(145 days)
The AngioDynamics, Inc. VenaCure NeverTouch Direct Procedure Kit is indicated for the treatment of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein and other superficial veins of the lower extremity.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to AngioDynamics, Inc. It confirms that their "VenaCure NeverTouch Direct Procedure Kit" has been found substantially equivalent to legally marketed predicate devices.
However, this document does not contain specific information about acceptance criteria, device performance results, sample sizes for testing, expert qualifications, adjudication methods, or details about standalone or MRMC studies that would describe how the device met acceptance criteria. It primarily focuses on the regulatory approval and indications for use.
Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a clinical study report or performance evaluation.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 3 0 2012
AngioDynamics, Inc. % Ms. Teri Juckett 603 Queensbury Avenue Queensbury, New York 12804
Re: K112600
Trade/Device Name: AngioDynamics, Inc. VenaCure NeverTouch Direct Procedure Kit Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology
Regulatory Class: Class II Product Code: GEX Dated: January 25, 2012 Received: January 26, 2012
Dear Ms. Juckett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave and have 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 for associated in 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 I ou may) aters 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
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Page 2 - Ms. Teri Juckett
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 Of K Furt 007), adoling (21 CFR 803); good manufacturing practice requirements as set de rice-relation daverse overily (21 CFR Part 820); and if applicable, the electronic forth in the quality by brokes (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 11 you desire specific advice to: your corntersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the 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 Tou may obtain other general 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Confidential
INDICATIONS FOR USE
510(k) Application: Traditional 510(k) Submission
AngioDynamics, Inc. VenaCure NeverTouch Direct Procedure Kit Device Name:
Indications for Use:
The AngioDynamics, Inc. VenaCure NeverTouch Direct Procedure Kit is indicated for The Anglobynames, inc. "The great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great the treatment of varies were was was was was the was reflux of superficial veins of the lower extremity.
X Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil RPolh for nxm
(Division Sign bm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112600
AngioDynamics VenaCure NeverTouch Direct Procedure Kit 510(k) Design History File 100520
§ 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.