BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM

K132850 · Rti Surgical, Inc. · GXQ · Mar 31, 2014 · Neurology

Device Facts

• Record ID: K132850
• Device Name: BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
• Applicant: Rti Surgical, Inc.
• Product Code: GXQ · Neurology
• Decision Date: Mar 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated as a dura substitute for the repair of dura mater.

Device Story

Device is a sterile, collagenous connective tissue graft derived from bovine pericardium. Processed via proprietary tissue preservation and gamma irradiation to maintain mechanical strength and elasticity of native tissue. Used as a dura substitute in neurosurgery; applied by surgeons to repair dura mater. Provides a scaffold for replacement by endogenous tissue; suturable; forms a watertight seal. Benefits include effective dural closure and integration into host tissue. Supplied as terminally sterilized sheets in various sizes.

Clinical Evidence

Evidence includes bench testing, animal implantation, and clinical literature. Bench tests: cytotoxicity (non-cytotoxic), suture pullout, burst strength, and shrink temperature showed equivalence to predicates. Animal study: demonstrated resorption and integration. Clinical evidence: prospective cohort study (Sabatino et al., 2014) compared autologous galea-pericranium vs. Tutopatch, showing adequate performance with no adverse effects. Retrospective evaluation (Filipi et al., 2000) of 32 patients using Tutoplast bovine pericardium confirmed ease of suturing, watertight seal, and favorable clinical outcomes.

Technological Characteristics

Non-crosslinked bovine pericardium; collagenous connective tissue with three-dimensional intertwined fibers. Terminally sterilized via gamma irradiation. Form factor: sheets of various sizes. Mechanical properties: retains native tissue elasticity and strength. Biocompatible; resorbable scaffold.

Indications for Use

Indicated for patients requiring repair of the dura mater during neurosurgical procedures.

Regulatory Classification

Identification

A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

Predicate Devices

• Dura-Guard (K950956 and K982282)
• Dura-Matrix (K061487)
• Lyoplant (K970851)

Reference Devices

• Tutopatch bovine pericardium (K991296, K073097, K081538 and K091142)
• Tutoplast Dura Mater (K910555)
• Tutodent (K073097)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a square with rounded corners, followed by the word "surgical" in a simple, sans-serif font. The letters "rti" are in a bold, blocky font, while the word "surgical" is in a lighter, more open font.

MAR 3 1 2014

K132860

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# 05 510(k) Summary

Date: March 315, 2014

Submitted By:

Esther Carbon Manager, Global Regulatory Labeling RTI Surgical, Inc. 11621 Research Circle Alachua, FL 32615 Tel: [phone] Fax: [phone]

## Trade Name:

Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, Tutoplast® Bovine Pericardium DM

## Classification Name and Code:

Dura substitute (21 CFR 882.5910, product code GXQ)

## Substantial Equivalence:

The proposed device is substantially equivalent to the predicate device Dura-Guard (K950956 and K982282) and Lyoplant (K970851) in intended use, material, design and function. The proposed device is substantially equivalent to the predicate device Dura-Matrix (K061487) in intended use, design and function. The proposed device is similar in design, function, materials and processing to reference devices Tutopatch™ bovine pericardium (K991296, K073097, K081538 and K091142) and similar to intended use, function, design and processing to reference device Tutoplast® Dura Mater (K910555).

## Device Description:

The proposed device is composed of bovine pericardium processed through a proprietary tissue preservation and sterilization process which includes gamma irradiation. The proposed device is composed of collagenous connective tissue with three-dimensional intertwined fibers and can be fixed regardless of the direction of the device. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue. The proposed device in its unopened, undamaged package is sterile.

## Indications for Use:

The device is indicated as a dura substitute for the repair of dura mater.

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# Summary of Technological Characteristics

Summary of Tachnological Characteristics:
The device is composed of non-crosslinked bovine pericardium that has ben material, design del production as listed in the blo
belo

| Characteristic | Proposed Device | Predicate Device,<br>Dura-Guard<br>(K950956 and<br>K982282) | Predicate Device,<br>DuraMatrix<br>(K061487) | Predicate Device,<br>Lyoplant<br>(K970851) | Reference Device,<br>Tutopatch<br>(K991296,<br>K081538, K091142) | Reference Device,<br>Tutodent<br>(K073097) | Reference Device,<br>Tutoplast<br>processed human<br>dura<br>mater(K910555) |
|-------------------------|-----------------------------------------------------|-------------------------------------------------------------|----------------------------------------------|--------------------------------------------|------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | Dura substitute | SAME | SAME | SAME | Surgical mesh | Barrier, Animal<br>Source, Intraoral | SAME |
| Material | Bovine pericardium | SAME | Bovine collagen | Collagen from<br>bovine pericardium | SAME | SAME | Human dura |
| Design | Terminally sterilized<br>sheets in various<br>sizes | Aseptically<br>processed sheets<br>in various sizes | Resorbable,<br>suturable<br>membrane | Absorbable,<br>suturable<br>membrane | SAME | SAME | SAME |
| Function | Dura substitute | SAME | SAME | SAME | Scaffold for soft<br>tissue repair | Scaffold for soft<br>tissue repair | SAME |
| Processing | Proprietary tissue<br>sterilization process | Apex processing | Proprietary<br>processing | Proprietary<br>processing | SAME | SAME | SAME |
| Chemical<br>composition | | | | | | | Not applicable to these devices |
| Energy Source | | | | | | | Not applicable to these devices |

