The Antegrade LeMills Valvulotome consists of small metal antegrade cutting blade with atraumatic distal edge. The blade is a part of a long stainless steel 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 provided document is a 510(k) premarket notification for the Antegrade LeMills Valvulotome, a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on novel performance studies and acceptance criteria as would typically be found for AI/ML-based devices or those requiring clinical trials for efficacy.

Based on the content provided, it is not possible to extract the information requested regarding acceptance criteria and a study proving the device meets them in the context of AI/ML performance, multi-reader multi-case studies, or complex ground truth establishment. This is because the device is a physical surgical tool (a valvulotome) designed to cut venous valves, and its approval relies on bench testing and comparison to existing predicate devices, not on diagnostic performance or AI algorithm validation.

However, I can extract the available information related to performance testing that was conducted:

1. A table of acceptance criteria and the reported device performance:

The document mentions "Functional/Safety Testing" and "Summary of Product Testing" but does not provide a specific table with acceptance criteria and corresponding reported device performance values. It generally states that the device meets performance requirements.

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the document for specific numerical thresholds.	The verification activities conducted indicate that Antegrade LeMills Valvulotome device meets the product performance requirements of the device specifications and does not raise any additional safety issues.
Tests listed:
Dimensional Comparison	(Implied to meet specifications)
Sharpness Test (Effectiveness Test)	(Implied to be effective for cutting venous valves)
Visual Inspection	(Implied to meet quality standards)
Joint Tensile Strength (Pull Test)	(Implied to meet required strength)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified in the document. The tests appear to be bench-top physical tests performed on the device itself, rather than studies involving patient data.
Data Provenance: Not applicable as it's not a data-driven diagnostic or AI device. The tests are for the physical properties and function of the surgical tool.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts/Qualifications: Not applicable. Ground truth for physical device testing is typically established through engineering specifications, material standards, and functional performance benchmarks, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. This concept is relevant for interpreting ambiguous clinical data, not for physical device testing.

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:

MRMC Study: No. This device is a surgical tool, not a diagnostic imaging device or an AI-assisted diagnostic tool.

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

Standalone Performance: Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used:

Ground Truth Type: For the physical tests mentioned (Dimensional Comparison, Sharpness Test, Visual Inspection, Joint Tensile Strength), the 'ground truth' would be the engineering specifications and design requirements for the device. For biocompatibility and sterilization, the ground truth is adherence to recognized standards (ISO 10993, ANSI/AAMI/ISO 11135-1:2007).

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not applicable.

Summary

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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

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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 (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 Industry and Consumer Education 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,

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

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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)

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510k Summary

Submitter's Information

Name:	LeMaitre Vascular, Inc.
Address:	63 Second AvenueBurlington, MA 01803
Phone:	781-425-1706
Fax:	781-425-5049
Contact Person:	Anna KasserisRegulatory Affairs SpecialistEmail: akasseris@lemaitre.com
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
EstablishmentRegistration:	1220948
Establishment:	63 Second AvenueBurlington, MA 01803
Predicate Device:	LeMills Valvulotome (Retrograde) K132047
Reference Device:	Mills Valvulotome (Antegrade), Pre-amendment
Device Description:	The Antegrade LeMills Valvulotome consists of smallmetal antegrade cutting blade with atraumatic distal edge.The blade is a part of a long stainless steel wire that allowsit to be inserted into the venous anatomy. It is held by aplastic handle. It is designed for cutting the venous valves.Once the valves have been rendered ineffectual, the veincan then be utilized as an arterial conduit.
Intended Use:	The LeMills Valvulotome is intended to cut venous valves.
Summary of TechnologicalCharacteristics:	The Antegrade LeMills Valvulotome maintains the sametechnological characteristics as the predicate RetrogradeLeMills Valvulotome.
Functional/Safety Testing:	The verification activities conducted indicate thatAntegrade LeMills Valvulotome device meets the productperformance requirements of the device specifications anddoes not raise any additional safety issues.
Sterilization:	The device is ethylene oxide (EO) sterilized according toANSI/AAMI/ISO 11135-1:2007, "Sterilization of MedicalDevices - Validation and Routine Control of EthyleneOxide Sterilization"
Biocompatibility:	Biocompatibility of the device has been assessed accordingto ISO 10993 guidelines for an externally communicatingdevice with limited contact duration (<24 hours), incirculating blood. The assessment concluded thatAntegrade LeMills is biocompatible.
Summary of ProductTesting:	The following tests have been completed to evaluate thesafety and performance of the Antegrade LeMillsValvulotome:Dimensional Comparison Sharpness Test (Effectiveness Test) Visual Inspection Joint Tensile Strength (Pull Test)
Summary of Pre-clinicalStudy:	N/A
Conclusion:	LeMaitre Vascular has demonstrated that the AntegradeLeMills Valvulotome substantially equivalent to thepredicate devices based on its intended use andfundamental scientific technology.

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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).