(20 days)
No
The device description focuses on disposable components for a laser procedure and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is indicated for "endovascular coagulation" and "treatment of varicose veins and varicosities associated with superficial reflux", indicating it is used to directly treat a medical condition.
No
Explanation: The device is described as an "endovascular coagulation" kit and procedure kit which is used for treatment ("treatment of varicose veins and varicosities", "treatment of incompetence and reflux"). It introduces a laser fiber to coagulate veins, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly lists physical components such as fibers, introducer sheaths, guidewires, and needles, indicating it is a hardware-based medical device kit.
Based on the provided information, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes procedures performed within the patient's body (endovascular coagulation, introduction into peripheral vasculature) for the treatment of conditions like varicose veins and superficial vein reflux. This is an in vivo application.
- Device Description: The components listed (laser fiber, introducer sheath, guidewire, needle) are all designed for direct interaction with the patient's anatomy during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body to diagnose or monitor a condition. IVD devices are used to perform tests on biological specimens in vitro.
Therefore, these devices are therapeutic medical devices used for surgical procedures, not IVD devices.
N/A
Intended Use / Indications for Use
VenaCure EVLT NeverTouch Procedure Kit: The AngioDynamics 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."
VenaCure EVLT NeverTouch Direct Introducer Sheath: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Introducer Sheath is indicated for use with the VenaCure The EVLT NeverTouch Direct Procedure Kit to introduce the laser fiber into the peripheral vasculature.
VenaCure EVLT NeverTouch Direct Procedure Kit: "The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of variose 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, DYB
Device Description
VenaCure EVLT NeverTouch and NeverTouch Direct Fiber Procedure Kits should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower extremity.
VenaCure EVLT NeverTouch Procedure Kit: The VenaCure EVLT Fiber Procedure Kits include single use disposable devices for use with a laser for the treatment of varicose veins. In addition, the Trè-Sheath Introducer is available both in the kits and provided individually. The main components of the NeverTouch Procedure Kit are identified below:
- 600μ VenaCure EVLT NeverTouch Fiber
- 4Fr Tre' Sheath Introducer
- 0.035" Guidewire
- 19 Gauge or 21 Gauge Entry Needle
VenaCure EVLT NeverTouch Direct Fiber Procedure Kit: The VenaCure EVLT NeverTouch Direct Procedure Kits is comprised of single use disposable devices for use with a laser for the treatment of varicose veins. The VenaCure EVLT NeverTouch Direct Fiber Procedure Kits are comprised of
- . 21 Gauge Entry Needle
- 0.018" Guidewire
- . Introducer Sheath/Dilator Assembly
- Fiber
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, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: The proposed VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits and the predicate/reference devices have the same indications for use, intended use, principles of operation, and fundamental scientific technology. The labeling updates to the VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits do not affect the materials, design, biocompatibility/sterilization, technical characteristics, functionality, performance (bench), or usability therefore new testing was not conducted to support the change and previous testing was leveraged from the predicate (K171921) and reference devices (K170695 and K112600).
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2023
AngioDynamics, Inc. Laura Dwyer Regulatory Affairs Specialist 603 Oueensbury Queensbury, New York 12804
Re: K231945
Trade/Device Name: VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits 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, DYB Dated: June 29, 2023 Received: June 30, 2023
Dear Laura Dwyer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Premarket Notification - Special 510(k) VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits 2023 June 29
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023 |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| k) Number (if known) | K231945 |
| Device Name | VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits |
| Indications for Use (Describe) | |
| VenaCure EVLT NeverTouch Procedure Kit: | The AngioDynamics 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." |
| VenaCure EVLT NeverTouch Direct Introducer Sheath: | The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Introducer Sheath is indicated for use with the VenaCure |
"The EVLT NeverTouch Direct Procedure Kit to introduce the laser fiber into the peripheral vasculature."
VenaCure EVLT NeverTouch Direct Procedure Kit
5100
Devi Vena
Indic Ven "The Grea asso of su
Ven
"The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of variose 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."
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Confidential and Proprietary to AngioDynamics, Inc.
3
510(K) SUMMARY FOR THE VENACURE EVLT NEVERTOUCH DIRECT PROCEDURE KIT AND VENACURE EVLT TRE'SHEATH AND VENACURE EVLT NEVERTOUCH PROCEDURE KITS
| A. | SPONSOR | AngioDynamics, Inc.
