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K Number
K133561
Device Name
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
2013-12-19

(29 days)

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

K102796,K100199

Not Found

No
The summary describes a physical medical device (sheath) and its intended use in a laser treatment procedure. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on physical properties and biocompatibility.

Yes
The device is indicated for the treatment of various vein conditions, directly providing a therapeutic effect by enabling endovascular coagulation.

No

Explanation: The device is a sheath used during endovascular venous laser treatment procedures to deliver a laser fiber, indicating a therapeutic or interventional function, not a diagnostic one. Its stated 'Intended Use / Indications for Use' also describes treatment rather than diagnosis.

No

The device description clearly states it is a physical sheath used as a conduit for a laser fiber, and the performance studies involve testing physical properties of the sheath. This indicates it is a hardware device, not software-only.

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 body (endovascular coagulation of veins). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a patient's health.
  • Device Description: The device is a sheath used as a conduit for a laser fiber within the patient's vein. This is a surgical/interventional device, not a diagnostic tool that analyzes samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.

Therefore, the VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits are medical devices used for treatment, not for in vitro diagnostic purposes.

N/A

Intended Use / Indications for Use

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.

Product codes

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Great Saphenous Vein (GSV), 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 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.

Key Metrics

Not Found

Predicate Device(s)

K102796 and K100199

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.

0

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:

D.

| Trade Name: | VenaCure EVLT Tre' Sheath
VenaCure 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' Sheath
VenaCure 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 |

or

E. 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.

F. Intended Use:

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.

1

◆

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.

2

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

3

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:

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.

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