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.

AI/ML Overview

Here's an analysis of the provided text regarding the Biodesign® Onlay Dural Graft, focusing on the acceptance criteria and supporting studies as requested:

Acceptance Criteria and Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a standalone clinical trial with pre-defined acceptance criteria. The acceptance criteria are implicitly tied to performing "similarly" to predicated devices and meeting established ISO standards for biocompatibility.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Bench Testing (Mechanical)	Performs similarly to predicate devices on: - 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." (No specific numerical values or comparative data are provided in the summary, only the qualitative statement of similarity.)
Biocompatibility Testing	Meets ISO 10993-1 standard for: - 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." (No specific numerical results are provided, only the qualitative statement of meeting the standard.)
Animal Study (Performance)	Adequate performance as an onlay implant with no adverse health effects (e.g., physiological, histological, functional).	"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." (Qualitative statement of adequate performance.)
Clinical Equivalence (Implicit)	Similar intended use, materials, and technological characteristics to predicate devices.	The Table of Substantial Equivalence (page 2) explicitly compares the device to Durasis Dural Substitute (K031850) and DuraGen II Dural Regeneration Matrix (K043427) across various parameters (Indications for Use, Material, Dimensions, Thickness), highlighting the similarities. The overall conclusion states: "The Biodesign® Onlay Dural Graft is substantially equivalent to its predicate devices in terms of physical characteristics and safety and effectiveness."

Study Details

Sample sizes used for the test set and the data provenance:
- Bench Testing: The document does not specify the sample size for each mechanical test (suture retention, ultimate tensile strength, burst strength).
- Biocompatibility Testing: The document does not specify the sample size for each biocompatibility test.
- Animal Study: The document indicates a "rat model" but does not specify the number of rats used.
- Clinical Studies (mentioned but not detailed): The text mentions "clinical studies using the device in cranial base dural repair" in the context of demonstrating equivalence, but no details of these studies (sample size, design, provenance) are provided in this summary. It's possible these refer to previously cleared clinical data for the predicate Durasis Dural Substitute, as it is from the same manufacturer and uses identical composition.
Data Provenance:
- Bench testing and biocompatibility testing were likely conducted in a lab setting by Cook Biotech Incorporated.
- The animal study was conducted using a rat model, likely at a research institution or contract research organization.
- The "clinical studies" mentioned are not detailed, so their provenance is unknown from this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This section is not applicable as the studies described (bench, biocompatibility, animal) do not involve human expert interpretation for ground truth establishment in the way, for example, a diagnostic imaging study would. The acceptance criteria are based on objective measurements (mechanical properties, biological responses) or established ISO standard adherence.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. The studies described are not of a nature that would require human adjudication of results to establish ground truth or compare interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. This submission is for a physical medical device (dural graft), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance are not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This is not an algorithmic or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: Ground truth is established by standardized mechanical testing protocols and measurement instruments.
- Biocompatibility Testing: Ground truth is established by adherence to ISO 10993-1 standard methods and predetermined acceptable ranges for various biological responses (e.g., cytotoxicity, hemolysis).
- Animal Study: Ground truth is established by physiological observation, histological examination, and functional assessment by trained animal researchers/veterinarians, evaluating for "adverse health effects."
The sample size for the training set:
- This is not applicable. This device is a physical implant, not an AI model or a diagnostic software, so there is no concept of a "training set" in the context of AI/machine learning. The device itself is "trained" through its manufacturing process and design, informed by historical data and scientific principles, but not in the algorithmic sense.
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.

Summary

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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: +1 (765) 497-3355 FAX: +1 (765) 807-7709

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:

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® OnlayDural Graft	DuraGen II DuralRegeneration Matrix	Durasis DuralSubstitute
Manufacturer	Cook BiotechIncorporated	Integra LifeSciences	Cook BiotechIncorporated
510(k)Number	K131015	K043427	K031850
Indications forUse	Intended for use as adura substituteforrepair of dura mater.	DuraGen II DuralRegeneration Matrix isindicated as a durasubstitute for the repairof dura mater.†	Intended for use as a durasubstitute for repairingdura mater.
Material	Porcine small intestinalsubmucosaPrimarily Types I, III,IV and VI collagen	Bovine tendon collagen	Porcine small intestinalsubmucosaPrimarily Types I, III, IVand VI collagen.
Dimensions	1 x 2 cm, 1 x 3 cm, 2 x3 cm, 2.5 x 2.5 cm, 2.5x 7.5 cm, 4 x 7 cm, 5 x5 cm, 7.5 x 7.5 cm, 7 x10 cm	1 x 1 in to 5 x 7 in(2.5 x 2.5 cm to 12.7 x17.8 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).