(78 days)
The SUILE Ointment Wound Dressing is indicated for the management of 1ª and 2ª4 degree burns, partial thickness wounds, donor sites and abrasions.
SUILE Ointment Wound Dressing
I apologize, but the provided text is a 510(k) clearance letter from the FDA for a wound dressing, not a study report or a document detailing the acceptance criteria and performance of a device based on a specific study.
Therefore, I cannot extract the information required to answer your questions as it is not present in the provided text. The document is primarily about regulatory approval and does not contain details regarding:
- Acceptance criteria and reported device performance in a table format.
- Sample size or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance of an algorithm.
- Type of ground truth used.
- Sample size for a training set.
- Method for establishing ground truth for a training set.
This document confirms that the SUILE Ointment Wound Dressing is "substantially equivalent" to legally marketed predicate devices for the indicated uses, but it does not provide the detailed study results you are asking for.
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Public Health Service
JUL - 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hedonist Biochemical Technologies Co., Ltd c/o Eric Luo, Ph.D. 2828 W. Parker Road, Suite #207 Plano, Texas 75075
Re: K041013
Trade/Device Name: SUILE Ointment Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 18, 2004 Received: April 20, 2004
Dear Dr. Luo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becement of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered print to May 20, 1978, the econdance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Free, market the device, subject to the general controls provisions of the Act. The r ou may, dierely mains of the Act include requirements for annual registration, listing of general controls provincities, 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 If your device is elassince (controls. Existing major regulations affecting your device can may or sabject to dash ware and 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 or unry 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 Orth 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 - Eric Luo, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you're begin finding of substantial equivalence of your device to a legally promative hotifications on "ceresults 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), please If you demo specific an Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
Muriam C. Provost
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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510(k) Number (if known): K041013
Device Name: SUILE Ointment Wound Dressing
Indications For Use:
The SUILE Ointment Wound Dressing is indicated for the management of 1ª and 2ª4 degree burns, partial thickness wounds, donor sites and abrasions.
Prescription Use_ V (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
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510(k) Number K641013
N/A