(79 days)
Not Found
No
The document describes a wound dressing and does not mention any AI or ML technology.
Yes
The device is a dressing used to support the healing process of various types of wounds, including chronic dermal ulcers and acute wounds, which directly contributes to therapy.
No
The device is described as a "moisture retentive dressing" used to aid the healing of wounds by providing a moist environment; it does not diagnose conditions.
No
The device description clearly identifies the device as a "moisture retentive dressing," which is a physical 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 to provide a moisture-retentive dressing for wound healing. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the dressing and how it interacts with the wound environment to promote healing. It does not mention any analysis of biological samples or diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies mentioned are biocompatibility tests, which assess the safety of the material in contact with the body, not its diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a wound dressing, which is a medical device used for treatment and protection, not diagnosis.
N/A
Intended Use / Indications for Use
CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers including full-thickness wounds, such as pressure ulcers, leg ulcers and diabetic ulcers, and on acute wounds such as abrasions, lacerations, biopsies, and oven and closed surgical wounds. The dressing provides a moist wound environment that is supportive of the healing process.
Product codes
MGP
Device Description
CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers, including full thickness wounds such as pressure ulcers and diabetic ulcers and for acute wounds, such as abrasions, lacerations, biopsies, and open and closed surgical wounds. CombiDERM ACD wicks exudate away from the wound and provides a moist wound environment that is supportive of the healing process. The moist environment aids autolytic debridement and allows non-traumatic removal of the dressing without damaging newly formed tissue.
CombiDERM ACD contains an absorbent pad to manage heavy exudate. Both dressings are indicated for acute and chronic wounds and are equivalent in terms of their moist wound healing properties and wound exudate management.
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
Biocompatability tests performed on CombiDERM ACD have demonstrated that this product is nonirritating, non-cytotoxic, non-hemolytic and has a weak allergenic potential. All tests were conducted in accordance with Good Laboratory Practices.
Key Metrics
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 shows a series of numbers and a date. The numbers at the top appear to be "6973717". Below the numbers, the date "DEC 1 1997" is printed. The text is in black and the background is white.
510(k) Premarket Notification CombiDERM™ ACD™ ACD™ Absorbent Cover Dressing
ITEM 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant: ConvaTec, A Division of E.R. Squibb and Sons, Inc. 100 Headquarters Park Drive, Skillman, NJ 08558
Adrienne McNally, Senior Manager, Regulatory Affairs Contact: (908)281-2630
Device: CombiDERM ACD Absorbent Cover Dressing (Occlusive Wound and Burn Dressing)
Substantially Equivalent Device: SignaDRESS Hydrocolloid Dressing K962590
CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers, including full thickness wounds such as pressure ulcers and diabetic ulcers and for acute wounds, such as abrasions, lacerations, biopsies, and open and closed surgical wounds. CombiDERM ACD wicks exudate away from the wound and provides a moist wound environment that is supportive of the healing process. The moist environment aids autolytic debridement and allows non-traumatic removal of the dressing without damaging newly formed tissue.
CombiDERM ACD is contraindicated for use on individuals with a known sensitivity to the dressing or its components.
CombiDERM ACD is substantially equivalent to ConvaTec's SignaDRESS Hydrocolloid Dressing, Both dressings have the identical hydrocolloid adhesive and similar polyurethane backing films. CombiDERM ACD contains an absorbent pad to manage heavy exudate. Both dressings are indicated for acute and chronic wounds and are equivalent in terms of their moist wound healing properties and wound exudate management.
Biocompatability tests performed on CombiDERM ACD have demonstrated that this product is nonirritating, non-cytotoxic, non-hemolytic and has a weak allergenic potential. All tests were conducted in accordance with Good Laboratory Practices.
1
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 stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Ms. Adrienne McNally Senior Manager. Regulatory Affairs ConvaTec PO Box 5254 Princeton, New Jersey 08543-5254
Re: K973717
CombiDERM™ ACD™ Absorbent Cover Dressing Regulatory Class: Unclassified Product Code: MGP Dated: September 25, 1997 Received: September 29, 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 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
Enclosure
3
510(k) Premarket Notification CombiDERMIM ACDTM Absorbent Cover Dressing
1J: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Ne
Device Name: CombiDERM ACD
Indications for Use;
CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers including full-thickness wounds, such as pressure ulcers, leg ulcers and diabetic ulcers, and on acute wounds such as abrasions, lacerations, biopsies, and oven and closed surgical wounds. The dressing provides a moist wound environment that is supportive of the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
toeedo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K973717
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use (Optimal Format 1-2-96)
ConvaTec - A Division of E.R. Squibb & Sons. Inc. CombiDERM™ ACDTM - A trademark of ConvaTec SignaDRESS™ Hydrocolloid Dressing . A Irademark of ConvaTec