(539 days)
Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1st and 2nd degree burns; donor sites
CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Calgitrol™ AG Silver Alginate Foam and Gel Foam Dressings). This letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory approval letter, not a study report.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping human profiles, creating a sense of unity and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2002
ADRI · George H. Scherr Director P. O. Box 134 Park Forest. Illinois 60466
Re: K011618
Trade/Device Name: Calgitrol™ AG Silver Alginate Foam and Gel Foam Dressings, with or without Maltodextrin
Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 22, 2002 Received: August 23, 2002
Dear Dr. Scherr:
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. Drue, 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. Iisting 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 – Dr. George H. Scherr
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21 CFR Part 807.97). 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,
Muram C. Phurst
(cl 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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Page 1 of 1
510(k) Number (if known); ' K011618
Device Name: CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin
Indications for Use:
Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1* and 2nd degree burns; donor sites
..
uriam C. Thorst
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011618
(PLEASE DO NOT WRITE: BELOW THIS GINE-CONTINUE ON-ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.108) જ્ઞર
Over-The Counter Use
(Optional: Format 1-2-96);
N/A