(126 days)
The LeMills Valvulotome is intended to cut venous valves.
The LeMills Valvulotome consists of small metal retrograde cutting blade with atraumatic distal edge. The blade is a part of a long section of wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.
The LeMills Valvulotome is a medical device designed to cut venous valves. The provided text is a 510(k) summary for its clearance.
Here's an analysis of the provided information, specifically addressing the requested points:
K132047: LeMills Valvulotome
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document references "product performance requirements of the device specifications" and "Summary of Product Testing," but it does not explicitly list quantitative acceptance criteria or detailed reported performance values. Instead, it focuses on demonstrating substantial equivalence to a pre-amendment predicate device (Mills Valvulotome) through functional and safety testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional/Safety Testing: Device meets product performance requirements of device specifications. | The device meets the product performance requirements of the device specifications and does not raise any additional safety issues. |
| Sterilization: Validated for ethylene oxide (EO) sterilization. | Validated for ethylene oxide (EO) sterilization according to ANSVAAMI/ISO 11135-1:2007. |
| Biocompatibility: Materials are biocompatible for externally communicating device with limited contact duration ( |
§ 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).