The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport 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. Examples of 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

With the exception of the Softport™ assembly, there are no changes to the components in the currently marketed foam and gauze wound dressing kits. The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport consist of the following components:

Foam Kits: Polyurethane foam wound filler, a Softport 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 qauze wound filler, a Softport 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 Softport assembly attaches to an exudate canister to carry exudate from the wound. The kits are designed specifically for use with the RENASYS EZ / EZ Plus and RENASYS GO negative pressure wound therapy devices and canisters which have been cleared under 510(k) numbers K091470, K102001 and K083375.

AI/ML Overview

This submission describes the RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™, which adds a Softport assembly to existing Negative Pressure Wound Therapy (NPWT) dressing kits. The evaluation focuses on demonstrating that the new Softport assembly maintains the safety and effectiveness of the previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on functional performance and biocompatibility of the new Softport component, ensuring it performs comparably to the predicate device and does not introduce new risks.

Acceptance Criteria	Reported Device Performance
The Softport shall serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows.	The device was evaluated under a number of verification and validation tests to ensure performance requirements were met, demonstrating the Softport's ability to transmit negative pressure and collect exudate.
The Softport shall function throughout the recommended maximum elapsed time of 72 hours between dressing changes.	Verification and validation tests confirmed the Softport's functionality for the specified 72-hour duration.
The Softport will continue to serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows when compressed at its terminal end (atop the wound dressing).	Verification and validation tests established that the Softport maintains its conduit function even when compressed at its terminal end.
The Softport shall incorporate a controlled leak path that does not contribute to RENASYS EZ and RENASYS GO NPWT therapy devices false blockage or leak alarms.	Verification and validation tests demonstrated that the Softport's leak path design does not cause false blockage or leak alarms in the associated NPWT devices.
Biocompatibility of all components, including the new Softport assembly, shall comply with ISO 10993.	Biocompatibility testing for the Softport assembly was successfully completed per applicable parts of ISO 10993, including Cytotoxicity, Skin Irritation, and Skin Sensitization. All other existing components were already compliant with ISO 10993.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "verification and validation tests" conducted for the Softport. It mentions that these tests were performed to ensure performance requirements were met.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of the tests (functional and biocompatibility), they are typically conducted in a controlled laboratory or testing environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

No information is provided regarding the use of "experts" to establish ground truth for this device's testing. The ground truth for functional performance is established by engineering specifications and objective measurements against those specifications. For biocompatibility, the ground truth is established by adherence to recognized international standards (ISO 10993) and the results of laboratory tests.

4. Adjudication Method for the Test Set

No adjudication method for a "test set" is mentioned, as the testing described is primarily objective performance and safety testing, not human-read evaluation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a critical component. This submission is for wound dressing kits, and the testing focuses on the functional performance and biocompatibility of the device itself.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the described testing is akin to standalone performance. The verification and validation tests evaluate the physical device's ability to meet its functional specifications and biocompatibility requirements independently, without human interaction as part of the evaluated performance metric.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

Engineering Specifications and Performance Standards: For functional aspects (negative pressure transmission, exudate collection, leak path control, 72-hour functionality, and performance under compression).
International Biocompatibility Standards: Specifically, ISO 10993 for Cytotoxicity, Skin Irritation, and Skin Sensitization.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device, as it is a physical medical device (wound dressing kit) undergoing traditional engineering and biological compatibility testing, not an artificial intelligence/machine learning algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no training set for this type of medical device submission.

Summary

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510(k) Summary

RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™ JUN 2 2 2011

Submitter: Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
Contact: Laura D. Reynolds, RAC Director Requlatory Affairs 727-329-7702

ന്ന് Date Prepared: May 16, 2011
Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport 4. Classification Name/Code: Powered Suction Pump / 21 CFR 878.4780 Product Classification: Class II Product Code: OMP

Predicate Device Information: 5.

RENASYS-F NPWT Foam Dressing kits ர்
Smith & Nephew, Inc. b.
510(k) # K082211 C.
Versatile 1 Wound Vacuum System ರ.
BlueSky Medical (Smith & Nephew, Inc.) e.
510(k) #K042134 f.

6. Device Description:

Foam Kits: Polyurethane foam wound filler, a Softport assembly and transparent film drape. The foam kits are supplied sterile, single use and are offered in three sizes; small, medium and large.

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K110647 Page 2/4

7. Intended Use:

The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport 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 (neqative 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 wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

8. Summary of Non-Clinical Testing:

The RENASYS Foam and Gauze Wound Dressing Kits with Softport were evaluated under a number of verification and validation tests to ensure performance requirements were met.

