(50 days)
Not Found
Not Found
No
The document describes a sterile, absorbent pad dressing for wound management and does not mention any AI or ML capabilities.
Yes
The device is intended for the management of wounds, including various types of ulcers and surgical incisions, which falls under therapeutic indications for treating medical conditions.
No.
The device is a non-diagnostic absorbent pad dressing for wound management, used to absorb exudate and protect wounds, not to diagnose medical conditions.
No
The device description clearly identifies it as a sterile, absorbent pad dressing, which is a physical, non-software component.
Based on the provided information, the ConvaTec Nonwoven Pad is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The ConvaTec Nonwoven Pad is a wound dressing. Its intended use is to manage wound exudate and protect wounds. It is applied directly to the wound on the patient's body.
The description clearly indicates it's a topical dressing for wound management, not a device used for testing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.
The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.
Product codes
KMF
Device Description
Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.
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
Under the guidance of a healthcare professional
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 Pad versus TENDERSORB® WET PRUF® Abd Pad. Test results show the two products to be equivalent.
Nonwoven Pad 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 Pad is considered to be non-toxic. All tests were conducted in accordance with Good Laboratory Practices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TENDERSORB® WET PRUF® Abd Pad
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
APR 1 5 1998
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: | Ameer Ally, Director,Regulatory Affairs
(908) 904-2543 |
| Device: | Nonwoven Pad |
| Substantially
Equivalent Device: | TENDERSORB® WET PRUF® Abd Pad
(Kendall Healthcare Products Company) |
Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.
Nonwoven Pad is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.
Nonwoven Pad is substantially equivalent to Kendall's TENDERSORB® WET PRUF® Abd Pad . 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.
Comparative bench testing was conducted on Nonwoven Pad versus TENDERSORB® WET PRUF® Abd Pad. Test results show the two products to be equivalent.
Nonwoven Pad 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 Pad is considered to be non-toxic. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1998
Mr. Ameer Ally Director, Regulatory Affairs ConvaTec P.O. Box 5254 Princeton, New Jersey 08558
K980720 Re: Trade Name: ConvaTec Nonwoven Pad Regulatory Class: Unclassified Product Code: KMF Dated: February 23, 1998 Received: February 24, 1998
Dear Mr. Ally:
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. 1.
-
- 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 - Mr. Ally
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,
Mark n Mullein
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 Pad
Indications for Use:
The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optimal Format 1-2-96)
Mark N-Milke
Image /page/3/Picture/11 description: The image contains two distinct handwritten symbols or characters. The symbol on the left appears to be a cursive letter or a stylized design, with a loop at the top and a curved line extending downward. Below this, there's a smaller, somewhat illegible inscription. The symbol on the right is bolder and more geometric, featuring a vertical line intersected by a horizontal stroke at the top, resembling a modified letter or a unique mark.
(Division Sign-Off)
- Division of General Restorative Devices
510(k) Number. K980720