RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device

K151326 · Smith & Nephew, Inc. · OMP · Jul 16, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151326
• Device Name: RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
• Applicant: Smith & Nephew, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Jul 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Lightweight, powered suction pump for negative pressure wound therapy (NPWT); applies continuous or intermittent negative pressure to wound sites. Input: wound exudates, irrigation fluids, infectious materials; output: removal of fluids into a disposable canister. Used in acute care settings and professional healthcare environments; operated by qualified healthcare professionals. Device connects to wound dressing via tubing and canister; powered by mains or internal battery. Healthcare providers monitor device status via LED indicators and audible alarms. Therapy promotes wound healing by managing exudate and infectious materials. Device features include IV pole/bed rail mounting and switch protection.

Clinical Evidence

Bench testing only. Verification included pumping capacity, negative pressure delivery in continuous/intermittent modes, canister-full alarm functionality using simulated wound exudate, system performance under fault conditions, and high air leak scenarios. Compliance with safety standards (IEC 60601-1, UL 60601-1) and EMC standards (IEC 60601-1-2) confirmed.

Technological Characteristics

Powered suction pump; mains or battery-powered. Features include disposable canisters (800ml/250ml) with bacterial overflow guards. Materials: ultrasonically welded lids, solidifier gel packs. Standards: ISO 13485, ISO 14971, ISO 15223, IEC 60601-1, UL 60601-1. Connectivity: None. Sterilization: N/A (non-sterile canisters).

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing via fluid removal. Applicable to chronic, acute, traumatic, sub-acute, dehisced wounds, ulcers (pressure/diabetic), partial-thickness burns, flaps, and grafts. Intended for use in acute care and professional healthcare settings under professional supervision.

Regulatory Classification

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.

Predicate Devices

• RENASYS EZ MAX Negative Pressure Wound Therapy Device (K142979)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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.

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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.<br>970 Lake Carillon Drive<br>Suite 110<br>St. Petersburg, FL 33716 |
| Establishment Registration Number: | 3006760724 |
| Contact Person: | Laura Reynolds<br>Director Regulatory Affairs |
| Phone Number: | [phone] |
| Date Prepared: | July 16, 2015 |
| Device Description | |
| Trade Name: | RENASYS™ EZ PLUS Negative Pressure Wound<br>Therapy Device |
| Generic/Common Name: | Powered Suction Pump |
| Classification Name: | Powered Suction Pump; 21 CFR 878.4780<br>Product Code: OMP |

#### Predicate Device Information

| Subject Device | Predicate Device | 510k# | Clearance<br>Date |
|-----------------------------------------------------------|----------------------------------------------------------|---------|-------------------|
| RENASYS EZ PLUS Negative<br>Pressure Wound Therapy Device | RENASYS EZ MAX Negative<br>Pressure Wound Therapy Device | K142979 | 04/29/2015 |

#### Device Description

RENASYS EZ PLUS Negative Pressure Wound Therapy Device

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.

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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

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.

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:<br>RENASYS EZ PLUS NPWT | Predicate Device:<br>RENASYS™ EZ MAX NPWT<br>(K142979) |
|----------------------------------------------|-----------------------------------------|--------------------------------------------------------|
| Indications for Use: | Identical | Identical |
| Components | Substantially equivalent | Substantially equivalent |
| Principle of Operation | Identical | Identical |
| Operating Time (Battery) | Identical | Identical |
| Negative Pressure<br>Range | Identical | Identical |
| High Flow/Leak Rate<br>Alarm Threshold Limit | Same | Same |
| Sterilization | N/A | N/A |

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| | Subject Device:<br>RENASYS EZ PLUS NPWT | Predicate Device:<br>RENASYS™ EZ MAX NPWT<br>(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<br>(shrouds) built in the front<br>case on either side of the<br>ON/OFF switch. | Switch protection added to<br>the front of the case on all<br>sides of the ON/OFF switch |
| Alarm indications | Flashing LED, except the<br>battery failure Solid yellow<br>LED<br>Audible indication | Solid LED illumination, except<br>the battery charging indicator<br>Audible indication modified to<br>comply with 60601-1-8 2nd<br>edition |
| IV Pole mount | Affixes to IV poles up to 1 ¼"<br>pole diameter. | Redesign to combine IV<br>Pole/Bed Rail Mount. IV Pole<br>Mount will affix to poles up to<br>2" diameter. |
| Bed rail mount | Back of device has folding<br>stainless steel bed hooks to fit<br>up to 2 ¼" in diameter. | Redesign to combine IV<br>Pole/Bed Rail Mount. Bed<br>Rail Mount will accommodate<br>bed rails up to 3" in diameter. |

# RENASYS EZ PLUS NPWT Canisters Only

| | Subject Device:<br>RENASYS EZ PLUS NPWT | Predicate Device:<br>RENASYS EZ MAX<br>NPWT(K142979) |
|------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------------------|
| Canisters | Identical | Identical |
| Bacterial Overflow<br>Guard housing material | Identical | Identical |
| 250ml S-Canister resin | Identical | Identical |
| 800ml S-Canister and<br>(including lid) and<br>250ml S-Canister lid<br>resin | Identical | Identical |
| 800ml S-Canister;<br>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.