(73 days)
The GORE Introducer Sheath is used to facilitate the introduction of guidewires, catherers and other investible medical devices with such introduction.
The GORE Introducer Sheath is designed to provide easy access to the vascular system while providing convenient access to che vaborfally The device allows introduction of angiographic exchanges . catheters, balloon catheters, other relevant catheters, guidewires and endovascular devices into a vessel. The gardewired and theath is composed of biocompatable materials and is provided sterile.
The GORE Introducer Sheath is comprised of the introducer file Gox introducer The introducer sheath is composed of a sheath, sheath hub and cap, and hemostasis valve. The dilator is composed of a dilator tube and dilator valve body .
This is a regulatory submission for a medical device (GORE® Introducer Sheath) seeking substantial equivalence to a predicate device. As such, it does not contain the type of study data and acceptance criteria typically found for diagnostic algorithms or AI-driven devices.
The document states that the GORE® Introducer Sheath is substantially equivalent to a predicate device (FAST-CATH™ Hemostasis Introducer) based on:
- The same manufacturing process
- The same biocompatible materials
- The same quality specifications
- The same packaging materials and process
- The same sterilization process
- Similar indications for use
Therefore, the submission relies on demonstrating similarity to an already approved device rather than presenting new performance data against specific acceptance criteria.
To directly answer your request based only on the provided text, many of the requested fields cannot be filled as they are not relevant to this type of 510(k) submission.
Here's a breakdown of what can and cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission doesn't present performance data against specific acceptance criteria for a new device's efficacy, but rather asserts substantial equivalence to a predicate device based on manufacturing, materials, and process similarities.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance
Not applicable. No "test set" in the context of a performance study is mentioned. The submission is based on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by experts is described as this is not a diagnostic device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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 or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is established or discussed as this is a device based on substantial equivalence.
8. The sample size for the training set
Not applicable. There is no training set mentioned for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth establishment mentioned.
§ 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
(a)
Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.