(3037 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
Yes
The device explicitly states what it is NOT labeled for, including having an accelerating effect on wound healing, being a permanent dressing, or a treatment or cure for any wound. This implies that its primary use is related to wound care, even if not for the purposes listed. Devices that interact with the body to manage or treat a condition, even if not explicitly curing, are considered therapeutic.
No
The provided text describes limitations on what the device cannot be labeled for (e.g., accelerating wound healing, treatment, cure), which suggests it is not a diagnostic device. There is no information indicating it identifies, diagnoses, or monitors a disease or condition.
Unknown
The provided text is a list of disclaimers and limitations on the intended use of a device. It does not contain any description of the device itself, its components, or its functionality. Therefore, it is impossible to determine if it is a software-only medical device.
Based on the provided text, there is no indication that this device is an IVD (In Vitro Diagnostic).
The text focuses on limitations regarding the device's labeling and intended use related to wound care (burns, healing, dressing types, treatment). IVDs are devices used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
The description provided does not align with the typical characteristics or intended use of an IVD.
N/A
Intended Use / Indications for Use
"...This device may not be labeled for use on third degree burns. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. This device may not be labeled as a treatment or a cure for any type of wound."
Product codes
FRO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Mr. A. Bart Flick Research Director Argentum International LLC 36 Lake Rabun Road Lakemont, Georgia 30552
Re: K984205 Trade Name: Silverlon™ Adhesive Strip Regulatory Class: Unclassified Product Code: FRO Dated: November 24, 1998 Received: November 24, 1998
Dear Mr. Flick:
This letter corrects our substantially equivalent letter of February 22, 1999.
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 to device referents as a correst marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been the chaonielin accordance with the provisions of the Federal Food, Drug, and Cosmetic Act recrassified in accordine approval of a premarket approval (PMA). You may, therefore, (100) that as not required to the general controls provisions of the Act. The general market the devilos, but your to annual registration, for annual registration, listing of controlo pro researing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:
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This device may not be labeled for use on third degree burns.
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This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1
Page 2 - Mr. A. Bart Flick
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
This letter will allow you to continue 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.
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Page 3 -- Mr. A. Bart Flick
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 prease contact to , "Misbranding by reference to premarket notification" (21CFR Part 102.97). You may obtain other general information on your responsibilities under the Act 007:57): Touring Sciall Careers, 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/dsma/dsmamain.html
Sincerely yours,
Mardi X. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health