(81 days)
Not Found
No
The 510(k) summary describes a wound dressing and does not mention any AI or ML components, image processing, or performance studies related to algorithmic analysis.
Yes
The device is intended for the management and treatment of open wounds and various types of ulcers, which are therapeutic purposes.
No
This device is described as a wound dressing for the management of open wounds, indicating a therapeutic or treatment purpose rather than a diagnostic one.
No
The device description clearly states "Amerigel™ Ointment Saturated Wound Dressing," indicating a physical wound dressing product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the management of open wounds" and lists various types of wounds it is used to dress. This is a therapeutic application, not a diagnostic one.
- Device Description: It is described as a "Wound Dressing," which is a topical application for wound care.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is to manage and dress wounds, which falls under the category of wound care products, not diagnostics.
N/A
Intended Use / Indications for Use
Intended use: For the management of open wounds. Indications: For use as a wound dressing to manage pressure ulcers stages I-IV, stasis ulcers, diabetic skin ulcers, skin irritation, cuts, abrasions and skin irritations associated with periostomal care.
Product codes
MGQ
Device Description
Amerigel™ Ointment Saturated Wound Dressing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ron Maddix Amerx Health Care Corporation 1150 Cleveland Street, Suite 410 Clearwater, Florida 34615
AUG 1 2 1997
Re: K971918 Amerigel™ Ointment Saturated Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: May 15, 1997 Received: May 23, 1997
Dear Mr. Maddix:
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) 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.
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- 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). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
1
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 (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.
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
2
May 15, 1997 Amerx Health Care Corporation 510(k) submission for a Saturated Non-Interactive Wound Dressing (Amerigel)
Predicate
510(k) Number (if known): K970133 - April 14, 1997 for Amerigel™ Ointment Wound
Dressing
Device Name: Amerigel™ Ointment Saturated Wound Dressing
Amerigel™ Ointment Saturated Wound Dressing
Intended use:
For the management of open wounds.
Indications: For use as a wound dressing to manage pressure ulcers stages I-IV, stasis ulcers, diabetic skin ulcers, skin irritation, cuts, abrasions and skin irritations associated with periostomal care.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE OMN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971918 |
| Prescription Use
(Per 21 CFR 801.109 | OR | Over-the-Counter Use
(Optional Format 1-2-96) |
|---------------------------------------------------------|----|--------------------------------------------------|
| | | |
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