RENASYS-G Gauze Dressing Kits with Soft Port

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked, with the top one being the most prominent and each subsequent profile slightly offset and partially obscured by the one above. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 31, 2016 Smith & Nephew, Inc. Ms. Laura Revnolds Director, Regulatory Affairs 970 Lake Carillon Drive, Suite 300 St. Petersburg, FL 33716 Re: K162129 Trade/Device Name: RENASYS-G Gauze Dressing Kits with Soft Port Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: July 29, 2016 Received: August 1, 2016 Dear Ms. Reynolds: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K162129 Device Name RENASYS-G Gauze Dressing Kits with Soft Port #### Indications for Use (Describe) The RENASYS-G Gauze Dressing Kits with Soft Port are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems 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. Appropriate wound types include: | Chronic | | |--------------------------------------|--| | Acute | | | Traumatic | | | Sub-acute and dehisced wounds | | | Ulcers (such as pressure ordiabetic) | | | Partial-thickness burns | | | Flaps and Grafts | | Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of that, the text "smith&nephew" is written in orange. #### Wound Management Smith & Nephew, Inc. 970 Lake Carillon Drive Suite 300 St. Petersburg, FL 33716 Customer Care Center: 1 800 876-1261 www.smith-nephew.com # 510(k) SUMMARY ### General Information | Submitter Name/ Address: | Smith & Nephew, Inc.<br>970 Lake Carillon Drive<br>Suite 300<br>St Petersburg, FL 33716 | |------------------------------------|-----------------------------------------------------------------------------------------| | Establishment registration Number: | 3006760724 | | Contact Person: | Laura Reynolds<br>Director Regulatory Affairs | | Phone Number: | (727) 686-8736 | | Date Prepared: | August 30, 2016 | Device Description | Trade Name: | RENASYS™-G Gauze<br>Dressing Kit with Soft Port | |------------------------|---------------------------------------------------------| | Common or Usual Name: | Negative Pressure Wound Therapy<br>Powered suction pump | | Device Classification: | Powered suction pump; 21 CFR 878.4780<br>Class II | | Product Code: | OMP | ### Predicate Device Information | 510(k)# | Device | Clearance Date | |---------|-----------------------------------------------------------------------------------------------------------------------------------|----------------| | K142979 | RENASYS EZ MAX Negative<br>Pressure Wound Therapy System and<br>RENASYS Foam and Gauze NPWT<br>Wound Dressing Kits with Soft Port | Apr 29, 2015 | {4}------------------------------------------------ ### Device Description #### RENASYS Gauze NPWT Wound Dressing Kit with Soft Port The RENASYS Gauze Wound Dressing Kit with Soft Port consists of the following components: - . Antimicrobial gauze wound filler - Soft Port assembly - Non-adherent wound contact layer ● - RENASYS Transparent film ● - . Saline bullet - . No Sting Skin Prep - . Wound ruler The RENASYS-G Gauze kits are offered in four sizes: small, medium, large and extralarge. The components of the kit are individually packaged and sterilized and kitted in a non-sterile kit package. The kit is single use. The Soft Port assembly attaches to an exudate canister to deliver negative pressure wound therapy to the wound. The qauze kits are designed specifically for use with the RENASYS negative pressure wound therapy devices and canisters. #### Indications for Use The RENASYS-G Gauze Wound Dressing Kit with Soft Port is intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems 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. Appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts. {5}------------------------------------------------ ### Comparison between Subject and Predicate Devices ### RENASYS-G Gauze Dressing Kit with Soft Port | | Subject Device: | Predicate Device: | |------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | | | 510(k)# K142979 | | Trade Name: | RENASYS-G Gauze<br>Dressing Kit with Soft Port | RENASYS EZ MAX NPWT<br>and RENASYS Foam and<br>Gauze Dressing Kits with<br>Soft Port | | Indications for Use: | Substantially equivalent | Substantially equivalent | | Materials: | Substantially equivalent | Substantially equivalent | | Soft Port Assembly: | Substantially equivalent | Substantially equivalent | | Single-use or<br>Reusable: | Single-use | Single-use | | Method of<br>Sterilization: | Identical | Identical | | Biocompatibility: | All components comply with<br>ISO 10993 | All components comply with<br>ISO 10993 | | Packaging: | Individually packaged and<br>sterilized components are<br>kitted into Tyvek pouch.