THALAFIX NATURAL SEA SALT DRESSING

K980779 · Dumex Medical Surgical Products, Ltd. · KMF · Jun 26, 1998 · General Hospital

Device Facts

• Record ID: K980779
• Device Name: THALAFIX NATURAL SEA SALT DRESSING
• Applicant: Dumex Medical Surgical Products, Ltd.
• Product Code: KMF · General Hospital
• Decision Date: Jun 26, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications: minor cuts, minor burns and minor lacerations. Under the guidance of a health care professional, the Thalafix Natural Sea-Salt Dressing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.

Device Story

Thalafix Natural Sea-Salt Dressing is a dry wound dressing impregnated with crystalline seawater salt. Applied topically to moderately to heavily exudating wounds, the dressing absorbs exudate and creates a moist, hypertonic environment. This environment facilitates autolytic debridement. Used in clinical settings or by patients for minor wounds under professional guidance. The device serves as a passive dressing to manage wound moisture and support natural healing processes. It does not accelerate healing or act as a permanent skin substitute.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dry dressing impregnated with crystalline seawater salt. Form factor is a wound dressing. No electronic components, software, or active energy sources.

Indications for Use

Indicated for patients with moderately to heavily exudating wounds, including minor cuts, minor burns, minor lacerations, surgical incisions/excisions, venous stasis ulcers, pressure ulcers, and decubitus ulcers. Contraindicated for third-degree burns.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 1998

Sharmini Atheray Dumex Medical Surgical Products, LTD 104 Shorting Road Scarborough, Ontario M1S3S4

K980779 Re: Trade Name Thalafix Natural Sea Salt Dressing Regulatory Class: Unclassified Product Code: KMF Dated: June 10, 1998 Received: June 11, 1998

Dear Sharmini 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.
- This device may not be labeled as having any accelerating effect on the rate 2. of wound healing or epithelization.
- 3. 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 4. 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

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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 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.

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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FDA CDRH ODE

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Form B

## Indications for Use Form

510(k) Number (if known): と 980ママ 9

Device Name: Dhalafix Natural dea Palt

Indications for Use:

The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications: minor cuts, minor burns and minor lacerations. Under the guidance of a health care professional, the Thalafix Natural Sea-Salt Dressing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus 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

storative Devices
Reply Number 2980779