The RENASYS EZ PLUS 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 PLUS professional healthcare facility model (REF 66800697) 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 Description

The RENASYS EZ PLUS 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the RENASYS™ EZ PLUS Negative Pressure Wound Therapy Device. This notification aims to demonstrate substantial equivalence to a predicate device, the RENASYS EZ MAX Negative Pressure Wound Therapy Device (K142979).

The document details the device description, indications for use, and a summary comparison between the subject and predicate devices. It also outlines the non-clinical (bench) tests conducted to verify that the modifications to the RENASYS EZ PLUS NPWT meet design specifications and demonstrate substantial equivalence.

Important Note: The provided text does not include information about acceptance criteria, reported device performance in a statistical table, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML device studies. This document is a regulatory submission for a non-AI/ML medical device where the primary goal is demonstrating substantial equivalence to a predicate device through bench testing, not through clinical or AI performance metrics.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of the available information and, where information is not present, an explanation of why:

1. Table of Acceptance Criteria and Reported Device Performance

Rationale: The provided text describes the regulatory clearance of a Negative Pressure Wound Therapy (NPWT) device. This is a traditional medical device, not an AI/ML powered device. The "acceptance criteria" and "reported device performance" in the context of this document refer to the successful completion of a series of non-clinical (bench) tests designed to demonstrate that the device meets its design specifications and is substantially equivalent to a predicate device. These are functional and safety performance metrics, not diagnostic accuracy metrics typically reported for AI/ML.

Since this is not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" as typically presented for AI/ML devices (e.g., sensitivity, specificity, AUC) is not applicable here. The document focuses on demonstrating substantial equivalence to an existing predicate device rather than meeting specific performance thresholds in a clinical study for a novel AI algorithm.

Acceptance Criteria Category	Specific Criteria (Implicitly Met by Successful Testing)	Reported Device Performance (Summary from Text)
Functional Equivalence	- Pumping capacity equivalent to predicate device. - Delivers negative pressure at individual pressure settings, identical to predicate device. - Delivers continuous and intermittent NPWT identical to predicate 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."
Alarm Functionality	- Canister Full alarm functions correctly using simulated wound fluid.	- "Verification of Canister Full alarm functionality using wound fluid designed to simulate chemistry and protein content of real exudate." (Implies successful verification)
Robustness & Safety	- System performance in foreseeable fault conditions is maintained. - System performance with high air leaks at the dressing site is maintained. - System performance in worst-case scenarios (exudate viscosity/protein) is maintained.	- "Verification of system performance in foreseeable fault conditions." (Implies successful verification) - "Verification of system performance when running with high air leaks at the dressing site." (Implies successful verification) - "Verification of system performance in worst case scenarios with ranges of exudate viscosity and protein content." (Implies successful verification). The overall conclusion states: "Performance testing has been successfully completed to demonstrate that the RENASYS EZ PLUS NPWT device and canisters are substantially equivalent to the predicate devices for the intended use."
Standards Compliance	- Compliance with relevant ISO, IEC, BS EN, and UL standards (e.g., ISO13485, ISO 14971, IEC 60601-1-2).	- "Device complies with the following standards: ISO13485:2003, ISO 14971:2012, ISO 15223-1:2012, ISO 15223-2:2010, BS EN 980:2008, BS EN 1041:2008 +A1:2013, IEC 60601-1-2:2007, IEC 60601-1: :1988 + A1:1991 + A2:1995, UL 60601-1."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of this type of device. The "test set" here refers to the conditions and samples used in the bench testing. The document states "wound fluid designed to simulate chemistry and protein content of real exudate" and mentions "worst case scenarios with ranges of exudate viscosity and protein content", but does not specify numerical sample sizes for these test materials.

Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The data provenience is from non-clinical bench testing conducted to verify design specifications and substantial equivalence, not from clinical patient data. The manufacturer is Smith & Nephew, Inc., located in St. Petersburg, FL, USA, suggesting the testing was likely overseen by them, but the specific location of the bench testing is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated labels for patient data. For this device, the "truth" is established by engineering and performance specifications and comparison to the predicate device, not by expert interpretation of patient data.

