(36 days)
The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal and other peripheral placements. Do not use for neural placements.
The AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements.
The AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bidirectional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.
This looks like a 510(k) summary for a medical device. Based on the provided text, the device is a Catheter Introducer called the AuST Steerable Sheath.
Here's the analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of specific quantitative acceptance criteria for each performance test (e.g., "Tensile strength must be > X N"). Instead, it states that the device "passed" a series of tests. Therefore, the table below will list the tests performed and the reported outcome.
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility testing (per ISO 10993-1:2023) | Passed |
| Sterilization validation (per ANSI/AAMI/ISO 11135) | Passed |
| Packaging validation (per ANSI/AAMI/ISO 11607-1) | Passed |
| Visual Inspection | Passed |
| Simulated use testing (with ancillary devices) | Passed |
| Deflection verifications | Passed |
| Valve liquid leak test | Passed |
| Tensile tests | Passed |
| Sheath and Dilator Dimensional verification (OD/ID, working length, curl diameter) | Passed |
| Dilator removal force | Passed |
| Flush test | Passed |
| Torque test | Passed |
2. Sample size used for the test set and the data provenance:
The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the individual tests.
Regarding data provenance: The studies are laboratory-based performance tests of the device itself, not human subject data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" don't directly apply in the usual clinical study sense. The testing would have been conducted by the manufacturer (CenterPoint Systems LLC) or a contract lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided for this type of device submission. The "ground truth" for catheter introducers is typically established by engineering specifications, international standards, and performance test methods, not by expert consensus on clinical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable for this type of device and testing. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, where disagreements among experts need resolution. For physical device performance tests, the outcome is determined by objective measurements against predefined specifications.
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:
This is not applicable. The AuST Steerable Sheath is a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness analysis would not be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is not an algorithm or software. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests of the AuST Steerable Sheath is based on engineering specifications, recognized international and national standards (e.g., ISO 10993-1, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 11607-1), and the intended function of the device. For example, for a "Tensile test," the ground truth is a specific force value or range that the device must withstand without failure, as defined by its design and relevant standards.
8. The sample size for the training set:
This is not applicable. The device is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This is not applicable. There is no training set for this 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).