The Ventrio™ Light Hernia Patch is indicated for use in the reconstruction of soft tissue in procedures involving soft tissue repair where weakness exists, such as for the repair of hernias. The TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device.

Device Description

The proposed Ventrio Light Hernia Patch with TRM Antimicrobial Coating is a selfexpanding, nonabsorbable, sterile prosthesis. It contains two primary layers of monofilament polypropylene mesh to form a positioning pocket. This pocket is stitched with a polytetrafluroethylene (PTFE) monofilament thread to an expanded polyfluoroethylene (ePTFE) sheet. The two primary layers of polypropylene mesh are constructed of a lighter weight, "larger-pore" (as defined below), knitted polypropylene monofilament approximately 0.0043" in diameter. The polypropylene mesh used in the proposed device weighs approximately 51% less per unit area than the polypropylene mesh used in the posterior layer of the predicate Ventrio Hernia Patch (0.024 g/in' versus 0.049 g/in2). The pore size of the mesh used in the proposed product is 0.082 in2 as compared to 0.019 in for the mesh used in the posterior layer of the predicate Ventrio Hernia Patch. The device contains SorbaFlex™ Memory Technology, which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, The SorbaFlex Memory Technology is comprised of an extruded and fixation. polydioxanone (PDO) monofilament that is contained within a knitted polypropylene mesh sleeve. The PDO monofilament is dyed violet with D&C Violet No. 2 and fully degrades in vivo by means of hydrolysis with absorption essentially complete in 6-8 months.

The proposed Ventrio Light Hernia Patch surfaces are coated with TRM Antimicrobial Coating, which is comprised of a bioresorbable L-tyrosine succinate polymer (T) and antimicrobial agents rifampin (R) and minocycline (M). The coating is shaded orange in color due to the color of the antimicrobial agents. The TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device during the initial healing process for up to 7 days following surgery. The bioresorbable L-Tyrosine succinate polymer is essentially absorbed in 6 - 8 months based on in vitro studies.

The fascial side of the Ventrio Light Hernia Patch (polypropylene) allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue in-growth into the device. The visceral side of the device (ePTFE) has a submicronic porosity to minimize tissue attachment to the device.

AI/ML Overview

Acceptance Criteria and Device Performance for Ventrio™ Light Hernia Patch with TRM Antimicrobial Coating (K113229)

This submission (K113229) outlines the substantial equivalence of the Ventrio™ Light Hernia Patch with TRM Antimicrobial Coating to its predicate devices. The "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate devices, particularly regarding its modified characteristics and the addition of an antimicrobial coating. The study performed aims to support this substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present acceptance criteria in a quantitative table format with corresponding performance results. Instead, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices across various attributes, particularly that differences do not adversely affect safety and effectiveness. The "reported device performance" is a summary of the outcomes of the various tests conducted to support this claim.

Acceptance Criterion (Implied)	Reported Device Performance
Biocompatibility	Device is biocompatible per ISO 10993 series standards.
Physical and Functional Characteristics (compared to Ventrio Hernia Patch predicate)	Laboratory bench testing demonstrated that differences stemming from: - Lighter weight, larger pore polypropylene mesh (primary layers) - Polypropylene mesh sleeve for PDO monofilament - Reduced number of sizes (5 vs 9) do not adversely affect safety and effectiveness.
Peritoneal Tissue Attachment (in vivo)	Evaluated in porcine study. (Specific outcomes not detailed, but implied to be acceptable for substantial equivalence).
Mesh Contracture (in vivo)	Evaluated in porcine study. (Specific outcomes not detailed, but implied to be acceptable for substantial equivalence).
Mechanical Tissue In-growth (in vivo)	Evaluated in porcine study. (Specific outcomes not detailed, but implied to be acceptable for substantial equivalence).
Host Inflammatory Response (in vivo)	Evaluated in porcine study. (Specific outcomes not detailed, but implied to be acceptable for substantial equivalence).
Antimicrobial Efficacy (TRM coating)	Speed to Kill: Tested analytically and in vitro. Kinetic Drug Release (KDR): Tested analytically and in vitro. Drug Content and Impurity: Tested analytically and in vitro. Microbial Colonization/Abscess Formation: Two in vivo dorsal rabbit infection model studies performed, showing the coating reduces or inhibits microbial colonization and macroscopic abscess formation.
Polymer Degradation (TRM coating)	Tested analytically and in vitro.
Interaction with Device Components (ePTFE, PDO)	Testing showed no interaction with ePTFE and PDO, and no adverse effect on the release profile of rifampin and minocycline.

Note: The document focuses on demonstrating that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use, and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The specific quantitative acceptance limits for each test are not provided in this summary.

