SVED Wound Treatment System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 4, 2015 Cardinal Health % Allison Scott Navigant Consulting Incorporated 9001 Wesleyan Road, Suite 200 Indianapolis. Indiana 46268 Re: K142916 Trade/Device Name: Sved® Wound Treatment System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 23, 2015 Received: January 26, 2015 Dear Ms. 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 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S - Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K142916 RT12516 Device Name Sved® Wound Treatment System ## Indications for Use (Describe) The Cardinal Health NPWT SVED system is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burder estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 510(k) Summary Sved Wound Treatment System Cardinal Health # 510(k) Summary #### I. Submitter Information Cardinal Health 1500 S Waukegan Road Waukegan, IL 60085 Allison Scott, RAC Contact Person: 317-228-8719 Allison.Scott@Navigant.com Date Prepared: January 23, 2015 #### II. Device Information Name of Device: Common Name: Classification Name(s): Regulatory Class: II Product Code: OMP Sved® Wound Treatment System Negative Pressure Wound Therapy Powered Suction Pump Powered Suction Pump (21 CFR 878.4780) #### III. Predicate Device | 510(k) Number | Device Name | Submitter Name | |---------------|----------------------|-----------------| | K093564 | SVED Wound Treatment | Innovative | | | System | Therapies, Inc. | This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### IV. Device Description The SVED® Wound Treatment System is an AC-powered, portable suction device with battery backup that provides localized negative pressure wound therapy when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The system consists of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressing, canister tubing with clamps and connectors, polyurethane drape with adhesive, and irrigation tubing with clamps and connectors. The system is intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The SVED ® Wound Treatment System provides care in the acute, extended and home care settings. {4}------------------------------------------------ #### V. Intended Use(s) The Cardinal Health NPWT SVED system is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings. #### VI. Comparison of Technological Characteristics This submission is to provide an update to the existing cleared Sved® Wound Treatment System. The subject and predicate devices are based on the following same technical elements: - . Continuous and Intermittent treatment modes - 70mmHg, 120mmHg & 150mmHg Pressure Ranges ● - Pressure sensing technology within the pump - Available for use with 300cc and 500cc canisters ● - . Use AC and Rechargeable battery The following technological differences exist between the subject and predicate devices: - . The updated Sved® Wound Treatment System has an updated indications for use to include partial-thickness burns. This better aligns the indications for use with the "OMP" regulation definition. - . The updated Sved® Wound Treatment System has had other enhancements including: - o Enhanced solenoid activation on AC to DC transition - Enhancements to the Leak Alarm O - Changed the alarm volume level scale to provide a way for the caregiver O to adjust the volume. - New motor with the same specifications as the previous motor o - O Addition of LED Therapy Timer/Display #### VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. ## Electrical Safety and Electromagnetic Compatibility (EMC) Electrical safety and EMC testing were conducted on the Sved® Wound Treatment System. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. {5}------------------------------------------------ 510(k) Summary Sved Wound Treatment System Cardinal Health ## Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator. ## Clinical Usability Testing A single-center, unblinded, observational, simulated use usability evaluation of the Cardinal Health Sved System with 34 adult Healthcare Professionals (HCPs) and lay-user Subjects as patient/caregiver surrogates. Following enrollment and training. approximately half of each Subject cohort was guided through either [1] a Directed Use Case trial in which they were asked to read and follow the written instructions to complete study tasks (documentation validation), or through [2] an Unassisted Use Case trial in which the written instructions were made available but the Subjects were free to decide to use them (interface usability validation). A final interview to capture root cause for any use errors or close calls, and any remaining Subject feedback or questions was conducted before releasing the Subject from the study. Results from the study were used to update the risk analysis plan and user manual, as needed. # VIII. Conclusions The electrical safety and EMC testing and software verification and validation demonstrate that the Sved® Wound Treatment System should perform as well as the predicate device in the specified use conditions.