(86 days)
Not Found
Not Found
No
The 510(k) summary describes a passive wound dressing with activated charcoal for odor control. There is no mention of any computational or analytical capabilities, let alone AI or ML. The performance studies are bench tests and biocompatibility tests, not related to algorithmic performance.
No.
The device is a wound dressing designed to manage malodorous wounds and absorb exudate, not to directly treat or cure a disease or condition in a therapeutic manner beyond general wound care.
No
Explanation: The device is a wound dressing designed to manage malodorous wounds and absorb exudate, not to diagnose medical conditions.
No
The device description clearly outlines multiple physical components (absorbent layers, film layers, activated charcoal pad), indicating it is a physical medical device, not software-only.
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 management of malodorous acute and chronic wounds. This involves applying a dressing to a wound on the body.
- Device Description: The device is a wound dressing with various layers designed to absorb exudate and control odor.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is applied directly to the wound.
Therefore, the ConvaTec Odor Control Wound Dressing is a topical wound care device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ConvaTec Odor Control Wound Dressing is indicated for the management of malodorous acute and chronic wounds such as pressure ulcers, leg ulcers, and diabetic ulcers. It may be used as a primary dressing for superficial wounds or with deeper wounds as a secondary dressing.
Product codes
KMF
Device Description
ConvaTec Odor Control Wound Dressing is a sterile, non-adhesive dressing with an absorbent wound contact laver, a water-resistant film layer, an activated charcoal central pad, a non-woven absorbent pad layer and a smooth water- resistant outer film 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
Comparative bench testing was conducted on Hollister Odor-Absorbent Dressing and ConvaTec Odor Control Wound Dressing.
ConvaTec Odor Control Wound Dressing has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995), The results of this testing demonstrate that ConvaTec Odor Control Wound Dressing is considered to be nonsensitizing, non-toxic, non-hemolytic and a negligible irritant.
Key Metrics
Not Found
Predicate Device(s)
Hollister Odor-Absorbent Dressing
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.
0
OCT - 1 1997
ITEM 8: SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510(k) Premarket Notification is to request clearance to market ConvaTec Odor Control Wound Dressing.
ConvaTec Odor Control Wound Dressing is a sterile, non-adhesive dressing with an absorbent wound contact laver, a water-resistant film layer, an activated charcoal central pad, a non-woven absorbent pad layer and a smooth water- resistant outer film layer.
ConvaTec Odor Control Wound Dressing is indicated for the management of malodorous acute and chronic wounds such as pressure ulcers and diabetic ulcers. It may be used as a primary dressing for superficial wounds or with deeper wounds as a secondary dressing.
ConvaTec Odor Control Wound Dressing is contraindicated for use on individuals with known sensitivity to the dressing or its components.
ConvaTec Odor Control Wound Dressing is substantially equivalent to Hollister Odor-Absorbent Dressing. Both dressings have essentially the same intended uses and characteristics. ConvaTec Odor Control Wound Dressing is similar in construction and design to Hollister's Odor Absorbent Dressing whereby both dressings are sterile, non-adhesive with a multilayer construction containing a central carbon layer.
Comparative bench testing was conducted on Hollister Odor-Absorbent Dressing and ConvaTec Odor Control Wound Dressing.
ConvaTec Odor Control Wound Dressing has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995), The results of this testing demonstrate that ConvaTec Odor Control Wound Dressing is considered to be nonsensitizing, non-toxic, non-hemolytic and a negligible irritant.
ConvaTec, A Division of E.R. Squibb & Sons, Inc.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Adrienne McNally . Manager, Regulatory Affairs ConvaTec. Inc. PO Box 5254 Princeton, New Jersey 08543-5254
OCT - 1 1997
Re: K972530 ConvaTec Odor Control Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: July 3, 1997 Received: July 7, 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.
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This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
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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).
2
Page 2 - Ms. Adrienne McNally
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 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
(Optimal Formate 1-2-96)
ITEM 1J: INDICATIONS FOR USE STATEMENT
1972530 510(k) Number (if known): Not Known
Device Name: ConvaTec Odor Control Wound Dressing
Indications for Use:
ConvaTec Odor Control Wound Dressing is indicated for the management of malodorous acute and chronic wounds such as pressure ulcers, leg ulcers, and diabetic ulcers. It may be used as a primary dressing for superficial wounds or with deeper wounds as a secondary dressing.
(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 General Restorative Devices
| 510(k) Number | K972530 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ | Over-the-Counter Use |
|---|---|---|
| ------------------ | -------------- | ---------------------- |
(Per 21 CFR 801.109)