(181 days)
The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.
The Sentrant Introducer Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments.
The dilator is radiopaque and has a flexible tapered tip that facilitates atraumatic tracking through the vasculature. There is a dilator grip at the proximal end of the dilator shaft. The dilator grip has a female Luer taper fitting on the proximal end to allow flushing of the device, and a threaded-feature at the distal end to allow the dilator to be secured to the sheath seal housing (dilator locking mechanism).
The introducer sheath is comprised of a hydrophilic-coated, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension assembly with a 3-way valve is attached to the seal housing. A radiopaque (RO) marker band is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.
The provided text is a 510(k) summary for the Medtronic Sentrant Introducer Sheath with Hydrophilic Coating. This document describes the device and its equivalence to a predicate device, but it does not contain information about acceptance criteria and a study proving a specific device performance metric meets those criteria. Instead, it outlines a series of non-clinical performance tests conducted to demonstrate general safety and effectiveness for substantial equivalence to a predicate device, which had a different sterilization method.
Therefore, many of the requested details about acceptance criteria, reported device performance (in terms of specific clinical or technical metrics for an AI/device performance study), sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
The document states that "All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence" for the following non-clinical performance data. It does not provide specific numerical acceptance criteria or quantitative performance results for each test.
| Test Performed | Reported Device Performance (General Statement) |
|---|---|
| Design Verification Testing | Predetermined acceptance criteria met; results passed to support substantial equivalence. |
| Sterilization Validation | Predetermined acceptance criteria met; results passed to support substantial equivalence. |
| Biocompatibility Testing | Predetermined acceptance criteria met; results passed to support substantial equivalence. |
| Packaging Design Verification | Predetermined acceptance criteria met; results passed to support substantial equivalence. |
| Shelf Life Testing | Predetermined acceptance criteria met; results passed to support substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document does not describe specific "test sets" in the context of clinical performance or algorithm evaluation with data provenance. The tests listed are non-clinical (e.g., sterilization, packaging, biocompatibility).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes non-clinical tests, not expert-adjudicated ground truth for a clinical dataset.
4. Adjudication method for the test set
Not applicable. The document describes non-clinical 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
No. This document does not pertain to an AI-assisted device or a multi-reader multi-case study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe an algorithm or AI performance.
7. The type of ground truth used
Not applicable in the context of clinical accuracy or algorithm performance. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards and methods for validating those specific device characteristics (e.g., ISO standards for sterilization, biocompatibility, packaging).
8. The sample size for the training set
Not applicable. The document does not describe an AI or machine learning model with a training set.
9. How the ground truth for the training set was established
Not applicable. The document does not describe an AI or machine learning model with a training set.
§ 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).