(89 days)
The Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.
The Renal Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque marker and is hydrophilically coated on the distal 5 cm. It comes packaged with a dilator, a rotating hemostatic valve (or a detachable hemostatic valve), and a dilator retaining clip.
This document describes a medical device, the "Renal Guiding Sheath," and its submission for FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device, not on AI/algorithm performance. Therefore, many of the requested fields related to AI, ground truth, and expert evaluation are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Tests) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Penetration | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Kink Resistance | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Leakage | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Tensile Strength | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Tortuous Path / Durability | Substantially equivalent to Super Arrow-Flex Percutaneous Sheath Introducer Set |
| Sterility Assurance Level (SAL) | 10^-6 (validated according to ANSI / AAMI / ISO 11135-1994) |
| Biocompatibility | Blood contacting materials found to be biocompatible (tested in accordance with FDA General Program Memorandum #G95-1 / ISO 10993) |
| Expiration Dating | 30 months |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify sample sizes for each performance test. The data provenance is not mentioned beyond the fact that tests were performed to demonstrate substantial equivalence. It is likely internal testing without country-of-origin specification, and it is implied to be prospective testing (performance evaluations of the new device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical instrument, not an AI or diagnostic algorithm that requires expert-established ground truth for its performance evaluation in this context. The performance tests are engineering and biological evaluations.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or clinical cases to establish ground truth for AI algorithms. For physical device performance tests, standards and objective measurements are used.
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 document describes a physical medical device, not an AI system. Therefore, no MRMC study or AI assistance effect size is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, so standalone performance is not relevant.
7. The Type of Ground Truth Used
For the performance tests:
- Engineering Standards / Objective Measurements: For tests like Penetration, Kink Resistance, Leakage, Tensile Strength, and Tortuous Path / Durability, the "ground truth" would be the successful adherence to pre-defined engineering specifications and measurable performance within acceptable limits, often compared directly to the predicate device's measured performance.
- Validated Standards: For sterilization, the ground truth is established by validation against ANSI / AAMI / ISO 11135-1994 to achieve a specified SAL.
- Biocompatibility Standards: For biocompatibility, the ground truth is conformity with test recommendations in FDA General Program Memorandum #G95-1 (ISO 10993).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a physical device, not an AI algorithm.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).