The SURGISIS® Biodesign Tissue Graft is intended to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.

The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.

This device is intended for one-time use.

Device Description

The SURGISIS® Biodesign Tissue Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a range of sizes. The device is packaged in a dried state, and is supplied sterile in a sealed double pouch system.

AI/ML Overview

This 510(k) summary describes a medical device, the SURGISIS® Biodesign Tissue Graft, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the way a diagnostic AI/ML device submission would. This submission is for a material (surgical mesh), not a software algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established, standalone performance) are not applicable to this type of device submission.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (SURGISIS® Biodesign Tissue Graft K062697 and Veritas® Collagen Matrix K062915) in terms of intended use, materials, and technological characteristics.	The SURGISIS® Biodesign Tissue Graft is acting as its own predicate for K062697, and is substantially equivalent to Veritas® Collagen Matrix (K062915). It has the same technological characteristics and intended use, with the exception of the additional intended use for minimizing tissue attachment to viscera. Substantial equivalence was shown through bench and biocompatibility testing submitted in previous cleared 510(k)s.
Minimize tissue attachment to viscera.	"All studies concluded that SURGISIS® Biodesign Tissue Graft demonstrates minimal tissue attachment to the viscera when compared to a named predicate."

Acceptance Criteria (Implied)

Reported Device Performance

Substantial equivalence to predicate device (SURGISIS® Biodesign Tissue Graft K062697 and Veritas® Collagen Matrix K062915) in terms of intended use, materials, and technological characteristics.

The SURGISIS® Biodesign Tissue Graft is acting as its own predicate for K062697, and is substantially equivalent to Veritas® Collagen Matrix (K062915). It has the same technological characteristics and intended use, with the exception of the additional intended use for minimizing tissue attachment to viscera. Substantial equivalence was shown through bench and biocompatibility testing submitted in previous cleared 510(k)s.

Minimize tissue attachment to viscera.

"All studies concluded that SURGISIS® Biodesign Tissue Graft demonstrates minimal tissue attachment to the viscera when compared to a named predicate."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The document refers to "a number of animal studies."
Data Provenance: "animal studies from published and unpublished literature." The country of origin is not specified but Cook Biotech Incorporated is based in West Lafayette, IN, USA. The studies would be considered prospective for the specific claims they aimed to prove.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The studies are animal studies, so the "ground truth" would likely be based on pathological and gross examination findings by veterinarians or researchers, rather than expert human interpretation of images or signals.

4. Adjudication method for the test set

Not applicable as this is not an AI/ML diagnostic study. The "ground truth" would be determined by direct observation and scientific assessment in animal studies.

5. 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

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" was established through direct observation and measurement in animal studies, focusing on outcomes like tissue attachment to viscera.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of medical device submission.

9. How the ground truth for the training set was established

Not applicable.

Summary

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510(k) Premarket Notification: SURGISIS® Biodesign Tissue Graft

K073391

Page 1 of 2

9 510(K) SUMMARY

Submitted by:

MAR 2 1 2008

Perry W. Guinn VP Regulatory Affairs and Quality Assurance Cook Biotech Incorporated 1425 Innovation Place West Lafavette. IN 47906 (765) 497-3355 November 30, 2007

Device:

Trade Names:

Common/Usual Name: Proposed Classification Name: SURGISIS® Biodesign Tissue Graft, SIS Hernia Repair Device Surgical Mesh Surgical Mesh 21 CFR §878.3300 (79FTM) Class II

Intended Use:

The SURGISIS® Biodesign Tissue 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.

The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.

The device is intended for one-time use.

Predicate Devices:

The SURGISTS® Biodesign Tissue Graft is substantially equivalent to itself (D.C. #K062697) acting as its own predicate and is substantially equivalent to Veritas® Collagen Matrix (D.C. #K062915) manufactured by Synovis Surgical Innovations.

Device Description:

Substantial Equivalence:

The SURGISIS® Biodesign Tissue Graft is similar with respect to intended use, rnaterials and technological characteristics to its predicate devices in terms of section 510(k) substantial equivalence, as shown through bench and biocompatibility testing submitted in previous cleared 510(k)s.

Company Confidential

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Page ② of ②

Indication Testing:

A number of animal studies from published and unpublished literature were conducted specific to the subject of this submission. All studies concluded that SURGISIS® Biodesign Tissue Graft demonstrates minimal tissue attachment to the viscera when compared to a named predicate.

Conclusions Drawn from Tests:

The SURGISIS® Biodesign Tissue Graft is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the additional intended use, which is the subject of this submission.

Company Confidential

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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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2008

Cook Biotech, Inc. % Mr. Perry W. Guinn VP, Quality Assurance & Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906-1000

Re: K073391

Trade/Device Name: SURGISIS® Biodesign Tessue Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 26, 2008 Received: February 27, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Perry W. Guinn

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 begin 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Millman

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):

Device Name: SURGISIS® Biodesign Tissue Graft

Indications For Use:

The SURGISIS® Biodesign Tissue Graft is intended to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.

The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.

This device 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 CDRH, Office of Device Evaluation (ODE)

Page 1 of

Mark A. Melhus

Division of General, Restorative, and Neurological Devices

510(k) Number K07339/

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.