(117 days)
This device is intended for remote endarterectomy of peripheral blood vessels during vascular reconstruction.
The MollRing MultiTASC is a single use, sterile and disposable device designed for vascular surgeons use during remote endarterectomy procedures for the facilitation of dissecting, cutting and removing atheromatous plaque core within the peripheral vascular system.
The Subject Device is a fixed, circumferential, blunt-edged, sterile, single use cutting tool. It consists of two stainless steel coaxial metal rings (proximal and distal rings) which are connected by a stainless steel rod and hypo tube system. The modular rod and hypo tube system connects to a plastic operator's handle with selective positions for ring alignment (cutting/dissecting phase).
The device is introduced over the proximal end of the atheromatous plaque core of a peripheral vascular vessel. With the two stainless steel coaxial metal rings in "alignment position", they are advanced to the distal end of the plaque core. As the device transverses the vessel it acts as a conventional circumferential dissection ring stripper, removing the plaque core to the distal endpoint. The device is then switched via the operator handle to "un-alignment position", which spreads the distal and proximal rings, thus cutting and securing the plaque core. Once secured, the device is withdrawn, facilitating the core removal.
Based on the K121415 document, here's a breakdown of the acceptance criteria and the study conducted:
This document is a 510(k) summary for a medical device (MollRing MultiTASC Dissection/Transection Device), not a study report for an AI/ML device. Therefore, the questions related to AI/ML specific aspects (like expert consensus for ground truth, sample sizes for training/test sets, MRMC studies, standalone performance, and human reader improvement with AI) are not applicable to this document. This submission focuses on non-clinical performance and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Design Specifications) | Reported Device Performance |
|---|---|
| Dimensional Verification | Met product design specifications |
| Ring Weld Strength | Met product design specifications |
| Weld Flex Strength | Met product design specifications |
| Inner and Outer Hypo Tube Bond Strength | Met product design specifications |
| Coupler Attachment Strength | Met product design specifications |
| T-Handle Pull Force | Met product design specifications |
| T-Handle Torsion Strength | Met product design specifications |
| Device Actuation | Met product design specifications |
| Shaft Bend | Met product design specifications |
| Ring Cutting Force | Met product design specifications |
| Compression Fatigue | Met product design specifications |
| Shelf Life Testing | Met product design specifications |
| Sterilization (Ethylene Oxide) | Validated according to ANSI/AAMI/ISO 11135-1:2007 |
| Biocompatibility | Met ISO 10993 guidelines for an externally communicating device with limited contact duration ( |
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).