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

Laboratory Bench Testing: Not specified.
In vivo Porcine Study: The sample size is not explicitly stated in the summary.
In vivo Dorsal Rabbit Infection Model Studies: "Two in vivo dorsal rabbit infection model studies" were performed. The number of animals per study is not specified.
Analytical and in vitro testing (speed to kill, KDR, drug content/impurity, polymer degradation): Not specified.

Data Provenance:

The studies mentioned (porcine, rabbit) are "in vivo" studies, implying prospective animal studies designed specifically for this submission.
The country of origin for the data is not specified, but given the US FDA submission context, it is presumed to be conducted either in the US or in facilities compliant with relevant US regulations for animal studies.

3. Number of Experts and Qualifications for Ground Truth

The provided document describes non-clinical performance testing (bench, animal, in vitro) for substantial equivalence. It does not involve human clinical data, diagnostic interpretation, or visual assessment by experts defining ground truth in the way an AI/ML device study would. Therefore, this section is not applicable to this 510(k) summary. No radiologists, pathologists, or similar experts were used to establish ground truth in this context.

4. Adjudication Method

As this is a non-clinical device submission not involving human interpretation or diagnosis, an adjudication method for a test set is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted. This device is a surgical mesh, not a diagnostic imaging or AI-assisted interpretation device. Therefore, a study to measure human reader improvement with or without AI assistance is not applicable.

6. Standalone Performance Study

The primary studies conducted (laboratory bench testing, in vivo animal studies, analytical and in vitro testing) assessed the standalone performance of the device's physical properties, biological interactions, and antimicrobial efficacy. These are not "algorithm only without human-in-the-loop performance" in the context of AI, but rather directly evaluate the device's functional characteristics.

7. Type of Ground Truth Used

The "ground truth" for the various tests was established through:

Direct physical measurements and engineering specifications: For bench testing of physical and functional characteristics.
Histopathological analysis and visual observation: For in vivo animal studies (peritoneal tissue attachment, mesh contracture, tissue in-growth, host inflammatory response, microbial colonization, abscess formation). This would involve trained veterinary pathologists or researchers.
Chemical and microbiological assays: For analytical and in vitro testing of antimicrobial efficacy (speed to kill, KDR, drug content, impurity) and polymer degradation.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for AI/ML models. This submission is for a physical medical device (surgical mesh), not an AI/ML device. Therefore, a "training set" in this context is not applicable. The device's design, materials, and manufacturing processes are developed through traditional engineering and R&D, not machine learning training.

9. How Ground Truth for the Training Set Was Established

As there is no AI/ML training set, this question is not applicable.

Summary

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K 113229

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) Summary is provided per the requirements of section 807.92(c).

Submitter Information:

JUL 20 2012

Submitter's Name:	Stephanie Baker, BS, MBARegulatory Affairs Project Manager
Address:	Davol Inc., Subsidiary of C. R. Bard, Inc.
	100 Crossings Boulevard
	Warwick, RI 02886
Telephone:	(401) 825-8588
Fax:	(401) 825-8765
Device Name:
Trade Name:	VentrioTM Light Hernia Patch with TRMAntimicrobial Coating
Antimicrobial Coating
Common/Usual Name:	Surgical MeshPolymeric Surgical Mesh
Classification Name:	Mesh, Surgical, PolymericAntimicrobial Agent
Classification Code:	Class II, § 878.3300, Product Code FTL

Predicate Device Names:

Bard Ventrio Hernia Patch, K081777 (Davol Inc.), FDA cleared on September . 29,2008; K100229 – Special (Davol Inc.), FDA cleared on April 21,2010
Pivit AB Antimicrobial Mesh, K053656 (TyRx Pharma, Inc.), FDA cleared on ● July 14, 2006
Pivit AB-ST Antimicrobial Mesh, K093524 (TyRx Pharma, Inc), FDA cleared . on March 26,2010

PREMARKET NOTIFICATION FOR VENTRIO™ LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING

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Device Description:

Intended Use:

The Ventrio Light Hernia Patch is indicated for use in the reconstruction of soft tissue in procedures involving soft tissue repair where weakness exists, such as for the repair of hernias. The TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device.

PREMARKET NOTIFICATION FOR VENTRIO™ LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING

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K113229

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Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:

The proposed Ventrio Light Hernia Patch with TRM Antimicrobial Coating is similar in intended use and in technological characteristics and performance when compared to the predicate devices Ventrio Hernia Patch, Pivit AB and Pivit AB-ST. All devices are intended for use in the reconstruction and repair of soft tissue deficiencies where weakness exists such as hernia repair. In addition, all devices are similar in technological characteristics with regard to materials, design, sterilization, packaging and labeling, Where minor technological differences exist between the proposed device and the predicate devices, performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.

