Tutopatch bovine pericardium is intended for the reinforcement of tissue during general and plastic surgery repair. The labeling reveals that the applicant and all predicate devices have the same intended use as a general and plastic surgery surgical mesh.

Tutopatch bovine pericardium is intended for use to reinforce soft tissue where weakness exists in general and plastic surgery applications and is indicated for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, repair of rectal prolapse using an abdominal approach (excluding rectocele), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, ventral, scrotal, and umbilical).

Device Description

Tutopatch bovine pericardium is a Tutoplast® Processed, solvent-dehydrated gamma irradiated preserved bovine pericardium surgical mesh. Tutopatch bovine pericardium consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic formulative structure to support replacement by new endogenous tissue. Tutopatch bovine pericardium is supplied in sterile double-packaged peelable pouches and comes in a variety of sizes.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the Tutopatch bovine pericardium device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The FDA submission for Tutopatch bovine pericardium does not define specific quantitative acceptance criteria in the provided text. Instead, it states that the device was evaluated against general performance standards for safety, biocompatibility, and mechanical strength. The reported performance indicates that the device met these general expectations.

Acceptance Criteria (General)	Reported Device Performance
Safety	Tutopatch bovine pericardium has been evaluated for safety. In all instances, it functioned as intended, and all test results and characteristics observed were as expected. The Tutoplast® Process leaves no deleterious residue and minimizes antigenic potential. The device is terminally sterilized by gamma-irradiation. The manufacturer believes the Tutoplast® Process poses no additional questions of safety.
Biocompatibility	Tutopatch bovine pericardium has been evaluated for biocompatibility. In all instances, it functioned as intended, and all test results and characteristics observed were as expected. The processing ensures the tissue is reduced to its fiber and mineral components, and the process leaves no deleterious residue.
Toxicity	Tutopatch bovine pericardium has been evaluated for toxicity. In all instances, it functioned as intended, and all test results and characteristics observed were as expected.
Pyrogenicity	Tutopatch bovine pericardium has been evaluated for pyrogenicity. In all instances, it functioned as intended, and all test results and characteristics observed were as expected.
Sterility	Tutopatch bovine pericardium has been evaluated for sterility. The finished products are terminally sterilized by gamma-irradiation. In all instances, it functioned as intended, and all test results and characteristics observed were as expected.
Mechanical Strength / Structural Characteristics	Tutopatch bovine pericardium has been evaluated for mechanical strength. The device consists of collagenous connective tissue with three-dimensional intertwined fibers, providing multidirectional mechanical strength. It retains the mechanical strength and elasticity of the native tissue. The gamma-irradiated material exhibits excellent tensile strength, burst strength, and reapproximates well around suture holes, resisting leakage of fluids. It has a wall thickness similar to that of native pericardium and is flexible. In all instances, it functioned as intended.
Biomechanical Characteristics	Data collected demonstrate the device has the necessary biomechanical characteristics to function safely and effectively as a surgical mesh.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that the device was "evaluated by a number of tests."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The provided text does not mention the use of experts to establish ground truth for a test set, nor does it refer to any clinical studies involving expert assessment. The evaluation appears to be based on laboratory and material property testing.

4. Adjudication Method for the Test Set

As there's no indication of a test set requiring expert ground truth or human assessment, an adjudication method is not applicable/not mentioned in the provided documentation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in the provided documentation. The submission focuses on the material properties and processing of the surgical mesh rather than comparative clinical performance involving human readers or AI.

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

This is not applicable as the device is a physical surgical mesh, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the evaluation of the Tutopatch bovine pericardium appears to be based on established material science principles, biocompatibility standards, and mechanical testing protocols as they apply to surgical mesh materials. The tests performed include assessments for safety, biocompatibility, toxicity, pyrogenicity, sterility, and mechanical strength. This is not a clinical "ground truth" derived from patient outcomes or expert consensus on diagnostic imaging.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical surgical mesh and not an AI or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as the device is a physical surgical mesh and not an AI or machine learning model.

Summary

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ADVANCING SCIENCE, SAFETY & INNOVATION

RTI BIOLOGICS"

Attachment 1:

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS In Accordance with the Safe Medical Device Act of 1990

Tutopatch™ bovine pericardium

1) Submitted by:

RTI Biologics, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4347 Fax: 386-418-1627

Contact person:

Travis Arola, MS, RAC, CTBS Regulatory Affairs Manager Telephone: (386) 418-8888 Facsimile: (386) 418-1627 E-mail: tarola@rtix.com

1. Original Date Prepared: August 25, 2000 Date Updated: October 24, 2012
1. Name of Medical Device: Tutopatch™ bovine pericardium Proprietary Name: Classification Name: Mesh, Surgical

4) Device Classification:

The Center for Devices and Radiological Health has classified bovine pericardium used for general and plastic surgery indications (Mesh, Surgical, Polymeric) as a Class II device pursuant to 21 CFR §878.3300.

