(308 days)
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer 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.
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) premarket notification letter from the FDA to AngioDynamics Inc. regarding their Percutaneous Introducer and VenCureEVLT Procedure Kit. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory provisions. The "Indications for Use" section describes what the device is intended for but does not provide performance metrics or study details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
AngioDynamics Inc. c/o Ms. Teri Juckett 603 Queensbury Ave Queensbury, NY 12804
NOV 2-6 2010
Re: K100199
Trade/Device Name: AngioDynamics Percutaneous Introducer and VenCureEVLT Procedure Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulatory Class: Class II Product Code: GEX Dated: November 8, 2010 Received: November 10, 2010
Dear Ms. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Juckett
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 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/ReportalProblem/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 Small 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,
W.M.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Image /page/2/Picture/1 description: The image shows the text 'K100199' on the top line. The second line of text says 'Nov. 2 6 2010'. The text appears to be handwritten and is in black ink. The image is a close-up of the text.
510(k) Application: Traditional 510(k): Device Modification
Device Name: AngioDynamics, Inc. Percutaneous Introducer and VenaCureEVLT Procedure Kit
Indications for Use:
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer 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.
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.
OR
Prescription Use X (Per 21 CFR 801.109)
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)
W.M.A.
iovascular Devices
510(k) Number K100044
§ 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.