(84 days)
Not Found
No
The 510(k) summary describes a mechanical introducer sheath and associated kit components for introducing a laser fiber. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are focused on physical and mechanical properties.
No
The device is an introducer sheath used to guide a laser fiber into the vasculature, which is an accessory to a therapeutic procedure (endovascular coagulation) but not therapeutic itself.
No
The device is an introducer sheath used to insert a laser fiber for treating varicose veins, which is a therapeutic rather than diagnostic function. Its performance studies focus on physical properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is an introducer sheath, which is a physical medical device used to introduce a laser fiber into the peripheral vasculature. The performance studies also focus on physical characteristics and testing of the sheath and dilator.
Based on the provided information, the VenaCure EVLT NeverTouch Direct Introducer Sheath is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce a laser fiber into the peripheral vasculature for the treatment of varicose veins. This is an in vivo procedure, meaning it is performed within the living body.
- Device Description: The device is part of a kit used for endovascular coagulation, which is a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing samples outside of the body. This device is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The VenaCure EVLT NeverTouch Introducer Sheath is indicated for use with VenaCure EVLT NeverTouch Direct Kit to introduce the laser fiber into the peripheral vasculature
Product codes
DYB
Device Description
The proposed VenaCure EVLT NeverTouch Direct Introducer Sheath is currently provided in the VenaCure EVLT NeverTouch Direct Procedure Kits as a kit accessory as a legally marketed device covered under the manufacturers 510(k). The kit consists of a laser fiber, introducer sheath, entry needle, and a guidewire. The VenaCure EVLT NeverTouch Direct Procedure kit is used to treat patients with varicose veins via endovascular coagulation by dispersing energy from a diode laser directly into the vein being treated. The Introducer Sheath is used to introduce the laser fiber into the vein.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 performance testing included non-clinical bench testing. The following tests were performed.
- · Sheath Dimensional Testing
- · Dilator Dimensional Testing
- · Luer Fitting ISO Compliance
- · Tensile Testing
- · Sheath Leakage
- Hemostasis Valve Leakage
- · Biocompatibility per ISO 10993-1
This testing supports substantial equivalence of the proposed device to the predicate device as it confirms that both meet the same specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked slightly offset from each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2017
AngioDynamics, Inc. Robin Fuller Sr. Manager, Regulatory Affairs 26 Forest Street Marlboro, MA 01752
Re: K170695
Trade/Device Name: VenaCure EVLT NeverTouch Direct Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 28, 2017 Received: March 7, 2017
Dear Robin Fuller:
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
1
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 yours.
Jennifer R. Stevenson -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170695
Device Name
VenaCure EVLT NeverTouch Direct Introducer Sheath
Indications for Use (Describe)
The VenaCure EVLT NeverTouch Introducer Sheath is indicated for use with VenaCure EVLT NeverTouch Direct Kit to introduce the laser fiber into the peripheral vasculature
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(K) SUMMARY FOR THE ANGIODYNAMICS, INC. VENACURE EVLT NEVERTOUCH INTRODUCER SHEATH
Date Prepared: 25-May-2017
A. Sponsor:
AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752
B. Contact:
Robin Fuller Sr. Manager Regulatory Affairs Tel: 508-658-7986 Fax: 508-658-7976 Email: RFuller@angiodynamics.com
C. Subject Device:
| Trade Name: | AngioDynamics VenaCure EVLT NeverTouch Direct Introducer Sheath |
|---|---|
| Common Name: | Catheter Introducer |
| Regulation Number; | 21 CFR 870.1340 |
| Regulation Name: | Introducer Catheter |
| Regulatory Class: | Class II |
| Product Code: | DYB |
| Classification Panel: | Cardiovascular |
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D. Predicate Device:
| Trade Name: | Hemostasis Valve Catheter Introduce |
|---|---|
| 510(k) Reference: | K043525 |
| Common Name: | Catheter Introducer |
| Regulation Number; | 21 CFR 870.1340 |
| Regulation Name: | Introducer Catheter |
| Regulatory Class: | Class II |
| Product Code: | DYB |
| Classification Panel: | Cardiovascular |
E. Device Description:
The proposed VenaCure EVLT NeverTouch Direct Introducer Sheath is currently provided in the VenaCure EVLT NeverTouch Direct Procedure Kits as a kit accessory as a legally marketed device covered under the manufacturers 510(k). The kit consists of a laser fiber, introducer sheath, entry needle, and a guidewire. The VenaCure EVLT NeverTouch Direct Procedure kit is used to treat patients with varicose veins via endovascular coagulation by dispersing energy from a diode laser directly into the vein being treated. The Introducer Sheath is used to introduce the laser fiber into the vein.
