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.

AI/ML Overview

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.

Summary

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K132190

510(k) Summary

Submitter Information:

Name:	LeMaitre Vascular, Inc.
Address:	63 Second Avenue Burlington, MA 01803
Contact Person:	Anna Kasseris Regulatory Affairs Specialist Phone: 781-425-1706 Fax: 781-425-5049 Email: akasseris@lemaitre.com
Date Prepared:	July 10, 2013
Trade Name:	Expandable LeMaitre Valvulotome (ELV), Over-the-wire LeMaitre Valvulotome
Common Name:	Valvulotome
Classification Name:	External Vein Stripper
Class:	II (two)
Classification Panel:	Cardiovascular
Product Code:	MGZ
Establishment:	63 Second Avenue Burlington, MA 01803

AUG 0 5 2013

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DeviceDescription:	The ELV and OTW-LV are self-centering and self-sizing valvulotome usedfor blind lysis of vein valves. Once the valves have been renderedineffectual, it can then be utilized as an arterial conduit. Centering hoopskeep the devices centered in the vein and prevent the valve-cutting bladesfrom damaging the vein wall. The size of hoops and blades adjusts to theinternal diameter of the vein as the valvulotome is being drawn through thevessel. The OTW-LV facilitates navigation of the vein with the assistanceof a guidewire.
ProposedIntended Use:	It is used for the treatment of vascular disorders and more particularly forexcising or disrupting venous valves.
PredicateDevices:	K080178- Valvulotome by Koven,
Summary ofTechnologicalCharacteristics:	The ELV and OTW-LV are self-centering and self-sizing valvulotome usedfor blind lysis of vein valves. Upon deployment the centering hoops expandto the walls of the vessel. As the device is retracted the hoops keep theblade away from the vessel while allowing them to lyse the valves. TheOTW LV navigates the vein via a passage over a guidewire.
Summary ofProduct Testing:	No additional testing was performed for this submission.
Biocompatibility:	The biocompatibility of the devices were tested in accordance to ISO 10993guidelines.
Sterilization:	The device is validated for ethylene oxide (EtO) gas sterilization accordingto ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization".
Functional/SafetyTesting:	No additional testing was performed for this submission.
Summary of Pre-clinical Study:	No preclinical study was performed for this submission.

・

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LeMaitre Vascular has demonstrated that the ELV and OTW LeMaitre Conclusion: Valvulotome, are substantially equivalent to the predicate device based on its intended use and fundamental scientific technology.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HUMAN SERVICES - USA" surrounding it. The text is arranged in a circular fashion, following the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 5, 2013

LeMaitre Vascular, Inc. c/o Anna Kasseris Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

Re: K132190

Trade/Device Name: Expandable Le Maitre Valvulotome and Over-the-wire LeMaitre Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: Valvulotome, External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: July 10, 2013 Received: July 15, 2013

Dear Ms. Kasseris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Anna Kasseris

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman -S

Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K132190

Device Name: Expandable LeMaitre Valvulotome, Over-the-Wire LeMaitre Valvulotome

Indications for Use: It is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

Prescription Use _____ and/or Over-The Counter Use____________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ID NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram D. Zuckerman -S 2013.08.05 16:28:03 -04'00'

Regulation Number and Section

§ 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).