BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT

K131015 · Cook Biotech, Inc. · GXQ · Oct 8, 2013 · Neurology

Device Facts

• Record ID: K131015
• Device Name: BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
• Applicant: Cook Biotech, Inc.
• Product Code: GXQ · Neurology
• Decision Date: Oct 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biodesign Onlay Dural Graft is intended for use as a dura substitute for the repair of dura mater. The device is provided sterile and intended for one-time use.

Device Story

Biodesign Onlay Dural Graft is a bioabsorbable, extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). Implanted as a scaffold for dural repair, it facilitates infiltration by patient cells and remodeling into native tissue. Supplied in a lyophilized, sterile state, it can be placed without sutures during skull base dural repair. Used by neurosurgeons in clinical settings, the device serves as a physical barrier to replace or augment the dura mater, promoting healing and reducing potential for cerebrospinal fluid leaks.

Clinical Evidence

No clinical data provided in the document; evidence consists of bench testing, biocompatibility testing, and an animal study. Bench testing confirmed mechanical performance (suture retention, tensile, and burst strength) similar to predicates. Biocompatibility testing (genotoxicity, cytotoxicity, sensitization, systemic toxicity, etc.) on identical material (SurgiSIS Mesh) met ISO 10993-1 standards. Animal study in a rat model demonstrated adequate performance with no adverse physiological or histological effects.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS) containing Types I, III, IV, and VI collagen. Form factor: Lyophilized matrix, 154 µm to 680 µm thickness. Sterilization: Terminally sterilized. Biocompatibility: Tested per ISO 10993-1. Mechanical properties: Suture retention, ultimate tensile strength, and burst strength.

Indications for Use

Indicated for use as a dura substitute for the repair of dura mater in patients requiring cranial base dural repair.

Regulatory Classification

Identification

A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

Predicate Devices

• Durasis Dural Substitute (K031850)
• DuraGen II Dural Regeneration Matrix (K043427)

Reference Devices

• SurgiSIS Mesh

Submission Summary (Full Text)

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KB1015

OCT 0 8 2013

510(k) Premarket Notification: Biodesign® Dural Graft

#### 510(k) Summary

September 30, 2013

#### Cook Biotech Incorporated

#### Biodesign® Onlay Dural 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: Common Name: Classification Regulations: Biodesign Onlay Dural Graft Dura Substitute Class II, 21 CFR §882.5910 (84GXQ)

INDICATIONS FOR USE:

The Biodesign Onlay Dural Graft is intended for use as a dura substitute for the repair of dura mater. The device is provided sterile and intended for one-time use.

#### DEVICE DESCRIPTION:

The Biodesign Onlay Dural Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Biodesign Onlay Dural Graft is identical in composition and technology to that of its predicate Durasis Dural Substitute (K031850), also manufactured by Cook Biotech Incorporated and similar to its other predicate, DuraGen II Dural Regeneration Matrix (K043427) manufactured by Integra LifeSciences. The Biodesign Onlay Dural Graft is implanted as a dura substitute providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system. The Biodesign Onlay Dural Graft can be placed without sutures during skull base dural repair.

#### EQUIVALENCE TO MARKETED DEVICES

The Biodesign Onlay Dural Graft is similar with respect to intended use, and identical with respect to materials and technological characteristics to the predicate devices in terms of section 510(k) substantial equivalence, as shown through bench (ultimate

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510(k) Premarket Notification: Biodesign® Dural Graft

tensile strength, thickness, burst strength), animal (where the device was implanted as an onlay in a rat study), and biocompatibility testing (genotoxicity, direct contact in vitro hemolysis, cytotoxicity, muscle implantation, acute intracutaneous reactivity, sensitization, acute systemic toxicity, pyrogenicity, LAL endotoxins, subchronic systemic toxicity), and clinical studies using the device in cranial base dural repair.

#### Bench testing

The following mechanical tests were performed on finished, terminally sterilized devices:

- . Suture retention strength
- Ultimate tensile strength .
- Burst strength test .

The tests provided evidence that the Biodesign Onlay Dural Graft performed similarly to its predicate devices.

#### Biocompatibility testing

The following biocompatibility tests were performed on sterilized SurgiSIS Mesh, which is identical in composition to the Biodesign Onlay Dural Graft (according to the ISO 10993-1 standard):

- Genotoxicity �
- Direct contact in vitro hemolysis �
- Cytotoxicity .
- Muscle implantation .
- Acute intracutaneous reactivity .
- ISO Sensitization .
- Acute systemic toxicity .
- Pyrogenicity .
- LAL endotoxins .
- Subchronic systemic toxicity .

The results of these tests provided evidence that the Biodesign Onlay Dural Graft meets biocompatibility requirements of the ISO standard.

#### Animal Study

An animal study using finished devices in a rat model where the device was implanted using an onlay technique showed that the device performed adequately with no physiological, histological or functional evidence of adverse health effects were observed.

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・

| Device | Biodesign® Onlay<br>Dural Graft | DuraGen II Dural<br>Regeneration Matrix | Durasis Dural<br>Substitute |
|------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech<br>Incorporated | Integra LifeSciences | Cook Biotech<br>Incorporated |
| 510(k)<br>Number | K131015 | K043427 | K031850 |
| Indications for<br>Use | Intended for use as a<br>dura substitutefor<br>repair of dura mater. | DuraGen II Dural<br>Regeneration Matrix is<br>indicated as a dura<br>substitute for the repair<br>of dura mater.† | Intended for use as a dura<br>substitute for repairing<br>dura mater. |
| Material | Porcine small intestinal<br>submucosa<br>Primarily Types I, III,<br>IV and VI collagen | Bovine tendon collagen | Porcine small intestinal<br>submucosa<br>Primarily Types I, III, IV<br>and VI collagen. |
| Dimensions | 1 x 2 cm, 1 x 3 cm, 2 x<br>3 cm, 2.5 x 2.5 cm, 2.5<br>x 7.5 cm, 4 x 7 cm, 5 x<br>5 cm, 7.5 x 7.5 cm, 7 x<br>10 cm | 1 x 1 in to 5 x 7 in<br>(2.5 x 2.5 cm to 12.7 x<br>17.8 cm) | 2 x 2 cm to 10 x 20 cm |
| Thickness | 154 µm to 680 µm | 3.0 mm§ | 100 µm to 800 µm |

Table of Substantial Equivalence

† Cleared for use as an onlay.

\$ Zerris VA, James KS, et al. Repair of dura mater with processed collagen devices. J. Biomedical Materials research Part B: Applied Biomaterials. 2007; 83:580-588.

、

#### CONCLUSION:

The Biodesign® Onlay Dural Graft is substantially equivalent to its predicate devices in terms of physical characteristics and safety and effectiveness. .

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

October 8, 2013

Cook Biotech Incorporated % Mr. Perry W. Guinn Vice President, Quality Assurance & Regulatory Affairs 1425 Innovation Place West Lafayette, IN 47906-1000

Re: K131015

> Trade/Device Name: Biodesign™ Onlay Dural Graft Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: September 5, 2013 Received: September 6. 2013

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 (sec above) into cither class 11 (Special Controls) or class 111 (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 of medical

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Page 2 - Mr. Perry W. Guinn

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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.

Sincerely yours,

# Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K131015

Device Name: Biodesign® Onlay Dural Graft

Indications For Use:

The Biodesign Onlay Dural Graft is intended for use as a dura substitute for repair of dura mater. The device is provided sterile and is intended for one-time use.

> 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 IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

## Joyce M. Whang -S