F. Intended Use/Indications for Use:
The VenaCure EVLT NeverTouch Direct Introducer Sheath is intended for use with the VenaCure EVLT NeverTouch Direct Procedure kit. to introduce the laser fiber into the peripheral vasculature.
The predicate device is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
The slight differences in indications between the proposed and predicate device do not affect the intended therapeutic or surgical use of the device. Both are indicated for introducing intravascular devices into the peripheral vasculature, the proposed device is just specific to introduction of the laser fiber. Therefore, there is no effect on the safety and effectiveness of the device when used as labeled.
G. Summary of Similarities and Differences in Technology Characteristics and Performance:
The proposed device has the identical design and technical characteristics as the predicate device. The purpose of this 510(k) submission is to introduce into commercial distribution a sterile, single packaged VenaCure EVLT NeverTouch Direct Introducer Sheath. The proposed VenaCure EVLT NeverTouch Direct Introducer Sheath is currently provided in the VenaCure EVLT NeverTouch Direct Procedure Kits
H. Performance Data:
The performance testing included non-clinical bench testing. The following tests were performed.
- · Sheath Dimensional Testing
- · Dilator Dimensional Testing
- · Luer Fitting ISO Compliance
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- · Tensile Testing
- · Sheath Leakage
- Hemostasis Valve Leakage
- · Biocompatibility per ISO 10993-1
This testing supports substantial equivalence of the proposed device to the predicate device as it confirms that both meet the same specifications.
The following standards were followed for the proposed device:
. BIOCOMPATIBILITY
- The proposed VenaCure EVLT NeverTouch Introducer Sheath conforms to the following FDA o recognized standards:
- AAMI/ANSI/ISO 10993-1: 2009(R)2013, Biological evaluation of medical devices Part 1: । Evaluation and Testing Within a Risk Management Process
- ANSI/AAMI/ISO 10993-4: 2002(R)/2013 & A1:2006(R) 2013, Biological evaluation of | medical devices – Part 4: Selection of tests for interactions with blood
- AAMI/ANSI/ISO 10993-5: 2009(R)2014, Biological evaluation of medical devices Part 5: -Tests for In-Vitro cytotoxicity
- AAMI/ANSI/ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
- -AAMI/ANSI/ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- AAMI/ANSI/ISO 10993-12: 2012, Biological evaluation of medical devices Part 12: — Sample preparation and reference materials
- USP 37-NF-322014, Pyrogen Test —
STERILIZATION/MICROBIOLOGICAL
- The proposed VenaCure EVLT NeverTouch Introducer Sheath conforms to the following FDA o recognized standards:
- AAMI/ANSI/ISO 10993-7: 2008/(R) 2012, Biological evaluation of medical devices Part 7: । ethylene oxide sterilization residuals
- AAMI/ANSI/ISO 11135: 2014 Sterilization of Health Care Products Ethylene Oxide -— Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
- AAMI/ANSI/ISO 11138-1: 2006/ (R) 2010 Sterilization of Health Care Products; Biological — Indicators - Part 1: General Requirements
- -AAMI/ANSI/ISO 11737-1:2006 (R) 2011, Sterilization of Medical Devices-Microbiological Methods- Part 1: Estimation of Population on Microorganisms on Product
- AAMI ST72:2011 (2016), Bacterial Endotoxin Test methodologies, routine monitoring and alternatives to batch testing
- The proposed VenaCure EVLT NeverTouch Introducer Sheath conforms to the following o voluntary standards:
- EN 556-1: 2001. Sterilization of Medical Devices: 'Requirements for medical devices to be । labeled "sterile"-Part 1: Requirements for Terminally Sterilized Medical Devices
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- AAMI/ANSI/ISO 11138-2: 2009 Sterilization of Health Care Products; Biological Indicators l - Part 2: Biological Indicators of Ethylene Oxide Sterilization
PACKAGING
- The proposed VenaCure EVLT NeverTouch Introducer Sheath conforms to the following FDA o recognized standards:
- ISO 11607-1 First Edition, Packaging for terminally sterilized medical devices Part 1: । Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2: 2006(R)2010, Packaging for terminally sterilized medical devices Part 2: -Validation requirements for forming, sealing and assembly processes, 1ed
- ASTM F 88: 2009, Standard Test Method for Seal Strength of Flexible Barrier Materials -
- -ASTM F 1980-2016. Standard Guide for Accelerated Aging of Sterile Medical Device Packages
- -ASTM F 1929- 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- -ASTM F 1886: 2009(R)2013 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
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I. Conclusion:
The results of the non-clinical testing and a discussion of the similarities between the proposed and predicate device demonstrate that the proposed and predicate devices are substantially equivalent.