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## Performance Data Supporting Substantial Equivalence Determination:

The proposed device is equivalent to the predicate devices 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 and implantation in an animal model. Burst strength, uniaxial strength and suture pullout strength were substantially equivalent for the proposed and predicate devices. The table below summarizes the testing used to determine substantial equivalence of the proposed device.

| Test | Results | Conclusions |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Cytotoxicity - Inhibition<br>of Cell Growth Assay | No leachable materials were released in cytotoxic<br>concentrations from the device. The proposed device is<br>non-cytotoxic. | Substantially<br>equivalent |
| Suture Pull out (N) | The proposed device suture pull-out max load is comparable<br>to the DuraMatrix predicate device. | Substantially<br>equivalent |
| Burst Strength (N) | The proposed device burst strength is greater than the<br>DuraMatrix predicate device. | Substantially<br>equivalent |
| Shrink temperature (°C) | The shrink temperature of the proposed device is<br>comparable to the Lyoplant predicate device. | Substantially<br>equivalent |
| Max Load (N) | The maximum load at failure of the proposed device is<br>comparable to the DuraMatrix predicate device. | Substantially<br>equivalent |

Pyrogenicity of the device was evaluated using the Limulus Amoebocyte Lysate (LAL) assay on the final sterilized device. The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is <2.15 EU per device.

The functional properties of the proposed and predicate device were evaluated in a pre-clinical implantation study and the proposed device performed as well as a similar dura substitute. Clinical and gross pathology, cerebrospinal fluid leakage and the local effects of implantation were assessed and results demonstrate the proposed and predicate devices are substantially equivalent. The proposed device was increasingly resorbed. At the end time point the proposed device demonstrated moderate resorption and marked integration.

Clinical evaluation of the proposed device confirms the clinical substantial equivalence to the predicate devices. Sabatino et. al. (2014)1 present the results of a prospective cohort study which compared the clinical outcomes from duraplasty using autologous galea-pericranium and Tutopatch (the proposed device as marketed in the European market). The study evaluated postoperative results (with a minimum follow-up of 12 months), ease of use and procedure costs. The proposed device performed adequately with no evidence of adverse health effects. Filipi et. al. (2000)² present a retrospective evaluation that summarized the outcomes for 32 patients who received Tutoplast bovine pericardium dural grafts (proposed device as marketed in ex-US countries) as part of a variety of neurosurgical procedures. The proposed device was easily sutured with standard suture material and formed a watertight seal. The proposed device provided "excellent material implantation characteristics and favorable clinical outcome" and is recommended as a safe and suitable material for duraplasty. Filipi et. al. concluded, "these results confirm the excellent suitability of Tutoplast bovine pericardium for dural substitution". Results from in vitro, animal studies and clinical evaluation demonstrate that the proposed device is substantially equivalent to the predicate devices for use as a dura substitute.

Sabatino et. al., Autologous dural substitutes: A prospective study, 116, Clin. Neuro and Neurosurgery 20-23 (2014)

^3, Filipi, R., et al., Bovine pericardium for duraplasty: clinical results in 32 patients. Neurosurg Rev, 2001. 2042-3): g 103-7.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## March 31, 2014

RTI Surgical, Inc. Ms. Esther Carbon Manager, Global Regulatory Labeling 11621 Research Cir. Alachua, FL 32615

Re: K132850

Trade/Device Name: Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, or Tutoplast® Bovine Pericardium DM Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: February 24, 2014 Received: February 26, 2014

Dear Ms. Esther 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 addional in the 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 that I Dri has made a acceministered by other Federal agencies. You must comply

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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 devicerelated 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 [phone] or [phone] 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" (21 CFR 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,

# Joyce M. Whang -S

for Carlos L. Peña, PhD, MS 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)

## K132850

Device Name

Bovine Pericardium Suturable Dural Graft Tutoplast® Bovine Pericardium DM Tutopatch™ DM Graft

#### Indications for Use (Describe)

The device is indicated as a dura substitute for the repair of dura mater.

Type of Use (Select one or both, as applicable)

区Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Joyce M. Whang -S

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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