(78 days)
Management of venous cuts, for example, cuts resulting from any shape objects and abrasions, other superficial injuries, superficial wounds, burns (1st and 2nd degree) donor sites, post operative wound.
vitop® Dressing
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Vitop® Dressing," indicating that the device is substantially equivalent to legally marketed predicate devices.
The letter does not contain details about specific acceptance criteria testing, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. It focuses solely on the regulatory approval.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 1999 JUN
Wonder Bioenergy Hi-Tech America, Inc. c/o Mr. Arthur King K. Ma D & R Marketing Firm 108 N. Ynez Avenue, Suite 128 Monterey Park, California 91754
K990974 Re: Trade Name: Vitop® Dressing Regulatory Class: Unclassified Product Code: EFQ Dated: March 4, 1999 Received: March 23, 1999
Dear Mr. Ma:
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 the Federal Register. Please note: this response to your 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.
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Page 2 - Mr. Arthur King K. Ma
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) 594-4595. 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" (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 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K990974 510(k) NUMBER (IF KNOWN):
DEVICE NAME: vitop® Dressing
INDICATION FOR USE:
Management of venous cuts, for example, cuts resulting from any shape objects and abrasions, other superficial injuries, superficial wounds, burns (1st and 2nd degree) donor sites, post operative wound.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDEH, Office of Device Evaluation (ODE)
Pcotelefo
(Division Sign-Off) Division on Ceneral Staturative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter-Use (Optional Format 1-2-96)
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N/A