<br>RENASYS Transparent Film<br>lies flat in slightly larger<br>outer Tyvek pouch. | Individually packaged and<br>sterilized components are<br>kitted into Tyvek pouch.<br>RENASYS Transparent Film<br>is folded prior to placing in<br>pouch. | | Kit Shelf-life | 24 months | 9 months | | Kit configuration | Identical | RENASYS G - Gauze<br>Dressing Kits with Soft Port,<br>Small, Medium, Large, X-<br>large | | Product Codes: | | | | Renasys-G Gauze<br>Dressing Kit with<br>Soft Port-Small | 66020933 | 66800933 | | RENASYS-G<br>Gauze Dressing Kit<br>with Soft Port-<br>Medium | 66020934 | 66800934 | | RENASYS-G<br>Gauze Dressing Kit | | | | | Subject Device: | Predicate Device: | | Trade Name: | RENASYS-G Gauze<br>Dressing Kit with Soft Port | 510(k)# K142979<br>RENASYS EZ MAX NPWT<br>and RENASYS Foam and<br>Gauze Dressing Kits with<br>Soft Port | | with Soft Port-<br>Large | 66020935 | 66800935 | | RENASYS-G<br>Gauze Dressing Kit<br>with Soft Port-Extra<br>Large | 66020936 | 66800936 | {6}------------------------------------------------ ## Table of Modifications | Modification | Reason For Change | Verification Testing<br>Performed | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | The sterile RENASYS<br>Transparent Film is<br>currently folded prior to<br>being placed in the outer<br>packaging of the kit. The<br>modification is to place<br>the transparent film flat,<br>not folded, into the outer<br>packaging of the kit.<br>This change<br>necessitates increasing<br>the size of the outer | During routine transit<br>testing, Smith & Nephew<br>identified breaches in the<br>seal of the primary<br>packaging of the<br>Transparent Film<br>specifically in area of the<br>pouch where it is folded. | Transit testing was<br>conducted to assure the<br>sterile barrier of the<br>RENASYS Transparent<br>Film remains intact in<br>the flat configuration | | Product codes<br>referenced in the<br>predicate 510(k)<br>(K142979) have been<br>changed | There have been no<br>changes to the kit contents,<br>the product code changes<br>were due to internal<br>business decision. | NA | | Extend shelf life from 9<br>months to 24 months | Shelf life extension | Stability testing and<br>simulated wound model<br>testing on aged product<br>has been conducted to<br>assure acceptance<br>criteria are met. | {7}------------------------------------------------ ### Non-Clinical Tests (Bench) #### RENASYS-G Gauze Dressing Kit with Soft Port Testing has been conducted to verify the modifications to the RENASYS-G Gauze Dressing Kits with Soft Port meet design specifications and demonstrate substantial equivalence to the predicate device. - Verification that the change of the configuration of the Renasys Transparent Film in the outer pouch maintains package seal integrity during transit. - Verification that individually packaged and sterilized components within the kit . meet criteria for 24 month shelf life, including meeting performance specifications. #### Standards The device complies with the following standards: EN ISO 13485:2003 Quality Management Systems - Medical Devices - System requirements for regulatory purposes EN 1041:2008 +A1 Information Supplied by Manufacturers with Medical Devices ISO 15223-1:2012 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied. EN ISO 14971:2012 Medical Devices — Application of Risk Management to Medical Devices EN ISO 10993-1:2009 Biological evaluation of medical devices-Evaluation and testing with a risk management process EN 62366:2008: Medical devices - Application of usability engineering to medical devices #### Conclusion In establishing substantial equivalence to the currently marketed predicate device, Smith & Nephew, Inc. evaluated the indications for use, materials, technology and product specifications of the device. Verification testing has been successfully completed to demonstrate that the subject device RENASYS-G Gauze Dressing kits with Soft Port are substantially equivalent to the predicate device for the intended use.