CMB ANTIMICROBIAL DRESSING

K060237 · Silverleaf Medical Products, Inc. · FRO · Jun 15, 2006 · SU

Device Facts

• Record ID: K060237
• Device Name: CMB ANTIMICROBIAL DRESSING
• Applicant: Silverleaf Medical Products, Inc.
• Product Code: FRO · SU
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.

Device Story

CMB Antimicrobial Dressing is a single-layer woven polyester dressing containing elemental silver and zinc; intended for professional use on moderately to heavily exuding partial and full-thickness wounds. In the presence of wound exudate, the dressing acts as an antimicrobial barrier and helps maintain a moist wound healing environment when used with a secondary barrier. The device is applied by a clinician to the wound site. It benefits patients by providing a barrier to bacterial penetration, supporting wound management for various ulcer types and burns.

Clinical Evidence

Bench testing only. In vitro antimicrobial performance testing was conducted. Biocompatibility testing included cytotoxicity, irritation, sensitization, pyrogenicity, and systemic injection. No clinical data provided.

Technological Characteristics

Single-layer woven polyester dressing containing elemental silver and zinc. Functions as an antimicrobial barrier. Requires secondary barrier for exudate management. Non-electronic, non-software device.

Indications for Use

Indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds, including pressure, venous, and diabetic ulcers, burns, and donor/recipient graft sites.

Predicate Devices

• Acticoat Antimicrobial Dressing (K955453)
• Hydrocolloid with Zinc Wound Dressing (K973855)
• Absorbent Antimicrobial Wound Dressing (K033814)

Submission Summary (Full Text)

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## K060237

## CMB Antimicrobial Dressing

## 510(K) Summary of Safety and Effectiveness

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| 510(k) Summary<br>of Safety &<br>Effectiveness | The CMB Antimicrobial Dressing is an effective barrier to<br>bacterial penetration. It is intended for professional use only.<br>The dressing is for use on moderately to heavily exuding partial<br>and full-thickness wounds including decubitus ulcers, venous<br>stasis ulcers, surgical wounds, first- and second-degree burns,<br>grafts and donor sites. |
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| New Device Name: | CMB Antimicrobial Dressing |
| Predicate Device Names: | Acticoat Antimicrobial Dressing<br>(K955453)<br>Hydrocolloid with Zinc Wound<br>Dressing (K973855)<br>Absorbent Antimicrobial Wound<br>Dressing (K033814) |
| Device<br>Description | The CMB Antimicrobial dressing is a single layer dressing<br>consisting of a woven adsorbent polyester containing elemental<br>silver and zinc. In the presence of exudate, the dressing can be<br>used with an appropriate secondary barrier to help maintain a<br>moist wound healing environment. |
| Intended Use | As an antimicrobial barrier, place over partial and full-<br>thickness wounds such as: pressure ulcers, venous ulcers,<br>diabetic ulcers, burns and donor and recipient graft sites. |
| Indications<br>Statement | The CMB Antimicrobial Dressing is indicated for professional<br>use only as an antimicrobial barrier for partial and full-<br>thickness wounds such as: pressure ulcers, venous ulcers,<br>diabetic ulcers, burns and donor and recipient graft sites. |
| Technological<br>Characteristics | Technologically, the CMB Antimicrobial Dressing and<br>predicate devices are the similar in that they all contain a<br>fabric/gauze/pad component and an antimicrobial component.<br>The difference is that two antimicrobial components, silver and<br>zinc are included in the CMB dressing |
| Performance<br>Data | Antimicrobial performance was tested in vitro.<br>Biocompatibility tests performed on the CMB Antimicrobial<br>Dressing included cytotoxicity, irritation, sensitization,<br>pyrogenicity and systemic injection. An independent<br>laboratory performed the testing and test results are on file. |
| Conclusions | Based on the 510(k) summaries and the 510(k) statements (21<br>CFR 807) and the information and performance data provided<br>herein, we conclude that the CMB Antimicrobial Dressing is<br>substantially equivalent to the existing legally marketed<br>devices under the Federal Food, Drug and Cosmetic Act. |
| Contact | Debbie Koeneman, M.S.<br>Silverleaf Medical Products, Inc.<br>1100 E. University Drive, Suite 101<br>Tempe, AZ 85281 |
| Date | June 1, 2006 |

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CMB Antimicrobial Dressing 510(K) summary of Safety and Effectiveness continued,

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JUN 15 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Silverleaf Medical Products, Inc. % Ms. Debbie Koeneman, M.S. Director, Regulatory Affairs 1100 E. University, Suite 101 Tempe, Arizona 85281

Re: K060237 Trade/Device Name: CMB Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 2, 2006 Received: June 5, 2006

Dear Ms. Koeneman:

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 (?1 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 clectronic 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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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.

Hubert Lenoir

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

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510(k) Number (if known): K060237

Device Name: CMB Antimicrobial Dressing

Indications for Use:

The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> |
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| or | |
| Over-The- Counter Use | <span style="text-decoration: underline;"></span> |

(Optional Format 1-2-99)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices510(k) Number_K060237