(219 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.
The provided text describes the 510(k) premarket notification for a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It is important to note that this document is for a reprocessed medical device, meaning it is a device that has been previously used, cleaned, sterilized, and prepared for re-use. The testing conducted primarily focuses on ensuring the reprocessed device performs comparably to the original new device and meets safety standards, rather than testing new clinical efficacy.
Based on the provided information, I can extract the following details regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various functional and safety tests performed but does not explicitly state quantitative acceptance criteria or detailed numerical performance results for most of them. It generally states that testing was conducted "to demonstrate performance (safety and effectiveness)".
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are biocompatible (e.g., non-toxic, non-allergenic) | Passed (implied, as the device is deemed safe and effective) |
| Cleaning Validation | Device is adequately cleaned to remove contaminants | Passed (implied; reprocessing includes removal of visible soil and decontamination) |
| Sterilization Validation | Device is effectively sterilized to eliminate pathogens | Passed (implied; reprocessing includes sterilization) |
| Visual Inspection | Device meets visual quality standards | Passed (implied; each device is inspected) |
| Dimensional Verification | Device dimensions conform to original specifications | Passed (implied) |
| Electrical Continuity | Electrical components function as intended | Passed (implied) |
| Simulated Use | Device performs as expected under simulated operational conditions | Passed (implied) |
| Mechanical Characteristics | Device mechanical properties (e.g., steerability, flexibility) are maintained | Passed (implied) |
| Electrical Safety Testing | Device meets electrical safety standards (e.g., dielectric, current leakage) | Passed (implied) |
| Packaging Validation | Packaging maintains sterility and protects the device | Passed (implied) |
| Function/Intended Use | The reprocessed device performs identically to the predicate device for its indicated use (recording or stimulation, obtaining electrograms) | No changes to claims, clinical applications, patient populations, performance specifications, or method of operation compared to the predicate device. Stated to be "as safe and effective as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the functional and safety tests.
Regarding data provenance:
- The tests are described as "Bench and laboratory testing".
- The data is retrospective in the sense that it relies on demonstrating equivalence to an already marketed device (the predicate device). It's not a prospective clinical trial generating new outcome data directly on patients.
- The location of the testing is not explicitly stated, but it would have been conducted by Innovative Health, LLC, which is based in Scottsdale, Arizona, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For a reprocessed device and the types of engineering and safety tests described, ground truth would typically be established by internal engineering specifications, regulatory standards, and comparison to the original device's performance, rather than expert clinical consensus on a test set.
4. Adjudication Method for the Test Set:
This information is not applicable/not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document describes bench and laboratory testing to ensure the safety and effectiveness of the reprocessed device itself, not a study assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this is not an AI/algorithm-based device. The device is a physical electrophysiology catheter. Therefore, "standalone algorithm performance" is not applicable. The core of the submission is about the reprocessing process and ensuring the physical device's performance after reprocessing.
7. The type of ground truth used:
For the functional and safety testing, the ground truth is primarily based on:
- Engineering specifications and standards: For dimensional, electrical, and mechanical tests.
- Regulatory standards: For biocompatibility, cleaning, sterilization, and electrical safety.
- Performance of the original predicate device: The reprocessed device is demonstrated to have "identical" purpose, design, materials, function, and intended use to the predicate device, implying its performance should match the original.
8. The Sample Size for the Training Set:
This is not applicable. This is a reprocessed physical medical device, not an AI or 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 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).