RENASYS EZ

K082426 · Smith & Nephew, Inc. · OMP · Sep 5, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082426
• Device Name: RENASYS EZ
• Applicant: Smith & Nephew, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Renasys EZ is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

Device Story

Renasys EZ is a powered suction pump for Negative Pressure Wound Therapy (NPWT). System includes pump, accessory wound dressing kits, disposable canister, and filter. Device delivers continuous or intermittent topical negative pressure (40-80 mmHg) to wound site. Used in clinical settings to promote wound healing. Healthcare providers operate device to manage wound environment. Output is controlled suction; clinical decision-making relies on provider assessment of wound healing progress. Benefits include potential acceleration of wound closure through negative pressure application.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and comparison of technological characteristics.

Technological Characteristics

Powered suction pump for NPWT. Delivers 40-80 mmHg continuous or intermittent negative pressure. Includes disposable canister and filter. Electrical energy source. Class II device (21 CFR 878.4780).

Indications for Use

Indicated for patients requiring suction therapy to promote wound healing.

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

• Versatile 1 EZCare Wound Vacuum System (K061919)

Submission Summary (Full Text)

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K082426

SMITH & NEPHEW, INC. - PROPRIETARY INFORMATION

| 510(k) Summary | |
|------------------------------------|-----------------------------------------------------------------------------------------|
| SEP - 5 2008 | |
| General Information | |
| Submitters Name/Address: | Smith & Nephew, Inc<br>970 Lake Carillon Drive<br>Suite 110<br>St. Petersburg, FL 33716 |
| Establishment Registration Number: | 1017593 |
| Contact Person: | Laura Krejci - Regulatory Affairs Manager |
| Phone Number: | [phone] |
| Date Prepared: | August 20 ^th , 2008 |
| Device Description | |
| Trade Name: | Renasys ^™ EZ Negative Pressure Wound<br>Therapy |
| Generic/Common Name: | Suction Pump and Accessories |
| Classification Name: | Powered Suction Pump; 21 CFR 878.4780<br>Product Code; BTA |

# Predicate Device Information

Versatile 1 ™EZCare Wound Vacuum System cleared originally in k061919.

# Product Description

The Renasys EZ is a powered suction pump with accessory wound dressing kits, disposable canister and filter designed for Negative Pressure Wound Therapy (NPWT). The Renasys EZ is designed for use with various Smith & Nephew wound dressing kits to deliver a recommended therapeutic range of 40-80 mmHg of continuous or internittent topical negative pressure to a wound site for the purposes of wound healing.

### Intended Use

Renasys EZ is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

### 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 current marketed device. The device comparison demonstrated that the Renasys EZ is substantially equivalent to the marketed device and is safe and effective for the intended use.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its body and wings. The text is in a sans-serif font and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'APR - 7 2009

Smith & Nephew, Inc. % Ms. Laura Krejci 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716

Re: K082426

Trade/Device Name: Renasys EZ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 20, 2008 Received: August 22, 2008

Dear Ms. Krejci:

This letter corrects our substantially equivalent letter of September 5, 2008.

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 (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.

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

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Page 2 - Ms. Laura Krejci

limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### SMITH & NEPHEW, INC. - PROPRIETARY INFORMATION

Indications for Use

| 510(k) Number (unknown): | K082426 |
|--------------------------|------------|
| Device Name: | RENASYS EZ |

Indications for Use:

The Renasys EZ is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** k082426