LogoFDA 510(k) Search
K Number
K130671
Device Name
VENACURE EVLT NEVERTOUCH PROCEDURE KIT
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
2013-03-26

(14 days)

Product Code
GEX
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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
More Information

K112600

Not Found

No
The summary describes a procedure kit with physical components (fiber, sheath, needle, guidewire) and focuses on non-clinical performance testing of these components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.

Yes
The device is indicated for "endovascular coagulation of the great saphenous vein... for the treatment of varicose veins and varicosities... and for the treatment of incompetence and reflux of superficial veins of the lower extremity," which describes a therapeutic purpose.

No

The device is indicated for endovascular coagulation and treatment of varicose veins and superficial vein reflux, which are therapeutic interventions rather than diagnostic processes.

No

The device description explicitly lists physical components (fiber, sheath, dilator, needle, guidewire) and the performance studies focus on physical characteristics and simulated use, indicating it is a hardware-based medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes a procedure performed on the patient's veins (endovascular coagulation) to treat a medical condition (varicose veins and superficial vein reflux). This is a therapeutic intervention, not a diagnostic test performed on a sample taken from the body.
  • Device Description: The components listed (fiber, sheath, needle, guidewire) are tools used for a surgical or interventional procedure within the body. They are not designed to analyze biological samples.
  • Performance Studies: The performance studies focus on the physical and functional characteristics of the device itself (tensile strength, output testing, simulated use, biocompatibility), not on the accuracy or reliability of a diagnostic measurement.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

N/A

Intended Use / Indications for Use

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.

Product codes

GEX

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 ●

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

great saphenous vein, superficial veins of the lower extremity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

K112600

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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:

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

1

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.

2

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

3

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:

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.

Prescription Use X (Per 21 CFR 801.109)

OR

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