(62 days)
Elta Silver Antimicrobial Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Not Found
This document is a letter from the FDA regarding the 510(k) premarket notification for the "Elta Silver Antimicrobial Wound Gel". It states that the device is substantially equivalent to legally marketed predicate devices.
The information you are asking for, regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, and comparative effectiveness studies, is typically found in the premarket notification submission itself, which is a much more detailed document than this FDA clearance letter. This letter is simply the FDA's decision based on their review of that submission.
Therefore, this document does not contain the information requested in your prompt. It does not describe acceptance criteria, device performance, details of studies, sample sizes, or ground truth methodologies. It only states that the device has been found substantially equivalent for the indicated uses.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2007
AUG 22 2001.
Swiss-American Products, Inc. % Eric Luo, Ph.D. Director, Research and Development 2055 Luna Road, #126 Carrollton, Texas 75006
Re: K071703
Trade/Device Name: Elta Sivler Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: August 6, 2007 Received: August 7, 2007
Dear Dr. Luo:
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, Drug, 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, 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 (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 - Eric Luo, Ph.D.
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), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K071703
Device Name: Elta Silver Antimicrobial Wound Gel
Indications for Use:
Elta Silver Antimicrobial Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ 1607/1703
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