The device is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The device is intended for reinforcement of soft tissues in plastic and reconstructive surgery.

The device is intended for single patient use only.

Device Description

The proposed device is an implantable surgical mesh comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and is stored hydrated and ready to use. The proposed device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with host tissue. The device in its unopened, undamaged package is sterile.

AI/ML Overview

This document is a 510(k) premarket notification for the Fortiva™ porcine dermis and Tutoplast® porcine dermis surgical meshes. The purpose of this submission is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (K123356). The document describes the device's indications for use, technological characteristics, and performance data supporting its substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a numerical or target-based format. Instead, it demonstrates equivalence to a predicate device through various tests. Equivalence is the de-facto acceptance criteria in this context for a 510(k) submission.

Characteristic / Test	Acceptance Criteria (Implied: Equivalence to Predicate K123356)	Reported Device Performance (Fortiva™ porcine dermis, Tutoplast® porcine dermis)
Intended Use	Equivalent to predicate (Surgical mesh scaffold to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes)	Proposed device is equivalent to predicate in intended use.
Material	Equivalent to predicate (Porcine Dermis)	Proposed device is equivalent to predicate in material.
Design	Equivalent to predicate (Terminally sterilized sheets in various sizes)	Proposed device is equivalent to predicate in design.
Function	Equivalent to predicate (Scaffold for soft tissue repair)	Proposed device is equivalent to predicate in function.
Processing	Equivalent to predicate (Proprietary tissue sterilization process)	Proposed device is equivalent to predicate in processing.
Chemical composition	Equivalent to predicate (Not applicable to these devices)	Proposed device is equivalent to predicate in chemical composition.
Energy Source	Equivalent to predicate (Not applicable to these devices)	Proposed device is equivalent to predicate in energy source.
In vitro Biomechanical Properties	Equivalent to predicate for: - Tensile maximum load - Burst strength - Suture pullout strength	Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices.
Viral Inactivation	Demonstrated ability of process to inactivate model viruses with a wide range of characteristics.	Results demonstrate the ability of the process to inactivate viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance).
Pyrogenicity	Device did not elicit a pyrogen response in rabbit test; Endotoxin level <20 EU per device.	The device did not elicit a response in the rabbit pyrogen test. All device lots will be tested to ensure the endotoxin level is <20 EU per device.
Biocompatibility Testing	Passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing.	The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing.
Implantation Study (Structural & Functional Properties)	Equivalent to predicate for: - Maximum tensile strength at graft-host interface - Burst strength - Clinical and gross pathology - Local effects of implantation	Structural and functional properties of the proposed and predicate devices were equivalent for the evaluated implantation study. Results were equivalent.

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

The document does not specify a distinct "test set" in the context of human subject data, as this is a 510(k) submission based on in-vitro and animal studies demonstrating substantial equivalence to a predicate, not a new clinical trial.

For biomechanical properties (in vitro): The sample size for each test (tensile maximum load, burst strength, suture pullout strength) is not explicitly stated.
For viral inactivation: The sample size involved testing "porcine dermis at the stage in the chemical processing applicable to the chemical being evaluated." Specific numbers are not given.
For pyrogenicity: The standard rabbit pyrogen test involves a specific number of rabbits (typically 3, with provisions for additional rabbits if initial results are equivocal). The document states "the rabbit pyrogen test," implying adherence to a standard protocol, but doesn't give the exact number of rabbits used.
For biocompatibility (ISO 10993-1 testing): This standard typically involves a battery of tests (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity), each with its own sample size, often using various cell lines or animal models. Specific sample sizes are not provided.
For the implantation study (animal study): The sample size (number of animals or implants) is not explicitly stated. The provenance is animal data.

Data Provenance: The data comes from in-vitro lab testing and animal studies ("animals studies demonstrate that the proposed device is biocompatible"). There is no mention of human retrospective or prospective data.

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

This information is not applicable. The studies performed are not clinical studies relying on expert interpretation of images or symptoms to establish ground truth.

Biomechanical tests: Ground truth is established by physical measurement according to validated test methods.
Viral inactivation: Ground truth is established by laboratory assays measuring viral reduction.
Pyrogenicity: Ground truth is established by physiological response (temperature change) in rabbits.
Biocompatibility: Ground truth is established by standardized biological assays and observation in animal models.
Implantation study: Ground truth is established by physical measurements (tensile strength, burst strength) and histological/pathological examination of animal tissues.

