(84 days)
Not Found
Not Found
No
The summary describes a hydrogel wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the hydration and management of wounds, including aiding in autolytic debridement and creating a moist wound environment supportive of the healing process, which are therapeutic actions.
No
Explanation: The device, DuoDERM Hydroactive Gel, is described as a product for wound management and hydration, aiding in the healing process. Its function is therapeutic rather than diagnostic, meaning it treats conditions rather than identifying or analyzing them.
No
The device description clearly identifies the product as a "Hydroactive Gel," which is a physical substance used for wound management, not a software application.
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 hydration and management of wounds, which is a therapeutic application directly on the body.
- Device Description: The description reinforces its use as a wound dressing applied externally.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue) to provide diagnostic information. IVDs are used to diagnose diseases or conditions.
This device is a wound care product, not a diagnostic tool.
N/A
Intended Use / Indications for Use
DuoDERM Hydroactive Gel is designed for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulers, and diabetic ulcers. DuoDERM Hydroactive Gel provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing without damaging newly formed tissue.
Product codes (comma separated list FDA assigned to the subject device)
MGO
Device Description
The concept of DuoDERM Hydroactive Gel is not significantly different from other commercially available dressings intended for use in the management of wounds. DuoDERM Hydroactive Gel is indicated for use on partial and full thickness wounds such as pressure ulcers and diabetic ulcers. The gel is used for the management of wounds requiring hydration.
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): 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.
Not Found
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.
Not Found
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
510(k) Premarket Notification DuoDERM® Hydroactive® Gel
DEC 2 9 1997
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 Hydroactive Gel. In addition, ConvaTec intends to add diabetic ulcers to the product labeling, and remove all references to third degree burns in the product labeling.
The concept of DuoDERM Hydroactive Gel is not significantly different from other commercially available dressings intended for use in the management of wounds. DuoDERM Hydroactive Gel is indicated for use on partial and full thickness wounds such as pressure ulcers and diabetic ulcers. The gel is used for the management of wounds requiring hydration. DuoDERM Hydroactive Gel is substantially equivalent to SignaDRESS Hydrocolloid Dressing. The products are equivalent in intended use and function.
DuoDERM Hydroactive Gel is contraindicated for use on individuals with a known sensitivity to the gel or its components.
Data/information supporting the safety of DuoDERM Hydroactive Gel was presented in Premarket Notification K931618. All testing was performed in accordance with Good Laboratory Practice Regulations.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 29 1997
Ms. Adrienne McNally Senior Manager, Regulatory Affairs ConvaTec PO Box 5254 Princeton, New Jersey 08543-5254
Re: K973806 DuoDERM® Hydroactive® Gel Regulatory Class: Unclassified Product Code: MGO Dated: October 3, 1997 Received: October 6, 1997
Dear Ms. McNally:
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:
- This device may not be labeled for use on third degree burns. 1.
-
- 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 3. dressing, or as an artificial (synthetic) skin.
-
- 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
2
Page 2 - Ms. Adrienne McNally
registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
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
3
K 973806
519(k) Premarket Notification DuoDERM® Hydroactive® Gel
ITEM 1J: INDICATIONS FOR USE STATEMENT
510(k) Number (if known); Not Known
Device Name: DuoDERM Hydroactive Gel
Indications for Use:
DuoDERM Hydroactive Gel is designed for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulers, and diabetic ulcers. DuoDERM Hydroactive Gel provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing without damaging newly formed tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Alan Webb
(Division Sign-Off Division of Gene 510(k) Number
Prescription Use_X (Per 21 CFR 801.109)
OR
Over the Counter Use (Optimal Format 1-2-96)
Convalec - A Division of E.R. Squibb & Sons, Inc. DuaDERM® Kydroactive® Gel- A trademark of ConvaTec 11 SignaDRESS™ Hydrocolloid Dressing-A trademark of ConvaTec