Device:	Mesh, Surgical
Medical Specialty:	General and Plastic Surgery
Product Code:	FTM
Class:	2
510(k) Exempt?	No
Regulation Number:	21 CFR §878.3300

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RTI|BIOLOGICS® K991296 page 2/3

ADVANCING SCIENCE, SAFETY & INNOVATION

5) Device Description:

6) Indication for Use:

7) Technological Characteristics and Substantial Equivalence

Tutopatch bovine pericardium is a Tutoplast® Processed, solvent dehydrated, gamma-irradiated preserved bovine pericardium surgical mesh. All tissues are recovered from cattle free of BSE. The processing of Tutopatch bovine pericardium consists of a strict, quality controlled procedure, which involves thorough cleaning, processing, dehydration and preservation. The process leaves no deleterious residue and minimizes antigenic potential.

The Tutoplast® Process begins with thorough screening of the raw tissue such as the bovine pericardium. Tissues meeting the screening criteria are then cleaned with saline solutions of various concentrations, resulting in the osmotic destruction of cells so that the source tissue is reduced to its fiber and mineral components.

After processing with inorganic agents such as hydrogen peroxide and 1N sodium hydroxide, the tissue is preserved by the extraction of water using organic solvents, e.g., acetone. The dense collagenous fiber structure of the tissue is retained during this method of preservation. Collagenous connective tissue with three dimensionally intertwined fibers retains the multidirectional and mechanical . strength of native tissue, while providing the basic formative structure to support replacement by new endogenous tissue.

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ADVANCING SCIENCE, SAFETY & INNOVATION

RTI BIOLOGICS" 191296

After preservation, the tissue is cut into standardized sizes and packaged in transparent, double peel pouches. The finished products are terminally sterilized by gamma-irradiation. The gamma-irradiated material exhibits excellent tensile strength, burst strength, reapproximates well around suture holes, resisting leakage of fluids. It has a wall thickness similar to that of native pericardium and is flexible, making it convenient to implant. RTI Biologics, Inc. believe that product subjected to the Tutoplast® Process posed no additional questions of safety and effectiveness.

8) Statement of Substantial Equivalence:

Tutopatch bovine pericardium is substantially equivalent in function and intended use to the following devices:

a) Peri-Guard® Pericardium 510(k) K983162

b) Supple Peri-Guard® Pericardium 510(k) K983162

c) Peri-Strips Staple Line Reinforcement - Sleeve Configuration 510(k) K983162

d) Peri-Strips® Staple Line Reinforcement - Strip Configuration 510(K) K98310 e) Peri-Strips DryTM Staple Line Reinforcement 510(k) K983162

9) Performance Data:

Tutopatch bovine pericardium has been evaluated by a number of tests for safety, biocompatibility, toxicity, pyrogenicity, sterility and mechanical strength. In all instances, Tutopatch bovine pericardium functioned as intended and all test results and characteristics observed were as expected. Summaries and reports of all data are contained in the Premarket Notification submission.

10) Conclusions:

The data collected demonstrate that the device has the necessary structural, biocompatibility, and biomechanical characteristics to function safely and effectively as a surgical mesh.

THIS SPACE IS LEFT BLANK INTENTIONALLY

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "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 body or wings.

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

Tutogen Medical U.S., Inc. % Mr. P.J. Pardo, MS, MT (ASCP) Director of Quality Assurance 13709 Progress Boulevard, Box 19 Alachua, Florida 32615

K991296 Re: Trade/Device Name: TUTOPATCH® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM. OXH, PAJ, DXZ Dated: August 25, 2000 Received: September 6, 2000

Dear Mr. Pardo:

This letter corrects our substantially equivalent letter of October 6, 2000.

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

July 1, 2013

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Page 2 - Mr. P.J. Pardo, MS, MT (ASCP)

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 (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 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/Safetv/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR Peter D. Rumm -S

Mark N. Melkerson Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2: Indications for Use

510(k) Number (if known): K991296

Tutopatch™ bovine pericardium Device Names:

Indications for Use:

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K991296

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.