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.

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

The RENASYS EZ MAX Professional Healthcare Facility model (66801309) is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

Device 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 primary changes made are in relation to compliance with the IEC 60601-1 electrical safety standards. The predicate device complies with the IEC 60601-1 200 edition series while the RENASYS EZ MAX NPWT complies with the IEC 60601-1 3rd Edition series of electrical safety standards

RENASYS EZ MAX NPWT is compatible with existing Smith & Nephew wound dressing kits currently on the market.

AI/ML Overview

The provided document describes the K132466 submission for the RENASYS™ EZ MAX Negative Pressure Wound Therapy Device. This submission is for a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission primarily relies on non-clinical (bench) testing to show equivalence in performance, safety, and technological characteristics rather than extensive clinical studies on human subjects.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test)	Reported Device Performance
Pumping capacity is equivalent to the predicate device.	Pumping capacity is equivalent to the predicate device.
Device provides negative pressure at individual pressure settings of 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180 and 200mmHg, identical to the predicate device.	Device provides negative pressure at individual pressure settings of 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180 and 200mmHg, identical to the predicate device.
The device delivers negative pressure in a continuous and intermittent operating mode identical to the predicate device.	The device delivers negative pressure in a continuous and intermittent operating mode identical to the predicate device.
The device including canisters interface with existing RENASYS NPWT wound dressing kits.	The device including canisters interface with existing RENASYS NPWT wound dressing kits.
Device pressure setting remains unchanged when the device is locked and actuation of the Therapy Knob is attempted.	Device pressure setting remains unchanged when the device is locked and actuation of the Therapy Knob is attempted.
Device has a protection feature/mechanism to maintain the intended functional state (Continuous ON, OFF, Intermittent ON).	Device has a protection feature/mechanism to maintain the intended functional state (Continuous ON, OFF, Intermittent ON).
Device attaches to IV poles ranging in diameter from 1/2 inches.	Device attaches to IV poles ranging in diameter from 1/2 inches.
Device bed rail clamp attaches to a bed rail (or equivalent) up to 3 inches in diameter.	Device bed rail clamp attaches to a bed rail (or equivalent) up to 3 inches in diameter.
Device canister bracket withstands side impact load simulating a worst case failure mode for clinical use.	Device canister bracket withstands side impact load simulating a worst case failure mode for clinical use.
Device complies with specified electrical safety standards (IEC 60601-1-2:2007, IEC 60601-1:2005, ANSI/AAMI ES60601-1:2005, IEC 60601-1-8:2006, IEC 60601-1-6:2010, IEC 62366:2007).	Device complies with the following standards: IEC 60601-1-2:2007(3rd edition), IEC 60601-1:2005 (3rd edition), ANSI/AAMI ES60601-1:2005 Version (R2012), IEC 60601-1-8:2006 (2nd edition), IEC 60601-1-6:2010 (3rd Edition), IEC 62366:2007 (1st edition).

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

The document details non-clinical bench testing. Therefore, there isn't a "test set" in the sense of patient data. The testing involved physical devices and components to verify performance and compliance with standards. The data provenance is derived from these bench tests, conducted by the manufacturer (Smith & Nephew, Inc.). No specific country of origin for patient data is relevant here, nor is it retrospective or prospective in the clinical study context.

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

Not applicable. For bench testing of a medical device's physical and electrical performance, "ground truth" is established by engineering specifications, validated test protocols, and compliance with recognized standards. It does not involve human experts in the way clinical studies often do for image interpretation or diagnosis.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. Bench testing directly measures device performance against predefined engineering criteria.

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

Not applicable. This submission concerns a physical medical device (Negative Pressure Wound Therapy pump), not an AI-powered diagnostic tool requiring MRMC studies.

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

Not applicable. This device is not an algorithm or AI system. Its performance is measured directly through bench tests as a standalone physical product.

7. The type of ground truth used

The ground truth used for these bench tests is engineering specifications, established performance parameters of the predicate device, and recognized international and national electrical safety and medical device standards. The goal was to prove the RENASYS EZ MAX performs identically to the predicate and complies with updated safety standards.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device, so there is no "training set."

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

Not applicable. As there is no training set.

Summary

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K132466

2 We are smith&nephew

Wound Management 727 392-1261

に

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

OCT 23 2013

General Information Submitters Name/Address:

Smith & Nephew, Inc. 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716

3006760724 Establishment Registration Number: Contact Person: Laura Reynolds Director Regulatory Affairs Phone Number: (727) 329-7702 Date Prepared: September 20, 2013 Device Description RENASYS™ EZ MAX Negative Pressure Wound Trade Name: Therapy Device Generic/Common Name: Powered Suction Pump Classification Name: Powered Suction Pump; 21 CFR 878.4780 Product Code: OMP

Predicate Device Information

510(k) #	Device	Clearance Date
K102001	RENASYS EZ PLUS	08/06/2010

Device Description

RENASYS EZ MAX NPWT is compatible with existing Smith & Nephew wound dressing kits currently on the market.

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Indications for Use

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 .

Non-Clinical Tests (Bench)

Testing has been conducted to verify the modifications to the RENASYS EZ MAX device 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 of 40, 50, 60, . 70, 80, 90, 100, 120, 140, 160, 180 and 200mmHg, identical to the predicate device.
. The device delivers negative pressure in a continuous and intermittent operating mode identical to the predicate device.
. The device including canisters interface with existing RENASYS NPWT wound dressing kits.
Device pressure setting remains unchanged when the device is locked and . actuation of the Therapy Knob is attempted
. Device has a protection feature/mechanism to maintain the intended functional state (Continuous ON, OFF, Intermittent ON).
Device attaches to IV poles ranging in diameter from 1/2 inches. .
. Device bed rail clamp attaches to a bed rail (or equivalent) up to 3 inches in diameter.
. Device canister bracket withstands side impact load simulating a worst case failure mode for clinical use.
. Device complies with the following standards:
- IEC 60601-1-2:2007(3rd edition) Medical electrical equipment Part 1-2: o 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: O

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General Requirements for Safety,

ANSI/AAMI ES60601-1:2005 Version (R2012) Medical Electrical o Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-8:2006 (2nd edition) Medical electrical equipment Part 1o 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 1-0 6: General requirements for basic safety and essential performance -Collateral standard. Usability
IEC 62366:2007 (1st edition) Medical devices Application of usability o engineering to medical devices. (General)

Summary of Safety and Effectiveness

In establishing substantial equivalence to the currently marketed predicate device, 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 is substantially equivalent to the predicate device and is safe and effective for the intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

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

October 23, 2013

Re: K132446

Trade/Device Name: RENASYS" EZ MAX Negative Pressure Wound Therapy Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: September 20, 2013 Received: September 23, 2013

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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Page 2 - Ms. Laura Reynolds

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark Nielkerson -S

Mark N. Melkerson Acting 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): K132446

Device Name: RENASYS™ EZ MAX Negative Pressure Wound Therapy Device

Indications For Use:

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 .

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.