The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Device Description

The VenaCure EVLT Tre' Sheath is a 4F sheath used during endovascular venous laser treatment procedures. The sheath is used as a conduit for placing a laser fiber. The product will be offered in 25, 45, 65 and 90cm lengths. The VenaCure EVLT Tre' Sheath will be provided both as a standalone product and also packaged with a variety of procedural accessories.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kit). It details the device's intended use and claims substantial equivalence to a predicate device.

Crucially, this document describes a traditional medical device, not an AI/ML-based device. Therefore, the concepts of "acceptance criteria for an AI algorithm," "sample size for a test set," "ground truth establishment," "MRMC studies," "standalone performance," or "training sets" as they relate to AI/ML are not applicable here.

The "performance data" mentioned in the document refers to non-clinical performance and material testing for the physical device, such as tensile strength, torque, and biocompatibility, as per regulatory requirements for medical devices.

If this were an AI/ML device, the detailed information about studies and acceptance criteria would be essential. However, for a physical medical device submission, the focus is on demonstrating safety and effectiveness through different types of testing and comparison to legally marketed predicate devices.

Therefore, I cannot extract the requested information as it pertains to AI/ML device validation from this document.

Summary

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

October 10, 2014

AngioDynamics Incorporated Dr. Teri L. Juckett Manager, Global Regulatory Affairs 603 Queensbury Avenue Queensbury, New York 12804

Re: K142614

Trade/Device Name: VenaCure EVLT Tre' Sheath, VenaCure EVLT NeverTouch Procedure Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 5, 2014 Received: September 16, 2014

Dear Dr. Juckett:

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

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Page 2 - Dr. Teri L. Juckett

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 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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.

Binita S. Ashar -S 2014.10.10 17:49:57 -04'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known)

Device Name:

VenaCure EVLT Tre' Sheath VenaCure EVLT NeverTouch Procedure Kit

Indications for Use:

Prescription Use: X (Per 21 CFR Subpart D And/Or

Over-the-Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(K) SUMMARY FOR THE VENACURE EVLT NEVER TOUCH TRE' SHEATH INTRODUCER AND VENACURE EVLT NEVER TOUCH PROCEDURE KIT

Date Prepared: 05 September 2014

A. Sponsor:

AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804

B. Contact:

Teri L. Juckett Manager, Global Regulatory Affairs Tel: 518-795-1142 Fax: 518-742-4323 Email: tjuckett(@angiodynamics.com

C. Device Name:

Trade Name:	VenaCure EVLT Tre' SheathVenaCure EVLT NeverTouch Procedure Kit
Common/Usual Name:	Greater Saphenous Vein Procedure Kit
Classification Name:	Laser Instrument, Surgical Powered(21CFR§878.4810, Class II, Pro-Code GEX)
Classification Panel:	General Hospital & Plastic Surgery
Predicate Device:
Trade Name:	VenaCure EVLT Tre' SheathVenaCure EVLT NeverTouch Procedure Kit
Common/Usual Name:	Greater Saphenous Vein Procedure Kit
Classification Name:	Laser Instrument, Surgical Powered(21CFR§878.4810, Class II, Pro-Code GEX)
Classification Panel:	General Hospital & Plastic Surgery

E. Device Description:

F. Intended Use:

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G. Summary of Similarities and Differences in Technology Characteristics and Performance:

The proposed device has similar materials, design, components, and technical characteristics as the predicate device.

H. Performance Data:

The proposed VenaCure EVLT Tre' Sheath and VenaCure NeverTouch EVLT Procedure Kit are substantially equivalent to the specified predicate devices based on a comparison of technological characteristics and the results of non-clinical performance and material testing, which include:

. Tensile
Torque
Biocompatibility per ISO 10993-1 .

I. Conclusion:

The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.