4. Adjudication method for the test set

This information is not applicable as there is no mention of human readers or subjective assessments requiring adjudication in the context of a "test set" for this type of submission.

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 a 510(k) submission for a surgical mesh, not an AI-powered diagnostic device. An MRMC study is not relevant to demonstrating substantial equivalence for this device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The ground truth used for the various studies includes:

Physical Measurements: For biomechanical properties (tensile strength, burst strength, suture pullout strength).
Laboratory Assays: For viral inactivation (measuring viral reduction) and endotoxin levels.
Physiological Response: For pyrogenicity (rabbit temperature response).
Pathological/Histological Examination: For the implantation study, assessing clinical and gross pathology, as well as local effects of implantation in animal models.
Validated Biocompatibility Tests: According to FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set." The studies performed are for device characterization and equivalence to a predicate.

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

October 27, 2014

RTI Surgical Incorporated Ms. Kristina Hall Manager, Regulatory Affairs Submissions 11621 Research Circle Alachua, Florida 32615

Re: K142070

Trade/Device Name: Fortiva™ porcine dermis, Tutoplast® porcine dermis Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXF Dated: July 29, 2014 Received: July 30, 2014

Dear Ms. Hall:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 Industry and Consumer Education 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.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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004 Indications for Use

510(k) Number (if known): K142070

Device Names:	Fortiva™ porcine dermis
	Tutoplast® porcine dermis

Indications for Use:

The device is intended for single patient use only.

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)

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Image /page/3/Picture/2 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, with a small green square on top of the "i". To the right of the blue square, the word "surgical" is written in gray. The logo is simple and modern, and the colors are bright and eye-catching.

005 510(k) Summary

Date: July 28, 2014

Submitted By: Kristina Hall Manager, Regulatory Affairs Submissions RTI Surgical, Inc. 11621 Research Circle Alachua, FL 32615 Tel: 386-418-8888 Fax: 386-418-1627

Trade Name:

Fortiva™ porcine dermis, Tutoplast® porcine dermis

Classification Name and Code:

Mesh, surgical (21 CFR 878.3300, product code FTM)

Substantial Equivalence:

The proposed device is substantially equivalent to the predicate device Fortiva™ porcine dermis and Tutoplast® porcine dermis (K123356) in intended use, material, design, function and processing.

Description:

Indications for Use:

The device is intended for single patient use only.

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Image /page/4/Picture/2 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in blue, with a small green square above the "i". To the right of "rti" is the word "surgical" in gray. A small trademark symbol is located in the upper right corner of the logo.

Summary of Technological Characteristics:

This device is comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and stored hydrated and ready to use. The device has the same technological characteristics as the predicate device in material, design, function, and processing as listed in the table below:

Characteristic	Proposed Device	Predicate Device(K123356)
Intended Use	Surgical mesh scaffold to reinforce soft tissue whereweakness exists and for the surgical repair ofdamaged or ruptured soft tissue membranes.
Material	Porcine Dermis
Design	Terminally sterilized sheets in various sizes
Function	Scaffold for soft tissue repair
Processing	Proprietary tissue sterilization process
Chemical composition	Not applicable to these devices
Energy Source	Not applicable to these devices

Performance Data Supporting Substantial Equivalence Determination:

The proposed device is equivalent to the predicate device in intended use, material, design, function, and processing. The biomechanical properties of the proposed and predicate devices were equivalent for the evaluated series of in vitro tests. Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices.

The ability of the manufacturing process to inactivate model viruses was evaluated using porcine dermis at the stage in the chemical processing applicable to the chemical being evaluated. The results demonstrate the ability of the process to inactivate viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance) when used to process porcine dermis for the proposed device.

Pyrogenicity of the device was evaluated using the rabbit pyrogen test on the final sterilized device. The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is <20 EU per device.

The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. The structural and functional properties of the proposed and predicate devices were equivalent for the evaluated implantation study. Maximum tensile strength at the graft-host interface, burst strength, clinical and gross pathology, and the local effects of implantation were assessed and results were equivalent for the proposed and predicate devices. Results from in vitro and animal studies demonstrate that the proposed device is biocompatible, and as safe and effective as the predicate for use as a scaffold to repair soft tissue deficiencies.

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.