RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters

Q: Who is the manufacturer of RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters?

Smith & Nephew, Inc. filed the 510(k) submission for RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters (K142979).

Q: What is the FDA product code for RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K142979 · Smith & Nephew, Inc. · OMP · Apr 29, 2015 · General, Plastic Surgery

Device Facts

Record ID	K142979
Device Name	RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters
Applicant	Smith & Nephew, Inc.
Product Code	OMP · General, Plastic Surgery
Decision Date	Apr 29, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The RENASYS EZ MAX NPWT is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via 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. RENASYS EZ MAX professional healthcare facility model (REF 66801309) is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

Device Story

RENASYS EZ MAX is a lightweight, powered suction pump for negative pressure wound therapy (NPWT). Device connects to a wound dressing via tubing and a disposable canister; applies continuous or intermittent negative pressure to remove wound exudates, irrigation fluids, and infectious materials. Operated in acute care or professional healthcare settings by qualified clinicians. Pump powered by mains or internal battery. System includes disposable canisters (with/without solidifier) and sterile foam or gauze dressing kits with a Soft Port assembly. Clinicians monitor wound status and device performance via alarms and indicators; output facilitates wound management and healing. Device benefits patients by managing wound environment and removing infectious materials.

Clinical Evidence

Bench testing only. No clinical data presented. Verification included pumping capacity, pressure delivery (continuous/intermittent), alarm functionality (canister full, high leak), and system performance under fault conditions and varying exudate viscosities. Biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity) performed per ISO 10993.

Technological Characteristics

Powered suction pump; mains or internal battery. Materials: polyurethane foam, antimicrobial gauze, plastic canisters, Soft Port assembly. Standards: ISO 13485, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 10993, ISO 11135. Connectivity: None. Sterilization: Ethylene oxide for dressing kits.

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing via removal of fluids, exudates, and infectious materials. Applicable to chronic, acute, traumatic, sub-acute, dehisced wounds, ulcers (pressure/diabetic), partial-thickness burns, flaps, and grafts.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

RENASYS EZ MAX Negative Pressure Wound Therapy Device (K132446)
RENASYS EZ PLUS Negative Pressure Wound Therapy Device (K102001)
RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port (K110647)

