(86 days)
Indicated for use in ambulatory phlebectomy procedures for resection and ablation of varicose veins.
The Smith & Nephew TriVex™ System consists of a control unit mounted on a pedestal stand, dual peristaltic pumps, an illuminator, resector handpiece and footswitches.
The Smith & Nephew TriVex™ System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Biocompatibility requirements (ISO 10993-1) | Meets biocompatibility requirements. |
| Electrical safety standards for BF type equipment (UL 60601-1 and IEC 60601-1) | Meets electrical safety standards. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Substantial Equivalence to Predicate Devices | The device is deemed "substantially equivalent in Intended Use and Fundamental Scientific Technology" and "substantially equivalent in design, materials, function and intended use" to the predicate devices: Dyonics® Varicose Vein Ablation System (K990723), Subcutaneous Illuminator (K991323), Smith & Nephew Xenon Light Source (K994084), and H.K. Surgical Klein Pump (K012044). No specific numerical performance metrics are provided for the TriVex system's efficacy in vein ablation or resection beyond this statement of equivalence. |
2. Sample Size and Data Provenance for Test Set:
The provided document does not contain any information about sample sizes for a test set or the provenance of any clinical data (e.g., country of origin, retrospective or prospective). The submission primarily focuses on substantial equivalence based on technological characteristics and safety standards.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
This information is not provided in the document. As no clinical test set performance data is detailed, information about experts for ground truth establishment is absent.
4. Adjudication Method for Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention or describe any MRMC comparative effectiveness study comparing human readers with and without AI assistance. This device is not an AI-powered diagnostic system; it's a surgical tool.
6. Standalone (Algorithm Only) Performance Study:
The document does not describe any standalone algorithm performance, as the device is a physical surgical system, not an algorithm.
7. Type of Ground Truth Used:
Based on the provided text, the "ground truth" for the device's acceptance is based on its compliance with established safety and biocompatibility standards (ISO 10993-1, UL 60601-1, IEC 60601-1) and its substantial equivalence to existing legally marketed predicate devices in terms of intended use, design, materials, and function. There is no mention of clinical outcome ground truth in a study.
8. Sample Size for Training Set:
This information is not applicable and not provided. The TriVex™ System is a medical device, not an AI model requiring a training set in the conventional sense. Its "training" would be through engineering design, material selection, and manufacturing processes, guided by established standards and predicate device characteristics, not data-driven machine learning.
9. How Ground Truth for Training Set Was Established:
This information is not applicable and not provided. The "ground truth" for the development of such a device stems from engineering principles, regulatory compliance requirements, and the established safety and efficacy of the predicate devices it aims to be equivalent to.
In summary:
The acceptance of the Smith & Nephew TriVex™ System by the FDA, as indicated by the 510(k) clearance (K032387), is based on its demonstration of substantial equivalence to existing predicate devices and its compliance with relevant biocompatibility and electrical safety standards. The submission focuses on these aspects rather than detailed clinical performance studies with specific patient or image-based test sets, which are typically required for diagnostic algorithms or novel therapeutic devices requiring extensive clinical validation.
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).