V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U

{0}------------------------------------------------ K100657 pg 10+3 ## 510(k) SUMMARY | | V.A.C.Ulta™ Negative Pressure Wound Therapy System | | | |------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Date prepared | July 26, 2010 | | | | 510(k) owner | KCI USA, Inc. | | | | Name | KCI USA, Inc. (Kinetic Concepts, Inc.) | | | | Address | 6203 Farinon Drive; San Antonio, Texas 78249 | | | | Fax number | 210 255-6727 | | | | Name of contact person | Margaret Marsh | | | | Contact telephone number | 1 800 275-4524; Request Regulatory Affairs. | | | | Name of the device | | | | | Trade or proprietary name | V.A.C.Ulta™ Negative Pressure Wound Therapy System<br>(V.A.C.Ulta™ Therapy System) | | | | Common or usual name | Instillation and negative pressure wound therapy system | | | | Classification name | Negative Pressure Wound Therapy Powered Suction Pump<br>(and components) | | | | Legally marketed device(s) to which equivalence is claimed | V.A.C. Instillamat Device (K021501 and K091585) | | | | Device description | A negative pressure wound therapy system with an instillation feature<br>which allows controlled delivery and drainage of topical wound treatment<br>solutions and suspensions | | | | Device design | Negative pressure wound therapy system, in which instillation of topical<br>wound treatment solutions and suspensions and negative pressure<br>wound therapy is provided via software controlled pumps. Instillation<br>solutions and negative pressure are delivered through tubing to foam<br>dressings in the wound covered by an occlusive drape. Software<br>monitors both negative pressure during negative pressure wound therapy<br>as well as positive pressure during instillation of fluids to the wound bed.<br>Software also provides controls for help and alarm functions. | | | | Intended use of the device | The V.A.C.Ulta Negative Pressure Wound Therapy System is an<br>integrated wound management system that provides Negative Pressure<br>Wound Therapy with an instillation option. | | | | | Negative Pressure Wound Therapy in the absence of instillation is<br>intended to create an environment that promotes wound healing by<br>secondary or tertiary (delayed primary) intention by preparing the wound<br>bed for closure, reducing edema, promoting granulation tissue formation<br>and perfusion, and by removing exudate and infectious material. | | | | | The instillation option is indicated for patients who would benefit from<br>vacuum assisted drainage and controlled delivery of topical wound<br>treatment solutions and suspensions over the wound bed.<br><br>The V.A.C.Ulta™ Negative Pressure Wound Therapy System with and<br>without instillation is indicated for patients with chronic, acute, traumatic,<br>sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as<br>diabetic, pressure and venous insufficiency), flaps and grafts. | | | | Summary of the<br>technological<br>characteristics of<br>the device<br>compared to the<br>predicate device | Feature | V.A.C.Ulta Therapy<br>System | V.A.C. Instill Therapy<br>System | | | Dressing<br>system | Same as predicate | Foam based dressing with<br>occlusive drape | | | Pressure<br>sensing | Same as predicate | Via sensing pad in tubing line | | | Therapy<br>unit | Same as predicate | Software controlled pumps for<br>delivery of negative pressure<br>wound therapy and controlled<br>delivery of instillation fluids | | Summary of tests<br>conducted | The V.A.C.Ulta Therapy System and components were evaluated under a<br>number of design verification and validation tests that assure<br>conformance to design specifications.<br>The following bench tests were conducted on the V.A.C.Ulta Therapy<br>System:<br>Ability of the V.A.C.Ulta System to deliver NPWT in a comparable<br>manner to currently marketed V.A.C. NPWT Systems was<br>assessed at -50, -125 and -200 mmHg. Testing demonstrated<br>that the V.A.C.Ulta System delivers equivalent negative pressure<br>wound therapy. The ability of the V.A.C. Ulta System to deliver both NPWT and<br>intermittent fluid instillation within specification was assessed over<br>a continuous 96 hours period. Testing demonstrated the system<br>met performance specifications. Testing was conducted to confirm the ability of the therapy unit to<br>instill fluids within specified ranges and volumes, to provide<br>alarms and controls during negative pressure and instillation<br>therapy, and to provide a maximum flow rate that is equivalent to<br>that provided by the predicate. Testing demonstrated that all<br>requirements were met. Mechanical properties testing of the new foam dressing (under | | | V.A.C.Ulta™ Negative Pressure Wound Therapy System SEP 1 7 2010 {1}------------------------------------------------ : . {2}------------------------------------------------ | | appropriate mechanical properties for use during instillation.<br>• Peel force testing of the new drape documents that it is<br>equivalent to the currently marketed V.A.C. Drape.<br>• Software verification and validation testing confirms that the<br>software meets the requirements of the software requirements<br>specification.<br>Biocompatibility testing was performed in accordance to ISO 10993-1<br>standards, and results demonstrated that the device is biocompatible<br>according to these standards. | |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusions drawn | Testing demonstrates that the V.A.C.Ulta™ Therapy System is<br>substantially equivalent in terms of both indications for use and<br>technology to the predicate product. | Kloobs7 1993073 -278 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus-like symbol with three intertwined lines, representing health and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 KCI USA, Inc. % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249 SEP 1 7 2010 Re: K100657 Trade/Device Name: V.A.C. Ulta Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: July 26, 2010 Received: July 28, 2010 Dear Ms. Marsh: 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. Ilsting 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 misleading. 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 {4}------------------------------------------------ Page 2 - Ms. Margaret Marsh CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Sincerely yours, Mark N. Melkerson For Dir Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K100657 ## INDICATIONS FOR USE ## 510(k) Number (if known): K100657 Device Name: V.A.C.Ulta Negative Pressure Wound Therapy System SEP 1 7 2010 Indications for Use: The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The V.A.C.Ulta™ Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partialthickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts. Over-The-Counter Use × Prescription 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 KraybillPage _ of _ (Posted November 13, 2003) (Division Sign-Division of Surgicat. Orthopedic. and Restorative Devices 510(k) Number K60657