SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION

K063069 · Medical Molecular Therapuetics, LLC · FRO · Jul 13, 2007 · SU

Device Facts

• Record ID: K063069
• Device Name: SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
• Applicant: Medical Molecular Therapuetics, LLC
• Product Code: FRO · SU
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

OTC: For normal skin and minor wounds, ulcerations and burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing action. Professional: To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations.

Device Story

Silvaklenz is a buffered aqueous skin and wound cleansing solution containing cocamidopropyl betaine (surfactant) and ionic silver (antimicrobial). Supplied in spray bottles (2-16 oz), it is applied topically to wounds or skin. Mechanical action of fluid flow, aided by the surfactant, removes debris, necrotic tissue, and foreign particles. Ionic silver provides antimicrobial activity. Used in clinical settings by healthcare professionals or at home by patients for minor wounds. Output is a cleansed, moistened wound surface; facilitates healing by removing contaminants and reducing microbial load.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (ISO Modified Intracutaneous, USP/ISO Modified Systemic Toxicity, ISO Maximization Sensitization), cytotoxicity (Agarose Overlay Method), and antimicrobial performance (MIC/MBC Dilution, Zone of Inhibition, USP Antimicrobial Effectiveness, USP Microbial Limit, Bioburden Aerobic Total Count, and Microbial Challenge).

Technological Characteristics

Buffered aqueous solution containing cocamidopropyl betaine and ionic silver. Form factor: spray bottle (2, 4, 8, 16 oz). Mechanical cleansing via pump-spray delivery. Biocompatibility testing per ISO standards; antimicrobial testing per USP standards.

Indications for Use

Indicated for OTC use on normal skin, minor wounds, burns, abrasions, and irritated areas to remove debris. Indicated for professional use to cleanse, moisten, and irrigate dermal lesions including Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, and first/second degree burns.

Predicate Devices

• Dermacyn Wound Cleanser (K042729)
• Restore Wound Cleanser (K022670)
• X-Static Silverseal Hydrogel Wound Dressing (K040019)
• Acryderm Silver Antimicrobial Wound Gel (K011994)
• Antimicrobial Barrier Wound Contact Dressing (K023612)

Submission Summary (Full Text)

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Medical Molecular Therapeutics LLC 510(k) PreMarket Notificatione Silvaklenz ™ Antibacterial Silver Skin & Wound Cleanser Rev July 2007

# JUL 1 3 2007

page 1 of 3

K063069

#### 6

# 7. 510(k) Summary Information

#### 7.1 Submitter's Name and Address

Medical Molecular Therapeutics LLC Arthur B. Flick MD 36 Lake Rabun Road Lakemont, Georgia 30552

Contact Person: A. B. Flick MD Telephone: [phone] Email: [e-mail]

## 7.2 Date Prepared

20 August 2006

### 7.3 Device Name

| Trade Name: | Silvaklenz™ Antibacterial Silver Skin & Wound Cleanser |
|----------------------|--------------------------------------------------------|
| Common Name: | Silvaklenz™ |
| Classification Name: | Liquid Bandage KMF |

### 7.4 Predicate Devices 807.92(a)(3)

| Dermacyn Wound Cleanser | K042729 |
|----------------------------------------------|---------|
| Restore Wound Cleanser | K022670 |
| X-Static Silverseal Hydrogel Wound Dressing | K040019 |
| Acryderm Silver Antimicrobial Wound Gel | K011994 |
| Antimicrobial Barrier Wound Contact Dressing | K023612 |

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## 7.5 Device Description

page 27 3

A buffered skin and wound cleansing solution that is intended for the external cleansing of dermal wounds and skin. The mechanical action of the fluid moving across the skin or wound surface provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The product contains a surfactant (soap), cocamidopropyl betaine, to assist with the removal foreign material such as dirt and debris. After application the wound is rinsed with water or normal saline. The Silvaklenz Antibacterial Silver Skin & Wound Cleanser is clear, odorless and colorless. The product is available in 2 oz, 4 oz, 8 oz and 16 oz spray bottles.

#### 7.6 Assessment of Performance Data

Silvaklenz Antibacterial Silver Skin & Wound Cleanser has been subject to in vitro and in vivo biocompatibility (ISO Modified Intracutaneous Study, the USP and ISO Modified Systemic Toxicity Study and the ISO Maximization Sensitization) and cytotoxicity testing (Agarose Overlay Method). These tests support the safe use of Silvaklenz Antimicrobial Silver Skin & Wound Cleansing Solution in contact with breached or compromised skin. In vitro Antimicrobial testing was assessed by the standard the MIC and MBC Dilution Methods. Zone of Inhibition, USP Antimicrobial Effectiveness Test <51>. USP Microbial Limit Test <61>, Bioburden Aerobic Total Count and Microbial Challenge Test.

#### 7.7 Statement of Intended Use

OTC: For normal skin and minor wounds, ulcerations and burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing action.

Professional: To cleanse, moisten and irrigate dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations.

### 7.8 Technological Characteristics and Substantial Equivalence Silvaklenz Antibacterial Silver Skin & Wound Cleanser is a combination

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510(k) PreMarket Notification Medical Molecular Therapeutics LLC Silvakienz TM Antibacterial Silver Skin & Wound Cleanser Rev July 2007 3

product within the meaning of section 503(g) of the Federal Food, Drug, and Cosmetic Act (Act) and Title 21 of the Code of Federal Regulations (CFR) section 3.2(e)(1) and (2). In accordance with section 503(g)(1) of the Act and 21 CFR section 3.4, Silvaklenz Antibacterial Silver Skin & Wound Cleanser had three modes of action. One mode of action of the product is that of the device components (the pump-spray and the remaining ingredients of the aqueous solution) mechanically remove debris, necrotic tissue and foreign particles from the skin and wound surface. A second mode of action of the product is that of the cocamidopropyl betaine (drug component) reduces the surface tension and thereby assist with mechanical cleansing and debridement. A third mode of action is ionic silver (drug component) that functions as an antimicrobial agent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are arranged in a way that creates a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Public Health Service

JUL 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Molecular Therapeutics, LLC % Arthur B. Flick, MD 36 Lake Rabun Road Lakemont, Georgia 30552

Re: K063069

Trade/Device Name: Silvaklenz Antibacterial Silver Skin & Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: June 7, 2007 Received: June 11, 2007

Dear Dr. Flick:

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 such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 -- Arthur B. Flick, MD

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Vik Mark N. N Aelkerson Director Division of General, Restorative 2 and Neurological Devices 7 Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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## 5. INDICATIONS FOR USE

Device Name: Silvaklenz Antibacterial Silver Skin & Wound Cleanser

For the Over-The-Counter Indications:

For normal skin and minor wounds, ulcerations and burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing action.

For Professional Prescription Indications:

To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 2063069