(122 days)
The Reprocessed Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
The Reprocessed Marinr steerable/deflectable tip electrode catheter is a flexible, radiopaque catheter constructed of extruded polymer over stainless steel braid. The catheter is designed for intracardiac recording or stimulation. The Marinr catheter handle controls allow precise tip placement within the heart.
The provided document is a 510(k) premarket notification for a Reprocessed Marinr Diagnostic EP Catheter. It focuses on demonstrating substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial report for an AI/ML powered device.
Therefore, many of the requested elements (like "reported device performance," "sample size used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set sample size," or "ground truth for training set") are not applicable or not explicitly provided in this type of regulatory submission. This document describes a reprocessing method for an existing medical device, not the development or evaluation of a novel algorithm.
However, I can extract the acceptance criteria related to the reprocessed device's functional and safety testing, and summarize the type of study conducted.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Reported Performance (Summary) |
|---|---|---|
| Safety | Biocompatibility | Met established standards for biocompatibility. |
| Cleaning Validation | Demonstrated effective removal of visible soil and decontamination. | |
| Sterilization Validation | Demonstrated sterilization efficacy. | |
| Electrical Safety Testing (Dielectric and Current Leakage) | Met established electrical safety requirements. | |
| Functional Effectiveness | Functional Testing: Visual Inspection | Passed visual inspection for integrity. |
| Functional Testing: Dimensional Verification | Dimensions were verified to be within specifications. | |
| Functional Testing: Electrical Continuity and Resistance | Met continuity and resistance requirements. | |
| Functional Testing: Simulated Use | Performed as intended during simulated use. | |
| Functional Testing: Mechanical Characteristics | Maintained necessary mechanical characteristics. | |
| Packaging | Packaging Validation | Met established packaging integrity and shelf-life requirements. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "bench and laboratory testing" which implies tests were performed on a representative sample of reprocessed catheters.
- Data Provenance: Not applicable in the context of clinical data provenance. The testing was laboratory-based, performed by the manufacturer, Innovative Health, LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The device is a reprocessed diagnostic catheter; its performance is evaluated against engineering and safety specifications, not by expert interpretation of clinical images or data in a diagnostic context. "Ground truth" here refers to objective measurements and validated protocols, not expert consensus.
4. Adjudication method for the test set
- Not applicable. Performance was assessed through objective laboratory and bench tests, not expert adjudication of diagnostic outcomes.
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 not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-powered device. The device does not operate as an algorithm.
7. The type of ground truth used
- The "ground truth" for the reprocessed device's performance relies on objective engineering and safety specifications, validated test methods (e.g., for biocompatibility, sterility, electrical safety, mechanical properties), and comparison against the performance of new (predicate) devices as established through their original clearance. It does not involve expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic clinical study.
8. The sample size for the training set
- Not applicable. This is not an AI-powered device and therefore does not have a "training set" in the machine learning context.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study conducted was a series of bench and laboratory tests designed to demonstrate the continued safety and functional effectiveness of the Reprocessed Marinr Diagnostic EP Catheter after reprocessing. The manufacturer, Innovative Health, LLC, performed these tests.
The tests covered several critical areas:
- Biocompatibility: To confirm the reprocessed device remains safe for contact with human tissue.
- Cleaning Validation: To ensure the reprocessing effectively removes contaminants.
- Sterilization Validation: To confirm the device is rendered sterile after reprocessing.
- Functional Testing: This included visual inspection, dimensional verification, electrical continuity and resistance checks, simulated use, and assessment of mechanical characteristics to ensure the device retains its intended performance.
- Electrical Safety Testing: To verify the electrical integrity and safety of the device.
- Packaging Validation: To ensure the device remains sterile and protected until use.
The overall conclusion reached by Innovative Health, LLC, is that "The Reprocessed Marinr Catheter is as safe and effective as the predicate devices described herein," based on the successful completion of these functional and safety tests. This approach is typical for the 510(k) pathway for reprocessed devices, where substantial equivalence to a legally marketed predicate device is demonstrated through verified reprocessing protocols and performance testing.
§ 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).