(88 days)
KERLIX* Super Sponges, Profore* Wound Contact Laver, NU GAUZE*
Not Found
No
The summary describes a sterile gelling gauze wound dressing and its performance in bench testing and biocompatibility studies, with no mention of AI or ML technology.
Yes
The device is used in the management of acute and chronic wounds, which is a therapeutic intervention.
No
The device is a wound dressing used for managing wounds, which is a treatment or management function, not a diagnostic one.
No
The device description clearly states it is a "sterile gelling gauze" made of physical materials (viscose yarn, co-spun alginate and viscose), indicating it is a physical medical device, 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 management of acute and chronic wounds, including diabetic ulcers. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a sterile gelling gauze made of viscose and alginate. This is a physical dressing for wound care.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are specifically designed to perform tests in vitro (outside the body) on samples taken from the human body. This device is applied in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
Knitted Wound Dressing Standard, WCL and Ribbon can be used in the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon as a packing strip for cavity wounds, fistulae and sinuses.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
Knitted Wound Dressing is a sterile gelling gauze. The warp (fibers running top to bottom) consist of viscose yarn, while the wefts (fibers running left right) are a co-spun alginate and viscose.
Knitted Wound Dressing Standard, WCL and Ribbon are comprised of absorbent gelling yarns for the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon, as a packing strip for cavity wounds, fistulae and sinuses.
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)
Comparative bench testing was conducted on the Knitted Wound Dressing versus its substantially equivalent products. Test results show the products to be equivalent.
Knitted 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 Knitted Wound Dressing is considered to be non-sensitizing, non-toxic, non-hemolytic and a negligible irritant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KERLIX* Super Sponges, Profore* Wound Contact Laver, NU GAUZE*
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 6 1000
510(k) Premarket Notification Knitted Wound Dressing
ITEM 8: SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510(k) Premarket Notification is to request clearance to market Knitted Wound Dressing, which be available in three presentations -Standard, WCL and Ribbon and will be labeled as an OTC product.
Knitted Wound Dressing is a sterile gelling gauze. The warp (fibers running top to bottom) consist of viscose yarn, while the wefts (fibers running left right) are a co-spun alginate and viscose.
Knitted Wound Dressing Standard, WCL and Ribbon are comprised of absorbent gelling yarns for the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon, as a packing strip for cavity wounds, fistulae and sinuses.
Knitted Wound Dressing Standard, WCL and Ribbon are substantially equivalent to KERLIX* Super Sponges manufactured by The Kendall Company. ProforeWound Contact Laver manufactured by Smith & Nephew Medical Limited and NU GAUZE manufactured by Johnson & Johnson Medical Inc., respectively.
The products are equivalent in intended use and design. They all are considered general use wound care dressings which can be used in the management of acute and chronic wounds. Knitted Wound Dressing has the added feature of gelling fibers.
Comparative bench testing was conducted on the Knitted Wound Dressing versus its substantially equivalent products. Test results show the products to be equivalent.
Knitted 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 Knitted Wound Dressing is considered to be non-sensitizing, non-toxic, non-hemolytic and a negligible irritant.
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 graphic of three human profiles facing to the right, arranged in a cascading manner. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 6 1998
Ms. Adrienne McNally Senior Manager. Regulatory Affairs ConvaTec PO Box 5254 Princeton, New Jersey 08543-5254
Re: K974205
Knitted Wound Dressing (Standard, WCL, and Ribbon) Regulatory Class: Unclassified Product Code: KMF Dated: November 3, 1997 ...... Received: November 10, 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:
- l. 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 registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
2
Page 2 - Ms. Adrienne McNally
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 Knitted Wound Dressing
ITEM 1J: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known
Device Name: Knitted Wound Dressing
Indications for Use:
.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
Knitted Wound Dressing Standard, WCL and Ribbon can be used in the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon as a packing strip for cavity wounds, fistulae and sinuses. . .........................................................................................................
(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 | K974205 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-the-Counter Use
(Optimal Format 1-2-96) |
| ------------------------------------------ | ---- | ------------------------------------------------- |
|---|
11 ConvaTec, A Division of E.R.Squibb and Sons, Inc.