(270 days)
to enable clinicians to withdraw quantities of solution multiple times from vials without the need for needles.
Multi-Dose Vial Adapter & Bionector
The provided text is a U.S. FDA 510(k) clearance letter for the VYGON Multi-Dose Vial Adapter & Bionector. This type of document does not contain details about acceptance criteria, study design, or specific performance metrics of the device itself.
The letter is a regulatory approval, stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements, but not the technical data that would be used to establish acceptance criteria or prove performance.
Therefore, I cannot provide the requested information based on the input text. The information points you've asked for (acceptance criteria table, sample sizes, ground truth, expert qualifications, etc.) are typically found in the 510(k) submission summary or detailed study reports, which are not part of this clearance letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VYGON Corporation C/O Ms. Anne Marie Cesario Director, Regulatory Affairs Schiff & Company® 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
K963571 Re : VYGON Multi-Dose Vial Adapter & Bionector Trade Name: Requlatory Class: II Product Code: FMI Dated: April 30, 1997 Received: May 1, 1997 JUN - 2 1997
Dear Ms. Cesario:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Farts 800 to 895. rti substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister.
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Page 2 - Ms. Cesario
premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 of (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Tim Akers Ulatowski
Timothy A. Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Figure/1 description: This document appears to be a medical device submission form. It indicates that the 510(k) number is not yet assigned, and the device name is "Multi-Dose Vial Adapter & Bionector". The intended use is to enable clinicians to withdraw quantities of solution multiple times from vials without the need for needles. The device is intended for prescription use, and the 510(k) number is K963571.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).