RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT

K100787 · Smith & Nephew, Inc. · FTL · Sep 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100787
• Device Name: RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
• Applicant: Smith & Nephew, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Sep 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RENASYS™ - F/-AB Abdominal Wound Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Device Story

RENASYS-F/AB Abdominal Dressing Kit provides wound management interface for negative pressure wound therapy (NPWT). Kit components: hydrophobic reticulated polyurethane foam dressings; polyurethane organ protection layer; transparent film drapes; suction port assembly with tubing. Used in acute hospital settings (trauma, general/plastic surgery wards); applied by clinicians in operating theatre. Device connects to Smith & Nephew RENASYS EZ and EZ PLUS NPWT pumps. Foam placed over wound to facilitate exudate removal; organ protection layer shields viscera; film drapes seal site; suction port connects to pump canister. System enables NPWT to manage open abdominal wounds; supports temporary bridging of abdominal wall openings; facilitates repeat access. Benefits include exudate management and wound environment stabilization.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, irritation, sensitization, implantation, sub-acute toxicity, genotoxicity) performed per ISO 10993 for all components. Design verification testing confirmed performance specifications, negative pressure delivery, and exudate removal capabilities.

Technological Characteristics

Components: hydrophobic reticulated polyurethane foam, polyurethane organ protection layer, transparent film drapes, suction port assembly. Materials tested per ISO 10993. System is sterile, single-use. Operates via external NPWT pump (RENASYS EZ/EZ PLUS).

Indications for Use

Indicated for patients with open abdominal wounds with exposed viscera, including abdominal compartment syndrome, where primary closure is not possible or repeat abdominal entries are required.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• V.A.C.® Abdominal Dressing (K022011)

Submission Summary (Full Text)

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We are smith&nephew

Wound Management Smith & Nephew. Inc. 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716 T 727 392-1261 F 727 392-6914 or 727 392-0797 Customer Care Center: 1 800 876-1261 www.smith-nephew.com

# 510(k) Summary RENASYS™ -F/AB Abdominal Dressing Kit 510(k) # K100787

SEP 1 7 2010

- 1. Submitter: Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
- 2. Contact: Laura D. Reynolds, RAC Regulatory Affairs Manager 727-329-7702
- 3. Date Prepared: September 14, 2010
- RENASYS™ -F/AB Abdominal Dressing Kit 4. Device Name: Abdominal Dressing Kit Common Name: Classification Name: Mesh, Surgical, Polymeric, 21 CFR 878.3300 Product Classification/Code: Class II, FTL

## 5. Predicate Device Information:

V.A.C.® Abdominal Dressing KCI USA. Inc. 510(k) # K022011

### ം. Device Description:

The RENASYS™ -FIAB Abdominal Dressing Kit consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polvurethane organ protection layer, six transparent film drapes and a suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.

The RENASYS- FIAB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and EZ PLUS negative pressure wound therapy pumps and canister kits, which have been previously cleared under 510(k) numbers K082426, K091470 and K102001.

### 7. Intended Use:

The RENASYS- F/AB Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.

This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

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K100787
2 of 2
We are smith&nephew

## Summary of Non-Clinical Testing 8.

The following biocompatibility testing for all kit components has been successfully completed per applicable parts of ISO 10993:

| Kit Component | Tests Completed |
|------------------------|--------------------|
| Foam | Cytotoxicity |
| | Irritation |
| | Sensitization |
| Organ Protection Layer | Cytotoxicity |
| | Irritation |
| | Sensitization |
| | Implantation |
| | Sub-acute Toxicity |
| | Genotoxicity |
| Transparent Film Drape | Cytotoxicity |
| | Irritation |
| | Sensitization |
| Suction Port Assembly | Cytotoxicity |
| | Irritation |
| | Sensitization |
| | Sub-acute Toxicity |
| | Genotoxicity |

Design verification testing has been conducted to demonstrate the device meets the performance specifications, delivers negative pressure wound therapy to the wound and removes exudates.

#### Conclusions Drawn ு.

The RENASYS-F/AB Abdominal Dressing Kit has successfully undergone testing to demonstrate that the device is substantially equivalent to the predicate device and effective for the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

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

Smith and Nephew % Ms. Laura Reynolds, RAC Regulatory Affairs Manager 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716

SEP 1 7 2010

Re: K100787

Trade/Device Name: Renasys™ F/-AB Abdominal Wound Dressing Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 31, 2010 Received: September 1, 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. Iisting 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

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# Page 2 - Ms. Laura Reynolds, RAC

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/medicaldevices/resourcesforyou/industry/default.htm.

Sincerely yours,

fal D.St

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): ____________________________________________________________________________________________________________________________________________________

Device Name: RENASYS™ F/- AB Abdominal Wound Dressing Kit

SEP 1 7 2010

Indications for Use:

- ,

The RENASYS™ - F/-AB Abdominal Wound Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.

This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

| Prescription Use | X | AND/OR | Over-The-Counter Use |
|-----------------------------|---|--------|------------------------|
| (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)

(Division Sigh-Off)

Division of Surgical, Orthopedic, and Restorative Devices

| 510(k) Number | K106787 |
|---------------|---------|
|---------------|---------|