(238 days)
Like other, commercially available vascular irrigation sets and intravascular administration sets, the GORE irrigation system is intended to irrigate vascular tissue intraoperatively.
This includes use of the GORE irrigation system to infuse sterile irrigant solution into a vein to allow visualization of the valve destruction process during vein preparation for in-situ vascular bypass.
The GORE irrigation system is composed of biocompatible plastics consistent with those used in other commercially available irrigation systems and intravascular administration sets. All tissue and fluid-path materials will be documented as suitable for intended use per international standards and FDA guidances, prior to commercial distribution and clinical use.
The GORE irrigation system consists of a valve controller, tubing with introducer sheaths, and connections for infusion and drainage of irrigant solution into and from the clamped vein.
Here's the information regarding the acceptance criteria and study as requested, based on the provided text:
Important Note: The provided document is a 510(k) Premarket Notification Summary for the GORE Irrigation System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical trial data with detailed acceptance criteria and performance metrics against a pre-defined ground truth in the way a new, high-risk device might. Therefore, many of the requested points will not be explicitly found in this document. The responses below reflect what can be inferred or explicitly stated from this specific type of regulatory submission.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials suitable for intended use. | "All tissue and fluid-path materials will be documented as suitable for intended use per international standards and FDA guidances, prior to commercial distribution and clinical use." Also states, "As the same types of biocompatible plastics used in other irrigation sets will be used in the GORE irrigation set, and all materials used in the GORE irrigation set will be appropriately characterized and tested for biocompatibility, no new issues regarding materials are raised by the GORE device." |
| Technological Characteristics: Operates similarly to predicate devices; no new issues regarding use. | "As the GORE irrigation set operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for in-situ bypass, there are no new issues regarding the technological characteristics or use of the GORE device." And again, "As the GORE irrigation set is structured similarly and operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for in-situ bypass, there are no new issues regarding the technological characteristics or use of the GORE device." |
| Intended Use: Irrigation of vascular tissue intraoperatively for visualization during vein preparation for in-situ vascular bypass. | The stated intended use directly matches this criterion. The FDA letter confirms the device is "substantially equivalent (for the indications for use stated in the enclosure)." |
| Safety and Effectiveness: Demonstrate requisite structural, biocompatibility, and mechanical characteristics to function safely and effectively. | "This extensive clinical history demonstrates that GORE is capable of ensuring that its devices possess the requisite structural, biocompatibility and mechanical characteristics to function safely and effectively." (Referring to GORE-TEX Medical Products generally, not specific to this device's clinical study). |
Study Details (Based on available information in a 510(k) Summary)
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Sample size used for the test set and the data provenance:
- This document does not describe a "test set" in the context of a performance study with a specific sample size. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive new clinical data with a dedicated test set.
- Data provenance is not applicable for a traditional test set as no such study is described. The rationale for equivalence is based on material commonality and operational similarity to existing devices.
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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 for a test set is described, as the submission focuses on substantial equivalence based on design, materials, and intended use.
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Adjudication method for the test set:
- Not applicable. No test set requiring expert adjudication is described in the document.
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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:
- Not applicable. This device is a physical irrigation system, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm, so standalone algorithm performance is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this 510(k) submission, the "ground truth" for acceptance is primarily the established safety and effectiveness of the predicate devices and the GORE Irrigation System's similarity to them in materials, design, and intended use. Biocompatibility testing documentation is mentioned as a component.
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The sample size for the training set:
- Not applicable. This document does not describe a machine learning model or a training set.
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How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned in this regulatory document.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.