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.

AI/ML Overview

The provided document describes the K132850 submission for a Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, or Tutoplast® Bovine Pericardium DM. The submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with a specific study framework for entirely new performance standards.

Here's a breakdown based on the information provided, tailored to your request but highlighting the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission for substantial equivalence, "acceptance criteria" are typically defined by demonstrating performance comparable to legally marketed predicate devices, rather than predefined absolute thresholds for a novel device. The document uses predicate device performance as the benchmark for "substantial equivalence."

Test Category	Test	Acceptance Criteria (Implicit by Equivalence to Predicate)	Reported Device Performance	Conclusion (Device meets criteria)
Biocompatibility	Cytotoxicity - Inhibition of Cell Growth Assay	No leachable materials released in cytotoxic concentrations (comparable to predicate)	No leachable materials were released in cytotoxic concentrations from the device. The proposed device is non-cytotoxic.	Substantially equivalent
	Pyrogenicity (LAL Assay)	Endotoxin level < 2.15 EU per device (comparable to predicate, and for subsequent device lots)	The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is <2.15 EU per device.	Substantially equivalent
Mechanical Properties	Suture Pull out (N)	Max load comparable to the DuraMatrix predicate device.	The proposed device suture pull-out max load is comparable to the DuraMatrix predicate device.	Substantially equivalent
	Burst Strength (N)	Burst strength comparable to/not inferior to the DuraMatrix predicate device.	The proposed device burst strength is greater than the DuraMatrix predicate device.	Substantially equivalent
	Shrink temperature (°C)	Shrink temperature comparable to the Lyoplant predicate device.	The shrink temperature of the proposed device is comparable to the Lyoplant predicate device.	Substantially equivalent
	Max Load (N) (presumably ultimate tensile strength)	Maximum load at failure comparable to the DuraMatrix predicate device.	The maximum load at failure of the proposed device is comparable to the DuraMatrix predicate device.	Substantially equivalent
Functional Properties	Pre-clinical Implantation Study	Performed as well as a similar dura substitute, with comparable clinical and gross pathology, cerebrospinal fluid leakage, and local effects of implantation.	The proposed device performed as well as a similar dura substitute, demonstrating moderate resorption and marked integration at end time point.	Substantially equivalent
	Clinical Outcomes (Sabatino et. al., 2014)	Adequate performance with no evidence of adverse health effects, similar to autologous galea-pericranium.	Performed adequately with no evidence of adverse health effects.	Substantially equivalent
	Clinical Outcomes (Filipi et. al., 2000)	Easily sutured, formed a watertight seal, "excellent material implantation characteristics and favorable clinical outcome."	Easily sutured, formed a watertight seal, provided "excellent material implantation characteristics and favorable clinical outcome."	Substantially equivalent

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

In-vitro tests (Cytotoxicity, Suture Pull-out, Burst Strength, Shrink Temperature, Max Load, Pyrogenicity): The document does not specify the exact sample sizes (n-numbers) for these in vitro tests. This is common in 510(k) summaries where detailed raw data is often in the full submission, not the summary.
Pre-clinical Implantation Study (Animal Model): The sample size for the animal model is not specified. The data provenance is "animal model" (prospective, experimental).
Sabatino et al. (2014):
- Sample Size: Not explicitly stated how many patients received the proposed device, but it was a "prospective cohort study" comparing the proposed device (Tutopatch) to autologous galea-pericranium.
- Data Provenance: The study was published in "Clin. Neuro and Neurosurgery," indicating it was a clinical study. It appears to be prospective data, and the device was marketed as "Tutopatch" in the European market.
Filipi et al. (2000):
- Sample Size: 32 patients.
- Data Provenance: Retrospective evaluation of patients who received Tutoplast bovine pericardium dural grafts (the proposed device as marketed in ex-US countries). The study was published in "Neurosurg Rev."

