(102 days)
The GORE DrySeal Sheath 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 an 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.
Here's an analysis of the provided text regarding the GORE DrySeal Sheath, focusing on acceptance criteria and the supporting study information.
It's important to note that this document is a 510(k) Summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or effectiveness through extensive clinical trials. Therefore, the "study" referred to will be primarily bench testing (in-vitro performance and biocompatibility) rather than a clinical study in the traditional sense of comparing outcomes or measuring human reader performance.
Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" alongside specific numerical results. Instead, it states that "In-vitro design verification testing data demonstrate that the device is in compliance with ISO 11070 Sterile, single use intravascular catheter introducers and product labeling." and "The testing demonstrated acceptable results." for various tests.
Therefore, the acceptance criteria are implicitly defined as meeting the requirements of ISO 11070 and internal procedures for each test, and the reported device performance is simply that all tests yielded "acceptable results."
Here's the table based on the provided information:
Table 1: Acceptance Criteria and Reported Device Performance for GORE DrySeal Sheath
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sheath Working Length | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Dilator Length | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Guidewire Compatibility | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Sheath Tip to Dilator Transition | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Sheath/Valve Assembly Length | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Dimensional Compatibility with Devices | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Radiodetectability | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Tortuosity | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Kink Resistance | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Force at Break | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Strength of Union | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Removal Force | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Freedom from Leakage | Compliance with ISO 11070 and/or internal procedures | Acceptable |
| Cytotoxicity | Compliance with ISO 10993 requirements | Met requirements |
| Sensitization | Compliance with ISO 10993 requirements | Met requirements |
| Intracutaneous Toxicity | Compliance with ISO 10993 requirements | Met requirements |
| Systemic Toxicity | Compliance with ISO 10993 requirements | Met requirements |
| Hemocompatibility | Compliance with ISO 10993 requirements | Met requirements |
| Hemolysis | Compliance with ISO 10993 requirements | Met requirements |
| Prothrombin Time | Compliance with ISO 10993 requirements | Met requirements |
| Complement Activation | Compliance with ISO 10993 requirements | Met requirements |
| Thrombogenicity | Compliance with ISO 10993 requirements | Met requirements |
| Pyrogenicity | Compliance with ISO 10993 requirements | Met requirements |
Study Details
Based on the provided text, here's a breakdown of the study information:
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Sample size used for the test set and the data provenance:
- Sample Size: Design Verification testing was conducted on "the 12 Fr and 26 French Size sheaths." This indicates at least these two sizes were tested. The exact number of units/samples per size tested for each specific benchmark test (e.g., how many sheaths were subjected to "Force at Break" testing) is not specified in this summary.
- Data Provenance: The tests are described as "in-vitro testing" and "Bench / Performance Data." This means the data was generated in a laboratory setting, not from human or animal subjects. The country of origin of the data is not specified, but the manufacturer (W. L. Gore & Associates, Inc.) is based in the USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission and study. The "ground truth" for these tests (e.g., whether a sheath conforms to a specific length, or if a material is cytotoxic) is established by adherence to documented ISO standards and internal procedures, using calibrated laboratory equipment and trained technicians, not by expert consensus in interpretation.
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Adjudication method for the test set:
- This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or when interpreting subjective image data where expert consensus is needed to establish a definitive diagnosis or outcome. Here, the results are objective measurements against defined standards.
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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, an MRMC comparative effectiveness study was not done. This device is an introducer sheath, a physical medical device, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this product or its evaluation as described in this 510(k) summary.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. As mentioned, this is a physical medical device, not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests (e.g., sheath length, kink resistance) is defined by objective measurements and adherence to ISO standards (e.g., ISO 11070) and internal test protocols.
- For biocompatibility tests, the ground truth is established by conformance to ISO 10993 standards, which involve specific laboratory assays (e.g., cell culture for cytotoxicity, animal models for sensitization/toxicity).
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The sample size for the training set:
- This is not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" in the context of its development and evaluation as described here.
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How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this type of 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).