RENASYS EZ MAX 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.

RENASYS AB Abdominal Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary.

It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.

The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

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 neqative 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 guard 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 quard that attaches to the pump and canister tubing that attaches to the Soft Port assembly.

RENASYS AB Abdominal Dressing Kit with Soft Port consists of the following components:

Two large hydrophobic, reticulated polyurethane foam dressings that incorporate several ● cuts to facilitate custom sizing, if needed.
One organ protection layer made of non-adherent clear polyurethane film perforated with slits. The slits in the organ protection layer facilitate fluid removal under negative pressure wound therapy.
. Six 12" x 8" polyurethane transparent film drapes with acrylic adhesive backing. The drapes are placed over the foam and surrounding intact skin to create an airtight seal for the application of negative pressure wound therapy.
. One Soft Port suction assembly with tubing that attaches to the exudate collection canister. The Soft Port assembly is placed over a hole cut in the drape to facilitate application of negative pressure wound therapy to the wound.

The abdominal kit is designed specifically for use with the RENASYS EZ MAX negative pressure wound therapy devices and canisters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RENASYS™ EZ MAX Negative Pressure Wound Therapy Device and RENASYS™ AB Abdominal Dressing Kit with Soft Port, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for improved performance. The acceptance criteria are implicitly defined by the predicate device's performance and the successful completion of various verification tests to show that modifications do not negatively impact device function and usability, and that the new device performs identically or equivalently to the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance
RENASYS EZ MAX Negative Pressure Wound Therapy Device:
Pumping capacity is equivalent to predicate device.	Pumping capacity is equivalent to the predicate device.
Device provides negative pressure wound therapy at individual pressure settings, identical to the predicate device.	Device provides negative pressure wound therapy 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 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 simulated wound fluid.	Verification of Canister Full alarm functionality using wound fluid designed to simulate chemistry and protein content of real exudate (successfully completed).
Verification of system performance in foreseeable fault conditions.	Verification of system performance in foreseeable fault conditions (successfully completed).
Verification of system performance with high air leaks at the dressing site.	Verification of system performance when running with high air leaks at the dressing site (successfully completed).
Verification of system performance in worst-case scenarios with ranges of exudate viscosity and protein content.	Verification of system performance in worst case scenarios with ranges of exudate viscosity and protein content (successfully completed).
RENASYS AB Abdominal Dressing Kit with Soft Port:
Soft Port serves as a conduit between NPWT device and dressing kit by transmitting negative pressure and collecting exudate flows.	Verification that the Soft Port serves as a conduit between RENASYS EZ MAX NPWT device and RENASYS AB Abdominal Dressing Kit with Soft Port by transmitting negative pressure wound therapy and collecting exudate flows (successfully completed).
Soft Port functions throughout the recommended maximum elapsed time of 48 hours between dressing changes.	Verification that the Soft Port functions throughout the recommended maximum elapsed time of 48 hours between dressing changes (successfully completed).
Biocompatibility	All components comply with ISO 10993.

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

The document does not explicitly state the sample sizes used for the "test set" in terms of number of devices or number of tests performed. It refers to "testing" and "verification" but doesn't provide specific quantitative sample sizes for each test.

The data provenance is implied to be bench testing conducted by the manufacturer, Smith & Nephew, Inc. There is no mention of clinical data, human subjects, or country of origin for any experimental data.

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

Not applicable. This was a bench testing study for substantial equivalence, not a study involving expert-established ground truth for clinical diagnosis or outcome. The "ground truth" for the tests described would be the physical properties and performance characteristics being measured by the testing equipment and protocols.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There was no adjudication method described as this was not a human reader or diagnostic accuracy study.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (Negative Pressure Wound Therapy Device and Dressing Kit) and focuses on engineering and performance characteristics, not diagnostic interpretation by human readers.