26 Forest Street
Marlborough, MA 01752
USA |
|-----------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. | CONTACT | Laura Dwyer
Regulatory Affairs, Specialist I,
Tel: 508.658.7813
Email: laura.dwyer@angiodynamics.com |
| C. | DEVICE NAME | |
| | Trade Name: | VenaCure EVLT NeverTouch Direct Procedure Kits
VenaCure EVLT NeverTouch Procedure Kits |
| | Common/Usual Name: | VenaCure EVLT NeverTouch Procedure Kit
VenaCure EVLT NeverTouch Tre'Sheath
VenaCure EVLT NeverTouch Direct Procedure Kits
Venacure Evlt Nevertouch Direct Introducer Sheath |
| | Classification Name: | Powered laser surgical instrument |
| | Classification Panel: | General & Plastic Surgery
(21 CFR § 878.4810, Class II, Pro-Code GEX) |
| D. | PREDICATE DEVICE | |
| | 510(k): | K171921 |
| | Trade Name: | Venacure EVLT Nevertouch Procedure Kit |
| | Common/Usual Name: | VenaCure EVLT NeverTouch Procedure Kit
VenaCure EVLT Tre'Sheath |
| | Classification Name: | Powered laser surgical instrument |
| | Classification Panel: | General & Plastic Surgery
(21 CFR § 878.4810, Class II, Pro-Code GEX) |
| E. | REFERENCE DEVICES | |
| | 510(k): | K170695 |
| | Trade Name: | VenaCure EVLT NeverTouch Direct Introducer Sheath |
| | Common/Usual Name: | VenaCure EVLT NeverTouch Direct Introducer Sheath |
| | Classification Name: | Introducer, catheter |
| | Classification Panel: | General & Plastic Surgery
(21 CFR § 878.1340, Class II, Pro-Code DYB) |
| 510(k): | K112600 | |
| Trade Name: | VenaCure EVLT NeverTouch Direct Procedure Kit | |
| Common/Usual Name: | VenaCure EVLT NeverTouch Direct Procedure Kit
VenaCure EVLT NeverTouch Direct Introducer Sheath | |
| Classification Name: | Powered laser surgical instrument | |
| Classification Panel: | General & Plastic Surgery
(21 CFR § 878.4810, Class II, Pro-Code GEX) | |
Confidential and Proprietary to AngioDynamics, Inc.
4
E. DEVICE DESCRIPTION
VenaCure EVLT NeverTouch and NeverTouch Direct Fiber Procedure Kits should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower extremity.
VenaCure EVLT NeverTouch Procedure Kit
The VenaCure EVLT Fiber Procedure Kits include single use disposable devices for use with a laser for the treatment of varicose veins. In addition, the Trè-Sheath Introducer is available both in the kits and provided individually. The main components of the NeverTouch Procedure Kit are identified below:
- 600μ VenaCure EVLT NeverTouch Fiber
- 4Fr Tre' Sheath Introducer ●
- 0.035" Guidewire
- 19 Gauge or 21 Gauge Entry Needle ●
VenaCure EVLT NeverTouch Direct Fiber Procedure Kit
The VenaCure EVLT NeverTouch Direct Procedure Kits is comprised of single use disposable devices for use with a laser for the treatment of varicose veins. The VenaCure EVLT NeverTouch Direct Fiber Procedure Kits are comprised of
- . 21 Gauge Entry Needle
- 0.018" Guidewire ●
- . Introducer Sheath/Dilator Assembly
- Fiber ●
F. INDICATION FOR USE
VenaCure EVLT NeverTouch Procedure Kit & Tre' Sheath Set:
The VenaCure EVLT NeverTouch Procedure Kit is 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.
VenaCure EVLT NeverTouch Direct Procedure Kit:
The VenaCure EVLT NeverTouch Direct Procedure Kit is 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.
5
VenaCure EVLT NeverTouch Direct Introducer Sheath:
The VenaCure EVLT NeverTouch Direct Introducer Sheath is indicated for use with the VenaCure EVLT NeverTouch Direct Procedure Kit to introduce the laser fiber into the peripheral vasculature.
- G. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE The proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits and the predicate VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits are identical to one another (and therefore substantially equivalent) in all aspects, not limited to design, materials, manufacturing, specifications, dimensions, and indication for use. The difference is the proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits is an update to the labeling.
- H. DEVICE MODIFICATIONS AND RISKS ASSOCIATED WITH THE DESIGN MODIFICATION(S) Modifications made to the VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits were limited to updating the labeling.
There is no change to the principles of operation, indications for use, intended use, fundamental scientific technology, or technological characteristics between the proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits and the predicate/reference devices.
The impact of the changes as described within this submission were evaluated as part of the Risk Analysis activity in terms of new/existing risks and new/existing failure modes. The results of this Risk Analysis activity were compared to the current Risk Analysis; the conclusions drawn from this assessment, determined the proposed modifications did not impactor modify an existing risk nor necessitate a new or modified risk.
I. NON-CLINICAL TESTING
The proposed VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits and the predicate/reference devices have the same indications for use, intended use, principles of operation, and fundamental scientific technology. The labeling updates to the VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits do not affect the materials, design, biocompatibility/sterilization, technical characteristics, functionality, performance (bench), or usability therefore new testing was not conducted to support the change and previous testing was leveraged from the predicate (K171921) and reference devices (K170695 and K112600).
J. CONCLUSIONS
The proposed labeling change to the VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits does not change its intended use nor does it change the principles of operation. The proposed and predicate/reference devices are substantially equivalent.