(135 days)
The steerable guiding sheath, model Adelante Destino is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
The steerable guiding sheath, model Adelante® Destino, is designed to assist with the introduction of intravascular devices into the heart using a steerable feature to provide better maneuverability and easier access to hard-to-reach places in the heart. On the steerable handle there is a side port for aspiration and flushing. The guiding sheath comprises of: shaft, steerable handle and side port. The dilator is included with each sheath.
The provided text describes a 510(k) submission for the Adelante® Destino steerable guiding sheath. This document focuses on demonstrating substantial equivalence to predicate devices through functional and performance testing, rather than a clinical study evaluating AI performance or human reader improvement. Therefore, many of the requested points, such as AI-specific sample sizes, expert qualifications for ground truth in AI, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
| Test Name/ Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sheath visual and dimensional test | Visual and dimensional specifications and requirements for the Destino sheath must be met. | Pass |
| Pull test of sections test | Joints must withstand a pull force of 15 N or 3.37 lbf. | Pass |
| Sheath hub bond test | Sheath to hub joint must withstand a pull force of 15 N or 3.37 lbf. | Pass |
| Freedom from air leakage test | Sheath must not leak prior to and after the insertion of the dilator and a catheter/device. | Pass |
| Kink and roll test | The device should be free of any kinks and bends (before and after dilator removal). The sheath body sections must be smooth, properly bonded, and free from damages after the roll test. | Pass |
| Deflection and handle test | Assembled sheath should deflect 180 degrees in one direction and 90 degrees in the other direction. Sheath should move less than 20 degrees total after introducing test piece ten times. Lock should not break or the handle should not separate throughout the entire test. | Pass |
| Sheath thermal shock test | After testing, there shall be no discoloration, broken/frayed tubing, cracked split caps, or any other constructional defects or signs of degradation due to testing. | Pass |
| Dilator visual and dimensional test | Visual and dimensional specifications and requirements for the Destino dilator must be met | Pass |
| Sheath and dilator fit, functionality, and transition test | The hubs shall have a female 6% (Luer) taper conical fitting for syringes. The sheath must allow the insertion of a 8F (maximum) device. The dilator must be able to snap/lock into the sheath hub. There must be a smooth tapered transition between the sheath and dilator tips. The tips must have a radius free from sharp edges or damages. Any gap between the dilator and sheath must be less than 1 mm. | Pass |
| Device insertion and withdrawal test | The sheath/dilator tips, as well as the device, must be without damages after the Seldinger method. | Pass |
| Dilator thermal shock test | After testing, there shall be no discoloration, broken/frayed tubing, cracked split caps, or any other constructional defects or signs of degradation due to testing. | Pass |
| EtO residual levels testing | EtO residuals must be within limits | Pass |
| Bioburden testing | Bioburden levels must be within limits | Pass |
| Endotoxins testing | Endotoxins (LAL) levels must be within limits | Pass |
| Product sterility testing | Product must remain sterile | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes used for each functional and performance test.
- The data provenance is not specified beyond indicating "Functional and performance testing was conducted." This implies in-house laboratory testing, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for these engineering performance tests would be established by the test procedures and objective metrics, not by expert consensus in a clinical context.
4. Adjudication method for the test set:
- Not applicable. These are objective engineering tests with defined acceptance criteria.
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 510(k) submission for a medical device (steerable guiding sheath), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- The ground truth for the functional and performance tests is derived from established engineering and manufacturing specifications and test standards. These are objective, measurable outcomes.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI algorithm.
In summary: The submission for the Adelante® Destino describes a set of engineering and performance tests to demonstrate the safety and effectiveness of the device against predefined acceptance criteria. All tests passed, supporting the claim of substantial equivalence to predicate devices. The document does not involve AI, human reader studies, or clinical data.
§ 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).