(26 days)
The Destination Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.
The Destination® Carotid Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Carotid Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (dilator retaining clip is only available with codes containing the touhy-borst valve).
This document is a 510(k) summary for the Destination® Carotid Guiding Sheath, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against predefined acceptance criteria for a novel AI device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI-specific details cannot be extracted from this document.
However, I can extract information relevant to the performance section as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as a numerical threshold for a novel AI/diagnostic device. | Substantially equivalent to the predicate device (Carotid Guiding Sheath cleared under K012812). Equivalence shown through bench and cadaver testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified, but the testing involved "bench and cadaver testing." This suggests a mix of laboratory and pre-clinical data. No mention of human clinical data or country of origin.
- Retrospective or Prospective: Not indicated.
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 as this is not a diagnostic AI device requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This document describes physical device testing.
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 device is a guiding sheath, 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 not an algorithm. The device "is operated manually or by a manual process."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense for an AI device. The "ground truth" here would relate to the successful performance of the device in bench and cadaver testing, likely against established engineering and physiological parameters for catheter introducers.
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI 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).