DUMEX PAK-ITS WOVEN RIBBON PACKING by DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

The Dumex Pak-its-Woven Ribbon Packing is intended to absorb exudate from discharging wounds into a secondary dressing. The packing is indicated for the following exudating wounds: minor cuts, abrasions and incisions. The packing may also be used on infected wounds under the care of a health care professional.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Dumex Pak-its Woven Ribbon Packing" device, outlining its substantial equivalence to a predicate device and its intended use and limitations.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the given input.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle features a stylized image of an eagle with its wings spread, a common symbol of the United States. The eagle is depicted in a simple, graphic style, with bold lines forming its shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1998

Mr. Sharmini Atheray, M.Sc Manager for QA/RA Dumex Medical Surgical Products Limited 104 Shorting Road Scarborough, Ontario, Canada MIS3S4

Re: K980791

Trade Name: Dumex Pak- its Regulatory Class: Unclassified Product Code: EFO Dated: February 26, 1998 Received: March 2, 1998

Dear Mr. Atheray:

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:

1. 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.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. This device may not be labeled as a treatment or a cure for any type of wound.

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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.

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 vour 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

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Page 3 - Mr. Atheray

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

서비스 (1) 100 100

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Page 1 of 1 ,

Indications for Use Form

510(k) Number (if known): K980791

Device Name: Dumex Pak-its Woven Ribbon Packing

Indications for Use:

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__________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980711

Regulation Number and Section

N/A