Related Devices

K132446 — RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE · Smith & Nephew, Inc. · Oct 23, 2013
K143133 — RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device · Smith & Nephew, Inc. · Jul 23, 2015
K102001 — MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY · Smith & Nephew, Inc. · Aug 6, 2010
K082426 — RENASYS EZ · Smith & Nephew, Inc. · Sep 5, 2008
K091470 — RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 · Smith & Nephew, Inc. · Jul 9, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and movement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 29, 2015 Smith and Nephew Incorporated Ms. Laura Reynolds Director of Regulatory Affairs 970 Lake Carillon Drive, Suite 110 Saint Petersburg, Florida 33716 Re: K142979 Trade/Device Name: RENASYS® EZ MAX Negative Pressure Wound Therapy Device and RENASYS " Foam and Gauze NPWT Wound Dressing Kits with Soft Port" Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: March 26, 2015 Received: March 27, 2015 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 {1}------------------------------------------------ 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 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 - 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) K142979 #### Device Name RENASYS™ EZ MAX Negative Pressure Wound Therapy Device #### Indications for Use (Describe) The RENASYS EZ MAX NPWT is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via 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 RENASYS EZ MAX professional healthcare facility model (REF 66801309) is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional. | 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K142979 Device Name RENASYS™ Foam and Gauze NPWT Wound Dressing Kits With Soft Port™ Indications for Use (Describe) The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Soft Port are intended to be used in conjunction with Smith & Nephew NPWT (Negative Pressure Wound Therapy) systems. Smith & Nephew Negative Pressure Wound Therapy systems 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. 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ ### Wound Management 727 392-1261 Smith & Nephew, Inc. F 727 392-6914 or 727 392-0797 970 Lake Carillon Drive Customer Care Center: 1 800 876-1261 www.smith-nephew.com Suite 110 St. Petersburg, FL 33716 # 510(k) Summary | General Information | | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Submitters Name/Address: | Smith & Nephew, Inc. 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716 | | Establishment Registration Number: | 3006760724 | | Contact Person: | Laura Reynolds Director Regulatory Affairs | | Phone Number: | (727) 329-7702 | | Date Prepared: | October 14, 2014 | | Device Description | | | Trade Name: | RENASYS™ EZ MAX Negative Pressure Wound Therapy Device RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Soft Port™ | | Generic/Common Name: | Powered Suction Pump | | Classification Name: | Powered Suction Pump; 21 CFR 878.4780 Product Code: OMP | # Predicate Device Information | Current Device | Predicate Device | 510k# | Clearance Date | |-----------------------------------------------------------------------|----------------------------------------------------------------------|---------|-------------------| | RENASYS EZ MAX Negative Pressure Wound Therapy Device | RENASYS EZ MAX Negative Pressure Wound Therapy Device | K132446 | 10/23/2013 | | RENASYS EZ MAX Negative Pressure Wound Therapy Device Canisters | RENASYS EZ PLUS Negative Pressure Wound Therapy Device | K102001 | 08/06/2010 | | RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port | RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port | K110647 | 06/23/2011 | {5}------------------------------------------------ # Device Description #### RENASYS EZ MAX Negative Pressure Wound Therapy Device The RENASYS EZ MAX Negative Pressure Wound Therapy NPWT device is a lightweight, suction device intended for wound management via application of continuous or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. The technological characteristics of the new device have not changed. # RENASYS Canisters The 800ml and 250ml canisters are non-sterile, single use devices with a lid that is ultrasonically welded on. The canister kits contain a combination of solidifier gel pack, bacterial overflow quard that attaches to the pump and canister tubing that attaches to the Soft Port assembly. The 800ml canister without solidifier is a non-sterile, single use device with a lid that is ultrasonically welded on. The canister kit contains a bacterial overflow guard that attaches to the pump and canister tubing that attaches to the Soft Port assembly. #### RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port The RENASYS Foam and Gauze Wound Dressing Kits with Soft Port consist of the following components: Foam Kits: Polyurethane foam wound filler, a Soft Port assembly and transparent film drape. The foam kits are supplied sterile, single use and are offered in three sizes: small, medium and large. Gauze Kits: Antimicrobial gauze wound filler, a Soft Port assembly, non-adherent wound contact layer, transparent film drape, saline bullet, No Sting Skin Prep and wound ruler. The Gauze kits are offered in four sizes: small, medium, large and extra-large. The individual components of the kit are packed sterile 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. The foam and gauze kits are designed specifically for use with the RENASYS negative pressure wound therapy devices and canisters. # Indications