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510(k) Data Aggregation
(21 days)
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
It is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
The ELV and OTW-LV are self-centering and self-sizing valvulotome used for blind lysis of vein valves. Once the valves have been rendered ineffectual, it can then be utilized as an arterial conduit. Centering hoops keep the devices centered in the vein and prevent the valve-cutting blades from damaging the vein wall. The size of hoops and blades adjusts to the internal diameter of the vein as the valvulotome is being drawn through the vessel. The OTW-LV facilitates navigation of the vein with the assistance of a guidewire.
This document describes the 510(k) submission for the Expandable LeMaitre Valvulotome (ELV) and Over-the-wire LeMaitre Valvulotome.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided submission does not include specific acceptance criteria or quantitative performance data for the device. Instead, the submission states:
| Criterion | Description | Reported Performance |
|---|---|---|
| Substantial Equivalence | The device is substantially equivalent to a legally marketed predicate device based on intended use and fundamental scientific technology. | LeMaitre Vascular has demonstrated that the ELV and OTW LeMaitre Valvulotome are substantially equivalent to the predicate device (K080178- Valvulotome by Koven). |
| Biocompatibility | Devices were tested in accordance with ISO 10993 guidelines. | Biocompatibility was tested in accordance with ISO 10993 guidelines. |
| Sterilization | Validation for ethylene oxide (EtO) gas sterilization according to ANSI/AAMI/ISO 11135-1:2007. | The device is validated for ethylene oxide (EtO) gas sterilization according to ANSI/AAMI/ISO 11135-1:2007. |
| Functional/Safety Testing | No additional testing was performed for this submission. | "No additional testing was performed for this submission." |
| Summary of Pre-clinical Study | No preclinical study was performed for this submission. | "No preclinical study was performed for this submission." |
The submission explicitly states: "No additional testing was performed for this submission." and "No preclinical study was performed for this submission." This indicates that the regulatory clearance was based on demonstrating substantial equivalence to a predicate device, rather than new performance studies with pre-defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
No test set data is provided in this submission for the evaluation of the device's performance. The submission explicitly states "No additional testing was performed for this submission" and "No preclinical study was performed for this submission."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as no performance tests or studies requiring ground truth establishment were conducted or reported in this submission to demonstrate the device's efficacy or safety beyond substantial equivalence.
4. Adjudication Method for the Test Set:
Not applicable, as no performance tests or studies requiring adjudication were conducted or reported in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not performed. The submission explicitly states "No additional testing was performed for this submission" and "No preclinical study was performed for this submission." This device is a surgical tool, not an AI or imaging diagnostic device where MRMC studies are typically relevant.
6. If a Standalone (Algorithm Only) Performance Study was done:
No, a standalone performance study was not done. This device is a physical medical instrument (valvulotome), not a software algorithm.
7. The Type of Ground Truth Used:
Not applicable, as no performance studies requiring ground truth were conducted or reported in this submission. The basis for clearance is substantial equivalence to a predicate device.
8. The Sample Size for the Training Set:
Not applicable. This document is for a physical medical device (valvulotome), not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is a physical medical device and not an AI or machine learning algorithm.
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