(29 days)
The FlexSeal™ Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices and to minimize blood loss associated with such insertions.
The FlexSeal™ Introducer Sheath with Hydrophilic Coating contains the following disposable components:
- o One sterile introducer sheath with an active spring loaded hemostatic valve
- o One sterile radiopaque dilator
The FlexSeal™ Introducer Sheath with Hydrophilic Coating consists of an introducer sheath with hydrophilic coating and a dilator. The devices sizes are 14F, 16F and 18F. Three different lengths (20 cm, 28 cm and 35 cm) are available for each FlexSeal introducer size. An active hemostatic valve is integrated into the sheath.
The provided document describes a medical device called the "FlexSeal Introducer Sheath with Hydrophilic Coating" and outlines its clearance process with the FDA. However, the document does not contain information about AI/ML device performance, acceptance criteria, or a study involving human readers or ground truth determination as would be expected for an AI/ML medical device.
The document is a 510(k) summary for a traditional medical device (an introducer sheath), which is a physical product, not a software algorithm. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific types of ground truth are not applicable to the content provided.
The performance data presented focuses on physical and biocompatibility testing of the introducer sheath, to demonstrate its safety and effectiveness compared to a predicate device.
Here's the information that can be extracted from the document, tailored as closely as possible to your request, but acknowledging the device type:
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like the FlexSeal Introducer Sheath, the "acceptance criteria" are typically defined by engineering specifications and regulatory standards. The reported performance indicates that the device met these criteria.
| Acceptance Criteria (Test Performed) | Reported Device Performance (Results) |
|---|---|
| Visual surface inspection | Meets all specifications |
| Dimensions | Meets all specifications |
| Radiopacity visualization | Meets all specifications |
| Guidewire compatibility | Meets all specifications |
| Hemostasis valve leakage | Meets all specifications |
| Kink resistance | Meets all specifications |
| Bond tensile strength | Meets all specifications |
| Hydrophilic coating integrity | Meets all specifications |
| Luer compliance | Meets all specifications |
| Cracking pressure | Meets all specifications |
| USP particulate test | Meets all specifications |
| Packaging tests | Meets all specifications |
| Distribution tests | Meets all specifications |
| Usability studies | Meets all specifications |
| Biocompatibility: Cytotoxicity | Meets Requirements |
| Biocompatibility: Sensitization | Meets Requirements |
| Biocompatibility: Irritation/Intracutaneous Reactivity | Meets Requirements |
| Biocompatibility: Systemic (Acute) Toxicity | Meets Requirements |
| Biocompatibility: Genotoxicity | Meets Requirements |
| Biocompatibility: Hemocompatibility | Meets Requirements |
| Sterilization (Ethylene Oxide) | SAL 10-5 level achieved |
Regarding the AI/ML-specific questions (2-9):
The provided document describes a physical medical device (introducer sheath), not an AI/ML algorithm. Therefore, the following points are not applicable and cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not applicable for a physical device where "test set" refers to physical samples tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an introducer sheath's physical properties is established by engineering standards and validated lab tests, not expert consensus on data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 does not involve human readers interpreting data with/without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical tests, the "ground truth" is defined by the technical specifications and accepted standards for each test (e.g., a specific tensile strength value, a certain level of hemocompatibility).
- The sample size for the training set: Not applicable. There is no AI/ML training set for this device.
- How the ground truth for the training set was established: Not applicable. There is no AI/ML 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).