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.

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 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.

Device Description

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.

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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device. It details the device description, indications for use, comparison with predicate devices, and non-clinical tests conducted to demonstrate substantial equivalence. However, it does not contain information about the device's performance in terms of specific acceptance criteria, corresponding study results, or aspects typically associated with an AI/ML medical device such as sample sizes for test/training sets, data provenance, expert adjudication, or MRMC studies.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present quantitative performance results against such criteria for the device. Instead, it states that "comprehensive verification was completed which demonstrated acceptable device performance" or that certain aspects are "substantially equivalent" to predicate devices.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no ground truth determination by experts is described.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, as this is not an AI/ML device.
The type of ground truth used: Not applicable in the context of this device's testing. Testing focused on device functionality, materials, and safety (e.g., pumping capacity, alarm functionality, biocompatibility).
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

What the document does provide regarding testing and "acceptance" (or rather, verification of design specifications and substantial equivalence):

The document details various non-clinical (bench) tests conducted to verify that modifications to the RENASYS EZ MAX NPWT device and the RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port meet design specifications and demonstrate substantial equivalence to predicate devices. These tests relate to the functional performance, safety, and material characteristics of the device.

Table summarizing verification activities (from the "Verification Testing Performed" column):

Modification	Verification Testing Performed (Indicative of "Acceptance")
Addition of RENASYS EZ MAX 800ml S-Canister without Solidifier	Comprehensive verification was completed which demonstrated acceptable device performance.
Modification to half of the bacterial overflow guard housing material to a softer resin	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	Qualification studies demonstrated acceptable replacement of the resin.
Reduction in the amount of solidifier in the RENASYS EZ PLUS/EZ MAX 800ml S-Canister	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	Qualification studies demonstrated acceptable replacement of the resin.
Modification to the release paper liner of the Soft Port assembly to add an additional slit	Comprehensive verification was completed which demonstrated acceptable device performance and improved usability.
Modification to increase the Soft Port aperture size	Comprehensive verification was completed which demonstrated acceptable device performance.
Modification of the hole size and geometry in the mid and bottom poly sheet layers of the Soft Port Assembly	Comprehensive verification was completed which demonstrated acceptable device performance and improved usability.
Qualification of an alternate Controlled Leak Path (CLP) 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	Comprehensive verification demonstrated acceptable extension of shelf-life.
Addition of RENASYS G Sterile Gauze Dressing Kit with Soft Port	Comprehensive verification was completed which demonstrated acceptable device performance.

Specific Non-Clinical Tests for RENASYS EZ MAX Negative Pressure Wound Therapy 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 peaks at the dressing site.
Verification of system performance in worst-case scenarios with ranges of exudate viscosity and protein content.

Specific Non-Clinical Tests for RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port:

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 a full range of indicated disposable kits, spanning the range of wound sizes.
Biocompatibility testing on the new foam in accordance with ISO 10993 (Cytotoxicity, Skin Irritation, Skin Sensitization, System Toxicity).

The document concludes that these tests demonstrate substantial equivalence to the predicate devices for the intended use.

Summary

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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

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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

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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)

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."

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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.

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.

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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 DriveSuite 110St. Petersburg, FL 33716
Establishment Registration Number:	3006760724
Contact Person:	Laura ReynoldsDirector Regulatory Affairs
Phone Number:	(727) 329-7702
Date Prepared:	October 14, 2014
Device Description
Trade Name:	RENASYS™ EZ MAX Negative Pressure WoundTherapy DeviceRENASYS™ Foam and Gauze NPWT WoundDressing Kits with Soft Port™
Generic/Common Name:	Powered Suction Pump
Classification Name:	Powered Suction Pump; 21 CFR 878.4780Product Code: OMP

Predicate Device Information

Current Device	Predicate Device	510k#	ClearanceDate
RENASYS EZ MAX NegativePressure Wound Therapy Device	RENASYS EZ MAX NegativePressure Wound Therapy Device	K132446	10/23/2013
RENASYS EZ MAX NegativePressure Wound Therapy DeviceCanisters	RENASYS EZ PLUS NegativePressure Wound Therapy Device	K102001	08/06/2010
RENASYS Foam and GauzeNPWT Wound Dressing Kits withSoft Port	RENASYS Foam and GauzeNPWT Wound Dressing Kits withSoft Port	K110647	06/23/2011