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

Not applicable. This device is a physical medical device (pump and dressing kit), not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these tests was engineering and performance specifications based on the predicate devices and relevant industry standards (e.g., ISO, IEC). For instance, pumping capacity was compared to the predicate, and alarm functionality was verified against expected operational parameters using simulated wound fluid.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning study.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

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

February 22, 2016

Smith and Nephew Incorporated Ms. Laura Reynolds Director of Regulatory Affairs 970 Lake Carillon Drive, Suite 110 Saint Petersburg, Florida 33716

Re: K143133

Trade/Device Name: RENASYS™ EZ MAX Negative Pressure Wound Therapy Device, RENASYS™ AB Abdominal Dressing Kit with Soft Port Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP, FTL Dated: June 8, 2015 Received: June 9, 2015

Dear Ms. Reynolds:

This letter corrects our substantially equivalent letter of July 23, 2015.

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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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 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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Indications for Use

510(k) Number (if known) K143133

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

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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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Indications for Use

510(k) Number (if known) K143133

Device Name

RENASYSTM AB Abdominal Dressing Kit with Soft Port Device

Indications for Use (Describe)

RENASYS AB Abdominal Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary.

It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.

The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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."

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Image /page/4/Picture/0 description: The image shows the text "K143133" in a simple sans-serif font. Below this text, the phrase "Page 1 of 7" is displayed, indicating this is the first page of a document. The text is aligned to the left and presented against a plain white background.

Image /page/4/Picture/1 description: The image shows the logo for Smith & Nephew. The logo features a stylized orange flower-like symbol on the left. To the right of the symbol is the text "We are smith&nephew", with "We are" in gray and "smith&nephew" in orange.

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:	July 1, 2015
Device Description
Trade Name:	RENASYST™ EZ MAX Negative Pressure WoundTherapy (NPWT) Device
Generic/Common Name:	Powered Suction Pump
Classification Name:	Powered Suction Pump; 21 CFR 878.4780Product Code: OMP
Trade Name:	RENASYS™ AB Abdominal Dressing Kit with SoftPort™ Device
Generic/Common Name:	Mesh, Surgical Polymeric
Classification Name:	Mesh, Surgical Polymeric; 21 CFR 878.3300Product Code: FTL

Predicate Device Information

Predicate Device	510k#	ClearanceDate
RENASYS EZ MAX Negative Pressure Wound Therapy Device	K132446	10/23/2013
RENASYS EZ PLUS Negative Pressure Wound Therapy Device	K102001	08/06/2010
RENASYS AB Abdominal Dressing Kit with Soft Port	K112784	11/22/2011

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Predicate Device	510k#	ClearanceDate
RENASYS EZ MAX Negative Pressure Wound Therapy Device andRENASYS Foam and Gauze NPWT Wound Dressing Kits with SoftPort	K142979	04/29/2015

Device Description

RENASYS EZ MAX Negative Pressure Wound Therapy Device

RENASYS Canisters

RENASYS AB Abdominal Dressing Kit with Soft Port

RENASYS AB Abdominal Dressing Kit with Soft Port consists of the following components:

Two large hydrophobic, reticulated polyurethane foam dressings that incorporate several ● cuts to facilitate custom sizing, if needed.
One organ protection layer made of non-adherent clear polyurethane film perforated with slits. The slits in the organ protection layer facilitate fluid removal under negative pressure wound therapy.
. Six 12" x 8" polyurethane transparent film drapes with acrylic adhesive backing. The drapes are placed over the foam and surrounding intact skin to create an airtight seal for the application of negative pressure wound therapy.
. One Soft Port suction assembly with tubing that attaches to the exudate collection canister. The Soft Port assembly is placed over a hole cut in the drape to facilitate application of negative pressure wound therapy to the wound.

The abdominal kit is designed specifically for use with the RENASYS EZ MAX negative pressure wound therapy devices and canisters.

Indications for Use

RENASYS EZ MAX Negative Pressure Wound Therapy Device

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The RENASYS EZ MAX 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 AB Abdominal Dressing Kit with Soft Port

The RENASYS AB Abdominal Dressing Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.

