(24 days)
K/DEN number: Not Found
Not Found
No
The summary describes a physical medical device (sheath and procedure kits) used for endovascular procedures and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as a sheath used to facilitate a laser treatment procedure, not the therapeutic device itself. Its purpose is to act as a conduit for a laser fiber.
No
The device is described as a sheath used as a conduit for placing a laser fiber during endovascular venous laser treatment procedures. Its indicated use is for "endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities... and for the treatment of incompetence and reflux of superficial veins of the lower extremity." This description outlines a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "4F sheath used during endovascular venous laser treatment procedures" and is offered in various lengths, indicating it is a physical hardware device. The performance studies also focus on material and mechanical properties like tensile and torque strength, further confirming it is 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 within the patient's body (endovascular coagulation of veins). IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The device is a sheath used as a conduit for a laser fiber during a medical procedure. This is an interventional device, not a diagnostic one used for testing samples.
- Performance Studies: The performance studies mentioned (Tensile, Torque, Biocompatibility) are related to the physical properties and safety of the device for use within the body, not the accuracy or reliability of a diagnostic test.
The device described is an interventional medical device used for treating venous conditions, not for diagnosing them.
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 and material testing, which include: Tensile, Torque, Biocompatibility per ISO 10993-1.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.
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:
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)
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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:
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 |
| Predicate Device: | |
| 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 |
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.
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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.