(88 days)
DuoDERM CGF Control Gel Formula Border Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and acute wounds such as superficial wounds (e.g. minor abrasions), second degree burns and donor sites. DuoDERM CGF Control Gel Formula Border Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue,
The concept of DuoDERM CGF Control Gel Formula Border Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds.
The provided text is a 510(k) Premarket Notification for a wound dressing (DuoDERM CGF Control Gel Formula Border Dressing). This document details regulatory classification, indications for use, and substantial equivalence to a predicate device. However, it does not contain the type of performance study data and acceptance criteria typically found for diagnostic or AI-powered devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details because the document does not describe such a study for this type of medical device (wound dressing).
Specifically, the document states:
- "Data/information supporting the safety of DuoDERM CGF Control Gel Formula Border Dressing was presented in Premarket Notifications K901155. All testing was performed in accordance with Good Laboratory Practice Regulations." - This refers to safety testing, not a performance study against specific acceptance criteria for diagnostic accuracy or effectiveness in the way an AI algorithm would be evaluated.
- The 510(k) summary emphasizes substantial equivalence to a predicate device (SignaDRESS Hydrocolloid Dressing) based on intended use and dressing characteristics, rather than a quantifiable performance study with acceptance criteria.
Without a detailed performance study described in the provided text, I cannot fill out the requested table or answer the specific questions about sample size, ground truth, expert adjudication, or MRMC studies.
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510(k) Premarket Notification DuoDERM® CGF® Control Gel Formula Border Dressing
ITEM 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510 (k) Premarket Notification is to request clearance for claims specific to the moist wound environment created by DuoDERM CGF Control Gel Formula Border Dressing . In addition ConvaTec intends to add diabetic ulcers and remove all references to third degree burns from the product labeling.
The concept of DuoDERM CGF Control Gel Formula Border Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds. DuoDERM CGF Control Gel Formula Border Dressing is indicated for use on chronic wounds-dermal ulcers, including full thickness wounds, pressure ulcers, leg ulcers, diabetic ulcers, acute wounds-superficial wounds (e.g. minor abrasions), second degree burns, donor sites. DuoDERM CGF Control Gel Formula Border Dressing is substantially equivalent to SignaDRESS Hydrocolloid Dressing. The two products are equivalent in intended use and dressing characteristics.
DuoDERM CGF Control Gel Formula Border Dressing is contraindicated for use on individuals with a known sensitivity to the dressing or its components.
Data/information supporting the safety of DuoDERM CGF Control Gel Formula Border Dressing was presented in Premarket Notifications K901155. All testing was performed in accordance with Good Laboratory Practice Regulations.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Adrienne McNally Senior Manager, Regulatory Affairs ConvaTec PO Box 5254 Princeeton, New Jersey 08543-5254
DEC 2 3 1997
K973688 - DuoDERM CGF Control Gel Formula Border Dressing Re: K973689 - DuoDERM Hydroactive Dressing Regulatory Class: Unclassified Product Code: MGP Dated: September 19, 1997 Received: September 26, 1997
Dear Ms. McNally:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:
- These devices may not be labeled for use on third degree burns. 1.
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- These devices may not be labeled as having any accelerating effect on the rate of wound healing or evithelization.
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- These devices may not be labeled as long-term, permanent, or no-change dressings, or as artificial (synthetic) skin.
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- These devices 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 devices and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual
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Page 2 - Ms. Adrienne McNally
registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices 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 submissions 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 devices as described in your 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices 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 devices 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 devices, 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
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K 973688
518(k) Premarket Notification DueDERME CGFC Control Gel Formula Border Dressing
ITEM 1J: INDICATIONS FOR USE STATEMENT
S10(k) Number (if known): Not Known
Device Name: DueDERM CGF Control Gel Formula Border Dressing
Indications for Use:
DuoDERM CGF Control Gel Formula Border Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and acute wounds such as superficial wounds (e.g. minor abrasions), second degree burns and donor sites. DuoDERM CGF Control Gel Formula Border Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue,
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NERDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of General Restorative Devices 9 510(k) Number -
Prescription Use X (Per 21 CFR 801.109) OR
Over the Counter Use (Optimal Format 1-2-96)
Convallec . A Division of E.R. Squibb & Sons, Inc. DuoDERMO CGF® Control Gal Formula Border Dressing- A trodemark of ConvaTec SignaDRESS™ Hydrocolloid Dressing-A trademark of Convallec 11
N/A