The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kit is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Device Description

AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kits are offered with the following components:

600um Fiber with markings on the fiber to aid in withdrawal
Introducer Sheath and Dilator
Entry Needle
Guidewire

AI/ML Overview

The provided text describes the AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kit and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria for a study and the device performance against those criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed results from a clinical or performance study with defined acceptance criteria and statistical analysis.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

No Acceptance Criteria or Reported Performance: The document states that the device is substantially equivalent based on "non-clinical performance testing in accordance with ISO 10993 and in-house test criteria," which included a list of tests (Fiber to Tip Tensile, Fiber to SMA Tensile, Fiber output Testing, Surface Visual, Depth Marks, Simulated Use Testing, Biocompatibility per ISO 10993-1). However, it does not list specific acceptance criteria for these tests nor does it report the quantitative or qualitative results of these tests against any such criteria.
No Study Details: The document mentions "non-clinical performance testing," but it does not describe a "study" in the sense of a clinical trial or a statistically designed performance evaluation with sample sizes, ground truth establishment, expert involvement, or adjudication methods.
No Information on AI/Algorithm Performance: The device described is a medical kit for a surgical procedure (laser treatment for varicose veins). There is no mention of an AI or algorithm in its function, so questions related to standalone algorithm performance, MRMC studies, or human reader improvement with AI assistance are not applicable.

In summary, the provided text only states that non-clinical testing was performed and supports substantial equivalence, but it lacks the detailed performance data and study design information you've requested.

Summary

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Image /page/0/Picture/1 description: The image shows the word "angiodynamics" in a sans-serif font, with the letters in black. To the left of the word is a black abstract symbol that looks like a stylized knot or a geometric shape. The symbol is composed of curved lines that intersect and overlap, creating a sense of movement or flow.

MAR 2 6 2013

510(k) Summary: [As required by 21 CFR 807.92]

AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kit

Date Prepared: 08 March 2013

A. Sponsor:	AngioDynamics, Inc.
	603 Queensbury Avenue
	Queensbury, NY 12804
B. Contact:	Teri Juckett
	Regulatory Affairs Manager
	Phone: 518-795-1142
C. Device Name:
	Trade Name: AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kit
	Common/Usual Name: Greater Saphenous Vein Procedure Kit
	Classification Name: Laser Instrument, Surgical Powered
D. Classification:
	Class: Class II
	Product Code: GEX
	Regulation Number: 21 CFR 878.4810
E. Predicate Device:
	Predicate Name: AngioDynamics VenaCure EVLT NeverTouch Procedure Kit
	Predicate 510(k): K112600
	Panel: General & Plastic Surgery

F. Device Description:
AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kits are offered with the following components:
600um Fiber with markings on the fiber to aid in withdrawal ●
. Introducer Sheath and Dilator
Entry Needle .
Guidewire ●
G. Intended Use:

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of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

H. Technological Characteristics:
The proposed device has similar materials, design, components, and technical characteristics as the predicate device.
I. Performance Data:
The proposed AngioDynamics VenaCure EVLT NeverTouch Direct procedure kit is substantially equivalent to the specified predicate device based on a comparison of technological characteristics and the results of non-clinical performance testing in accordance with ISO 10993 and in-house test criteria, which included:
. Fiber to Tip Tensile
Fiber to SMA Tensile .
Fiber output Testing .
. Surface Visual
Depth Marks ●
Simulated Use Testing ●
. Biocompatibility per ISO 10993-1
J. 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

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

March 26, 2013

Angiodynamics, Incorporated % Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Avenue Queensbury, New York 12804

Re: K130671

Trade/Device Name: AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct 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: March 08, 2013 Received: March 12, 2013

Dear Ms. 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 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 -- Ms. Teri Juckett

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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, FOR Peter D. Rumm -S

Mark N. Melkerson Acting 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) Application: Special 510(k) Submission

Device Name: AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kit

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use _

Please do not write below this line - continue on another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden==================================================================================================================================================================

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130671

AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kit 510(k) Page 16 of 33

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.