(76 days)
The Hydrogel dressing is intended for use to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment around the wound. The dressing is appropriate applied to the following indications: minor cuts, minor lacerations. Under the guidance of a health professional the hydrogel dressing is also indicated for surgical incisions and excisions, venous stasis ulcers and decubitus ulcers.
Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel
This document is a 510(k) clearance letter from the FDA for the "Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel". It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance as requested.
The letter approves the marketing of the device based on its substantial equivalence to a predicate device, and it outlines limitations on labeling and claims. It does not provide details of clinical trials, performance studies, or the specific criteria used to evaluate the device's efficacy or safety.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details based on the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of unity and collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Mr. Sharmini Atheray, M.Sc Manager for QA/RA Dumex Medical Surgical Products Limited 104 Shorting Road Scarborough, Ontario M1S 3S4
Re: K980861
Trade Name: Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel Regulatory Class: Unclassified Product Code: MGQ Dated: March 4, 1998 Received: March 5, 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 vour device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
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- 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 2. 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 ... ... ....................................................................................................................................
- 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 mar- 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.
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Page 2 - Mr. Atheray
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 Evanaiion Center for Devices and Radiological Health
Enclosure
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COIO
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Form B
Page ! of /
Indications for Use Form
510(k) Number (if known): と 9 80 8 6 /
Device Name: Dumex Pak - ile Cotton GAUZe Indications for Use:
The Hydrogel dressing is intended for U Se to heavily exudating wounds. The dressing L absorb exudate and maindain a moret hyperTonic ronmen round. The dressing is pproporia applied to indications: minor cuts, minor the a following. lacerations. Under the quidance of nealth the hydrogel dressing is Also indicated gical incisions and excisions, venous stacis c and decobitus ulcers
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE
or
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use V
bocados
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K980861
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