(72 days)
CombiDERM™ ACD™
Not Found
No
The summary describes a traditional wound dressing with no mention of AI/ML technology or related concepts like image processing, training/test sets, or performance metrics associated with AI/ML models.
No
The device is a wound dressing designed to manage exudate and aid the healing of wounds, primarily acting as a barrier and absorbent rather than actively treating an underlying disease or condition in a therapeutic sense.
No
Explanation: The device is described as a wound dressing for managing wound exudate, which is a therapeutic function rather than a diagnostic one. It does not perform any assessment, measurement, or analysis to identify a condition or disease.
No
The device description clearly states it is a physical wound dressing comprised of an absorbent pad and a hydrocolloid layer, indicating it is a hardware medical device.
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 manage exudate. This is a topical application for wound care, not a test performed on samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: The description details the physical components of a wound dressing. It does not mention any reagents, instruments, or procedures used for in vitro testing.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Mention of analyzing biological samples.
- Reference to diagnostic or screening purposes.
- Discussion of analytical or clinical performance metrics related to diagnosis.
Therefore, the ConvaTec Non-Adhesive Dressing is a medical device for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ConvaTec Non-Adhesive Dressing is a sterile, absorbent wound dressing comprised of an absorbent pad containing acrylic polymer affixed to a hydrocolloid layer. The dressing is intended for use on moderately to heavily exuding chronic wounds such as pressure ulcers and diabetic ulcers and for moderately to heavily exuding acute wounds, such as abrasions, biopsies, and open and closed surgical wounds. The dressing may be used alone or in combination with other primary dressings to manage wound exudate.
Product codes
KMF
Device Description
ConvaTec Non-Adhesive Dressing is a sterile, absorbent wound dressing comprised of an absorbent pad containing acrylic polymer affixed to a hydrocolloid layer.
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)
Biocompatibility tests for ConvaTec Non-Adhesive Dressing have demonstrated that this product is nonirritating, non-cytotoxic, non-hemolytic and has a weak allergenic potential.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CombiDERM™ ACD™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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AUG 1 4 1997
510(k) Premarket Notification ConvaTec Non-Adhesive Dressing
Item 8: SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510 (k) Premarket Notification is to request clearance to market ConvaTec Non-Adhesive Dressing.
ConvaTec Non-Adhesive Dressing is a sterile, absorbent wound dressing comprised of an absorbent pad containing acrylic polymer affixed to a hydrocolloid layer. The dressing is intended for use on moderately to heavily exuding chronic wounds such as pressure ulcers and diabetic ulcers and for moderately to heavily exuding acute wounds, such as abrasions, biopsies, and open and closed surgical wounds. The dressing may be used alone or in combination with other primary dressings to manage wound exudate.
ConvaTec Non-Adhesive Dressing is contraindicated for use on individuals with a known sensitivity to the dressing or its components.
ConvaTec Non-Adhesive Dressing is substantially equivalent to ConvaTec's CombiDERM™ ACD™ The dressings are equivalent in design, intended use, composition and dressing characteristics.
Biocompatibility tests for ConvaTec Non-Adhesive Dressing have demonstrated that this product is nonirritating, non-cytotoxic, non-hemolytic and has a weak allergenic potential. The results of these studies are enclosed in Item 5 of this application.
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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 features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular pattern around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Adrienne McNally Manager, Regulatory Affairs ConvaTec, Inc. . . . . . . . . . . PO Box 5254 Princeton, New Jersey 08543-5254
AUG 1 4 1997
Re: K972062 ConvaTec Non-Adhesive Dressing Regulatory Class: Unclassified Product Code: KMF Dated: May 30, 1997 Received: June 3, 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 2. of wound healing or epithelization.
- 3 This device may not he 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
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Page 2 - Ms. Adrienne McNally
807.81).The general controls provisions of the Act include requirements for annual 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 ciass 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
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Page 3 - Ms. Adrienne McNally
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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510(k) Premarket Notification ConvaTec Non-Adhesive Dressing
ITEM 1J: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known
Device Name: ConvaTec Non-Adhesive Dressing
Indications for Use:
ConvaTec Non-Adhesive Dressing is indicated for use on moderately to heavily exuding chronic wounds such as pressure ulcers, leg ulcers and diabetic ulcers, and on moderately to heavily exuding acute wounds such as abrasions, lacerations, biopsies, and open and closed surgical wounds. The dressing may be used alone or in combination with other primary dressings to manage wound exudate.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ice Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative D 510(k) Number
Prescription Use (Per 21 CFR 801 109)
OR
Over the Counter Use (Optimal Formal 1-2-96)
ConvaTec, A Division of E.R. Squibb and Sons, Inc. CombiDERM™ ACD™ - A trademark of ConvaTec
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