(78 days)
Not Found
No
The description focuses on the physical properties and intended use of a hydroactive paste for wound management, with no mention of AI or ML.
Yes
This device is intended for the local management of exudating dermal ulcers, which is a therapeutic purpose.
No
Explanation: The device, DuoDERM Hydroactive Paste, is indicated for the management of exudating dermal ulcers, not for diagnosing conditions. Its description emphasizes its absorbent qualities and use as a dressing, not any diagnostic capabilities.
No
The device description clearly indicates it is a "Hydroactive Paste," which is a physical substance and therefore a hardware component, 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 "local management of exudating dermal ulcers." This describes a therapeutic or wound care application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on its function as an "absorbent dressing intended for use in the management of exudating wounds." This reinforces its role in wound care.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
- Anatomical Site: The anatomical site is "Dermal ulcers," which is the location of the wound being treated, not a source of a diagnostic sample.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to manage a wound directly.
N/A
Intended Use / Indications for Use
DuoDERM Hydroactive Paste is designed to be used with a secondary dressing such as DuoDERM Dressings for the local management of exudating dermal ulcers, including full thickness wounds, such as leg ulcers, pressure ulcers and diabetic ulcers.
Product codes
MGP
Device Description
The concept of DuoDERM Hydroactive Paste is not significantly different from other commercially available absorbent dressings intended for use in the management of exudating wounds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal ulcers, including full thickness wounds, such as leg ulcers, pressure ulcers and diabetic ulcers.
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)
Data/information supporting the safety of DuoDERM Hydroactive Paste was presented in Premarket Notification K881302 . All testing was performed in accordance with Good Laboratory Practice Regulations.
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/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '973807'. The numbers are written in a clear, legible manner, and the letter 'K' is distinct from the numbers.
DEC 2 3 1997
510(k) Premarket Notification DuoDERM® Hydroactive® Paste
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 healing environment created by DuoDERM Hydroactive Paste.
The concept of DuoDERM Hydroactive Paste is not significantly different from other commercially available absorbent dressings intended for use in the management of exudating wounds. DuoDERM Hydroactive Paste is indicated for use on exudating dermal ulcers, including full thickness wounds such as leg ulcers, pressure ulcers and diabetic ulcers. It is used in association with other DuoDERM® dressings. DuoDERM Hydroactive Paste is substantially equivalent to ConvaTec's SignaDRESS Hydrocolloid Dressing. The two products are equivalent in intended use and dressing characteristics.
DuoDERM Hydroactive Paste is contraindicated for use in patients with active vasculitis, such as, periarteritis nodosa, systemic lupus erythematosus, and cryoglobulinemia and on ulcers resulting from infection such as tuberculosis, syphilis or deep fungal infections.
Data/information supporting the safety of DuoDERM Hydroactive Paste was presented in Premarket Notification K881302 . All testing was performed in accordance with Good Laboratory Practice Regulations.
ConvaTec - A Division of E.R. Squibb & Sons, Inc.
DuoDERM® Hydroactive®Paste - A trademark of ConvaTec
SignaDRESS™ Hydrocolloid Dressing-A trademark of ConvaTec
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1997
Ms. Adrienna McNally Senior Manager, Regulatory Affairs ConvaTec PO Box 5254 Princeton, New Jersey 08543-5254
Re: K973807 DuoDERM® Hydroactive™ Paste Regulatory Class: Unclassified Product Code: MGP Dated: September 29, 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.
-
- 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 4. 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
Image /page/1/Picture/13 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's head and neck, formed by three overlapping profiles of human faces. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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Page 2 - Ms. Adrienna 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
Enclosure
3
510(k) Premarket Notification DuoDERM® Hydroactive® Paste
1J: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known
Device Name: DuoDERM Hydroactive Paste
Indications for Use:
DuoDERM Hydroactive Paste is designed to be used with a secondary dressing such as DuoDERM Dressings for the local management of exudating dermal ulcers, including full thickness wounds, such as leg ulcers, pressure ulcers and diabetic ulcers.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
(Optimal Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K923867
ConvaTec - A Division of E.R. Squibb & Sons, Inc. DuoDERM® Hydroactive®Paste - A trademark of ConvaTec SignaDRESS™ Hydrocolloid Dressing-A trademark of ConvaTec