This 510(k) summary (K111884) describes the LeMaitre Vascular OTW-Expandable LeMaitre Valvulotome (OTW-ELV), a device intended for cutting saphenous vein valves during in-situ bypass. The document focuses on demonstrating substantial equivalence to a predicate device (Expandable LeMaitre Valvulotome, K980723) through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Parameter (Not explicitly detailed as criteria, but inferred from testing)	Reported Device Performance	Comments
Biocompatibility	ISO MEM Elution Assay	Device demonstrated as non-toxic and non-sensitizing.	Results consistent with intended use.
	Complement Activation C3a and SC5b-9 Assay	Device demonstrated as non-toxic and non-sensitizing.	Results consistent with intended use.
	Platelet & Leukocyte Count	Device demonstrated as non-toxic and non-sensitizing.	Results consistent with intended use.
	ASTM Hemolysis Assay	Device demonstrated as non-toxic and non-sensitizing.	Results consistent with intended use.
	Partial Thromboplastin Time	Device demonstrated as non-toxic and non-sensitizing.	Results consistent with intended use.
	ISO Intracutaneous Reactivity	Device demonstrated as non-toxic and non-sensitizing.	Results consistent with intended use.
	Murine Local Lymph Node Assay	Device demonstrated as non-toxic and non-sensitizing.	Results consistent with intended use.
	ISO Acute Systemic Injection Test in the Mouse	Device demonstrated as non-toxic and non-sensitizing.	Results consistent with intended use.
Mechanical Performance	Tensile testing of all bond joints	Met established specifications.
	Dimensional verification against product design specifications	Met established specifications.
	Guidewire compatibility	Met established specifications.
	Trackability through in-vitro models (simulated use)	Met established specifications.
	Trackability through cadaver models (simulated use)	Met established specifications.
	Efficacy cutting of in-vitro vein valves (simulated use)	Met established specifications.	Device demonstrated consistent performance.
	Efficacy cutting of cadaver vein valves (simulated use)	Met established specifications.	Device demonstrated consistent performance.
	Hemostasis	Met established specifications.
	Fatigue testing	Met established specifications.

Study Proving Device Meets Acceptance Criteria:

The document describes a series of in-vitro bench-top and in-vitro cadaver tests to demonstrate the safety and performance of the OTW-ELV. While specific quantitative acceptance criteria values are not provided in this summary, the overall conclusion states: "All test results demonstrated that the materials chosen, the manufacturing process, and the design utilized for OTW-Expandable LeMaitre Valvulotome met the established specifications necessary for consistent performance during its intended use as well as substantial equivalence to its predicate." This implies that predefined specifications for each test were met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the specific sample sizes for each test in the test set (e.g., number of bond joints, number of cadaver veins, number of in-vitro models). It only lists the types of tests conducted.
Data Provenance: The tests are described as "in-vitro bench-top testing" and "in-vitro cadaver testing." This indicates the data is from laboratory settings, not from human subjects. The country of origin of the data is not specified, but the submitter is based in Burlington, MA, USA. The data is retrospective in the sense that it was collected as part of the premarket notification process for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed are engineering and chemical/biological characterizations of the device's physical properties and interactions with simulated tissues/materials. They do not involve expert interpretation or subjective evaluation of medical images or clinical outcomes. Therefore, there is no "ground truth" established by medical experts in the context of this performance data.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective measurements of physical, chemical, and biological properties, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (valvulotome) and the described tests are for its mechanical and biological performance, not for an AI-based diagnostic or assistive system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be the pre-defined engineering and safety specifications for each test. For example, for "Tensile testing of all bond joints," the ground truth would be a specific minimum tensile strength value established as acceptable. For "Efficacy cutting of in-vitro vein valves," the ground truth would be a successful and consistent cutting pattern without damage to the surrounding vessel, as defined by the test protocol.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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JUL 2 9 2011 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Section 5.0

A. Submitter Information

Submitter's Name:	LeMaitre Vascular Inc.
Address:	63 Second AvenueBurlington, MA 01803
Telephone:	781-221-2266
Fax:	781-425-5049
Contact Person:	Andrew Hodgkinson, Vice President ClinicalRegulatory and Quality Affairs
Date of Preparation:	July 28, 2011

B. Subject Device

Trade Name: Common/Usual Name: Classification Name:

OTW-Expandable LeMaitre Valvulotome Valvulotome Valvulotome (870.4885, Product Code MGZ)

C. Predicate Device Name:

Trade Name:

Expandable LeMaitre Valvulotome, (K980723)

D. Device Description:

The OTW ELV is a self-centering and self-sizing catheter used for cutting valves in the saphenous vein while navigating over a guidewire.

E. Intended Use:

The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during in-situ bypass.

F. Summary of Technological Characteristics

The OTW ELV navigates the vein via passage over a guidewire. Upon deployment, the centering hoops expand to the walls of the vessel. As the device is retracted, the hoops keep the blades away from the vessel while allowing them to cut the valves as they are encountered.

G. Performance Data:

Biocompatibility testing was conducted in accordance with AAMI/ANSI/ ISO 10993-1: 2003 Biological Evaluation of Medical Devices- Part 1 Evaluation and Testing. The following biocompatibility tests were conducted with results that demonstrated that the proposed device is non-toxic and non-sensitizing to biological tissues consistent with its intended use:

. ISO MEM Elution Assay
Complement Activation C3a and SC5b-9 Assay .
Platelet & Leukocyte Count .

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ASTM Hemolysis Assay ●
Partial Thromboplastin Time ●
ISO Intracutaneous Reactivity .
Murine Local Lymph Node Assay .
ISO Acute Systemic Injection Test in the Mouse t

The proposed OTW-ELV was tested through in-vitro bench-top testing as well as in-vitro cadaver testing. The following performance bench testing was completed for the OTW-ELV:

111 284

2.22

Tensile testing of all bond joints .
Dimensional verification against product design specifications t
Guidewire compatibility .
Trackability through in-vitro models (simulated use) .
Trackability through cadaver models (simulated use) .
Efficacy cutting of in-vitro vein valves (simulated use) .
Efficacy cutting of cadaver vein valves (simulated use) t
Hemostasis .
. Fatigue testing

All test results demonstrated that the materials chosen, the manufacturing process, and the design utilized for OTW-Expandable LeMaitre Valvulotome met the established specifications necessary for consistent performance during its intended use as well as substantial equivalence to its predicate.

H. Conclusion:

LeMaitre Vascular has demonstrated that the OTW-Expandable LeMaitre Valvulotomc is substantially equivalent to the predicate device based on its indications for use and fundamental scientific technology.

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

JUL 2 9 2011

LeMaitre Vasculature c/o Andrew Hodgkinson Vice President, Clinical, Regulatory, & Quality Affairs . 63 Second Avenue Burlington, MA 01803

Re: K111884

Trade/Device Name: OTW-Expandable LeMaitre Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: June 30, 2011 Received: July 1, 2011

Dear Mr. Hodgkinson:

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. However, we remind you 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.

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Page 2 – Mr. Andrew Hodgkinson

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 of medical devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Zuckerman, M

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

Enclosure

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SECTION 4: INDICATION FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Over-The-Wire Expandable LeMaitre Valvulotome

Indications for Use:

The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during In Situ bypass.

Prescription 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)

ovascular Devices

510(k) Number K111884

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).