RENASYS GO NEGATIVE PRESSURE WOUND THERAPY

K083375 · Smith & Nephew, Inc. · OMP · Feb 25, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083375
• Device Name: RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
• Applicant: Smith & Nephew, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Feb 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Renasvs™ GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing 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 Story

Renasys GO is a portable, lightweight powered suction pump for negative pressure wound therapy (NPWT). Device connects via tubing to a wound dressing to apply negative pressure and evacuate wound exudates, irrigation fluids, and infectious materials into a disposable canister. Operates via mains power or internal battery; includes shoulder strap and carry case for mobility. Used in hospital and homecare settings by clinicians or patients. Provides continuous or intermittent suction to promote wound healing. Healthcare providers monitor wound status and device function to adjust therapy as needed.

Clinical Evidence

Bench testing and electrical safety testing only; no clinical data provided.

Technological Characteristics

Powered suction pump; portable form factor with shoulder strap/carry case. Operates on mains power or internal battery. Compatible with existing Smith & Nephew wound dressing kits. Class II device.

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing by removing fluids, exudates, and infectious materials. Applicable to chronic, acute, traumatic, sub-acute, dehisced wounds, ulcers (pressure/diabetic), partial-thickness burns, flaps, and grafts.

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 Negative Pressure Wound Therapy System (K082426)
• Antlia II™ Suction Pump System (K070904)
• Medela® INVIA Liberty Secretion & Surgical Aspirator (K080357)

Submission Summary (Full Text)

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K683375 Pag

# 510(k) Summary Renasys™ GO Negative Pressure Wound Therapy

- Smith & Nephew, Inc. 1. Submitter: 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
FEB 2 5 2009

- 2. Contact: Laura Kreici Requlatory Affairs Manager 727-329-7702
- Device Name: Renasys™ GO Negative Pressure Wound Therapy క. Common Name: Powered Suction Pump Classification Name: Powered Suction Pump (21 CFR 878.4780) Product Classification/Code: Class II, JCX
- Predicate Device Information: 4.

Renasys TM. EZ Negative Pressure Wound Therapy System Smith & Nephew, Inc. 510(k) #K082426 Largo, FL

Antlia II™ Suction Pump System Innovative Therapies, Inc. Hunt Valley, MD

510(k) #K070904

Medela® INVIA Liberty Secretion & Surgical Aspirator 510(k) #K080357 Medela AG Laettichstrasse, Switzerland

#### 5. Device Description:

The Renasys GO NPWT device is a lightweight, portable suction device intended to deliver negative pressure to a wound at a range of pressure settings via a tube set connected to a wound dressing. The suction pump creates negative pressure and removes exudates from the wound site to a disposable canister. The device can operate either by a mains power supply or internal battery. Renasys GO is suitable for use in both a hospital and homecare setting and includes a shoulder strap and carry case for portability.

Renasys GO is compatible with existing Smith & Nephew wound dressing kits currently on the market.

#### Intended Use: 6.

Renasvs™ GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing 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.

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K083375 Page(2)

### Substantial Equivalence 7.

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 currently marketed devices. Performance testing and electrical safety testing has been successfully completed to demonstrate that tooling and enounced and ally equivalent to the marketed devices and is safe and effective for the intended use.

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Image /page/2/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 outstretched wings, symbolizing care and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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: K083375

Trade/Device Name: Renasys™ GO Negative Pressure Wound Therapy Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: December 22, 2008 Received: December 23, 2008

Dear Ms. Krejci:

This letter corrects our substantially equivalent letter of February 25, 2009.

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 (OS) 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 vou 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 vours.

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

Enclosure

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## Indications for Use

510(k) Number (if known): K083375

Device Name: Renasys™ GO Negative Pressure Wound Therapy

Indications for Use:

Renasys™ GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing 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

Ln. Ahmed

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

**510(k) Number** k083371

Prescription Use _ X (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)