for Use #### RENASYS EZ MAX Negative Pressure Wound Therapy Device The RENASYS EZ MAX NPWT is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials Appropriate wound types include: - . Chronic - Acute . - Traumatic ● {6}------------------------------------------------ - . Sub-acute and dehisced wounds - . Ulcers (such as pressure or diabetic) - . Partial-thickness burns - . Flaps and grafts RENASYS EZ MAX professional healthcare facility model (REF 66801309) is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional. # RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port The RENASYS Foam and Gauze Wound Dressing Kits with Soft Port are intended to be used in coniunction with Smith & Nephew NPWT (Negative Pressure Wound Therapy) systems. Smith & Nephew RENASYS 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. Both Indications for Use are identical to the predicates except the term "examples" has been removed from the appropriate wound types. # Summary Comparison between New and Predicate Devices | | New Device: | Predicate Device: | |----------------------------------------------|------------------------------|------------------------------| | | | 510(k)# K132446 | | Trade Name: | RENASYS EZ MAX NPWT | RENASYS EZ MAX NPWT | | Indications for Use: | Substantially equivalent | Substantially equivalent | | Components | Substantially equivalent | Substantially equivalent | | Principle of Operation | Identical | Identical | | Operating Time (Battery) | Identical | Identical | | Negative Pressure Range | Identical | Identical | | High Flow/Leak Rate Alarm Threshold Limit | Same | Same | | Sterilization | N/A | N/A | | Biocompability | No patient contact materials | No patient contact materials | | Alarms and Indicators | Identical | Identical | | Software | N/A | N/A | # RENASYS EZ MAX NPWT # RENASYS EZ MAX NPWT Canisters Only {7}------------------------------------------------ | | New Device: | Predicate Device: | |--------------------------------|-------------------------------------------------------------|--------------------------------| | | | 510(k)# K102001 | | Trade Name: | RENASYS EZ MAX NPWT | RENASYS EZ PLUS NPWT | | Indications for Use: | Substantially equivalent | Substantially equivalent | | Bacterial Overflow Guard | Material change to softer plastic outer casing of filter | Plastic outer casing of filter | | Material | Substantially equivalent | Substantially equivalent | | Canister without solidifier | New | N/A | | Canisters with Solidifier | Substantially equivalent | Substantially equivalent | # RENASYS - Foam and Gauze NPWT Wound Dressing Kits with Soft Port | | New Device: | Predicate Device: | |-----------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | | | 510(k)# K110647 | | Trade Name: | RENASYS - Foam and Gauze NPWT Wound Dressing Kits with Soft Port | RENASYS - Foam and Gauze Wound Dressing Kits with Soft Port | | Indications for Use: | Substantially equivalent | Substantially equivalent | | Materials: | Substantially equivalent | Substantially equivalent | | Soft Port Assembly: | Increased aperture size Two slits in paper release liner | Smaller aperture size One slit in paper release liner | | Single-use or Reusable: | Single-use | Single-use | | Method of Sterilization: | Identical | Identical | | Biocompatibility: | All components comply with ISO 10993 | All components comply with ISO 10993 | | Packaging: | Substantially equivalent | Substantially equivalent | | Kit Shelf-life | Same as the predicate | 9 months | | Kit configurations | RENASYS F- Foam Dressing Kits with Soft Port, Small, Medium, Large | RENASYS F- Foam Dressing Kits with Soft Port, Small, Medium, Large | | | RENASYS G - Gauze Dressing Kits with Soft Port, Small, Medium, Large, X-large | RENASYS G - Gauze Dressing Kits with Soft Port, Small, Medium, Large, X-large | | | RENASYS Soft Port Assembly | RENASYS Soft Port Assembly | | | RENASYS G Sterile Gauze | NA | {8}------------------------------------------------ | | New Device: | Predicate Device: | |-------------|------------------------------------------------------------------------|-------------------------------------------------------------------| | | | 510(k)# K110647 | | Trade Name: | RENASYS - Foam and Gauze NPWT Wound Dressing Kits with Soft Port | RENASYS - Foam and Gauze Wound Dressing Kits with Soft Port | | | Dressing Kit with Soft Port | | # Table of Modifications | Modification | Reason For Change | Verification Testing Performed | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Addition of RENASYS EZ MAX 800ml S-Canister without Solidifier | Product line extension | Comprehensive verification was completed which demonstrated acceptable device performance | | Modification to half of the bacterial overflow guard housing material to a softer resin | Reduced insertion force; Improved usability | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability | | Qualification of a replacement resin for the RENASYS EZ PLUS/EZ MAX 250ml S-Canister | Obsolete material | Qualification studies demonstrated acceptable replacement of the resin | | Reduction in the amount of solidifier in the RENASYS EZ PLUS/EZ MAX 800ml S-Canister | Less solidifier continues to meet acceptance criteria | Comprehensive verification was completed which demonstrated acceptable device performance | | Qualification of a replacement resin for the RENASYS EZ PLUS/EZ MAX 800ml S-Canister (including lid) and the RENASYS EZ PLUS/EZ MAX 250ml S-Canister lid | Obsolete material | Qualification studies demonstrated acceptable replacement of the resin | | Modification