(84 days)
The Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the carotid arteries.
The Carotid 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 15 cm. It comes packaged with a dilator, a rotating hemostatic valve (Y-connector), and a dilator retaining clip.
The provided document describes the safety and effectiveness of the Carotid Guiding Sheath. It is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial for a novel AI device would.
Therefore, many of the requested fields cannot be directly extracted from this type of regulatory submission. This document describes a medical device (a guiding sheath), not an AI/algorithm-based diagnostic device.
However, I can extract the relevant information regarding performance and equivalence.
Acceptance Criteria and Device Performance Study (as per the 510(k) document for a medical device)
This 510(k) submission demonstrates substantial equivalence to a predicate device, the Super Arrow-Flex Percutaneous Sheath Introducer Set (K924607), manufactured by Arrow International, Inc., by showing that the Carotid Guiding Sheath performs similarly. The acceptance criteria are implicit in matching the performance characteristics of the predicate device for safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Note: For medical devices in a 510(k), "acceptance criteria" are typically defined by meeting established performance benchmarks or demonstrating equivalence to a predicate device's performance. The "reported device performance" is the results of tests aimed at demonstrating this equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit: Equivalent to Predicate Device) | Reported Device Performance (Carotid Guiding Sheath) |
|---|---|---|
| Penetration | Must demonstrate comparable penetration characteristics to the predicate device. | Performed to demonstrate substantial equivalence to the predicate device. |
| Kink Resistance | Must demonstrate comparable kink resistance to the predicate device. | Performed to demonstrate substantial equivalence to the predicate device. |
| Leakage | Must demonstrate comparable leakage characteristics to the predicate device. | Performed to demonstrate substantial equivalence to the predicate device. |
| Tensile Strength | Must demonstrate comparable tensile strength to the predicate device. | Performed to demonstrate substantial equivalence to the predicate device. |
| Tortuous Path / Durability | Must demonstrate comparable durability and performance in tortuous paths to the predicate device. | Performed to demonstrate substantial equivalence to the predicate device. |
| Sterility | Sterility Assurance Level (SAL) of 10-6 in accordance with ANSI / AAMI / ISO 11135-1994. | Validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide an SAL of 10-6. |
| Biocompatibility | Blood contacting materials must be biocompatible as per FDA G95-1 (ISO 10993). | Blood contacting materials found to be biocompatible in accordance with FDA G95-1 (ISO 10993). |
| Expiration Dating | Established shelf-life for safe and effective use. | 30 months. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document refers to "the following tests were performed," implying specific test methods were used for each characteristic, but not a patient or human-subjects test set. These are likely in vitro or bench tests.
- Data Provenance: Not applicable. The tests are device performance tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This document describes a physical medical device (guiding sheath) and its engineering performance tests, not an AI/algorithm-based diagnostic device requiring expert ground truth for imaging or clinical outcomes. The "ground truth" here is the physical measurement or outcome of the bench test (e.g., whether the device kinks, leaks, or breaks at a certain force).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is not a clinical study involving human readers or interpretation of results. Results are likely determined by objective measurements from engineering tests.
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 physical medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Test Results / Engineering Standards: The "ground truth" for the performance tests (Penetration, Kink Resistance, Leakage, Tensile Strength, Tortuous Path / Durability) would be the objective measurements obtained during the execution of standardized engineering tests, compared against the performance of the predicate device or established specifications. For biocompatibility and sterilization, the ground truth is compliance with specific international standards (ISO 10993, ISO 11135-1994).
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As above, there is no training set for a physical medical device.
§ 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).