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for diagnostic or AI-based devices where human interpretation is the "ground truth." For a dural graft product like this, the "ground truth" is established by:

Biomechanical properties: Objective measurements from standardized laboratory tests.
Biocompatibility: Established by standardized cytotoxicity and pyrogenicity assays.
Animal study: Assessment by veterinary pathologists/researchers.
Clinical studies: Assessment by neurosurgeons or clinicians involved in the patient follow-up, observing outcomes like CSF leakage, adverse events, surgical handling, etc. The studies cited (Sabatino et al., Filipi et al.) describe methodologies where clinical outcomes are observed and reported by medical professionals, implicitly establishing the "ground truth" for clinical performance. The number and specific qualifications of the adjudicating experts for these clinical studies are not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

As this is not a diagnostic device or imaging-based assessment where consensus reads are common:

In-vitro tests: No adjudication method as these are objective measurements.
Animal study: Adjudication is typically part of the pathology review process, but not explicitly described here.
Clinical studies (Sabatino et al., Filipi et al.): No formal "adjudication method" like 2+1 or 3+1 is typically used for overall clinical outcomes in these types of surgical device studies. Clinical outcomes are recorded by treating physicians or study investigators, and significant events might undergo review, but not in the sense of a consensus ground truth reading.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed for evaluating the impact of a diagnostic tool (often AI) on human reader performance for diagnostic tasks. This device is a surgical implant (dural graft). The clinical studies cited evaluate the performance of the graft itself, not its impact on human reader accuracy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. This device is a passive surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

Biomechanical properties: Objective measurements (e.g., N for force, °C for temperature).
Biocompatibility: Results of standardized biological assays (e.g., cell culture, LAL assay).
Animal study: Gross pathology, histopathology, and clinical observation data.
Clinical studies (Sabatino et al., Filipi et al.): Clinical outcomes data (e.g., absence of CSF leakage, adverse events, ease of use, material integration, resorption, overall clinical judgment by surgeons).

8. The Sample Size for the Training Set

This question is not applicable as this is not an AI/ML device that requires a training set. The data presented are for evaluating the performance of the physical dural graft.

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

This question is not applicable as there is no training set for an AI/ML device.

Summary

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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

. .

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: 386-418-8888 Fax: 386-418-1627

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:

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
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Characteristic	Proposed Device	Predicate Device,Dura-Guard(K950956 andK982282)	Predicate Device,DuraMatrix(K061487)	Predicate Device,Lyoplant(K970851)	Reference Device,Tutopatch(K991296,K081538, K091142)	Reference Device,Tutodent(K073097)	Reference Device,Tutoplastprocessed humanduramater(K910555)
Intended Use	Dura substitute	SAME	SAME	SAME	Surgical mesh	Barrier, AnimalSource, Intraoral	SAME
Material	Bovine pericardium	SAME	Bovine collagen	Collagen frombovine pericardium	SAME	SAME	Human dura
Design	Terminally sterilizedsheets in varioussizes	Asepticallyprocessed sheetsin various sizes	Resorbable,suturablemembrane	Absorbable,suturablemembrane	SAME	SAME	SAME
Function	Dura substitute	SAME	SAME	SAME	Scaffold for softtissue repair	Scaffold for softtissue repair	SAME
Processing	Proprietary tissuesterilization process	Apex processing	Proprietaryprocessing	Proprietaryprocessing	SAME	SAME	SAME
Chemicalcomposition							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 - Inhibitionof Cell Growth Assay	No leachable materials were released in cytotoxicconcentrations from the device. The proposed device isnon-cytotoxic.	Substantiallyequivalent
Suture Pull out (N)	The proposed device suture pull-out max load is comparableto the DuraMatrix predicate device.	Substantiallyequivalent
Burst Strength (N)	The proposed device burst strength is greater than theDuraMatrix predicate device.	Substantiallyequivalent
Shrink temperature (°C)	The shrink temperature of the proposed device iscomparable to the Lyoplant predicate device.	Substantiallyequivalent
Max Load (N)	The maximum load at failure of the proposed device iscomparable to the DuraMatrix predicate device.	Substantiallyequivalent

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 (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" (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 (800) 638 2041 or (301) 796-7100 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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Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).