(58 days)
Not Found
No
The device description and performance studies focus on physical characteristics and material testing of a sheath and procedural accessories for endovascular venous laser treatment, with no mention of AI or ML.
Yes
The device is indicated for endovascular coagulation of veins and treatment of associated conditions, which are therapeutic interventions.
No
This device is designed for endovascular coagulation of veins to treat varicose veins and associated conditions, which is a therapeutic procedure, not a diagnostic one. It is used as a conduit for placing a laser fiber for treatment.
No
The device description clearly lists multiple physical components such as sheaths, guidewires, and needles, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the patient's body (endovascular coagulation of veins). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device components are instruments and accessories used for a surgical procedure (sheaths, guidewires, needles). They are not reagents, kits, or instruments designed for analyzing biological samples.
- Anatomical Site: The device is used within the veins of the lower extremity, which is an in-vivo application, not an in-vitro analysis of a sample.
Therefore, this device falls under the category of a surgical or procedural device, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits include a variety of procedural accessories:
- NeverTouch Fiber with Sheath-Loc Fitting
- Tre' Sheath Introducer with Dilator
- Teflon Coated Stainless Steel Guidewire (lengths from 70cm to 200cm)
- 0.018 Guidewire (Lengths from 45cm to 200cm)
- Micro Access Components:
- 21 gauge Entry Needle
- 5F x 10cm Sheath/Dilator
- 0.018" x 45cm Guidewire
- 19 gauge Entry Needle (optional)
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 the various procedural accessories detailed above.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed VenaCure EVLT Tre' Sheath and VenaCure NeverTouch EVLT Procedure Kit are substantially equivalent to the specified predicate device based on a comparison of technological characteristics and the results of non-clinical performance and material testing, which include:
- Leak Resistance
- Tensile Strength
- Dilator Withdrawal Force
- Dilator Insertion
- Biocompatibility per ISO 10993-1
Key results: 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central graphic. The graphic consists of three stylized human profiles facing to the right, with the profiles overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2017
AngioDynamics, Inc. Hans Kjolhede Specialist I, Global Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752
Re: K171921
Trade/Device Name: 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: June 26, 2017 Received: June 27, 2017
Dear Hans Kjolhede:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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.
Jennifer R. Stevenson -S3
For 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
2
Indications for Use
510(k) Number (if known)
Device Name
VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits
Indications for Use (Describe)
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.
| or both, as applicable) |
|---|
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one
3
510(K) SUMMARY FOR THE VENACURE EVLT TRE' SHEATH AND NEVERTOUCH PROCEDURE KITS
Date prepared: 06/26/2017
A. Sponsor
AngioDynamics, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Hans Kjolhede Global Regulatory Affairs HKjolhede@angiodyanmics.com (508) 658-7944
Subject Device:
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel:
Predicate Device
Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel:
Robin Fuller Sr. Manager Regulatory Affairs RFuller@angiodynamics.com (508) 658-7986
VenaCure EVLT Tre' Sheath VenaCure EVLT NeverTouch Procedure Kit
Greater Saphenous Vein Procedure Kit
21 CFR 878.4810
Laser Instrument, Surgical Powered
Class II
GEX
General Hospital & Plastic Surgery
AngioDynamics VenaCure EVLT Tre' Sheath And VenaCure EVLT NeverTouch Procedure Kit
Grater Saphenous Vein Procedure Kit
21 CFR 878.4810
Laser Instrument, Surgical Powered
Class II
GEX
General Hospital & Plastic Surgery
4
C. Device Description
The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits include a variety of procedural accessories:
- NeverTouch Fiber with Sheath-Loc Fitting
- Tre' Sheath Introducer with Dilator
- Teflon Coated Stainless Steel Guidewire (lengths from 70cm to 200cm) ●
- 0.018 Guidewire (Lengths from 45cm to 200cm)
- . Micro Access Components:
- o 21 gauge Entry Needle
- 5F x 10cm Sheath/Dilator O
- 0.018" x 45cm Guidewire o
- 19 gauge Entry Needle (optional) O
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 the various procedural accessories detailed above.
D. 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.
E. Technological Characteristics
The proposed device will now incorporate a blue silicone gasket lubricated with silicone into the Tre' Sheath Hemostasis Valve Assembly. Additionally, the housing of the Tre' Sheath Hemostasis Valve Female Luer and Tre' Sheath Hemostasis Valve Body will be altered to compensate for the addition of the silicone gasket. Indications for Use and all other technological characteristic will remain the same as the predicate.
F. Performance Data
The proposed VenaCure EVLT Tre' Sheath and VenaCure NeverTouch EVLT Procedure Kit are substantially equivalent to the specified predicate device based on a comparison of technological characteristics and the results of non-clinical performance and material testing, which include:
- . Leak Resistance
- Tensile Strength
- Dilator Withdrawal Force ●
- Dilator Insertion
- Biocompatibility per ISO 10993-1 ●
5
G. 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.