V.A.C. GRANUFOAM SILVER PROTECTION DRESSING

K050261 · Kinetic Concepts, Inc. · OMP · May 26, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050261
• Device Name: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
• Applicant: Kinetic Concepts, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The V.A.C.® GranuFoam® Silver Protection dressing is intended for use with the V.A.C.® family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.

Device Story

V.A.C. GranuFoam Silver Protection dressing is a wound care accessory for V.A.C. negative pressure wound therapy systems. Device consists of reticulated polyurethane foam with silver coating. Used in clinical settings to promote wound healing by providing a barrier to bacterial penetration and facilitating drainage/removal of infectious material and fluids. Applied by healthcare providers as part of negative pressure wound therapy; output is the physical management of the wound environment. Benefits include infection reduction and support for healing in various wound types.

Clinical Evidence

Bench testing only. Comparative in vitro testing demonstrated antibacterial effectiveness against predicate silver dressings. Comparative bench testing provided evidence of equivalence in physical properties compared to predicate GranuFoam dressings. Biocompatibility testing performed in accordance with ISO-10993.

Technological Characteristics

Material: Reticulated polyurethane foam with silver coating. Form factor: Dressing for negative pressure wound therapy. Sterilization: Gamma-irradiation. Biocompatibility: ISO-10993 compliant.

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts, and partial thickness burns requiring negative pressure wound therapy.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• V.A.C.® GranuFoam® Silver Dressing (K041642)
• V.A.C.® GranuFoam® Dressing (K032310)
• Johnson & Johnson Silvercel™ Wound Dressing (K024298)

Submission Summary (Full Text)

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K0T0261

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## MAY 2 6 2005

# 510(k) Summary V.A.C.® GranuFoam® Silver Protection Dressing

| 1. Submitter: | KCI USA, Inc (Kinetic Concepts, Inc.)<br>8023 Vantage Drive<br>San Antonio, TX 78230 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Christy Oviatt<br>Sr. Regulatory Affairs Specialist |
| 3. Date Summary Prepared: | February 2, 2005 |
| 4. Name of Device: | V.A.C.® GranuFoam® Silver Protection<br>Dressing |
| 5. Classification Name: | Accessory to Powered Suction Pump<br>21 CFR 878.4780<br>Class II |
| 6. Predicate Devices: | V.A.C.® GranuFoam® Silver Dressing (K041642)<br>V.A.C.® GranuFoam® Dressing (K032310)<br>Johnson & Johnson Silvercel™ Wound Dressing<br>(K024298) |

#### 7. Description of Device

The V.A.C. Granufoam Silver Protection dressing is an addition to the V.A.C. 9 product line of dressings designed specifically for use with the V.A.C. 0 Family of negative pressure devices.

#### 8. Indication for Use

The V.A.C.® GranuFoam® Silver Protection dressing is intended for use with the V.A.C. 8 family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.

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Keror261
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KCI USA, Inc V.A.C.® GranuFoam® Silver Protection Dressing

## 9. Technological Characteristics and Substantial Equivalence

The V.A.C. GranuFoam Silver Protection dressing is comprised of black, reticulated, polyurethane foam covered with a silver coating. The substantial equivalence for the V.A.C. GranuFoam Silver Protection dressing is based on the indications, intended use and technological features.

The V.A.C. GranuFoam® Silver Protection dressing is considered substantially equivalent to the V.A.C. GranuFoam™ Silver dressing (K.041642) and the Johnson & Johnson Silvercel Wound Dressing (K024298) in terms of an antimicrobial barrier. Comparative in vitro testing to demonstrate antibacterial effectiveness was conducted on the V.A.C. GranuFoam® Silver Protection dressing, the V.A.C. GranuFoam® Silver dressing and the Johnson & Johnson Silvercel™ Wound dressing.

The V.A.C. GranuFoam® Silver Protection dressing is considered substantially equivalent to the V.A.C. GranuFoam® Silver dressing (K041642) and the V.A.C. GranuFoam® dressing (K032310) in terms of use with the V.A.C. family of negative pressure devices used to help promote wound healing through means including drainage and removal of infectious material or other fluids. Comparative bench testing was conducted to provide evidence of equivalence in physical properties of the three dressings.

Verification of the biocompatibility of the V.A.C. GranuFoam® Silver Protection dressing is based on GLP testing of the gamma-irradiated dressing in accordance with ISO-10993.

#### 10. Conclusion

Based on the information presented above it is concluded that the V.A.C. GranuFoam® Silver Protection dressing can be marketed for its intended use and is substantially equivalent to the identified predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the caduceus symbol.

APR - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230

Re: K050261

Trade/Device Name: V.A.C.® GranuFoam® Silver Protection Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: April 25, 2005 Received: April 26, 2005

Dear Ms. Oviatt:

This letter corrects our substantially equivalent letter of May 26, 2005.

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 (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

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## Page 2 - Ms. Christy Oviatt

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 continue 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 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/dsma/dsmamain.html.

Sincerely yours,

Fok Dottor

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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KOTO261

## Indications for Use

510 (k) Number (if known): K050261

Device Name: V.A.C. GranuFoam® Silver Protection Dressing

Indications for Use:

The V.A.C. ® GranuFoam® Silver Protection dressing is intended for use with the V.A.C. ® family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.

Prescription Use
(Per 21 CFR 801.109)
✓

AND/OR

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

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

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

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

K050761

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