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Device Description

RENASYS EZ MAX Negative Pressure Wound Therapy Device

RENASYS Canisters

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

Appropriate wound types include:

. Chronic
Acute .
Traumatic ●

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. Sub-acute and dehisced wounds
. Ulcers (such as pressure or diabetic)
. Partial-thickness burns
. Flaps and grafts

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 PressureRange	Identical	Identical
High Flow/Leak RateAlarm 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

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	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 OverflowGuard	Material change to softerplastic outer casing of filter	Plastic outer casing of filter
Material	Substantially equivalent	Substantially equivalent
Canister withoutsolidifier	New	N/A
Canisters withSolidifier	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 GauzeNPWT Wound Dressing Kitswith Soft Port	RENASYS - Foam and GauzeWound Dressing Kits withSoft Port
Indications for Use:	Substantially equivalent	Substantially equivalent
Materials:	Substantially equivalent	Substantially equivalent
Soft Port Assembly:	Increased aperture sizeTwo slits in paper release liner	Smaller aperture sizeOne slit in paper release liner
Single-use orReusable:	Single-use	Single-use
Method ofSterilization:	Identical	Identical
Biocompatibility:	All components comply withISO 10993	All components comply withISO 10993
Packaging:	Substantially equivalent	Substantially equivalent
Kit Shelf-life	Same as the predicate	9 months
Kit configurations	RENASYS F- Foam DressingKits with Soft Port, Small,Medium, Large	RENASYS F- Foam DressingKits with Soft Port, Small,Medium, Large
	RENASYS G - Gauze DressingKits with Soft Port, Small,Medium, Large, X-large	RENASYS G - Gauze DressingKits with Soft Port, Small,Medium, Large, X-large
	RENASYS Soft Port Assembly	RENASYS Soft Port Assembly
	RENASYS G Sterile Gauze	NA

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	New Device:	Predicate Device:
		510(k)# K110647
Trade Name:	RENASYS - Foam and GauzeNPWT Wound Dressing Kitswith Soft Port	RENASYS - Foam and GauzeWound Dressing Kits withSoft Port
	Dressing Kit with Soft Port

Table of Modifications

Modification	Reason For Change	Verification TestingPerformed
Addition of RENASYS EZMAX 800ml S-Canisterwithout Solidifier	Product line extension	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance
Modification to half of thebacterial overflow guardhousing material to asofter resin	Reducedinsertionforce;Improved usability	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance andimproved usability
Qualification of areplacement resin for theRENASYS EZ PLUS/EZMAX 250ml S-Canister	Obsolete material	Qualification studiesdemonstrated acceptablereplacement of the resin
Reduction in the amountof solidifier in theRENASYS EZ PLUS/EZMAX 800ml S-Canister	Less solidifier continues to meetacceptance criteria	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance
Qualification of areplacement resin for theRENASYS EZ PLUS/EZMAX 800ml S-Canister(including lid) and theRENASYS EZ PLUS/EZMAX 250ml S-Canister lid	Obsolete material	Qualification studiesdemonstrated acceptablereplacement of the resin
Modification to therelease paper liner of theSoft Port assembly to addan additional slit	Improved usability	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance andimproved usability
Modification to increasethe Soft Port aperture size	Improved usability	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance
Modification	Reason For Change	Verification TestingPerformed
Modification of the holesize and geometry in themid and bottom polysheet layers of the SoftPort Assembly	Improve manufacturability	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance andimproved usability
Qualification of analternate Controlled LeakPath (CLP) adhesivematerial	Alternate adhesive material	Qualification studiesdemonstrated acceptablecriteria met
Extension of the shelf-lifeof the RENASYS Foamand Gauze NPWTDressing Kits with SoftPort from 9 months to 24months	Shelf-life extension	Comprehensive verificationdemonstrated acceptableextension of shelf-life
Addition of RENASYS GSterile Gauze DressingKit with Soft Port	Product line extension	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance

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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.

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. 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

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. 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.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
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.(b)
Classification. Class II.