The RENASYS EZ PLUS 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.

Device Description

The Renasys EZ PLUS NPWT device is a lightweight, suction device intended for wound management via application of continual 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. Renasys EZ PLUS is suitable for use in either a hospital or homecare setting. Renasys EZ PLUS is compatible with existing Smith & Nephew wound dressing kits currently on the market.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Renasys™ EZ PLUS Negative Pressure Wound Therapy device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety: Compliance with UL 60601-1 and IEC 60601-1	Testing in accordance with UL 60601-1 and IEC 60601-1 was conducted and found satisfactory.
Electromagnetic Compatibility: Compliance with IEC 60601-1-2	Testing in accordance with IEC 60601-1-2 was conducted and found satisfactory.
Design Specifications: Meeting design specifications	Testing was conducted to verify the changes in the Renasys EZ PLUS met design specifications.
Substantial Equivalence: To predicate device (K091470 - Renasys™ EZ) for intended use.	Performance testing and electrical safety testing successfully demonstrated substantial equivalence to the marketed predicate device and safety and effectiveness for intended use. The FDA concurred with this determination.

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

Test Set: The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The conducted testing appears to be primarily non-clinical bench testing.
Data Provenance: The data provenance is from bench testing conducted by the manufacturer, Smith & Nephew, Inc. No information on country of origin for clinical or patient data is provided, as no clinical study is detailed.

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

This question is not applicable as the provided document describes non-clinical (bench) testing, not a clinical study involving human patients where "ground truth" would be established by experts. The "ground truth" in this context is adherence to established engineering and safety standards.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human adjudication process described for the non-clinical bench testing. The evaluation is against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was done. This device is a negative pressure wound therapy (NPWT) device, which is a physical medical device, not an AI or imaging-related diagnostic tool. Therefore, the concept of "human readers" and "AI assistance" does not apply.

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

This question is not applicable as the device is a physical medical device for wound therapy, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering standards and design specifications (e.g., UL 60601-1, IEC 60601-1-2, internal design specifications) rather than clinical ground truth like pathology or outcomes data. The primary "ground truth" for substantial equivalence is the performance and safety profile of the predicate device (Renasys™ EZ).

8. The Sample Size for the Training Set

This question is not applicable as this device is a physical medical device and does not involve machine learning algorithms with a "training set."

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

This question is not applicable as there is no "training set" for this type of device.

Summary

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510(k) Summary

General Information

Submitters Name/Address:

Smith & Nephew, Inc 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716 AUG 2010 - 6

Establishment Registration Number: Contact Person:

Phone Number:

Date Prepared:

Device Description

Trade Name:

Generic/Common Name: Classification Name:

Predicate Device Information

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

3006760724

Laura Reynolds Regulatory Affairs Manager

(727) 329-7702

August 4, 2010

Renasys™ EZ PLUS Negative Pressure Wound Therapy

Powered Suction Pump

Powered Suction Pump; 21 CFR 878.4780 Product Code: OMP

510(k) #	Device	Clearance Date
K091470	Renasys™ EZ	07/09/2009

Device Description

Renasvs EZ PLUS 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 in accordance with UL 60601-1 and IEC 60601-1 was conducted for electrical safety.

Testing in accordance with IEC 60601-1-2 was conducted for electromagnetic compatibility.

Testing was conducted to verify the changes in the Renasys EZ PLUS met design specifications and demonstrated substantial equivalence to its predicate device.

Summary of Safety and Effectiveness

In establishing substantial equivalence to the current marketed 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 PLUS is substantially equivalent to the marketed device and is safe and effective for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

AUG - 0 2010

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

Smith & Nephew, Inc. % Ms. Laura Revnolds Regulatory Affairs Manager 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716

Re: K102001

Trade/Device Name: Renasys™ EZ PLUS Negative Pressure Wound Therapy Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: July 12, 2010 Received: July 15, 2010

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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): K102001

AUG - 6 2010

Device Name: Renasys™ EZ Plus

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 × (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)

currence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102001

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.