(199 days)
The Reprocessed DECANAV™ Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, in the Coronary Sinus. In addition, the Reprocessed DECANAV™ Catheter is used with compatible Carto® 3 EP Navigation Systems to provide catheter tip location information.
The Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. In addition, the Reprocessed WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and coronary sinus.
The Reprocessed DECANAV™ Catheter is a sterile, single patient use device designed to be used with the CARTO® 3 EP 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 Reprocessed DECANAV™ Catheter has a single proximal electrode that can be used for unipolar recording signals. The Reprocessed DECANAV™ Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in curve types D and F. Pushing the thumb knob forward causes the catheter tip to bend (curve); when the knob is pulled back, the tip straightens. The plane of the curved tip can be rotated during use. The Reprocessed DECANAV™ Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.
The Reprocessed WEBSTER® Duo-Decapolar Catheter (DDP) is a sterile, single patient use device designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. Tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumb knob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.
The provided text describes the 510(k) summary for reprocessed electrophysiology catheters, which are medical devices, not AI/ML-enabled software. Therefore, the questions related to AI/ML device performance, such as sample size for test sets (data provenance), number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, and training set information (sample size, ground truth establishment), are not applicable to this document.
The document discusses acceptance criteria and device performance in the context of demonstrating substantial equivalence for reprocessed medical devices to their predicate devices.
1. A table of acceptance criteria and the reported device performance
The document lists several tests performed to demonstrate appropriate functional characteristics and substantial equivalence to predicate devices. It states that "Performance testing shows the Reprocessed DECANAV™ and Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheters perform as originally intended." and "Results demonstrated substantial equivalence to the predicate devices."
Specific acceptance criteria (e.g., numerical thresholds for compliance) are not explicitly detailed in this summary. However, the types of tests conducted serve as the basis for determining if the reprocessed devices meet acceptable performance comparable to the original predicate devices.
| Acceptance Criteria (Implicit by Test Type) | Reported Device Performance |
|---|---|
| Cleaning Validation | Validated |
| Sterilization Verification | Verified |
| Ethylene Oxide Residual Testing | Compliant with ISO 10993-7 |
| Packaging Validation | Compliant with ASTM D4169, ASTM F88, ASTM F2096 |
| Shelf-Life Validation | Validated to ASTM 1980-07 |
| Functional Performance (Bench Testing) | "Perform as originally intended" (through simulated use, visual inspection, and fatigue testing) |
| Joint Bond Strength | "Perform as originally intended" |
| Torsional Resiliency | "Perform as originally intended" |
| Tip Buckle | "Perform as originally intended" |
| Fluid Integrity | "Perform as originally intended" |
| Deflection Cycling | "Perform as originally intended" |
| Flexation Cycling | "Perform as originally intended" |
| Shaft Stiffness | "Perform as originally intended" |
| Electrical Continuity | "Perform as originally intended" |
| Electrical Leakage | "Perform as originally intended" |
| Electrical Connector Cycling | "Perform as originally intended" |
| Cable to Handle Retention Strength | "Perform as originally intended" |
| CARTO® 3 System Compatibility of Duo-Decapolar | "Perform as originally intended" |
| CARTO® 3 System Recognition of DECANAV Electrical Resistance and Isolation | "Perform as originally intended" |
| Coronary Sinus Handling | "Perform as originally intended" |
| Biocompatibility | Compliant with ISO 10993-1, including Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility |
2. Sample size used for the test set and the data provenance
The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." It does not specify the exact sample size for each test or the total test set.
- Data provenance: Not explicitly stated, but the testing was conducted by Sterilmed, Inc. or its contractors in the context of their reprocessing efforts. This would be considered internal data from the reprocessing process. The data is retrospective in the sense that it evaluates the reprocessed devices after manufacturing, but the tests themselves are prospective studies on those samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a reprocessed electrophysiology catheter. Performance is assessed through engineering and biocompatibility tests against established specifications and comparison to the original (OEM) device, not through expert human review of interpretative data like medical images.
4. Adjudication method for the test set
This question is not applicable, as the performance evaluation relies on objective engineering and biological test results, not expert human interpretation or adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This question is not applicable. MRMC studies are typically used to evaluate the diagnostic accuracy of imaging systems or AI algorithms by comparing performance with and without an AI assist. This document is for a reprocessed medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an AI/ML-enabled device.
7. The type of ground truth used
The "ground truth" for the performance of these reprocessed catheters is established by:
- Engineering specifications and performance characteristics of the original equipment manufacturer (OEM) predicate devices. The reprocessed devices are tested to ensure they meet these specifications.
- Compliance with recognized standards for medical device reprocessing, safety, and performance (e.g., ISO 10993 for biocompatibility, ASTM standards for packaging and shelf-life, and internal functional performance criteria designed to mimic intended use).
- Visual inspection for physical integrity.
Essentially, the ground truth is the performance and safety profile of the new, original predicate device.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML-enabled device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for an AI/ML algorithm.
§ 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).