(231 days)
The Reprocessed Supreme Diagnostic Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Reprocessed Supreme Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The provided text describes a 510(k) premarket notification for Reprocessed Supreme Diagnostic Electrophysiology (EP) Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the typical sense of a human-in-the-loop or standalone AI performance study.
The "acceptance criteria" here refer to the various engineering and performance characteristics that the reprocessed catheters must meet to be considered safe and effective and substantially equivalent to the original, new devices and the predicate reprocessed devices. The "study" proving these criteria are met consists of a series of bench and laboratory tests.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Biocompatibility | Complies (implied by "Functional and Safety Testing") |
| Cleaning Validation | Complies (implied by "Functional and Safety Testing") |
| Sterilization Validation | Complies (implied by "Functional and Safety Testing") |
| Visual Inspection | Complies (implied by "Functional and Safety Testing") |
| Dimensional Verification | Complies (implied by "Functional and Safety Testing") |
| Electrical Continuity and Resistance | Complies (implied by "Functional and Safety Testing") |
| Simulated Use | Complies (implied by "Functional and Safety Testing") |
| Mechanical Characteristics | Complies (implied by "Functional and Safety Testing") |
| Electrical Safety Testing (Dielectric and Current Leakage) | Complies (implied by "Functional and Safety Testing") |
| Packaging Validation | Complies (implied by "Functional and Safety Testing") |
| Reprocessing Cycle Limit | No more than three (3) times. Devices reaching max cycles are rejected. |
| Reprocessor Restriction | Reprocessing only by Innovative Health; excludes devices previously reprocessed by other reprocessors. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each bench and laboratory test. It generally refers to "bench and laboratory testing" conducted. The provenance of the data is implicitly from internal tests conducted by Innovative Health, LLC. This would be a retrospective analysis of the reprocessed devices' performance against set standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is generally not applicable to the testing of physical medical devices like catheters. The "ground truth" is established by engineering specifications, regulatory standards (e.g., for biocompatibility, sterility), and the performance characteristics of the predicate device. Expert involvement would be in the design and execution of the tests, and interpretation of results against objective criteria, rather than establishing a subjective "ground truth" from data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical evaluations or expert review of data (e.g., medical images) where there can be inter-rater variability. For physical device testing, the results are typically quantitative measurements that either meet or do not meet predefined criteria.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC comparative effectiveness study is used for diagnostic systems, particularly AI-driven ones, to assess how human performance changes with AI assistance. This document describes the re-processing of a physical medical device, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. There is no AI algorithm involved in the function or reprocessing of these electrophysiology catheters. The device itself is a physical tool, not a software algorithm. The "standalone" performance here refers to the device's inherent function, which is assessed through the various functional and safety tests mentioned.
7. Type of Ground Truth Used
The ground truth used here consists of:
- Engineering Specifications: Defined parameters for dimensions, electrical properties, mechanical strength, etc., derived from the original device design and performance requirements.
- Regulatory Standards: Requirements for biocompatibility (e.g., ISO 10993), sterilization (e.g., ISO 11135, ISO 11137), cleaning validation, and electrical safety.
- Predicate Device Performance: The demonstrated performance of the legally marketed predicate devices (K151622 and K161769) sets the benchmark for substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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).