(210 days)
The GORE® DrySeal Sheath with hydrophilic coating is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
The GORE® DrySeal Sheath consists of a hydrophilic coated introducer sheath with GORE® DrySeal Valve attached, a dilator, and a syringe.
The introducer sheath is a polyethylene tube with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath has an insert molded hub on the trailing end, which is attached to the GORE® DrySeal Valve.
The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5mL of saline into the space, using the provided syringe, during procedural preparation of the device.
The dilator has a tapered leading end and provides dilatation of the access vessel. A mark on the trailing end of the dilator ensures correct positioning of the dilator within the sheath.
The GORE® DrySeal Sheath with hydrophilic coating, referenced in K121234, is an introducer sheath designed to provide a conduit for endovascular devices while minimizing blood loss. The primary modification from the predicate device (K093791) is the addition of a hydrophilic coating. The study primarily focuses on demonstrating substantial equivalence to the predicate device, with a particular emphasis on the performance of the new hydrophilic coating.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria with numerical targets. Instead, it relies on demonstrating that the device meets the requirements of applicable standards and performs as designed and comparably to the predicate device.
| Test/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of ANSI/AAMI/ISO 10993 | "Results for all biocompatibility testing demonstrate that the materials used meet the requirements of ANSI/AAMI/ISO 10993." (All individual tests listed as "Pass") |
| Cytotoxicity | Pass MEM Assay (qualitative) | Pass |
| Sensitization | Pass Murine Local Lymph Node Assay | Pass |
| Intracutaneous Reactivity | Pass Intracutaneous Irritation Test | Pass |
| Acute Systemic Toxicity | Pass Acute Systemic Study in Mice | Pass |
| Hemocompatibility | Pass Complement Activation, Hemolysis Assay, In vivo Thrombogenesis, Prothrombin Time Assay | Pass |
| Pyrogenicity | Pass Rabbit Pyrogen Test | Pass |
| Sterilization Validation | Meets requirements of ANSI/AAMI/ISO 11135-1, AAMI TIR 28 | Tests were performed and found to confirm equivalence to the predicate device. |
| Packaging Integrity | Demonstrated integrity | Tests were performed and found to confirm equivalence to the predicate device. |
| Product Shelf-Life | Demonstrated shelf-life | Tests were performed and found to confirm equivalence to the predicate device. |
| Design Verification | Meets specified performance criteria | "The proposed device meets the performance criteria of design verification as specified by test protocols." |
| Lubricity | Comparable to predicate device; performs as designed | "The results demonstrate that the lubricity of the GORE® DrySeal Sheath with hydrophilic coating performs as designed, is suitable for its intended use, and that it is substantially equivalent to the predicate device." |
| Particulation | Comparable to predicate device | Comparative analysis performed. |
| Overall Substantial Equivalence | No new issues of safety and efficacy compared to predicate | "Any differences in the technological characteristics do not raise any new issues of safety and efficacy." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each test. The studies appear to be laboratory-based and conducted by W. L. Gore & Associates, Inc. The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from internal company testing. The studies are not clinical trials and thus the terms "retrospective" or "prospective" do not directly apply in the usual clinical sense. These are pre-market device verification and validation tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a 510(k) submission for a device like an introducer sheath undergoing mechanical and biological testing. The "ground truth" for these tests is established by adhering to recognized international standards (e.g., ISO, AAMI) and internal test protocols, not by expert medical consensus on individual cases. The expertise lies in the engineers and scientists conducting and evaluating the tests against these standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. Performance is assessed against pre-defined success/failure criteria based on established standards and design 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
Not applicable. This is not an AI-enabled device or a diagnostic device involving human interpretation where MRMC studies would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI-based device. The device itself is evaluated for its physical and biological performance characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria is based on:
- International Standards: e.g., ANSI/AAMI/ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135-1 for sterilization.
- Comparative Analysis: Ensuring the new device's performance (e.g., lubricity, particulation) is equivalent to or better than the legally marketed predicate device (K093791).
- Design Specifications: Meeting internal design verification protocols ("The proposed device meets the performance criteria of design verification as specified by test protocols.").
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device would refer to its design and engineering development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI/ML algorithm.
§ 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).