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510(k) Data Aggregation
(110 days)
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.
This document is a 510(k) Premarket Notification from the FDA for a reprocessed medical device, specifically a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It details the device, its indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional & Safety Testing | |
| Biocompatibility | Met |
| Cleaning Validation | Met |
| Sterilization Validation | Met |
| Visual Inspection | Met (part of functional testing) |
| Dimensional Verification | Met (part of functional testing) |
| Electrical Continuity | Met (part of functional testing) |
| Simulated Use | Met (part of functional testing) |
| Mechanical Characteristics | Met (part of functional testing) |
| Electrical Safety Testing | Met (Dielectric and Current Leakage) |
| Packaging Validation | Met |
| Reprocessing Cycle Limit | Reprocessed no more than 3 times; device rejected from further reprocessing after reaching maximum cycles. |
| Reprocessing Exclusivity | Reprocessing performed only by Innovative Health; excludes devices previously reprocessed by other reprocessors. |
Note: The document states that the functional and safety testing was conducted "to demonstrate performance (safety and effectiveness)" and the conclusion is that the device is "substantially equivalent," implying that all these tests met their respective acceptance criteria. Specific quantitative acceptance criteria (e.g., "electrical continuity must be X ohms") are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the functional and safety testing mentioned.
Therefore, the sample size for the test set is not specified.
The data provenance is from bench and laboratory testing conducted by Innovative Health, LLC. The country of origin of the data is implicitly the United States, as Innovative Health, LLC. is based in Scottsdale, Arizona, and is interacting with the U.S. FDA. The testing conducted is likely prospective in nature, as it was performed to support the 510(k) submission for the reprocessed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the establishment of a "ground truth" in the sense of expert consensus on diagnostic imaging or clinical findings, as it pertains to a physical medical device (a catheter) and its reprocessing. The "testing" involved demonstrating physical, electrical, and sterilization performance. Therefore, this section is not applicable in the context of this device and submission.
4. Adjudication Method for the Test Set
This section is not applicable as the tests performed are objective measurements (e.g., electrical continuity, dimensional verification) or validations (e.g., sterilization, cleaning), not subjective assessments requiring expert 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 section is not applicable. The device is a physical medical instrument (a mapping catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a physical medical instrument (a mapping catheter), not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics of this device is established by:
- Engineering specifications and standards: These define acceptable dimensional tolerances, electrical properties, and mechanical characteristics for a functional catheter.
- Biocompatibility standards: Defines acceptable levels of biological response to materials.
- Sterilization and cleaning validation protocols: These define validated processes to ensure sterility and cleanliness, often with established microbial reduction or residue limits.
- Predicate device performance: The reprocessed device is compared to the performance characteristics of the original cleared device and other predicate reprocessed devices to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of this device. The device is a physical product, not an algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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