(92 days)
The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus.
The catheter provides tip location when used with the compatible Carto 3 EP Navigation Systems.
The Reprocessed DecaNav Catheter has been designed to be used with the Carto 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The catheter has a single proximal electrode that can be used for unipolar recording signals. The catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use.
This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the Reprocessed DecaNav Diagnostic Electrophysiology Catheter. Instead, it describes various tests performed to demonstrate its safety and effectiveness, and then concludes that the device is "as safe and effective as the predicate devices."
Therefore, the table will reflect the types of tests conducted, which imply the areas of performance that were evaluated.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Passed (demonstrated) |
| Cleaning Validation | Passed (demonstrated) |
| Sterilization Validation | Passed (demonstrated) |
| Functional Testing: | |
| - Visual Inspection | Passed (inspected) |
| - Dimensional Verification | Passed (verified) |
| - Electrical Continuity & Resistance | Passed (tested) |
| - Simulated Use | Passed (tested) |
| Mechanical Characteristics | Passed (tested) |
| Electrical Safety Testing: | |
| - Dielectric & Current Leakage | Passed (tested) |
| Packaging Validation | Passed (validated) |
| Overall Safety and Effectiveness | Concluded to be as safe and effective as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each individual test (e.g., how many catheters were tested for electrical continuity). It generally states that "Bench and laboratory testing was conducted."
- Sample Size: Not specified in the provided text.
- Data Provenance: The tests listed are "Bench and laboratory testing." This suggests prospective, controlled laboratory studies conducted by the manufacturer, Innovative Health, LLC. The country of origin is not explicitly stated, but Innovative Health, LLC. is located in Scottsdale, Arizona, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" and expert review as typically understood in AI/imaging studies (e.g., for diagnostic accuracy) is not directly applicable here. This document describes a medical device undergoing reprocessing for which safety and functional performance are being evaluated. The "ground truth" is established by adherence to engineering specifications, validated cleaning/sterilization processes, and comparison to the original device's performance.
Therefore:
- Number of Experts: Not applicable in the context of expert consensus for ground truth as per typical AI studies. The "experts" would be the engineers and quality control personnel performing the tests and validating the processes according to established standards.
- Qualifications of Experts: Not specified. It can be inferred that these would be qualified professionals in biomedical engineering, quality assurance, microbiology (for sterilization/cleaning), etc.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements or validated processes rather than subjective interpretations requiring 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
Not applicable. This is a submission for a reprocessed medical device (a catheter), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Engineering specifications and design parameters of the original (new) device.
- Validated laboratory methods and industry standards for testing biocompatibility, cleaning, sterilization, electrical safety, and mechanical performance.
- Comparison to the predicate device's known performance characteristics.
Essentially, the reprocessed device's performance is compared against the performance of a new device and established medical device standards.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not a machine learning 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).