(88 days)
Not Found
No
The summary describes a hydroactive wound dressing and makes no mention of AI or ML technology.
No.
The DuoDERM Hydroactive Dressing is a wound dressing that aids in maintaining a moist wound environment for healing, which is a supportive function, not a direct therapeutic intervention. It's described as an absorbent dressing to cover exudating wounds, similar to other non-therapeutic wound care products.
No
Explanation: The device is a wound dressing designed to support healing, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly indicates it is a physical dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a dressing applied to wounds to aid in healing. This is a topical application and does not involve testing samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description confirms it's an absorbent dressing for covering wounds.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a wound dressing, which is a therapeutic device applied externally.
N/A
Intended Use / Indications for Use
DuoDERM Hydroactive Dressing is indicated for use on chronic wounds such as pressure ulcers, diabetic ulcers and acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive 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.
Product codes
MGP
Device Description
The purpose of this 510 (k) Premarket Notification is to request clearance for the claims specific to the moist wound healing environment created by DuoDERM Hydroactive Dressing. In addition, ConvaTec intends to add diabetic ulcers to the indications for use and remove all references to third degree burns from the product labeling.
The concept of DuoDERM Hydroactive Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
ConvaTec's SignaDRESS Hydrocolloid Dressing
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Premarket Notification DuoDERM® Hydroactive® Dressing
ITEM 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510 (k) Premarket Notification is to request clearance for the claims specific to the moist wound healing environment created by DuoDERM Hydroactive Dressing. In addition, ConvaTec intends to add diabetic ulcers to the indications for use and remove all references to third degree burns from the product labeling.
The concept of DuoDERM Hydroactive Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds. DuoDERM Hydroactive Dressing is indicated for use on chronic wounds-pressure ulcers, including full-thickness wounds, leg ulcers, diabetic ulcers, acute wounds-surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive Dressing is substantially equivalent to ConvaTec's SignaDRESS Hydrocolloid Dressing. The two products are equivalent in intended use and dressing characteristics.
DuoDERM Hydroactive Dressing is contraindicated for use on individuals with a known sensitivity to the dressing or its components.
Data/information supporting the safety of DuoDERM Hydroactive Dressing was presented in Premarket Notifications K821656. All testing was performed in accordance with Good Laboratory Practices Regulations.
ConvaTec - A Division of E.R. Squibb & Sons, Inc. DuoDERM® Hydroactive® Dressing - A trademark of ConvaTec SignaDRESS™ Hydrocolloid Dressing-A trademark of ConvaTec
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing the department's role in protecting and promoting the health and well-being of the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
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 23 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.
- These devices may not be labeled as having any accelerating effect on the 2. rate of wound healing or epithelization.
- These devices may not be labeled as long-term, permament, or no-change 3. dressings, or as artificial (synthetic) skin.
- These devices may not be labeled as a treatment or a cure for any type of 4. 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
2
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
3
510(k) Premarket Notification DuoDERM® Hydroactive® Dressing
1J: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known
Device Name: DuoDERM Hydroactive Dressing
Indications for Use:
DuoDERM Hydroactive Dressing is indicated for use on chronic wounds such as pressure ulcers, diabetic ulcers and acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of | ene |
| 510(k) Number | K97 3689 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over the Counter Use (Optimal Format 1-2-96) | |
|---|---|
| ---------------------------------------------- | -- |
ConvaTec - A Division of E.R. Squibb & Sons, Inc.
DuoDERM
®
Hydroactive
®
Dressing - A trademark of ConvaTecDuaDERMO Hydroactive® Dressing - A trademark of CorvaTec SignaDRESS™ Hydrocolloid Dressing-A trademark of ConvaTec