Qualifications of Experts: Not applicable. The verification and validation of such a device are typically performed by engineers, quality assurance personnel, and regulatory affairs specialists.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of ground truth in AI/ML studies. This is not relevant for bench testing of a physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This is not an AI-powered device, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

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

Standalone Study: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the bench testing, the "ground truth" equates to the established engineering specifications, performance parameters of the predicate device, and compliance with recognized industry standards. For example, the "ground truth" for pumping capacity would be the specified output pressure range, and the "truth" for alarm functionality would be the correct activation of alarms under specific fault conditions as per design. It is not clinical "ground truth" such as pathology or outcomes data.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not involve machine learning or a training set.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a staggered formation, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

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

Re: K151326

Trade/Device Name: RENASYS™ EZ PLUS Negative Pressure Wound Therapy Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: June 23, 2015 Received: June 24, 2015

July 16, 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 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

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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/ResourcesforYou/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.

For

Sincerelv vours.

Joshua C. Nipper -S

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)

Device Name

RENASYS™ EZ PLUS 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)

|X 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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (8/14)

Page 1 of 1

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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 Suite 110 www.smith-nephew.com 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 16, 2015
Device Description
Trade Name:	RENASYS™ EZ PLUS Negative Pressure WoundTherapy Device
Generic/Common Name:	Powered Suction Pump
Classification Name:	Powered Suction Pump; 21 CFR 878.4780Product Code: OMP

Predicate Device Information

Subject Device	Predicate Device	510k#	ClearanceDate
RENASYS EZ PLUS NegativePressure Wound Therapy Device	RENASYS EZ MAX NegativePressure Wound Therapy Device	K142979	04/29/2015

Device Description

RENASYS EZ PLUS Negative Pressure Wound Therapy Device

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The technological characteristics of the subject device have not changed from the predicate device.

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 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.

Indications for Use

RENASYS EZ PLUS Negative Pressure Wound Therapy Device

Appropriate wound types include:

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

The indications for Use statement are the same for both devices except the product name and code.

Summary Comparison between Subject and Predicate Devices

	Subject Device:RENASYS EZ PLUS NPWT	Predicate Device:RENASYS™ EZ MAX NPWT(K142979)
Indications for Use:	Identical	Identical
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

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	Subject Device:RENASYS EZ PLUS NPWT	Predicate Device:RENASYS™ EZ MAX NPWT(K142979)
Biocompability	No patient contact materials	No patient contact materials
Software	N/A	N/A
Locking Feature	Identical	Identical
On/Off Switch Protection	Front case protrusions(shrouds) built in the frontcase on either side of theON/OFF switch.	Switch protection added tothe front of the case on allsides of the ON/OFF switch
Alarm indications	Flashing LED, except thebattery failure Solid yellowLEDAudible indication	Solid LED illumination, exceptthe battery charging indicatorAudible indication modified tocomply with 60601-1-8 2ndedition
IV Pole mount	Affixes to IV poles up to 1 ¼"pole diameter.	Redesign to combine IVPole/Bed Rail Mount. IV PoleMount will affix to poles up to2" diameter.
Bed rail mount	Back of device has foldingstainless steel bed hooks to fitup to 2 ¼" in diameter.	Redesign to combine IVPole/Bed Rail Mount. BedRail Mount will accommodatebed rails up to 3" in diameter.

RENASYS EZ PLUS NPWT Canisters Only

	Subject Device:RENASYS EZ PLUS NPWT	Predicate Device:RENASYS EZ MAXNPWT(K142979)
Canisters	Identical	Identical
Bacterial OverflowGuard housing material	Identical	Identical
250ml S-Canister resin	Identical	Identical
800ml S-Canister and(including lid) and250ml S-Canister lidresin	Identical	Identical
800ml S-Canister;amount of solidifier	Identical	Identical

Non-Clinical Tests (Bench)

RENASYS EZ PLUS Negative Pressure Wound Therapy Device

Testing has been conducted to verify the modifications to the RENASYS EZ PLUS 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 PLUS NPWT device:

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. 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.

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(2"0 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: :1988 + A1:1991 + A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety
. UL 60601-1 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance 1st ed.

Conclusions

In establishing substantial equivalence to the predicate devices, Smith & Nephew, Inc. evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. Performance testing has been successfully completed to demonstrate that the RENASYS EZ PLUS NPWT device and canisters 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.