Antegrade LeMills Valvulotome

K142660 · LeMaitre Vascular, Inc. · MGZ · Oct 17, 2014 · Cardiovascular

Device Facts

• Record ID: K142660
• Device Name: Antegrade LeMills Valvulotome
• Applicant: LeMaitre Vascular, Inc.
• Product Code: MGZ · Cardiovascular
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4885
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LeMills Valvulotome is intended to cut venous valves.

Device Story

The Antegrade LeMills Valvulotome is a surgical instrument consisting of a small metal cutting blade with an atraumatic distal edge, mounted on a long stainless steel wire with a plastic handle. It is used by surgeons in a clinical setting to cut venous valves, rendering them ineffectual so the vein can be repurposed as an arterial conduit. The device is inserted into the venous anatomy; the surgeon manually manipulates the instrument to perform the cutting. It provides a mechanical means to facilitate vascular bypass procedures.

Clinical Evidence

Bench testing only. Performance evaluated via dimensional comparison, sharpness testing (effectiveness), visual inspection, and joint tensile strength (pull test). Biocompatibility assessed per ISO 10993 for limited contact (<24 hours) in circulating blood.

Technological Characteristics

Stainless steel wire with metal cutting blade and plastic handle. Ethylene oxide (EO) sterilized per ANSI/AAMI/ISO 11135-1:2007. Biocompatible per ISO 10993 for limited contact duration (<24 hours) in circulating blood. Manual surgical instrument.

Indications for Use

Indicated for cutting venous valves to render them ineffectual, allowing the vein to be utilized as an arterial conduit.

Regulatory Classification

Identification

An external vein stripper is an extravascular device used to remove a section of a vein.

Predicate Devices

• LeMills Valvulotome (Retrograde) (K132047)

Reference Devices

• Mills Valvulotome (Antegrade), Pre-amendment

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles an abstract representation of an eagle or a similar bird, with stylized feathers or wings.

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

October 17, 2014

Lemaitre Vascular, Inc. % Anna Kasseris Regulatory Affairs Specialist 63 Second Avenue Burlington, Massachusetts 01803

Re: K142660

Trade/Device Name: Antegrade LeMills Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: September 15, 2014 Received: September 18, 2014

Dear Anna 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 either 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K142660

Device Name Antegrade LeMills Valvulotome

Indications for Use (Describe) The LeMills Valvulotomes are intended to cut venous valves.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------|--|--|
| | | |

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510k Summary

## Submitter's Information

| Name: | LeMaitre Vascular, Inc. |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 63 Second Avenue<br>Burlington, MA 01803 |
| Phone: | 781-425-1706 |
| Fax: | 781-425-5049 |
| Contact Person: | Anna Kasseris<br>Regulatory Affairs Specialist<br>Email: [e-mail] |
| Date Prepared: | September 15, 2014 |
| Device Name: | Antegrade LeMills Valvulotome |
| Trade Name: | LeMills Valvulotome |
| Common Name: | External Vein Stripper |
| Classification Name: | Cardiovascular |
| Classification Panel: | 21CFR §870.4885 |
| Class: | II (2) |
| Product Code: | MGZ |
| Establishment<br>Registration: | 1220948 |
| Establishment: | 63 Second Avenue<br>Burlington, MA 01803 |
| Predicate Device: | LeMills Valvulotome (Retrograde) K132047 |
| Reference Device: | Mills Valvulotome (Antegrade), Pre-amendment |
| Device Description: | The Antegrade LeMills Valvulotome consists of small<br>metal antegrade cutting blade with atraumatic distal edge.<br>The blade is a part of a long stainless steel wire that allows<br>it to be inserted into the venous anatomy. It is held by a<br>plastic handle. It is designed for cutting the venous valves.<br>Once the valves have been rendered ineffectual, the vein<br>can then be utilized as an arterial conduit. |
| Intended Use: | The LeMills Valvulotome is intended to cut venous valves. |
| Summary of Technological<br>Characteristics: | The Antegrade LeMills Valvulotome maintains the same<br>technological characteristics as the predicate Retrograde<br>LeMills Valvulotome. |
| Functional/Safety Testing: | The verification activities conducted indicate that<br>Antegrade LeMills Valvulotome device meets the product<br>performance requirements of the device specifications and<br>does not raise any additional safety issues. |
| Sterilization: | The device is ethylene oxide (EO) sterilized according to<br>ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical<br>Devices - Validation and Routine Control of Ethylene<br>Oxide Sterilization" |
| Biocompatibility: | Biocompatibility of the device has been assessed according<br>to ISO 10993 guidelines for an externally communicating<br>device with limited contact duration (<24 hours), in<br>circulating blood. The assessment concluded that<br>Antegrade LeMills is biocompatible. |
| Summary of Product<br>Testing: | The following tests have been completed to evaluate the<br>safety and performance of the Antegrade LeMills<br>Valvulotome:<br>Dimensional Comparison Sharpness Test (Effectiveness Test) Visual Inspection Joint Tensile Strength (Pull Test) |
| Summary of Pre-clinical<br>Study: | N/A |
| Conclusion: | LeMaitre Vascular has demonstrated that the Antegrade<br>LeMills Valvulotome substantially equivalent to the<br>predicate devices based on its intended use and<br>fundamental scientific technology. |

{4}------------------------------------------------