(36 days)
The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.
The FlexCath Advance Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath can be deflected to provide additional maneuverability to catheters that are advance through the sheath and into the right or left chamber of the heart. The FlexCath Advance Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application addresses modifications to the 12 French (12F) FlexCath Steerable Sheath which resulted in the creation of the 12F FlexCath Advance Steerable Sheath (4FC12). Modifications were made to the stopcock, shaft (pullwire and ring assembly), deflection stopper, and barrel and slider assembly. In addition, an updated Technical Manual (Instructions for Use) and updated packaging labeling was developed for the FlexCath Advance Steerable Sheath.
The provided text describes a 510(k) submission (K123591) for the "FlexCath Advance™ Steerable Sheath & Dilator." This submission focuses on design modifications to an already cleared predicate device (FlexCath® Steerable Sheath & Dilator, Model 3FC12, K102176). The core of the submission is to demonstrate that the modified device is substantially equivalent to the predicate, meaning it performs as intended and does not raise new questions of safety or effectiveness.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative acceptance criteria with pass/fail values. Instead, it states that "All testing passed" and that the device "meet the established specifications." The reported performance is summarized as successful completion of various tests, demonstrating that the modified device's characteristics were not compromised and that it met design specifications.
| Test Category | Acceptance Criteria (Implicit) | Reported Performance |
|---|---|---|
| Sheath Valve Assembly Leak/Flush | No leakage, proper flushing functionality. | All testing passed. |
| Sheath Shaft Pull Wire Assembly | Proper deflection, system compatibility, no adverse interactions, adequate tensile strength. | All testing passed. |
| Stopper Catheter Sheath | No kinking, proper deflection. | All testing passed. |
| Barrel and Threaded Slider | Maintain deflection, maintain sheath shape. | All testing passed. |
| Shelf Life (12-month accelerated) | Device specifications met, function and mechanical characteristics not compromised. | All testing passed; function and mechanical characteristics not compromised. |
| Biocompatibility | Compliance with ISO 10993-1, USP Class VI; no cytotoxicity, sensitization, irritation, etc. | All test successfully passed. Assessed by supplier, equivalency to tested materials. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes (number of devices) used for each specific test (e.g., how many sheaths were tested for leak, how many for deflection). It mentions "accelerated aging study" for shelf life, implying a sample size was used for that, but the exact number is not provided.
The data provenance is from Medtronic CryoCath LP, Kirkland, Quebec, Canada, and Mounds View, MN, USA. The studies described are retrospective in the sense that they are bench tests conducted on manufactured devices to verify design modifications, rather than prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable here. The studies described are bench tests (mechanical, shelf-life, biocompatibility) rather than clinical studies where expert evaluation of, for example, medical images or patient outcomes would establish a "ground truth." The ground truth for these tests is based on objective measurements against engineering specifications and industry standards.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the tests are objective bench tests against defined specifications, there is no need for expert adjudication. The results are quantitative (e.g., pass/fail for leak, measurement of tensile strength, visual inspection for kink) rather than subjective.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable. The device is a "Steerable Sheath & Dilator," which is a medical instrument used for catheter introduction and positioning. It is not an AI-powered diagnostic or assistive tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. As explained above, this device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for the performance tests described is based on:
- Engineering Specifications: Defined parameters for mechanical performance (e.g., deflection range, tensile strength, leak limits).
- Industry Standards: Compliance with relevant ISO standards (e.g., ISO 10993 for biocompatibility) and FDA guidance.
- Predicate Device Performance: Although not explicitly an "acceptance criterion," the modified device's performance was compared against the known performance of the predicate device to demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The "design verification testing" is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).