(58 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and performance of a wound dressing, with no mention of AI or ML.
Yes.
The device is a wound dressing used for the management of wounds, which is a therapeutic purpose.
No
Explanation: The device is a nonwoven wound dressing used for managing various types of wounds, which is a therapeutic function, not a diagnostic one. It absorbs exudate and forms a gel; there is no mention of it being used to identify or determine a disease or condition.
No
The device description clearly states it is a "sterile wound 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the device is a "Nonwoven Dressing" used for managing wound exudate on the surface of the body. It is applied directly to the wound.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient's body. Its function is to absorb fluid from the wound itself.
Therefore, the Nonwoven Dressing falls under the category of a wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nonwoven Dressing is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Nonwoven Dressing absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
Nonwoven Dressing is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.
Product codes
KMF
Device Description
Nonwoven Dressing is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Nonwoven Dressing absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds
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)
Comparative bench testing was conducted on Nonwoven Dressing versus MULTIPAD™ Non-Adherent Wound Dressing. Test results show the two products to be equivalent.
Nonwoven 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 Nonwoven Dressing is considered to be nonsensitizing, non-cytotoxic, non-hemolytic and a negligible irritant. All tests were conducted in accordance with Good Laboratory Practices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MULTIPAD™ Non-Adherent Wound Dressing (DeRoyal)
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
510(k) Premarket Notification FEB 2 0 998 Nonwoven Dressing
ITEM 8: SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant: | ConvaTec, A Division of E.R. Squibb and Sons, Inc
100 Headquarters Park Drive, Skillman, NJ 08558 |
|----------------------------------|------------------------------------------------------------------------------------------------------|
| Contact: | Adrienne McNally, Senior Manager, Regulatory Affairs
(908) 281-2630 |
| Device: | Nonwoven Dressing |
| Substantially Equivalent Device: | MULTIPAD™ Non-Adherent Wound Dressing (DeRoyal) |
Nonwoven Dressing is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Nonwoven Dressing absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
Nonwoven Dressing is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.
Nonwoven Dressing is substantially equivalent to DeRoyal's MULTIPAD™ Non-Adherent Wound Dressing. Both products are equivalent in intended use, design and function. They are considered general use wound care dressings which can be used in the management of acute and chronic wounds. The absorbent material in the Nonwoven Dressing forms a gel which helps retain fluid and exudate.
Comparative bench testing was conducted on Nonwoven Dressing versus MULTIPAD™ Non-Adherent Wound Dressing. Test results show the two products to be equivalent.
Nonwoven 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 Nonwoven Dressing is considered to be nonsensitizing, non-cytotoxic, non-hemolytic and a negligible irritant. All tests were conducted in accordance with Good Laboratory Practices.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 20 1998
Ms. Adrienne McNally Senior Manager, Regulatory Affairs ConvaTec A Division of E.R. Squibb and Sons, Inc. 100 Headquarters Park Drive Skillman, New Jersey 08558
K974823 Re: Nonwoven Dressing Regulatory Class: Unclassified Product Code: KMF Dated: December 23, 1997 Received: December 24, 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 3. as an artificial (synthetic) skin. ...................................................................................................
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
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 registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
2
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
ITEM 1J: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known
Device Name: Nonwoven Dressing
Indications for Use:
Nonwoven Dressing is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic.ukers; leg-ulcers and pressure ulcers.
(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 | K974823 |
| 510(k) Number |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-the-Counter Use ✓
(Optimal Format 1-2-96) |
| ------------------------------------------ | ---- | --------------------------------------------------------------------------------------------------- |
|---|