(182 days)
The Reprocessed Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The catheter is to be used to map the atrial regions of the heart.
The Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Mapping Catheter (hereinafter Reflexion Spiral catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes. The Reflexion Spiral catheter has a loop and a proximal handle that contains a shaft actuator mechanism for varying the bi-directional (90°/180° minimum) distal portion of the shaft, a loop actuator mechanism for varying the loop diameter from approximately 25 mm to approximately 15 mm, and an electrical connector.
This document describes the validation of a reprocessed medical device, specifically the "Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter" (K191170). The acceptance criteria and the study proving the device meets these criteria are based on comparing the reprocessed device to its predicate devices through a series of functional and safety tests.
It's important to note that this is a 510(k) submission for a reprocessed device, not a novel AI/software medical device. Therefore, the concepts of "AI assistance," "human readers," "ground truth establishment by experts," "multi-reader multi-case (MRMC) studies," and "training/test sets with specific sample sizes for AI models" are not applicable in their conventional sense. The "study" here is a series of bench and laboratory tests demonstrating that the reprocessed device performs comparably and safely to the original, legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this reprocessed device are based on demonstrating that its performance is equivalent to the predicate devices and that it meets safety standards after reprocessing. The reported device performance aims to show this equivalence.
| Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Tested to ensure materials remain biocompatible after reprocessing. (Details not explicitly provided in the summary, but implied as satisfactory for clearance). |
| Cleaning Validation | Demonstrated effective removal of visible soil and decontamination processes. (Implied as satisfactory for clearance). |
| Sterilization Validation | Validated to ensure sterility after reprocessing. (Implied as satisfactory for clearance). |
| Functional Testing: | |
| Visual Inspection | Each device inspected for defects after reprocessing. (Implied as passing). |
| Dimensional Verification | Critical dimensions verified to be within specifications. (Implied as passing, as "functional equivalent" to predicate). |
| Electrical Continuity and Resistance | Electrical properties maintained after reprocessing. (Implied as passing). |
| Simulated Use | Performance evaluated under simulated clinical conditions. (Implied as passing, to demonstrate functional equivalence). |
| Mechanical Characteristics | Mechanical properties (e.g., flexibility, loop adjustment, distal reach) retained. (Implied as passing, to demonstrate functional equivalence). |
| Electrical Safety Testing: | |
| Dielectric and Current Leakage | Electrical safety parameters tested. (Implied as passing). |
| Packaging Validation | Ensures packaging maintains device integrity and sterility. (Implied as satisfactory for clearance). |
| Maximum Reprocessing Cycles | Reprocessed no more than one (1) time, tracked and rejected after max cycles. |
| Source Restriction | Reprocessing restricted to devices not previously reprocessed by others. |
2. Sample sizes used for the test set and the data provenance
The document does not specify exact sample sizes for each specific test (e.g., how many catheters were subjected to each functional test). However, the overall approach of a 510(k) for reprocessed single-use devices involves rigorous testing on a statistically relevant number of reprocessed units to ensure consistency and equivalence.
- Sample Size: Not explicitly stated as a number (e.g., 100 devices). Instead, it states "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Reflexion Spiral catheter." This implies a sufficient sample size was tested to establish the required equivalence and safety.
- Data Provenance: The testing was conducted by Innovative Health, LLC. The testing is assumed to be prospective as it's part of the premarket notification process for a specific reprocessed device iteration. The testing would have occurred in a controlled laboratory/bench setting in the USA (where Innovative Health is located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to a reprocessed medical device's performance validation in the way it applies to an AI/software device. The "ground truth" here is the established performance and safety profile of the original, legally marketed predicate device.
- "Experts": The "experts" are the engineers, scientists, and quality assurance personnel at Innovative Health who conducted and validated the tests, and implicitly, the FDA reviewers who assessed the submission. Their qualifications would include expertise in medical device testing, reprocessing, materials science, electrical engineering, etc.
- Establishment of "Ground Truth": The "ground truth" (i.e., acceptable performance) for the reprocessed device is its ability to meet or exceed the performance and safety characteristics of the predicate device, as demonstrated through the specified functional and safety tests. There isn't a "consensus" of external clinical experts on images or data; rather, it's a technical demonstration of equivalence.
4. Adjudication method for the test set
Not applicable in the context of an AI/software device's test set. The "adjudication" is essentially the detailed review and approval process by the FDA, based on the submitted test data.
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 device is an electrophysiology catheter, not an AI software intended to assist human readers (e.g., radiologists interpreting images).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical, reprocessed medical device, not a standalone algorithm. Its performance is inherent to the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is primarily based on the established performance specifications and safety profiles of the predicate devices. This is demonstrated through:
- Bench Testing Data: Direct measurements of physical, electrical, and mechanical properties.
- Laboratory Testing Data: Validation of cleaning, sterilization, and biocompatibility processes.
- "Simulated Use" Data: Performance under controlled, simulated clinical conditions.
There is no "expert consensus" on clinical interpretations or "pathology/outcomes data" being used as ground truth for this type of device's 510(k) clearance in the way it would be for a diagnostic AI.
8. The sample size for the training set
Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a reprocessed physical device, not an AI 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).