. The Softport shall serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows.
The Softport shall function throughout the recommended maximum elapsed time of 72 . hours between dressing changes.
. The Softport will continue to serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows when compressed at its terminal end (atop the wound dressing).
The Softport shall incorporate a controlled leak path that does not contribute to . RENASYS EZ and RENASYS GO NPWT therapy devices false blockage or leak alarms.

With the exception of the Softport™ assembly, none of the components in the currently marketed foam and gauze dressing kits have changed. Biocompatibility on all components has been successfully completed in accordance with applicable parts of ISO 10993.

The following biocompatibility testing for the Softport assembly has been successfully completed per applicable parts of ISO 10993:

. Cytotoxicity
Skin Irritation
Skin Sensitization .

9. Conclusion:

The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are substantially equivalent in design, materials, technology, function and intended use to the predicate devices named above. Verification and validation testing has been conducted to demonstrate the device is safe and effective for the intended use.

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K110647 page 34

Renasys Foam and Gauze NPWT Wound Dressing Kits with Softport

Device Comparison Table

Device:	Smith & NephewNew Device:	Predicate Device:	Predicate Device:
Name:	RENASYS™ - Foamand Gauze WoundDressing Kits withSoftport	RENASYS-F NPWTFoam Dressing kit	Versatile 1 WoundVacuum System(including gauzewound dressing kits)
510(k):	K110647	K082211	K042134
Manufacturer:	Smith & Nephew, Inc.	Smith & Nephew, Inc.	Blue Sky Medical(Smith & Nephew,Inc.)
Intended Use:	The RENASYS™Foam and GauzeNPWT WoundDressing Kits withSoftport are Intendedto be used inconjunction withSmith & NephewNPWT systems.Smith & NephewNPWT systems areindicated for patientswho would benefitfrom a suction device(negative pressurewound therapy) as itmay promote woundhealing via theremoval of fluids,including irrigationand body fluids,wound exudates andinfectious materials.Examples ofappropriate woundtypes include:chronic, acute,traumatic, sub-acuteand dehiscedwounds, uicers (suchas pressure ordiabetic), partial-thickness burns, flapsand grafts.	Foam dressing kits areintended to be used inconjunction with Smith& Nephew NegativePressure WoundTherapy systems todeliver negativepressure to thewound. Smith &Nephew NPWTsystems are indicatedfor patients who wouldbenefit from a suctiondevice particularly asthe device maypromote woundhealing. NPWT isappropriate for use onthe following wounds:· Pressure ulcers· Diabetic /neuropathic ulcers· Venous insufficiencyulcers· Traumatic wounds· Post-operative anddehisced surgicalwounds· Explored fistulas· Skin flaps and grafts	Indicated forpatients who woundbenefit from asuction deviceparticularly as thedevice may promotewound healing.
Materials:	Wound Filler:
	Hydrophobic,Polyurethane foamorAntimicrobial GauzeSoftport assembly:Polyurethane film,3-D knit polyesterfabric, Polyurethanefoam, Non-wovenpolyester,Polyurethane drapewith adhesivecoating,Polyurethane drape	Hydrophobic,Polyurethane foamSilicone drainPVC TubePolyurethane drape	Antimicrobial GauzeSilicone drainPVC TubePolyurethane drape
Single-use orReusable:	Single-use	Single-use	Single-use
Method ofSterilization:	Ethylene OxideOrIndividual kitcomponents individuallysterilized by EthyleneOxide or GammaIrradiation.	Ethylene Oxide	Individual kitcomponentsindividually sterilizedby Ethylene Oxide orGamma Irradiation.
Biocompatibility:	All componentscomply with ISO10993	All componentscomply with ISO10993	All componentscomply with ISO10993
Packaging:	Components packagedloose in a pouch thensterilizedOrPre-packaged andsterilized and placed inpackage as a	Components packagedloose in a pouch thensterilized	Pre-packaged andsterilized and placed inpackage as aconvenience kit

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K 110647 page 4/4

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Ms. Laura Reynolds Director, Regulatory Affairs 970 Lake Carillon Drive St. Petersburg, Florida 33716

JUN 2 2 2011

Re: K110647

Trade/Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport" Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP, BTA Dated: June 13, 2011 Received: June 14, 2011

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

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Page 2 - Ms. Laura Reynolds

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.

E. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K110647

Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

	Daniel Krone for MXM Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Surgical, Orthopedic,
	and Restorative Devices

Smith & Nephew - Proprietary Information

510(k) Number K110647

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.