HYBRID GRAFT

K111695 · Cook Biotech, Inc. · FTL · Apr 2, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K111695
• Device Name: HYBRID GRAFT
• Applicant: Cook Biotech, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hybrid Graft is for implantation to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The graft is supplied sterile and is intended for one-time use.

Device Story

Hybrid Graft is a surgical mesh for soft tissue reinforcement; composed of bioabsorbable extracellular collagen matrix (Small Intestinal Submucosa, SIS) and synthetic polypropylene mesh. Polypropylene layer is sandwiched between six layers of SIS (visceral side) and two layers of SIS (body wall side). Device is supplied sterile, vacuum-pressed, and dried in a double-pouch system. Used by surgeons in clinical settings for hernia or body wall defect repair. Provides mechanical reinforcement to surgical site; collagen component facilitates tissue integration while polypropylene provides structural support. Benefits include surgical repair of tissue weaknesses.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via suture retention, ultimate tensile strength, and diaphragmatic burst strength. Biocompatibility testing conducted per ISO 10993, including cytotoxicity, hemolysis, sensitization, systemic toxicity, pyrogenicity, and muscle implantation. Results demonstrate compliance with standards and substantial equivalence to predicates.

Technological Characteristics

Composite surgical mesh; materials: Small Intestinal Submucosa (SIS) collagen and polypropylene. Form factor: vacuum-pressed, laminated sheets (0.1 to 2.0 mm thickness). Dimensions: 15 cm x 22 cm to 30 cm x 30 cm or 15 cm diameter. Sterilization: sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring repair of a hernia or body wall defect where reinforcement or bridging material is needed to strengthen soft tissue.

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

• SIS Hernia Repair Device (K974540, K062697)
• SurgiSIS Mesh (K980431)
• PROCEED™ Ventral Patch (K061533)
• ULTRAPRO® Mesh (K033337)

Submission Summary (Full Text)

{0}------------------------------------------------

111695

# 510(k) Summary

APR - 2 2012

#### Cook Biotech Incorporated

#### Hybrid Graft

Manufacturer Name:

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: [phone] FAX: [phone]

Official Contact:

Perry W. Guinn

## DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | Hybrid Graft |
|-----------------------------|------------------------------------|
| Common Name: | Surgical Mesh |
| Classification Regulations: | Class II, 21 CFR §878.3300 (79FTL) |

INTENDED USE:

The Hybrid Graft is for implantation to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The graft is supplied sterile and is intended for one-time use.

## DEVICE DESCRIPTION:

The Hybrid Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS) and a polypropylene mesh. The collagen matrix is identical to the predicate SIS Hernia Repair Device (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch (K061533) and ULTRAPRO® Mesh (K033337), both manufactured by Ethicon, Incorporated. The Hybrid Graft is similar to both PROCEED and ULTRAPRO in that all are made of a composite of a bioabsorbable or collagen-based and synthetic (polypropylene) component. The polypropylene mesh in the Hybrid Graft is layered between six (6) layers of SIS on the side facing the viscera and two (2) layers of SIS on the side facing the body wall. The device is packaged in a vacuum pressed (dried), laminated state and supplied sterile in a sealed double pouch system.

{1}------------------------------------------------

# EQUIVALENCE TO MARKETED DEVICES

The Hybrid Graft is similar with respect to intended use and with respect to materials and technological characteristics to the predicate devices in terms of section 510(k) substantial equivalence, as shown through bench and biocompatibility testing:

# Bench Testing

Finished devices were tested for mechanical performance as follows:

- Suture retention ●
- Ultimate tensile strength ●
- Diaphragmatic burst strength .

The mechanical performance of the Hybrid Graft is adequate for the application.

# Biocompatibility testing

The SIS material comprising the Hybrid Graft was tested under ISO 10993 standards as follows:

- . Genototicity
- Direct contact in vitro hemolysis ●
- Cytotoxicity ●
- . Muscle implantation
- Acute intracutaneous reactivity ●
- ISO sensitization
- Acute systemic toxicity ●
- . Pyrogenicity
- LAL endotoxins ●
- Subchronic toxicity .

The Hybrid Graft was tested under ISO 10993 standard under the following:

- · Cytotoxicity
A Biocompatibility Assessment from NAMSA™ attesting to the biocompatibility of the Hybrid Graft was provided for this submission.

The results of the biocompatibility testing show that the Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates.

# Substantial Equivalence

See Table 1 below for a comparison of the subject device and its predicates.

{2}------------------------------------------------

| Device | Hybrid Graft | SIS Hernia Repair<br>Device | SurgiSIS Mesh | PROCEED™ Ventral<br>Patch | ULTRAPRO® Mesh |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech<br>Incorporated | Cook Biotech<br>Incorporated | Cook Biotech<br>Incorporated | Ethicon, Incorporated | Ethicon, Incorporated |
| 510(k)<br>Number | K111695 | K974540, K062697 | K980431 | K061533 | K033337 |
| Intended Use | To be implanted to<br>reinforce soft tissues<br>where weakness<br>exists. Indications<br>for use include the<br>repair of a hernia or<br>body wall defect<br>requiring the<br>addition of a<br>reinforcing or<br>bridging material to<br>obtain the desired<br>surgical result. | To be implanted to<br>reinforce soft tissues<br>where weakness exists.<br>Indications for use<br>include the repair of a<br>hernia or body wall<br>defect. | For implantation to<br>reinforce soft tissue. | For the repair of<br>hernias or other<br>abdominal fascial<br>defects that require the<br>addition of a<br>reinforcing or bridging<br>material to obtain the<br>desired surgical<br>results. | For the repair of<br>hernias and other<br>abdominal fascial<br>deficiencies that<br>require the addition<br>of a reinforcing or<br>bridging material to<br>obtain the desired<br>surgical result. |
| Material | Small intestinal<br>submucosa<br>Primarily Types I,<br>III, IV and VI<br>collagen<br>and polypropylene | Small intestinal<br>submucosa<br>Primarily Types I, III,<br>IV and VI collagen | Small intestinal<br>submucosa<br>Primarily Types I,<br>III, IV and VI<br>collagen | Oxidized regenerated<br>cellulose (ORC),<br>polypropylene | Poliglecaprone-25<br>and polypropylene |
| Dimensions | 15 cm x 22 cm to<br>30 cm x 30 cm, 15<br>cm diameter | 5 cm x 8 cm to 20 cm x<br>30 cm | 0.6 cm x 5 cm to 7<br>cm x 20 cm | 5 cm x 10 cm to 30.5<br>cm x 30.5 cm | 7.6 cm x 15 cm to 30<br>cm x 30 cm |
| Thickness | 0.1 to 2.0 mm | 0.1 to 1.5 mm | 0.1 to 2.0 mm | N/A | N/A |

Table 1 - Substantial Equivalence Table

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Cook Biotech, Incorporated % Mr. Perry W. Guinn Vice President, Regulatory Affairs and Quality Assurance 1425 Innovation Place West Lafayette, Indiana 47906-4224

APR - 2 2012

· Re: K111695

Trade/Device Name: Hybrid Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 14, 2012 Received: March 15, 2012

Dear Mr. Guinn:

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

{4}------------------------------------------------

## Page 2 - Mr. Perry W. Guinn

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Arthur
Dep. C.C.s D.n

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

Enclosure

{5}------------------------------------------------

KIIIBqr

# Indications for Use

510(k) Number (if known):

Device Name: Hybrid Graft

Indications For Use:

The Hybrid Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. This graft is supplied sterile and is intended for one-time use.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Daniel Kune fei McKay

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

510(k) Number K11695