(84 days)
The VenaCure EVLT NeverTouch Direct Introducer Sheath is indicated for use with VenaCure EVLT NeverTouch Direct Kit to introduce the laser fiber into the peripheral vasculature
The proposed VenaCure EVLT NeverTouch Direct Introducer Sheath is currently provided in the VenaCure EVLT NeverTouch Direct Procedure Kits as a kit accessory as a legally marketed device covered under the manufacturers 510(k). The kit consists of a laser fiber, introducer sheath, entry needle, and a guidewire. The VenaCure EVLT NeverTouch Direct Procedure kit is used to treat patients with varicose veins via endovascular coagulation by dispersing energy from a diode laser directly into the vein being treated. The Introducer Sheath is used to introduce the laser fiber into the vein.
The provided document is a 510(k) premarket notification for a medical device (VenaCure EVLT NeverTouch Direct Introducer Sheath). It is a regulatory submission focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a traditional clinical study with a human-in-the-loop AI system.
Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample size for test sets in an AI study, expert ground truth establishment, MRMC studies, standalone AI performance, training set details) are not applicable to this document. This document describes bench testing for physical and biocompatibility properties of a conventional medical device.
However, I can extract and restructure the relevant information present in the document in a way that approximates the requested format where possible, and clearly state when information is not available or not applicable.
Device: VenaCure EVLT NeverTouch Direct Introducer Sheath
Regulatory Pathway: 510(k) Premarket Notification (demonstrates substantial equivalence to a predicate device)
Study Type: Non-clinical bench testing to demonstrate physical and biological equivalence, not an AI performance study.
1. Table of Acceptance Criteria (for physical/biological properties) and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance/Result |
|---|---|
| Sheath Dimensional Testing | Confirms compliance with specifications, supports substantial equivalence |
| Dilator Dimensional Testing | Confirms compliance with specifications, supports substantial equivalence |
| Luer Fitting ISO Compliance | Confirms compliance with ISO standards, supports substantial equivalence |
| Tensile Testing | Confirms compliance with specifications, supports substantial equivalence |
| Sheath Leakage | Confirms compliance with specifications, supports substantial equivalence |
| Hemostasis Valve Leakage | Confirms compliance with specifications, supports substantial equivalence |
| Biocompatibility (per ISO 10993-1, -4, -5, -10, -11, -12, USP) | Conforms to recognized ISO and USP standards for biological evaluation |
| Sterilization/Microbiological (per ISO 10993-7, 11135, etc.) | Conforms to recognized ISO and AAMI standards for sterilization and microbiological control |
| Packaging (per ISO 11607-1, 11607-2, ASTM F 88, etc.) | Conforms to recognized ISO and ASTM standards for packaging integrity and sterility maintenance |
Note: The document states "This testing supports substantial equivalence of the proposed device to the predicate device as it confirms that both meet the same specifications," but does not provide specific numerical acceptance criteria or performance values in this summary. It indicates that the device "conforms to" various standards.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each bench test. Standard medical device bench testing often involves a defined number of units, but the specific quantity isn't detailed in this summary.
- Data Provenance: N/A. This is bench testing of manufactured devices, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of Experts
- N/A. Ground truth in the context of an AI study (e.g., image annotations) is not applicable here. Performance is based on engineering specifications and adherence to recognized standards for physical and biological properties.
4. Adjudication Method for the Test Set
- N/A. Adjudication is relevant for ambiguous cases in human expert review or AI ground truth establishment. This is physical/biological testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not a study involving human readers or AI assistance. It's a submission for a physical medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is an introducer sheath, not an algorithm or AI system.
7. The Type of Ground Truth Used
- N/A / Engineering Specifications & Regulatory Standards. The "ground truth" for this device's performance is adherence to established engineering specifications (e.g., dimensions, tensile strength, leakage rates) and compliance with recognized international standards for biocompatibility, sterilization, and packaging (e.g., ISO, AAMI, ASTM, USP).
8. The Sample Size for the Training Set
- N/A. No training set is applicable as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
- N/A. Not applicable as there is no training set for an AI/machine learning model.
§ 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).