1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME

K140042 · LeMaitre Vascular, Inc. · MGZ · Apr 10, 2014 · Cardiovascular

Device Facts

• Record ID: K140042
• Device Name: 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
• Applicant: LeMaitre Vascular, Inc.
• Product Code: MGZ · Cardiovascular
• Decision Date: Apr 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4885
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering, self-sizing surgical instrument used to excise or disrupt venous valves. It features centering hoops that maintain device position within the vein and cutting blades that adjust to the internal diameter of the vessel. The device is a modification of the Expandable LeMaitre Valvulotome, incorporating hydrophilic coatings to increase lubricity and facilitate navigation through veins, and a co-extruded sheath. It is intended for use by clinicians in a surgical setting. By cutting valves as the device is drawn through the vessel, it renders them ineffectual, aiding in the treatment of vascular disorders.

Clinical Evidence

Bench testing included dimensional verification, fatigue testing, flushability, force to insert/remove, force to open/close, and tortuous sheathing. A cadaver study was also conducted to evaluate performance. No clinical trial data on human subjects was required.

Technological Characteristics

Self-centering and self-sizing valvulotome with cutting blades. Features hydrophilic coatings for lubricity and a co-extruded sheath. Sterilized via ethylene oxide (EO) per ANSI/AAMI/ISO 11135-1:2007. Biocompatibility confirmed per ISO 10993 for limited contact (<24 hours) with circulating blood.

Indications for Use

Indicated for patients requiring treatment of vascular disorders, specifically for the excision or disruption of venous valves.

Regulatory Classification

Identification

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

Predicate Devices

• Expandable LeMaitre Valvulotome, Over-the-Wire LeMaitre Valvulotome (K132190)
• Expandable LeMaitre Valvulotome (K980732)

Submission Summary (Full Text)

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# 510 (k) Summary

# K140042

# APR 1 1 9612

#### Submitter's information:

| Name: | LeMaitre Vascular, Inc. |
|------------------------------|----------------------------------------------|
| Address: | 63 Second Avenue<br>Burlington, MA USA 01803 |
| Phone: | 781-425-1729 |
| Contact Person: | Xiang (Vic) Zhang |
| Date of preparation: | January 6, 2014 |
| Device Name: | 1.5mm HYDRO Expandable LeMaitre Valvulotome |
| Trade Name: | HYDRO Expandable LeMaitre Valvulotome |
| Common/ Classification Name: | Valvulotome, External Vein Stripper |
| Classification Panel: | 21CFR §870.4885 |
| Class: | II (2) |
| Product Code: | MGZ |
| Classification Panel: | Cardiovascular |

#### Establishment Registration: 1220948

Establishment: LeMaitre Vascular, Inc., 63 Second Avenue, Burlington, MA USA 01803

#### Proposed Subject Device Description:

The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering and self-sizing valvulotome device used for cutting vein valves. The centering hoops keep the device centered in the vein. The size of the centering hoops and cutting blades adjust to the internal diameter of the vein as the valvulotome is being drawn through the vessel cutting the valves and rendering them ineffectual. The modifications to the predicate device - Expandable LeMaitre Valvulotome (ELV)- include the addition of hydrophilic coatings and co-extruded sheath to create 1.5mm HYDRO Expandable LeMaitre Valvulotome. The hydrophilic coatings provide increased lubricity and allow the device to navigating veins easier.

#### Proposed Intended Use (Subject Device):

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

#### Predicate Intended Use:

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

#### Predicate Devices:

| 510(k): | K132190 (Change to indication) |
|--------------------|---------------------------------------------------------------------|
| Device Name: | Expandable LeMaitre Valvulotome, Over-the-Wire LeMaitre Valvulotome |
| SE Date: | 8/5/2013 |
| Regulation Number: | 21CFR §870.4885 |
| Device Class Name: | Valvulotome, External Vein Stripper |
| Device Class: | II |
| Product Code: | MGZ |
| 510(k): | K980732 |
| Device Name: | Expandable LeMaitre Valvulotome |
| SE Date: | 2/12/1999 |
| Regulation Number: | 21CFR §870.4885 |

Device Class Name: Valvulotome, External Vein Stripper Device Class: II

Product Code: MGZ

# Substantial Equivalence:

# Fundamental Scientific Technological Characteristics:

The 1.5mm HYDRO Expandable LeMaitre Valvulotome maintains the same intended use and fundamental scientific technology as the predicate device(s) and is substantially equivalent to the predicate device(s).

# Functional/ Safety testing:

The verification activities conducted on the subject device indicate that 1.5mm HYDRO Expandable LeMaitre Valvulotome meets the product performance specifications and the modifications do not raise any additional safety issues.

# Sterilization:

The device is validated for ethylene oxide (EO) sterilization according to ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization". The Sterilization process remains unchanged.

# Biocompatibility:

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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 (<24 hours), with circulating blood. The biocompatibility assessment established that 1.5mm HYDRO Expandable LeMaitre Valvulotome is biocompatible.

#### Summary of Product Testing:

The following tests have been completed to evaluate the performance of the Subject Device:

- Dimensional Verification .
- Fatigue Testing ●
- Flushability .
- . Force to insert and remove device
- Force to open and close device .
- Tortuous Sheathing ●
- Cadaver Study �

#### Conclusion:

LeMaitre Vascular has demonstrated that the subject device the 1.5mm HYDRO Expandable LeMaitre Valvulotome is substantially equivalent to the predicate device(s) based on the same intended use and fundamental scientific technology.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

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

April 10, 2014

Lemaitre Vascular, Inc. Mr. Xiang Zhang Director of Regulatory Affairs 63 Second Avenue Burlington, MA 01803 US

Re: K140042

> Trade/Device Name: 1.5mm Hydro Expandable Lemaitre Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: Valvulotome Regulatory Class: Class II Product Code: MGZ Dated: March 11, 2014 Received: March 12, 2014

Dear Mr. Zhang,

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 device

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Page 2 - Xiang Zhang

related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 [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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S
2014.04.10 15:12:05 -04'00'

for Bram D. Zuckerman, M.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)<br>Number<br>(if known) | K140042 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Device Name | 1.5mm HYDRO Expandable LeMaitre Valvulotome |
| Indications<br>for Use | It is used for the treatment of vascular disorders, and more particularly for<br>excising or disrupting venous valves. |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ X (Per 21 CFR 801. 109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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