AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027

K092086 · Amerx Health Care Corp. · SEJ · Jul 30, 2009 · SU

Device Facts

• Record ID: K092086
• Device Name: AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
• Applicant: Amerx Health Care Corp.
• Product Code: SEJ · SU
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Stage I - IV Pressure ulcers Venous stasis ulcers Vehous stasio aread by mixed vascular etiologies Diabetic skin ulcers . First and second degree burns Post-surgical incisions Cuts and abrasions

Device Story

AmeriGel® Wound Dressing PLUS is a hydrogel wound dressing containing 4% Lidocaine HCL for pain relief. Formulation includes Oakin (oak extract), Meadowsweet extract, water, and Zinc acetate in a Polyethylene glycol (PEG) base. Device maintains moist wound environment to support healing and autolytic debridement. Intended for use on various ulcers, burns, and surgical wounds. Applied topically to wound site. Provides analgesic effect to reduce patient discomfort during wound management. Packaged in plastic tubes; non-sterile.

Clinical Evidence

No clinical data. Substantial equivalence based on formulation comparison, biocompatibility testing (dermal irritation, sensitization, in-vitro cytotoxicity) performed on the predicate device, and established safety/efficacy of individual components (Lidocaine HCL).

Technological Characteristics

Hydrogel dressing; PEG base; contains 4% Lidocaine HCL, Oakin (oak extract), Meadowsweet extract, water, and Zinc acetate. pH range 7.0-7.2. Non-sterile. Packaged in plastic tubes. Autolytic debridement mechanism.

Indications for Use

Indicated for management of stage I-IV pressure ulcers, venous stasis ulcers, ulcerations of mixed vascular etiology, diabetic skin ulcers, first and second degree burns, post-surgical incisions, cuts, and abrasions.

Regulatory Classification

Identification

A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.

Predicate Devices

• Regenecare® Wound Gel (K020540)
• AmeriGel® Wound Dressing (K002136)

Submission Summary (Full Text)

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K092086
Page 107

510(k) Summary

**JUL 30 2008**

Date Prepared: July 08, 2009

## Submitter's Information:

Amerx Health Care Corporation 1300 S. Highland Ave. Clearwater, FL 33756 www.amerigel.com

# Contact Information:

Art W. Simonetti, LPN Director of Research & Regulatory Affairs Phone: [phone] Fax: [phone] Toll-Free: [phone] Email: [e-mail]

#### New Device Name:

Proprietary Name: Amerigel® Wound Dressing PLUS Common Name: Medicated Wound Gel Classification Name: Dressing, wound and burn, hydrogel w/drug and/or biologic Product Code: MGQ Regulatory Class: Unclassified

## Predicate Device #1:

Trade/Device Name: Regenecare® Wound Gel (510(k) # K020540) Regulation Name: Hydrogel Wound Dressing Product Code: MGQ Regulatory Class: Unclassified

# Predicate Device #2:

Trade/Device Name: AmeriGel® Wound Dressing (510(k) # K002136) Classification Regulation Name: Hydrogel Wound Dressing (21 CFR 878.4022) Regulatory Class: Class I, exempt Product Code: NAE

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# Device Description:

AmeriGel® Wound Dressing PLUS is a hydrogel that maintains a moist environment to support wound healing. We added 4% Lidocaine HCL to the formulation in our predicate device, AmeriGel® Wound Dressing. AmeriGel® Wound Dressing has been on the market for many years. With so many painful wounds, particularly venous stasis ulcers, we wanted to offer a wound gel that would help reduce the discomfort patients feel. Since AmeriGel® Wound Dressing has been doing so well for all these years, adding the 4% Lidocaine to the Polyethylene glycol (PEG) base will finally provide relief for those patients with painful wounds. When the Lidocaine was added to our formulation of Oakin (oak extract), Meadowsweet extract, water and Zinc acetate, the physical properties remained at a pH range of 7.0 - 7.2. Lidocaine HCL is well known to be GRASE (Generally regarded as safe and effective) and AmeriGel® Wound Dressing is also well known to be safe and effective, the combination of chemicals were found compatible, safe and effective.

AmeriGel® Wound Dressing PLUS would be used to manage stage I - IV pressure ulcers, venous stasis ulcers, ulcerations caused by mixed vascular etiologies, Diabetic skin ulcers, First and second degree burns, post-surgical incisions, cuts and abrasions..

#### Technological Characteristics:

AmeriGel® Wound Dressing PLUS is identical in formulation to AmeriGel® Wound Dressing, except with the addition of the Lidocaine. Regenecare® Wound Gel has similar action of its formulation. The PEG base provides moisture similarly to the Aloe Vera in Regenecare®. As they are both classified as hydrogels, they also autolytically debride. Both predicate devices are packaged in plastic tubes, as will AmeriGel® Wound Dressing PLUS. Regenecare® is sterile and AmeriGel® Wound Dressing is not, nor will AmeriGel® Wound Dressing PLUS. Biocompatibility for AmeriGel® Wound Dressing was previously established by dermal irritation test on rabbits, a sensitization test on guinea pigs, and In-vitro cytotoxicity test. Of course, AmeriGel® Wound Dressing has been marketed and used on humans for almost ten years without any adverse events.

# Substantial Equivalence:

The claim of substantial equivalence of AmeriGel® Wound Dressing PLUS to the predicate devices is based on the comparison of the intended use, product technical characteristics and performance. Accordingly, Amerx Health Care Corporation concluded that AmeriGel® Wound Dressing PLUS is safe and effective for its intended use, and will perform at least as well as the legally predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing its feathers.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IJUL 3 0 2009

Amerx Health Care Corporation % Mr. Art W. Simonetti, LPN Director of Research & Clinical Affairs 1300 S. Highland Avenue Clearwater, Florida 33756-6519

Re: K092086

Trade/Device Name: AmerGel® Wound Dressing PLUS Regulatory Class: Unclassified Product Code: FRO Dated: July 8, 2009 Received: July 9, 2009

Dear Mr. Simonetti:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Mr. Art W. Simonetti, LPN

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for Othms Df

Dep.

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: k092086

Device Name: AmeriGel® Wound Dressing PLUS

Indications for Use:

Stage I - IV Pressure ulcers Venous stasis ulcers Vehous stasio aread by mixed vascular etiologies Diabetic skin ulcers . First and second degree burns Post-surgical incisions Cuts and abrasions

Prescription Use (21 CFR 801 Subpart D) And/Or

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keene furmxm
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092086