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.

AI/ML Overview

The provided document describes a 510(k) submission for the 1.5mm HYDRO Expandable LeMaitre Valvulotome. This is a medical device, and the submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in the way a new diagnostic or AI-driven device often does.

Therefore, the structure of the response will be tailored to the information provided in a 510(k) summary for a physical medical device. Many of the requested categories (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of submission because it's not a diagnostic or AI device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by meeting product performance specifications and not raising additional safety issues, as compared to its predicate device. Specific quantitative acceptance criteria with corresponding performance values are generally not provided in this type of 510(k) summary for functional device modifications. The tests performed are primarily engineering and bench tests, with a cadaver study, to show that the modified device functions similarly and safely.

Acceptance Criterion (Implied)	Reported Device Performance
Meet product performance specifications (general)	"meets the product performance specifications"
Modifications do not raise any additional safety issues	"modifications do not raise any additional safety issues"
Achieve intended use (excising/disrupting venous valves)	Demonstrated through Cadaver Study, functional testing.
Biocompatibility for blood contact	"is biocompatible"
Sterilization validated	"is validated for ethylene oxide (EO) sterilization"
Maintain fundamental scientific technology as predicate	"maintains the same intended use and fundamental scientific technology as the predicate device(s)"
Dimensional accuracy	"Dimensional Verification" completed
Durability/Reliability (e.g., fatigue)	"Fatigue Testing" completed
Fluid dynamics/Lubricity (hydrophilic coating benefit)	"Flushability" completed
Ease of use (insertion/removal)	"Force to insert and remove device" completed
Mechanism function (opening/closing)	"Force to open and close device" completed
Navigability in tortuous anatomy	"Tortuous Sheathing" completed
Functionality in a biological environment (cutting valves)	"Cadaver Study" completed

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

Test Set Sample Size: Not explicitly stated for specific tests (e.g., how many devices for dimensional, fatigue, force tests). For the Cadaver Study, the sample size is not specified.
Data Provenance: Not specified. Standard practice for bench testing is typically done in a lab environment. Cadaver studies are usually conducted by the manufacturer or a contract research organization (CRO) in a controlled setting. No country of origin for the data is mentioned. The study is prospective for the device's performance given the modifications.

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

This concept is not applicable here as this is a physical device, not an AI or diagnostic device that requires expert-established ground truth on a dataset. The "ground truth" for a medical device's performance is typically established through engineering standards, functional tests, and in vivo/cadaver studies where success is defined by the device performing its intended mechanical function.
For the cadaver study, it's implied that medical professionals (surgeons or similar) would have conducted or observed the study to assess functionality, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

Not applicable in the context of an AI/diagnostic device's performance evaluation. For engineering tests, results are typically assessed against pre-defined engineering specifications. For the Cadaver Study, the "adjudication" would be whether the device successfully performed its function (cutting valves) and navigated the anatomy, likely assessed by the operating physician(s).

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 instrument, not an AI system.

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

Not applicable. This is a medical instrument, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on functional performance metrics derived from engineering tests (e.g., force measurements, dimension checks, fatigue cycles) and observations from the cadaver study confirming the device's ability to navigate and effectively cut venous valves in a simulated biological environment. There is also biocompatibility testing against ISO 10993 guidelines.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary

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510 (k) Summary

K140042

APR 1 1 9612

Submitter's information:

Name:	LeMaitre Vascular, Inc.
Address:	63 Second AvenueBurlington, 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:

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 (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/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)Number(if known)	K140042
Device Name	1.5mm HYDRO Expandable LeMaitre Valvulotome
Indicationsfor Use	It is used for the treatment of vascular disorders, and more particularly forexcising 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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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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).