The RENASYS AB Abdominal Dressing Kit with Soft Port is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Summary Comparison between New and Predicate Devices

RENASYS EZ MAX NPWT

	New Device: 510(k) K143133	Predicate Device: 510(k)# K142979	Predicate Device: 510(k)# K132446
Trade Name:	RENASYS EZ MAX NPWT	RENASYS EZ MAX Negative Pressure Wound Therapy Device and RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port	RENASYS EZ MAX NPWT
Indications for Use:	Substantially equivalent	Substantially equivalent	Substantially equivalent
Components	Substantially equivalent	Substantially equivalent	Substantially equivalent
Principle of Operation	Identical	Identical	Identical
Operating Time (Battery)	Identical	Identical	Identical

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	New Device:	Predicate Device:	Predicate Device:
	510(k) K143133	510(k)# K142979	510(k)# K132446
Trade Name:	RENASYS EZ MAXNPWT	RENASYS EZ MAXNegative PressureWound TherapyDevice and RENASYSFoam and GauzeNPWT WoundDressing Kits withSoft Port	RENASYS EZ MAXNPWT
Negative PressureRange	Identical	Identical	Identical
High Flow/Leak RateAlarm ThresholdLimit	Identical	Identical	Identical
Sterilization	N/A	N/A	N/A
Biocompability	No patient contactmaterials	No patient contactmaterials	No patient contactmaterials
Alarms andIndicators	Identical	Identical	Identical
Software	N/A	N/A	N/A

RENASYS EZ MAX NPWT Canisters Only

	New Device:510(k) K143133	Predicate Device:510(k)# K142979	Predicate Device:510(k)# K102001
Trade Name:	RENASYS EZ MAXNPWT	RENASYS EZ MAXNegative PressureWound Therapy Deviceand RENASYS Foamand Gauze NPWTWound Dressing Kitswith Soft Port	RENASYS EZ PLUSNPWT
Indications forUse:	Substantially equivalent	Substantially equivalent	Substantially equivalent
Bacterial OverflowGuard	Material change to softerplastic outer casing offilter	Material change to softerplastic outer casing offilter	Plastic outer casing offilter
Material	Substantially equivalent	Substantially equivalent	Substantially equivalent
Canister withoutsolidifier	New	New	N/A
Canisters withSolidifier	Substantially equivalent	Substantially equivalent	Substantially equivalent

{8}------------------------------------------------

RENASYS AB Abdominal Dressing Kit with Soft Port

	New Device:	Predicate Device:
Trade Name:	510(k) K143133RENASYS AB AbdominalDressing Kit with Soft Port	510(k)# K112784RENASYS ABAbdominal Dressing Kitwith Soft Port
Indications for Use:	Indicated for temporary bridgingof abdominal wall openingswhere primary closure is notpossible and/or repeatabdominal entries arenecessary. It is intended to beused in open abdominal woundswith exposed viscera, includingbut not limited to abdominalcompartment syndrome.This dressing kit is intended foruse in acute hospital settings(trauma, general and plasticsurgery wards) and shouldideally be applied in theoperating theatre.	Identical
Materials:	Substantially equivalent	Substantially equivalent
Soft Port Assembly:	Increased aperture sizeTwo slits in paper release liner	Smaller aperture sizeOne slit in paper releaseliner
Single-use orReusable:	Single-use	Single-use
Method ofSterilization:	Identical	Identical
Biocompatibility:	All components comply with ISO10993	All components complywith ISO 10993
Packaging:	Substantially equivalent	Substantially equivalent
Kit Shelf-life	12 months	12 months

Table of Modifications

Modification	Reason For Change	Verification TestingPerformed
Modification to therelease paper liner of theSoft Port assembly to addan additional slit	Improved usability	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance andimproved usability

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Modification	Reason For Change	Verification TestingPerformed
Modification to increasethe Soft Port aperture size	Improved usability	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance
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

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 wound therapy 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 AB Abdominal Dressing Kit with Soft Port

Testing has been conducted to verify the modifications to the RENASYS AB Abdominal Dressing Kit with Soft Port meet design specifications and demonstrate substantial equivalence to the predicate device.

. Verification that the Soft Port serves as a conduit between RENASYS EZ MAX NPWT device and RENASYS AB Abdominal Dressing Kit with Soft Port by transmitting negative pressure wound therapy and collecting exudate flows.
. Verification that the Soft Port functions throughout the recommended maximum elapsed time of 48 hours between dressing changes.

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 .

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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
. 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, and electrical safety testing has been successfully completed to demonstrate that the RENASYS EZ MAX NPWT device and canisters, and the RENASYS AB Abdominal Dressing Kit with Soft Port are substantially equivalent to the predicate devices for the intended uses.

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.