PROSIT WOUND TREATMENT DEVICE

K081977 · Silverleaf Medical Products, Inc. · FRO · Dec 1, 2008 · SU

Device Facts

• Record ID: K081977
• Device Name: PROSIT WOUND TREATMENT DEVICE
• Applicant: Silverleaf Medical Products, Inc.
• Product Code: FRO · SU
• Decision Date: Dec 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites. For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.

Device Story

Procellera™ is a single-layer antimicrobial wound dressing composed of woven absorbent polyester fabric embedded with elemental silver and zinc held by a biocompatible binder. The device design inherently generates a small electrical current in the presence of wound exudate. It is applied to the wound site and requires a secondary barrier to maintain a moist healing environment. The device is intended for use by clinicians in professional settings for complex wounds or by patients for minor skin injuries. The electrical current is intended to provide antimicrobial properties to the wound environment. It does not involve external power sources or active electronic components.

Clinical Evidence

No clinical data provided. Performance evidence consists of bench testing, antimicrobial testing, animal testing, and biocompatibility testing. Biocompatibility studies included cytotoxicity, irritation, sensitization, pyrogenicity, systemic injection, and 28-day subcutaneous implantation.

Technological Characteristics

Single-layer dressing; woven absorbent polyester fabric; elemental silver and zinc; biocompatible binder. Mechanism: inherent generation of low-level electrical current in the presence of wound exudate. Form factor: single-ply multi-filament spun threads.

Indications for Use

Indicated for partial/full-thickness wounds (pressure, venous, diabetic ulcers, burns, surgical incisions, graft sites) for professional use; indicated for minor cuts, scrapes, irritations, and abrasions for OTC use.

Predicate Devices

• CMB Antimicrobial Dressing (K060237)

Submission Summary (Full Text)

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081977 page 101

## Procellera™ (for Professional Use) 510(k) Summary of Safety and Effectiveness

Procellera™ is a single layer dressing consisting of the worker 510(K) Summary absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder.

> For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.

Procellera™ New Device Name:

CMB Antimicrobial Dressing (K060237) Predicate Device Name:

Device Description Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polvester fabric is single ply and is made from multi-filament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design.

In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.

For professional use, Procellera™ antimicrobial wound dressing is Indications indicated for partial and full-thickness wounds such as: pressure Statement ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.

Technologically, Procellera™ and the predicate device (CMB™ Technological Antimicrobial Wound Dressing) are identical. Procellera™ is the Characteristics same device as the predicate CMB™.

> A small amount of current is produced and it occurs because it is inherent to the design.

Performance Performance data were gathered via antimicrobial, animal, bench and biocompatibility testing. Biocompatibility tests performed on the Data cytotoxicity, irritation, sensitization. Procellera™: included 28 day subcutaneous pvrogenicity, systemic injection, and implantation.

Based on the 510(k) summaries and the 510(k) statements (21 CFR Conclusions 807) and the information and performance data provided herein, we conclude that the Procellera™ is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.

Contact

Jeffry Skiba Vomaris Innovations Inc. 3100 W Ray Rd, Suite 148 Chandler, AZ 85226 Phone: [phone] Fax: [phone]

Date

November 19, 2008

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Procellera™ (for Over The Counter Use)

#### 510(k) Summary of Safety and Effectiveness

510(K) Summary Procellera™ is a single laver dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder.

For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.

Procellera™ New Device Name:

Predicate Device Name: CMB Antimicrobial Dressing (K060237)

Device Description Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polyester fabric is single ply and is made from multifilament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design.

In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.

over-the-counter use, Procellera™ wound dressing is Indications For indicated for minor cuts, scrapes, irritations, and abrasions. Statement

Technologically, Procellera™ and the predicate device (CMB™ Technological Antimicrobial Wound Dressing) are identical. Procellera™ is the Characteristics same device as the predicate CMB™.

> A small amount of current is produced and it occurs because it is inherent to the design.

Performance Data

Performance data were gathered via antimicrobial, animal, bench and biocompatibility testing. Biocompatibility tests performed on the Procellera™: included cytotoxicity, irritation, sensitization, pyrogenicity, systemic injection, and 28 day subcutaneous implantation.

Conclusions

Based on the 510(k) summaries and the 510(k) statements (21 CFR 807) and the information and performance data provided herein, we conclude that the Procellera™ is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.

Contact

Jeffry Skiba Vomaris Innovations Inc. 3100 W Ray Rd, Suite 148 Chandler, AZ 85226 Phone: [phone] Fax: [phone]

Date

- November 19, 2008

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a bird-like figure.

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 0 1 2008

Vomaris Innovations, Inc. % Mr. Jeff Skiba President 3100 W Ray Road, Suite 148 Chandler, Arizona 85226

Re: K081977

Trade/Device Name: Procellera™ Regulatory Class: Unclassified Product Code: FRO Dated: October 23, 2008 Received: October 24, 2008

Dear Mr. Skiba:

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 (OS) 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. Jeff Skiba

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark H. Millman

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

Enclosure

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# Statement of Indications for Use

510(k) Number (if known):

K081977

Device Name:

Procellera™

Indications for Use:

· For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or

Over-The-Counter Use

(Optional Format 1-2-96)
Nul Reeds

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

081 લે ની 510(k) Number

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# Statement of Indications for Use

510(k) Number (if known):

K081977

Device Name:

Procellera™

Indications for Use:

For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription Use

Over-The-Counter Use.

(Optional Format 1-2-96)

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

510(k) Number