(164 days)
This introducer kit is intended for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.
Not Found
I apologize, but the provided text is a scanned document from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.
The document is a clearance letter stating that the Vygon Micro-Access Safety Introducer Kit has been found substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based on the provided text.
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Image /page/0/Picture/2 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines that suggest movement or flight. The logo is encircled by text, which is arranged in a circular fashion around the bird. The text is small and difficult to read, but it appears to be a company or organization name.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 2005
Vygon Corporation c/o Mr. Courtney Smith Regulatory Affairs/Quality Assurance Manager 2495 General Armistead Avenue Norristown, PA 19403-3685
Re: K051248 Vygon Micro-Access Safety Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: August 29, 2005 Received: September 1. 2005
Dear Mr. Smith:
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.
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Page 2 -- Mr. Courtney Smith
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualic complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that I DA nas made a decemmanon that your as read by other Federal agencies. You must a or any Federal statules and regulations administered or registration and listing (21
comply with all the Act's requirements, including, but not manages as set comply with an the Act s requirements, me, good manufacturing practice requirements as setter CFR Part 807); labening (21 CFR Part 800); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and STD, 1000-1 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (occions of review as described in your Section 510(k)
This letter will allow you to begin marketing your device of section of vice to le I his letter will anow you to begin hankeling your antial equivalence of your device to a legally premarket notification. The PDA miding of substantial experience of 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 If you desire specific advice for your de rice of the career note the regulation entitled, the regulation entitled, comaci the Office of Companies at (210) = 1.7 = 1.7 = 1.807.97). You may obtain " Misbranding by reference to premance notifications of the Act from the Division of Small other general information on your responsible in the toll-free number (800) 63-204) or html Manufacturers, international and Consanter Phistown: fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blummenhofer
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
510(k) Number (if known):
Vygon Micro-Access Safety Introducer Kit Device Name:
Indications For Use:
This introducer kit is intended for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.B. Remick
Page 1 of 1
on Sign-Off Division of Cardiovascular Devices 510(k) Number
§ 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).