(78 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 this device for neural placements.
The modified 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 modified AuST Steerable Sheath includes a longer catheter shaft, longer dilator, longer hydrophilic coating, modified hemostatic valve, and modified packaging.
The modified 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.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
The provided document is a 510(k) summary for a medical device (AuST Steerable Sheath) and does not describe a study involving an AI algorithm or human readers. It details the premarket notification process for a physical medical device, not a software or AI-driven diagnostic tool. Therefore, many of the requested points, such as expert consensus, MRMC studies, standalone algorithm performance, training set details, and specific performance metrics like sensitivity/specificity, are not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence of a modified physical device to a previously cleared predicate device, rather than proving a diagnostic algorithm's performance.
Below is the information that can be extracted from the provided text, primarily focusing on the performance criteria for the device itself rather than AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical medical device (catheter introducer) and not an AI algorithm, the "acceptance criteria" are generally that the device passes specific engineering and safety tests, and performs as intended. Specific quantitative acceptance values are not always explicitly stated in this type of summary but are implied by meeting standard requirements.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 | All test results met the requirements of ISO 10993-1, demonstrating no adverse biocompatibility risks. |
| Sterilization | ANSI/AAMI/ISO 11135 | Passed sterilization validation. |
| Packaging Integrity | ANSI/AAMI/ISO 11607-1 | Passed packaging validation. |
| Visual Inspection | - | Passed visual inspection. |
| Simulated Use/Compatibility | - | Passed simulated use testing, including use/compatibility with ancillary devices. |
| Deflection | - | Passed deflection verifications (Bi-directional, 180 Degrees). |
| Valve Functionality | - | Passed valve liquid/air leak test. |
| Mechanical Strength | - | Passed tensile tests. |
| Dimensional Accuracy | - | Passed sheath and dilator dimensional verification, including OD/ID, working length, and curl diameter. |
| Dilator Removal Force | - | Passed dilator removal force test. |
| Flush Functionality | - | Passed flush test. |
| Torque Performance | - | Passed torque test. |
Regarding AI-specific questions (2-9):
The provided document is a 510(k) premarket notification for a physical medical device (AuST Steerable Sheath), which is a catheter introducer. It does not describe an AI algorithm or a diagnostic study involving AI. Therefore, the following points are not applicable (N/A) to this document:
- Sample size used for the test set and the data provenance: N/A (Not an AI study)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI study)
- Adjudication method for the test set: N/A (Not an AI study)
- 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: N/A (Not an AI study)
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI study)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Not an AI study)
- The sample size for the training set: N/A (Not an AI study)
- How the ground truth for the training set was established: N/A (Not an AI study)
The performance data listed in the document (Section 1.7) refers to the physical and functional aspects of the steerable sheath itself, not the performance of an AI system.
§ 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).