(117 days)
Not Found
No
The device description details a purely mechanical tool with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are focused on mechanical properties.
No.
This device is designed for a surgical procedure (endarterectomy) to remove plaque, which is a treatment for a condition rather than a therapeutic device in itself designed to provide therapy.
No
The device is described as a surgical tool designed for cutting and removing plaque from blood vessels and does not mention any function for diagnosing conditions.
No
The device description clearly outlines a physical, single-use, sterile, disposable cutting tool made of stainless steel and plastic components, with no mention of software functionality. The performance studies listed are all related to the mechanical properties and physical performance of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for remote endarterectomy of peripheral blood vessels during vascular reconstruction." This describes a surgical procedure performed directly on the patient's body to remove plaque from blood vessels.
- Device Description: The description details a physical tool designed for dissecting, cutting, and removing plaque in vivo (within the living body). It's a mechanical device used during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
The device is clearly a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
This device is intended for remote endarterectomy of peripheral blood vessels during vascular reconstruction.
Product codes
DWX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
vascular surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed and the test results met the product design specifications.
- . Dimensional Verification
- . Ring Weld Strength
- . Weld Flex Strength
- Inner and Outer Hypo Tube Bond Strength
- Coupler Attachment Strength .
- T-Handle Pull Force
- T-Handle Torsion Strength .
- Device Actuation .
- Shaft Bend .
- . Ring Cutting Force
- Compression Fatigue .
- Shelf Life Testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K121415 page 1 of 3
Section 5: 510(k) Summary
Submitter's information:
5 2012 SEP
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue |
| Burlington, MA USA 01803 | |
| Phone: | 781-425-1727 |
| Contact: | Bryan Cowell, MSc., RAC |
Date of preparation: August 22, 2012
Device Name: MollRing® MultiTASCTM Dissection/Transection Device Trade Name: MollRing® MultiTASC™ Dissection/Transection Device Common/ Classification: Stripper, Artery, Intraluminal Classification Panel: 21CFR §870.4875 Class: II Product Code: DWX Establishment: LeMaitre Vascular, Inc., 63 Second Avenue, Burlington, MA USA 01803 Owner/Operator: 1220948 Establishment Registration: 1220948
Proposed Intended Use:
This device is intended for remote endarterectomy of peripheral blood vessels during vascular reconstruction.
Proposed Device Description:
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.
1
K1214115 page 2 of 3
| Predicate Device: | |
|---|---|
| 510(k): | K950813 |
| Device Name: | MollRing Endarterectomy Device |
| SE Date: | 07/25/1995 |
| Regulation: | 870.4875 |
| Device Class: | II |
| Common/ | |
| Classification | Stripper, Artery, Intraluminal |
| Product Code: | DWX |
Comparison of Substantial Equivalence: Intended Use:
The intended use of MollRing MultiTASC is identical to that of the predicate device.
Fundamental Scientific Technological Characteristics:
The MollRing MultiTASC and its predicate are both single use, sterile and disposable devices designed for vascular surgeons use during remote endarterectomy procedures for the facilitation of dissecting, cutting, stripping and removing atheromatous plaque cores within the peripheral vascular system. The difference between the MollRing MultiTASC and the predicate is that the MultiTASC is composed of two separate parts: the Shaft Ring Hub Assembly and T handle, while the predicate has the handle permanently attached to the shaft. The differences in design are not critical to the intended use of the device and do not raise any new questions regarding safety or effectiveness.
Functional/ Safety testing:
The verification activities conducted indicate that the MolliTASC device meets the product performance specifications and does not raise any additional safety issues.
Sterilization:
The device is validated for ethylene oxide (EO) sterilization according to ANSVAAMI/ISO 11135-1:2007, "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization"
Biocompatibility:
All blood contact portions of the device were subjected to Biocompatibility testing according to ISO 10993 guidelines for an externally communicating device with limited contact duration (