundamental safety and performance validations for a reprocessed medical device, ensuring it remains equivalent to the original, legally marketed device. It does not involve AI, clinical trials, or expert consensus studies for diagnostic interpretation. The focus is on demonstrating that the reprocessing does not compromise the device's original intended use, safety, or effectiveness.
§ 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).