DUMEX IODOFORM PACKING STRIP

K990332 · Dumex Medical Surgical Products, Ltd. · FRO · Apr 14, 1999 · SU

Device Facts

• Record ID: K990332
• Device Name: DUMEX IODOFORM PACKING STRIP
• Applicant: Dumex Medical Surgical Products, Ltd.
• Product Code: FRO · SU
• Decision Date: Apr 14, 1999
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U

Intended Use

FOR GENERAL USE - AS DRAINAGE WICK OR WOUND PACKING FOR WOUND MANAGEMENT

Device Story

Dumex Iodoform Packing Strip is a wound dressing used as a drainage wick or packing material for wound management. It is applied by healthcare professionals in clinical settings to assist in managing wound drainage. The device functions as a passive packing material; it does not actively treat or cure wounds, nor does it accelerate healing. It is intended for general use and is not for use on third-degree burns or as a permanent dressing.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on administrative review of device classification and intended use.

Technological Characteristics

Iodoform-impregnated packing strip. Form factor is a strip used for packing or drainage. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for use as a drainage wick or wound packing for general wound management. Not indicated for third-degree burns, accelerating wound healing or epithelization, long-term/permanent dressing, artificial skin, or as a treatment/cure for any wound type.

Submission Summary (Full Text)

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April 9, 2024

Dumex Medical Surgical Products, Ltd. Sharmini Atheray Manager, Quality Assurance and Regulatory Affairs 104 Shorting Road Scarborough, Ontario M1S 3S4 Canada

Re: K990332

Trade/Device Name: Dumex Iodoform Packing Strip Regulatory Class: Unclassified Product Code: FRO

Dear Sharmini Atheray:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 14, 1999. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code FRO.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, [e-mail].

Sincerely,

## Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three curved lines representing the eagle's wings and a curved line representing the eagle's body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 1999

Ms. Sharmini Atheray Manager, Quality Assurance and Regulatory Affairs Dumex Medical Surgical Products, LTD 104 Shorting Road Scarborough Ontario M1S3S4 Canada

K990332 Re:

Trade Name: Dumex Iodoform Packing Strip Regulatory Class: Unclassifed Product Code:MXI Dated: March 30, 1999 Received: March 31, 1999

Dear Ms. Atheray:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your boother be device is substantially equivalent (for the indications for above and we have determinedevices marketed in interstate commerce prior to May 28, use stated in the enerobare) to as Aedical Device Amendments or to devices that have been 1970, the Chactinent auto of the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your device subject to the general controls provisions (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 2. 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, I ne general controls pr manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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## Page 2 - Ms. Sharmini 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 (1 Chiainer Approval) in the Code of 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 with the Good Haandratt820) 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 regulation may round in regulation wice in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have w your premation 131 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) Finis letter will and in yourse 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] 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

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990332 Page

of Page 1

510(k) NUMBER (IF KNOWN): K990332
DEVICE NAME: DUMEX IODOFORM PACKING STRIA
INDICATIONS FOR USE:

FOR GENERAL USE - DN

AS DRADABADA No 2 WOND AACK WOUND MANAGEMENT

CONDUIT IN

(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
(Optional Format 1-2-96)

Sign-Off

(Division Sign-Off)
Division of General Restorative Devices K990332,
510(k) Number