(168 days)
Wound cover for patient care.
Gauze, Sponges Various Sizes, Non-Sterile and Sterile
The provided text is a 510(k) premarket notification letter from the FDA regarding "Gauze Sponges." This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML device evaluations.
Therefore, I cannot fulfill your request for the specific information regarding a study, as this information is not present in the provided text. The document is simply an FDA clearance for a medical device (gauze sponges) that was deemed substantially equivalent to existing devices, without the need for the types of performance studies you are asking about for AI/ML products.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Ms. Ginger Talley Quality Assurance VitalCare Group, Inc. 15800 N.W. 13th Avenue Miami, Florida 33169
Re: K983016 Trade Name: Gauze Sponges Regulatory Class: Unclassified Product Code: EFQ Dated: December 23, 1998 Received: December 30, 1998
Dear Ms. Talley:
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 - Ms. Ginger Talley
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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INDICATIONS FOR USE
Applicant: VitalCare Group, Inc. 15800 N.W. 13th Avenue Miami, FL 33169
510(k) Number (if Known): __
Device Name: Gauze, Sponges Various Sizes, Non-Sterile and Sterile
Indications for Use: Wound cover for patient care.
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K983016
510(k) Number
Prescription Use Xor or Over-The-Counter
N/A