The LeMills Valvulotome consists of small metal retrograde cutting blade with atraumatic distal edge. The blade is a part of a long section of wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.

AI/ML Overview

The LeMills Valvulotome is a medical device designed to cut venous valves. The provided text is a 510(k) summary for its clearance.

Here's an analysis of the provided information, specifically addressing the requested points:

K132047: LeMills Valvulotome

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document references "product performance requirements of the device specifications" and "Summary of Product Testing," but it does not explicitly list quantitative acceptance criteria or detailed reported performance values. Instead, it focuses on demonstrating substantial equivalence to a pre-amendment predicate device (Mills Valvulotome) through functional and safety testing.

Acceptance Criteria	Reported Device Performance
Functional/Safety Testing: Device meets product performance requirements of device specifications.	The device meets the product performance requirements of the device specifications and does not raise any additional safety issues.
Sterilization: Validated for ethylene oxide (EO) sterilization.	Validated for ethylene oxide (EO) sterilization according to ANSVAAMI/ISO 11135-1:2007.
Biocompatibility: Materials are biocompatible for externally communicating device with limited contact duration (<24 hours), in circulating blood.	Assessment concluded LeMills is biocompatible according to ISO 10993 guidelines for an externally communicating device with limited contact duration (<24 hours), in circulating blood.
Dimensional Comparison: (Implicit: dimensions should be comparable to predicate)	Completed (0 Dimensional comparison listed). No specific values provided.
Sharpness Test (Effectiveness Test): (Implicit: device effectively cuts venous valves)	Completed. No specific metrics or results provided, but the conclusion states "LeMills Valvulotome is substantially equivalent to the predicate device based on its intended use and fundamental scientific technology."

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

The document does not specify a sample size for any test set related to performance or clinical evaluation. The tests mentioned (dimensional comparison, sharpness) appear to be bench or lab-based assessments rather than patient-based studies. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).

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

This information is not applicable as the studies described are not clinical trials or diagnostic assessments requiring expert established ground truth. The tests are focused on the physical and functional aspects of the device itself.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of clinical studies or diagnostic assessments where adjudication of results would be required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not a diagnostic imaging device typically evaluated with MRMC studies. The approval is based on substantial equivalence to a predicate device, supported by bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This concept is not applicable to the LeMills Valvulotome. This is a manual surgical device; there is no "algorithm only" component.

7. The Type of Ground Truth Used:

For the tests performed:

Dimensional Comparison: Ground truth would be the design specifications and measurements of the device itself and the predicate device.
Sharpness Test (Effectiveness Test): Ground truth would likely be established by a defined testing methodology to assess cutting efficacy in a simulated environment (e.g., cutting a specific material mimicking venous valve tissue).
Sterilization: Ground truth is defined by regulatory standards (ANSVAAMI/ISO 11135-1:2007).
Biocompatibility: Ground truth is defined by regulatory guidelines (ISO 10993).

There is no mention of pathology, expert consensus from clinical cases, or outcomes data used to establish ground truth for the performance tests in this 510(k) summary.

8. The Sample Size for the Training Set:

This information is not applicable. The LeMills Valvulotome is a physical medical device, not a machine learning or AI-based system that requires a training set.

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

This information is not applicable for the reasons stated above.

Summary

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K132047

NOV 0 5 2013

510 (k) Summary

Submitter's information:

LeMaitre Vascular, Inc.
63 Second Avenue
Burlington, MA USA 01803
781-425-1727
781-425-5049

Contact Person: Bryan Cowell, MSc., RAC

Date of preparation:	July 1, 2013
Device Name:	LeMills Valvulotome
Trade Name.	LeMills Valvulotome
Common/ ClassificationName:	External Vein Striper
Classification Panel:Class:	21CFR §870.4885II (2)

Product Code: MGZ

Establishment Registration: 1220948

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

Owner/Operator: 1220948

Proposed Device Description:

Proposed Intended Use:

The LeMills Valvulotome is intended to cut venous valves.

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Predicate Device:

Device Name: Mills Valvulotome, Pre-amendment device.

Substantial Equivalence:

Fundamental Scientific Technological Characteristics:

The LeMills Valvulotome maintains the same fundamental Scientific Technology as the Mills Valvulotome and is used to cut venous valves.

Functional/ Safety testing:

The verification activities conducted indicate that LeMills Valvulotome device meets the product performance requirements of the device specifications and does not raise any additional safety issues.

Sterilization:

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

Biocompatibility:

Materials used in this device were subjected to Biocompatibility assessment according to ISO 10993 guidelines for an externally communicating device with limited contact duration (<24 hours), in circulating blood. The assessment concluded that LeMills is biocompatible.

Summary of Product Testing:

The following tests have been completed to evaluate the safety and performance of LeMills Valvulotome compared with the predicate device:

0 Dimensional comparison
. Sharpness Test (Effectiveness Test)

Conclusion:

LeMaitre Vascular has demonstrated that the LeMills Valvulotome is substantially equivalent to the predicate device based on its intended use and fundamental scientific technology.

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

November 5, 2013

LeMaitre Vascular, Inc. Andrew Hodgkinson Vice President of Regulatory, Quality, and Clinical 63 Second Avenue Burlington, MA 01803

Re: K132047

Trade/Device Name: LeMills Valvulotome Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: MGZ Dated: October 24, 2013 Received: October 28, 2013

Dear Andrew 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. 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Andrew Hodgkinson

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" (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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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) Number (if known)

K132047/5001

Device Name LeMills Valvulotome

Indications The LeMills Valvulotome is intended to cut venous valves. for Use

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)

ﺮ

Over-The-Counter Use_

Bra 2013

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).