AVANCE FOAM DRESSING KITS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three overlapping profiles facing right, resembling a family or group of people. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 26, 2015 Molnlycke Health Care US LLC Ms. Angela L. Bunn, RAC Director Regulatory Affairs for the Americas 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092 Re: K141847 Trade/Device Name: Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad and Mepitel® Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 24, 2015 Received: February 27, 2015 Dear Ms. Bunn: 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, # Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use ### 510(k) Number (if known) K141847 ### Device Name A vance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad and Mepitel® ### Indications for Use (Describe) The Avance® NPWT system, with associated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts. Type of Use (Select one or both, as applicable) X 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) {3}------------------------------------------------ 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 burden 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." {4}------------------------------------------------ #### 510(k) SUMMARY OF SAFETY AND EFFICACY This 510(k) summary of safety and efficacy information is being submitted in accordance with the requirements of 21 CFR 807.92(c). Date Prepared: October 1, 2014 Applicant: Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 Registration number: 3004763499 Owner/Operator Number: 9067000 Official Correspondent: Angela L. Bunn, RAC Director, Regulatory Affairs of the Americas Tel: 678-250-7930 Fax: 678-250-7981 e-mail: angela.bunn@molnlycke.com Trade/Proprietary Name: Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad™ and Mepitel® Common Name: NPWT Dressing Kits Classification Name: Powered Suction Pump Device Class: Class II Regulation Number: 21 CFR 878.4780 Product Code: OMP Avance Foam Dressing Kits including Foam. Transparent Film Predicate Device Name(s): and Transfer Pad and Avance® Foam Dressing Kits including Foam, Film with Safetac® and Transfer Pad - K122132 Mepitel® - K984371 #### Description of Device: Mölnlycke Health Care holds a current clearance for a group of Negative Pressure Wound Therapy dressing kits known as Avance Foam Dressing Kits including: Transparent Film and Transfer Pad as well as the Avance Foam Dressing Kits including: Film with Safetac and Transfer Pad (K122132). This additional offering has been developed to allow the clinician a selection of dressing products to meet their patient's specific needs. {5}------------------------------------------------ | Product<br>Code | Proposed Product Description | |-----------------|---------------------------------------------------------------------------------------| | 662152 | Avance® Foam Dressing Kit including: Transparent Film, ViewPad™ – Small | | 662252 | Avance® Foam Dressing Kit including: Transparent Film, ViewPad™ – Medium | | 662352 | Avance® Foam Dressing Kit including: Transparent Film, ViewPad™ – Large | | 662452 | Avance® Foam Dressing Kit including: Transparent Film, ViewPad™ and Mepitel® – Small | | 662552 | Avance® Foam Dressing Kit including: Transparent Film, ViewPad™ and Mepitel® – Medium | | 662652 | Avance® Foam Dressing Kit including: Transparent Film, ViewPad™ and Mepitel® – Large | | 664152 | Avance® Foam Dressing Kit including: Film with Safetac®, ViewPad™ – Small | | 664252 | Avance® Foam Dressing Kit including: Film with Safetac®, ViewPad™ – Medium | | 664252 | Avance® Foam Dressing Kit including: Film with Safetac®, ViewPad™ – Large | | 662018 | Avance® ViewPad™ | The subject device of this submission, the Avance Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad™ and Mepitel® is an offering of components developed for negative pressure wound therapy. These dressing kits which are intended for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac ViewPad™ and Mepitel® is a combination of different components developed and arranged to meet the needs of the clinician for specific size and types of wounds. #### Intended Use/Indication for Use: The Avance® NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts. #### Performance Data: The Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac® ViewPad™and Mepitel® perform in the same manner as the predicate device kits (K122132) and are compatible with a similar type of pump. The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior. {6}------------------------------------------------ The fluid was efficiently transported from the wound model without lockage or problems. The system was tested over the time period of 73 hours without any problems or errors. #### Clinical Testing: No clinical data was required. #### Conclusion: Based on the information presented in this submission, it can be concluded that the Avance® Foam Dressing Kits Including components such as: Transparent Film, Film with Safetac®, ViewPad™ and Mepitel® are substantially equivalent to the predicate device(s) identified with respect to intended use, materials (with the exception of ViewPad™ Materials), design and technological characteristics.