BIODERM SCIENCES WOUND CREAM

K042352 · Bioderm Sciences, Inc. · FRO · Oct 17, 2005 · SU

Device Facts

• Record ID: K042352
• Device Name: BIODERM SCIENCES WOUND CREAM
• Applicant: Bioderm Sciences, Inc.
• Product Code: FRO · SU
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

BioDerm Sciences Wound Cream is intended to externally manage dermal lessions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, and dermal ulcers (venous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid). This product is intended for sale by or on the order of a physician (or properly licensed practitioner).

Device Story

BioDerm Sciences Wound Cream is an aqueous-based, acidic zinc/iron-saline cream; supplied in 100g aluminum tubes with tamper-resistant seals. Applied topically by clinician or patient to minor abrasions, lacerations, cuts, scalds, and 1st/2nd degree burns; functions as a wound cover or filler to provide a moist, low pH (3.0-3.4) environment and essential minerals to aid healing. May be used with secondary absorbent dressings (gauze, gel, alginate, foam, hydrocolloid). Output is a physical barrier/environment; assists in wound management; benefits patient by promoting healing environment.

Clinical Evidence

Bench testing and animal studies provided. Porcine model study (University of Miami) demonstrated effectiveness of metallic salt solutions in healing burns and partial-thickness wounds. Sensitization testing in guinea pigs showed no sensitization; toxicity testing in mice showed no toxicity. Historical clinical performance data cited from 14 years of European marketing under the name 'NAWA, Medical Elektrolyt-Salbe S'.

Technological Characteristics

Aqueous-based, acidic (pH 3.0-3.4) zinc/iron-saline cream. Contains zinc chloride, iron chloride, and trace elements. Supplied in 100g aluminum tubes. Non-electronic, non-sterile (implied by application type).

Indications for Use

Indicated for external management of dermal lesions including lacerations, post-operative wounds, partial and full-thickness wounds, and dermal ulcers (venous stasis, pressure). Contraindicated for patients with known allergic reactions to the dressing or its components, third-degree burns, or wounds where the dermis is severely damaged or missing.

Predicate Devices

• BioDerm Sciences Wound Solution (K040683)
• BioDerm Sciences Wound Spray (K042084)

Reference Devices

• Dermagran Wound Management System (K970660)

Submission Summary (Full Text)

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OCT 17 2005
K042352

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# VII. 510(k) summary as described in § 807.92

#### 510(k) Summary

BioDerm Sciences Wound Spray

Dermagran Wound Management System

| Submitter: | BioDerm Sciences, Inc.<br>Enterprise Center<br>9 Industrial Park Drive, Suite 1N<br>Oxford, Mississippi 38655<br>Phone: [phone]<br>Fax [phone] | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Ed Gubish Ph. D. <[e-mail]><br>Chief Scientific Officer | |
| Preparation Date: | June 30, 2005 | |
| Proprietary Device Name: | BioDerm Sciences Wound Cream | |
| Classification Name: | Wound Dressing | |
| Predicate Device: | BioDerm Sciences Wound Solution | K040683 |
| | BioDerm Sciences Wound Spray | K042084 |

BioDerm Sciences Wound cream is an aqueous-based, Description: acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals.

K970660

BioDcrm Sciences Wound cream is similar in chemical composition to the previously approved BioDerm Sciences Wound Solution. Although the zinc chloride and iron chloride contents are similar, the pH value is somewhat higher (ph 3.0-3.4 vs. 2.8); and other trace elements have been added, making it somewhat more comparable in content to BioDerm Sciences Wound Spray. Unlike BioDerm Sciences Wound Solution and Spray, this product is applied as a cream. BioDerm Sciences Wound Cream is supplied in 100 g aluminum tubes. A metal seal at the tip of the tube must be broken in order to use the contents, thus rendering the packaging tamper-resistant. The dressing is applied by squeezing the cream from the tube onto the affected skin.

BioDerm Sciences Wound cream is intended for external Intended Use: management of minor abrasions, lacerations, cuts, scalds, and 14 and 2nd burns. It can be used in conjunction with a conventional dressing that absorbs fluids (i.c. gauze, gcl, alginate, foam, hydrocolloid).

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K042352

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BioDcrm Sciences Wound cream is contraindicated for use when patients are known to have had allergic reactions to this dressing or its components. It is not suitable for use on third degree burns, or for any wound for which the dermis has been severely damaged or is missing.

# Comparison of Technological Characteristics:

The FDA has cleared a number of wet dressings for marketing. All have in common that they are saline solutions based on sodium chloride or metallic salts with a pH less than or equal to 7 (i.e. acidic). They may or may not contain additives such as nutrients. BioDerm Sciences Wound Cream contains similar proportions and amounts of zinc chloride and iron chloride as the predicate devices BioDerm Sciences Wound Solution and Wound Spray. Like the Dermagran Wound Management System, which is essentially a lanolin-based ointment containing zinc chloride and other nutrients, the water-based BioDerm Sciences Wound Cream is applicd and used as a wound cover or filler.

A broad range of chemical compositions is currently available. The chemical composition of BioDerm Sciences Wound Cream is within the range of chemical compositions of these predicate devices and is substantially equivalent in terms of its safety and effectivencss. (See Table 2)

#### Performance:

A study of various formulations of with varying strength levels of the metallic salts, performed at the University of Miami (Department of Dermatology & Cutaneous Surgery) using a porcine model demonstrated the effectivencss of the solutions contained in the BioDerm Wound Cream as an and to the body's healing of burns, and partial thickness wounds. No sensitization was demonstrated in tests with guinea pigs and no toxicity was observed in mice receiving intraperitoneal injections. The identical product has been marketed in Europe for fourteen years under the name "NAWA, Medical Elektrolyt-Salbe S" with satisfactory performance and no reports of adverse side effects. The Elektrolyt-Salbe is registered as Klasse IIa with registration number: DE/CA65/622-2678.1N4/8.

### Conclusions:

When used as directed, BioDerm Scicnces Wound Cream is safe and effective as a wound dressing.

## Other Information:

This product is intended for sale by or on the order of a physician (or properly licensed practitioner).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three curved lines forming the body and head.

Public Health Service

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edward R. Gubish, Ph.D. Chief Scientific Officer BioDerm Sciences, Inc. 101 Orchard Ridge Drive, Suite 1N Gaithersburg, Maryland 20878

Re: K042352

Trade/Device Name: BioDerm Sciences Wound Cream Regulatory Class: Unclassified Product Code: FRO Dated: September 27, 2005 Received: September 28, 2005

Dear Dr. Gubish:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becament in d the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use battled in 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, de Moos that have been i that do not require approval of a premarket approval application (PMA). and Cosmetter resert ince) and the device, subject to the general controls provisions of the Act. The I ou may, diererey, mains 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 r lease of actived and I Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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.

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Page 2- Edward R. Gubish, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your a finding of substantial equivalence of your device to a legally premated 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 If you attire 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 other general 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,

Mark N. Melkerson

Mark N. Melkerson ్రాల్య Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K042352

Devicc Name: BioDerm Sciences Wound Cream

Indications for Use:

BioDerm Sciences Wound Cream is intended to externally manage dermal lessions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, 15 and 200 as racerations, post operative (cargenous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).

X Prescription Usc (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE.)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_Kod2352