V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for KCI. The logo consists of a stylized graphic to the left of the letters "KCI". The graphic is made up of four curved lines that are stacked on top of each other. The letters "KCI" are in a bold, sans-serif font. Image /page/0/Picture/1 description: The image shows handwritten text. The first line reads "K102956". The second line reads "pg 1 of 2", indicating it is page 1 of 2. ### 510(k) SUMMARY V.A.C. GranuFoam Silver Protection Dressing A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. | Submitter Information [21 CFR 807.929(a)(1)] | | |-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | KCI USA, Inc. (Kinetic Concepts, Inc.) | | Address | 6203 Farinon Drive | | | San Antonio, TX 78249 | | Phone number | 210.515.4126 | | Fax number | 210.255.6727 | | Establishment<br>Registration Number | 1625774 | | Name of contact<br>person | Shannon Scott, Regulatory Affairs Manager | | Date prepared | December 14, 2010 | | Name of the device [21 CFR 807.92(a)(2)] | | | Trade or proprietary<br>name | V.A.C. GranuFoam Silver® Protection Dressing | | Common or usual<br>name | Negative pressure wound therapy dressing | | Classification name | Negative pressure wound therapy powered suction pump | | Classification panel | General and Plastic Surgery | | Regulation | 878.4780 | | Product Code(s) | OMP | | Legally marketed<br>device(s) to which<br>equivalence is claimed<br>[21 CFR 807.92(a)(3)] | V.A.C. GranuFoam Silver Protection Dressing (K053627) | | Device description<br>[21 CFR 807.92(a)(4)] | The V.A.C. GranuFoam Silver Protection Dressing is a component of the V.A.C.<br>Therapy System which is an integrated negative pressure wound management<br>system. The dressing is polyurethane foam with a silver coating designed<br>specifically for use with the V.A.C. family of negative pressure wound therapy<br>devices. | | Indications for use<br>[21 CFR 807.92(a)(5)] | The V.A.C. GranuFoam Silver Protection Dressing is intended for use with the<br>V.A.C. family of negative pressure wound therapy systems to help promote wound<br>healing. The dressing is an effective barrier to bacterial penetration and may help<br>reduce infection in chronic, acute, traumatic, subacute and dehisced wounds,<br>partial thickness burns, ulcers (such as diabetic, pressure or venous<br>insufficiency), flaps and grafts. | DEC 1 5 2010 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left, followed by the letters "KCI" in a bold, sans-serif font. A small registered trademark symbol appears to the right of the "I". K102956 pg 2082 ## 510(k) SUMMARY V.A.C. GranuFoam Silver Protection Dressing | Summary of the technological characteristics of the device compared to the predicate device<br>[21 CFR 807.92(a)(6)] | | | |-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | New Device<br>V.A.C. GranuFoam<br>Silver Protection Dressing | Predicate<br>V.A.C. GranuFoam<br>Silver Protection Dressing<br>K053627 | | Indications for use | Same as predicate with the<br>addition of venous insufficiency<br>ulcers, cleared under 510(k)<br>K091585.<br><br>The V.A.C. GranuFoam Silver<br>Protection Dressing is intended<br>for use with the V.A.C. family of<br>negative pressure wound therapy<br>systems to help promote wound<br>healing. The dressing is an<br>effective barrier to bacterial<br>penetration and may help reduce<br>infection in chronic, acute,<br>traumatic, subacute and<br>dehisced wounds, partial<br>thickness burns, ulcers (such as<br>diabetic, pressure or venous<br>insufficiency), flaps and grafts. | The V.A.C. GranuFoam Silver<br>Protection Dressing is intended<br>for use with the V.A.C. family of<br>negative pressure wound<br>therapy systems to help promote<br>wound healing. The dressing is<br>an effective barrier to bacterial<br>penetration and may help reduce<br>infection in chronic, acute,<br>traumatic, subacute, and<br>dehisced wounds, diabetic<br>ulcers, pressure ulcers, flaps,<br>grafts and partial thickness<br>burns. | | Dressing composition | Same as predicate | Black, reticulated, polyurethane<br>foam with silver coating | | Antibacterial activity | Same as predicate | Studies of antibacterial activity<br>against S. aureus, P.<br>aeruginosa, and E. coli. | | Performance Data [21 CFR 807.92(b)] | | | | [21 CFR 807.92(b)(1)]<br>Summary of non-clinical tests conducted for determination of substantial equivalence | Studies of the antibacterial activity of the predicate device were previously conducted against S. aureus, P.<br>aeruginosa, and E. coli. In support of the proposed change to the product specification, testing has been<br>conducted and the product has been shown to pass these tests with equivalent results. | | | [21 CFR 807.92(b)(2)]<br>Summary of clinical tests conducted for determination of substantial equivalence or of clinical<br>information | No clinical tests were necessary. | | | Conclusions drawn [21 CFR 807.92(b)(3)] | The V.A.C. GranuFoam Silver Protection Dressing and its predicate (K053627) are identical in product<br>design, composition and processing. V.A.C. GranuFoam Silver Protection Dressing is substantially<br>equivalent to its predicate (K053627) in terms of safety, function and indications for use. | | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, possibly representing health and human services. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 KCI USA, Inc. % Shannon Scott Regulatory Affairs Manager 6203 Fairnon Drive San Antonio, Texas 78249 DEC 15 2019 Re: K102956 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: November 22, 2010 Received: November 23, 2010 Dear Shannon Scott: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleding. 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 limited to: registration and listing (21 {3}------------------------------------------------ Page 2 - Shannon Scott CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 801); good manufacturing of medical forth in the quality systems (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control (QD) regulation (21 CFR Part 820); and if applicable, the elections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Pat 801), please go to http://www.fda.gov/AboutEDA/CentersOff go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/11/20/2019 the Center for Devices and Radiological Hoolth in ODE DRH/CDRHOffices/ucm/11/5809.htm for the Center for Devices and Radiological Health's (CDRH's) Offices/ucm1115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, p note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part and of the other chance, "Insolanding of Ference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regu CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its the many of the Act from the (800) 638-2041 or (301) 796-7100 or at its International and (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Harvard Business Resources for You/industry/default.htm. Sincerely yours, Az 13-nt Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 102956 DEC 1 5 2010 ## INDICATIONS FOR USE 510(k) Number (if known): 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, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. Prescription Use _ Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David Kume for MXM Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices Page of (Posted November 13, 2003) 510(k) Number K102956 Page 1