to the release paper liner of the Soft Port assembly to add an additional slit | Improved usability | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability | | Modification to increase the Soft Port aperture size | Improved usability | Comprehensive verification was completed which demonstrated acceptable device performance | | Modification | Reason For Change | Verification Testing Performed | | Modification of the hole size and geometry in the mid and bottom poly sheet layers of the Soft Port Assembly | Improve manufacturability | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability | | Qualification of an alternate Controlled Leak Path (CLP) adhesive material | Alternate adhesive material | Qualification studies demonstrated acceptable criteria met | | Extension of the shelf-life of the RENASYS Foam and Gauze NPWT Dressing Kits with Soft Port from 9 months to 24 months | Shelf-life extension | Comprehensive verification demonstrated acceptable extension of shelf-life | | Addition of RENASYS G Sterile Gauze Dressing Kit with Soft Port | Product line extension | Comprehensive verification was completed which demonstrated acceptable device performance | {9}------------------------------------------------ # Non-Clinical Tests (Bench) RENASYS EZ MAX Negative Pressure Wound Therapy Device Testing has been conducted to verify the modifications to the RENASYS EZ MAX NPWT meet design specifications and demonstrate substantial equivalence to the predicate device. The list below summarizes the bench testing undertaken and successfully completed for the RENASYS EZ MAX NPWT device: - . Pumping capacity is equivalent to the predicate device. - Device provides negative pressure at individual pressure settings, identical to the . predicate device. - Verification that the device delivers negative pressure wound therapy in a continuous and ● intermittent operating mode identical to the predicate device. - Verification of Canister Full alarm functionality using wound fluid designed to simulate . chemistry and protein content of real exudate. - Verification of system performance in foreseeable fault conditions. ● - . Verification of system performance when running with high air leaks at the dressing site - . Verification of system performance in worst case scenarios with ranges of exudate viscosity and protein content. #### RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port Testing has been conducted to verify the modifications to the RENASYS Foam and Gauze Wound Dressing Kits with Soft Port meet design specifications and demonstrate substantial equivalence to the predicate device. {10}------------------------------------------------ - . Verification that the Soft Port serves as a conduit between RENASYS EZ MAX NPWT device and NPWT wound dressings by transmitting negative pressure and collecting exudate flows. - . Verification that the Soft Port functions throughout the recommended maximum elapsed time of 72 hours between dressing changes. - Verification of system performance with full range of indicated disposable kits, spanning ● range of wound sizes Biocompatibility on the new foam has been successfully completed in accordance with applicable parts of ISO 10993 as follows: - . Cytotoxicity - Skin Irritation ● - Skin Sensitization - . System Toxicity There have been no other changes to patient contacting materials from the predicate devices. Device complies with the following standards: - . ISO13485:2003, Medical Devices - Quality Management Systems - ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices . - ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, . labelling, and information to be supplied Part 1: General requirements.(General) - . ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied-Part 2: Symbol development, selection and validation. (General) - BS EN 980:2008 Graphical Symbols for use in the labeling of Medical Devices ● - . BS EN 1041:2008 +A1:2013 Information Supplied by the Manufacturer with Medical Devices - IEC 60601-1-2:2007(3rd edition) Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, Interpretation Sheet - IEC 60601-1:2005 (3rd edition). Medical Electrical Equipment Part 1: General . Requirements for Safety - . ANSI/AAMI ES60601-1:2005 Version (R2012) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - IEC 60601-1-8:2006 (2nd edition) Medical electrical equipment Part 1-8: General ● requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical - IEC 60601-1-6:2010 (3rd Edition) Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - IEC 62366:2007 (1st edition) Medical devices - Application of usability engineering to medical devices. (General) - . ISO 11135: 2014 Medical Devices - Validation and routine control of ethylene oxide sterilization - . ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems {11}------------------------------------------------ - . ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals - . ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing with a risk management process - . AAMI/ ANSI HE75:2009 Human Factor Engineering-Design of Medical Devices # Conclusions In establishing substantial equivalence to the currently marketed predicate devices, Smith & Nephew, Inc. evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. Performance testing, biocompatibility testing and electrical safety testing has been successfully completed to demonstrate that the RENASYS EZ MAX NPWT device and canisters, and the RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port are substantially equivalent to the predicate devices for the intended use.