FORTIVA PORCINE DERMIS

K123356 · Rti Biologics, Inc. · FTM · Mar 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123356
• Device Name: FORTIVA PORCINE DERMIS
• Applicant: Rti Biologics, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Mar 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 single patient use only.

Device Story

Implantable surgical mesh; non-crosslinked porcine dermis; scaffold for soft tissue repair; promotes neovascularization and host tissue replacement. Supplied hydrated, terminally sterilized, ready for use. Used by surgeons in clinical settings for hernia and body wall defect repair. Provides mechanical reinforcement to surgical site; facilitates integration with patient tissue. Benefits include structural support for damaged soft tissue membranes.

Clinical Evidence

Bench testing and animal studies. In vitro testing: tensile maximum load, burst strength, and suture pullout strength equivalent to predicate. Viral inactivation validation performed. Pyrogenicity evaluated via rabbit test (negative). Biocompatibility confirmed per ISO 10993-1 and FDA Blue Book G95-1. Implantation study assessed graft-host interface strength, burst strength, and pathology, confirming equivalence to predicate.

Technological Characteristics

Non-crosslinked porcine dermis; terminally sterilized; hydrated form factor. Scaffold design. No energy source. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of damaged/ruptured membranes, specifically for hernia repair or body wall defects requiring bridging/reinforcing material.

Regulatory Classification

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.

Predicate Devices

• Strattice® (K070560)

Submission Summary (Full Text)

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ADVANCING SCIENCE, SAFETY & INNOVATION

# 05 510(k) Summary

Date: March 04, 2013

Submitted By:

Esther Carbon RTI Biologics, Inc. 11621 Research Circle Alachua, FL 32615 Tel: [phone] Fax: [phone]

Trade Name:

Fortiva™ porcine dermis, Tutoplast porcine dermis

Common Name: Surgical mesh

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 Strattice® (K070560) in intended use, material, design, and function.

#### 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.

#### Indications for Use:

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 single patient use only.

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MAR 0 5 2013

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### 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 and function as listed in the table below:

| Characteristic | Proposed Device | Predicate Device |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Surgical mesh scaffold to<br>reinforce soft tissue where<br>weakness exists and for the<br>surgical repair of damaged or<br>ruptured soft tissue membranes. | Surgical mesh scaffold to<br>reinforce soft tissue where<br>weakness exists and for the<br>surgical repair of damaged or<br>ruptured soft tissue membranes. |
| Material | Porcine Dermis | Porcine Dermis |
| Design | Terminally sterilized sheets in<br>various sizes | Terminally sterilized sheets in<br>various sizes |
| Function | Scaffold for soft tissue repair | Scaffold for soft tissue repair |
| Chemical composition | Not applicable to these devices. | Not applicable to these devices. |
| Energy Source | Not applicable to these devices. | 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, and function. The biomechanical properties of the proposed and predicate devices were evaluated in a 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 also evaluated in an 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 demonstrate the proposed and predicate devices are substantially equivalent. 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.

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center- WO66-G609 Silver Spring, MD 209930002

Letter dated: March 5, 2013

RTI Biologics, Incorporated % Ms. Esther Carbon Regulatory Labeling Specialist 11621 Research Circle P.O. Box 2650 Alachua, Florida 32616-1627

Re: K123356

Trade/Device Name: Fortiva™ porcine dermis,Tutoplast® porcine dermis Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 01, 2013 Received: February 04, 2013

Dear Ms. Carbon:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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,

Mark N. Melkerson -S

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

Enclosure

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## Indications for Use Statement

### 510(k) Number (if known): K123356

Device Names: Fortiva™ porcine dermis
Tutoplast® porcine dermis

#### Indications for Use:

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 single patient use only.

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)

JiyoungDang-S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123356

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