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

This document is a 510(k) Summary for a medical device called the "VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kit." It's a submission to the FDA for market clearance, not an AI performance study. Therefore, most of the requested information regarding acceptance criteria for AI devices and associated studies is not applicable.

However, I can extract the information that is present in the document which relates to the device's performance assessment for its 510(k) clearance.

Here's a breakdown of the relevant information:

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

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it describes "non-clinical performance testing" comparing the device to a predicate device. The implied acceptance criterion for these tests is "substantially equivalent" to the predicate, meaning the device performs similarly and meets the same safety and effectiveness standards.

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary)
Mechanical/Physical Properties	The proposed device has similar materials, design, components, and technical characteristics as the predicate device. The results of non-clinical performance testing demonstrate substantial equivalence. Specific tests include:
Visual Inspection	Passed/Met standards (implied by "substantially equivalent")
Sheath / Dilator Interface (Length and Force to Withdraw)	Passed/Met standards (implied by "substantially equivalent")
Depth Mark Spacing	Passed/Met standards (implied by "substantially equivalent")
Surface Friction Testing	Passed/Met standards (implied by "substantially equivalent")
Static Pressure Testing	Passed/Met standards (implied by "substantially equivalent")
Luer Lock Fitting Testing	Passed/Met standards (implied by "substantially equivalent")
Tensile Test Hub Joints	Passed/Met standards (implied by "substantially equivalent")
Needle Tensile	Passed/Met standards (implied by "substantially equivalent")
Functional Performance
Fiber Output	Passed/Met standards (implied by "substantially equivalent")
Biocompatibility
Biocompatibility per ISO 10993-1	Passed/Met standards (implied by "substantially equivalent")

Regarding the AI-specific questions, these are not applicable to this document as it describes a physical medical device, not an AI system.

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable: This document describes non-clinical performance testing of a physical medical device, not an AI algorithm. There is no "test set" in the context of data for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable: As above, this is not an AI study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: As above, this is not an AI study.
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: As above, this is not an AI study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: As above, this is not an AI study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the AI context: For this physical device, the "ground truth" (or reference standard) is established by recognized engineering and biocompatibility standards (e.g., ISO 10993-1) and the performance of the predicate device.
The sample size for the training set
- Not Applicable: This is not an AI study.
How the ground truth for the training set was established
- Not Applicable: This is not an AI study.

Summary

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DEC 1 9 2013

ﺮ

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

Date Prepared: 19-November-2013

A. Sponsor:

AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804

B. Contact:

Teri Juckett Manager, Global Regulatory Affairs Tel: 518-795-1142 Fax: 518-742-4323 Email: tjuckett@angiodynamics.com Lorraine M. Hanley Vice President, Global Regulatory Affairs Tel: 508-658-7945 Fax: 508-658-7976 Email: Ihanley(@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
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
Premarket Notification:	K102796 and K100199

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 testing, which include:

. Visual Inspection
Sheath / Dilator Interface (Length and Force to Withdraw) .
Depth Mark Spacing ●
Surface Friction Testing .
Static Pressure Testing .
Luer Lock Fitting Testing .
Tensile Test Hub Joints .
Needle Tensile .
. Fiber Output
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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

December 19, 2013

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

AngioDynamics Incorporated Ms. Lorraine M. Hanley Vice President, Global Regulatory Affairs 603 Queensbury Avenue Queensbury, New York 12804

Re: K133561

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: November 19. 2013 Received: November 26, 2013

Dear Ms. Hanley:

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 - Ms. Lorraine M. Hanley

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 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For 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

1 1999 1

K133561

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)

Neil R-Dade 201391 -05'00

(Division Sign-Off) for BSA

Division of Surgical Devices

510(k) Number _K133561

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.