AMERIGEL OINTMENT SATURATED WOUND DRESSING

K971918 · Amerx Health Care Corp. · MGQ · Aug 12, 1997 · SU

Device Facts

• Record ID: K971918
• Device Name: AMERIGEL OINTMENT SATURATED WOUND DRESSING
• Applicant: Amerx Health Care Corp.
• Product Code: MGQ · SU
• Decision Date: Aug 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For the management of open wounds.

Device Story

Amerigel™ Ointment Saturated Wound Dressing is a topical wound dressing used for management of various open wounds. Applied by clinicians or patients to affected skin areas; provides a protective environment for wound management. Device functions as a physical barrier; does not accelerate healing or epithelization; not for third-degree burns or long-term/permanent use. Intended for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Saturated wound dressing; topical ointment formulation. Non-interactive dressing type. No electronic components, software, or complex materials specified.

Indications for Use

Indicated for management of pressure ulcers (stages I-IV), stasis ulcers, diabetic skin ulcers, skin irritation, cuts, abrasions, and skin irritations associated with periostomal care.

Predicate Devices

• Amerigel™ Ointment Wound Dressing (K970133)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ron Maddix Amerx Health Care Corporation 1150 Cleveland Street, Suite 410 Clearwater, Florida 34615

AUG 1 2 1997

Re: K971918 Amerigel™ Ointment Saturated Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: May 15, 1997 Received: May 23, 1997

Dear Mr. Maddix:

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.
- 2. This device may not be labeled as having any accelerating effect on the rate 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.
- 4. 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.

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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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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May 15, 1997 Amerx Health Care Corporation 510(k) submission for a Saturated Non-Interactive Wound Dressing (Amerigel)

Predicate
510(k) Number (if known): K970133 - April 14, 1997 for Amerigel™ Ointment Wound
Dressing

Device Name: Amerigel™ Ointment Saturated Wound Dressing

## Amerigel™ Ointment Saturated Wound Dressing

## Intended use:

For the management of open wounds.

Indications: For use as a wound dressing to manage pressure ulcers stages I-IV, stasis ulcers, diabetic skin ulcers, skin irritation, cuts, abrasions and skin irritations associated with periostomal care.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE OMN ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | k971918 |

| Prescription Use<br>(Per 21 CFR 801.109 | OR | Over-the-Counter Use<br>(Optional Format 1-2-96) |
|---------------------------------------------------------|----|--------------------------------------------------|
| <div> <img alt="Checkmark" src="checkmark.png"/> </div> | | |

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