(62 days)
The AngioDynamics, Inc. ELVS Procedure Kit is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and is also indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
The AngioDynamics, Inc. ELVS Procedure Kit is indicated for use with 810 mm and 980 nm Diode Lasers with SMA 905 connectors.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device (AngioDynamics, Inc. ELVS Procedure Kit). It primarily addresses the regulatory approval process and includes the device's indications for use.
Crucially, this document focuses on confirming substantial equivalence to a predicate device and does NOT contain the detailed information necessary to answer your specific questions about acceptance criteria, study design, performance data, sample sizes, ground truth establishment, or expert qualifications.
The 510(k) clearance process typically involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. While this involves some form of testing and data, the details requested in your prompt (e.g., specific acceptance criteria, sample sizes for test/training sets, expert ground truth establishment) are generally contained within the full 510(k) submission, which is not provided here.
Therefore, I cannot provide the requested information based solely on this document. To answer your questions, I would need access to the actual 510(k) submission or a summary of the clinical/performance data presented in it.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
JUN 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Teri Juckett Regulatory Affairs Manager AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, New York 12804
Re: K031233
Trade/Device Name: AngioDynamics, Inc. ELVS 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: II Product Code: GEX Dated: April 16, 2003 Received: May 6, 2003
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Teri Juckett
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Application: Traditional 510(k)
AngioDynamics, Inc. ELVS Procedure Kit Device Name:
Indications for Use:
The AngioDynamics, Inc. ELVS Procedure Kit is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and is also indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
The AngioDynamics, Inc. ELVS Procedure Kit is indicated for use with 810 mm and 980 nm Diode Lasers with SMA 905 connectors.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K63/233
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
§ 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.