The proposed device, Ventrio Light Hernia Patch with TRM Antimicrobial Coating and the predicate devices Ventrio Hernia Patch, Pivit AB and Pivit AB-ST are all composed of knitted polypropylene monofilament mesh. Both the proposed device and the predicate device, Ventrio Hernia Patch, contain two primary layers of monofilament polypropylene mesh to form a positioning pocket stitched with PTFE monofilament to an ePTFE sheet. The proposed device has the same mesh configuration as the predicate, Ventrio Hernia Patch, except for four modifications, three of which are considered minor modifications.

The first minor modification involves the polypropylene monofilament mesh layer of the device. The proposed device is constructed of two primary layers of lighter weight, larger pore knitted polypropylene monofilament while the predicate Ventrio Hernia Patch contains only one layer of lighter weight, larger pore knitted polypropylene monofilament.

The second minor modification involves the polypropylene mesh surrounding the PDO monofilament recoil ring. In both the proposed and predicate devices, the PDO monofilament recoil ring is contained within polypropylene mesh. However, in the predicate device (small circle, large circle, small oval, medium oval and large oval sizes only) the PDO monofilament is contained by two layers of knitted mesh stitched with PTFE monofilament thread while in the proposed device the PDO monofilament is contained within a knitted polypropylene mesh sleeve is also used to contain the PDO monofilament in the extra large sizes of the predicate device.

The last minor modification involves the sizes of the devices. The predicate Ventrio Hernia Patch is marketed in 9 sizes, while the proposed device will be marketed in 5 sizes only (small circle, large circle, small oval, medium oval and large oval). In addition to the three minor modifications described above, one other modification includes the addition of the TRM antimicrobial coating containing the antimicrobial agents rifampin and minocycline to the proposed device as discussed below. Both the proposed device and the

PREMARKET NOTIFICATION FOR VENTRIO™ LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING

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predicate Ventrio Hernia Patch are packaged in the same materials. Tyyek and foil, and undergo ethylene oxide (EtO) sterilization.

The proposed and predicate devices Pivit AB and Pivit AB-ST are composed of knitted polypropylene mesh. The predicate devices Pivit AB and Pivit AB-ST are composed a single layer of knitted polypropylene mesh while the proposed device contains two primary layers of knitted polypropylene mesh stitched to an ePTFE sheet with PTFE monofilament thread. In addition, the proposed device contains an absorbable PDO recoil ring while the predicate devices Pivit AB and Pivit AB-ST do not contain any recoil mechanism. Both the proposed and predicate devices are coated with a bioresorbable Ltyrosine succinate polymer coating containing the antimicrobial agents rifampin and minocycline. The proposed device has the antimicrobial agents rifampin and minocycline (minocycline hydrochloride) in equal concentrations of approximately 115 ug/cm² while the predicate devices Pivit AB and Pivit AB-ST have the antimicrobial agents in equal concentrations of 86.11 ug/cm². Both the proposed device and the predicate devices Pivit AB and Pivit AB-ST are packaged in the same materials. Tyvek and foil. The predicate devices Pivit AB and Pivit AB-ST are gamma sterilized while the proposed device is sterilized with EtQ.

Performance Data:

Biocompatibility testing in accordance to the ISO 10993 series was conducted on the proposed finished device and the results indicate that the device is biocompatible per these standards.

Laboratory bench testing was performed to compare both physical and functional characteristics of the proposed device to those of the predicate device Ventrio Hernia Patch. In addition, an in vivo porcine study was performed to evaluate peritoneal tissue attachment, mesh contracture, mechanical tissue in-growth, and host inflammatory response associated with the proposed device at 4 weeks post-implantation. Two in vivo dorsal rabbit infection model studies were also performed to determine the amount of microbial colonization and macroscopic abscess formation associated with the proposed device after implantation and direct inoculation with bacteria. Analytical and in vitro testing was also performed on the proposed and predicate devices and include speed to kill, kinetic drug release (KDR), drug content and impurity, and polymer degradation testing.

Conclusion:

Results of the testing performed in support of this submission demonstrate that the Ventrio Light Hernia Patch with TRM Antimicrobial Coating is substantially equivalent to currently marketed predicate devices, Ventrio Hernia Patch, Pivit AB and Pivit AB-ST and is safe and effective for its intended use. In addition, the results of the testing show

PREMARKET NOTIFICATION FOR VENTRIO™ LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING

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that the components in the proposed device, specifically ePTFE and PDO, have no interaction with the TRM antimicrobial coating and do not affect the release profile of the antimicrobial agents rifampin and minocycline.

PREMARKET NOTIFICATION FOR VENTRIO™ LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract emblem that resembles an eagle or bird-like figure with stylized wings.

Public Health Service

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

C.R. BARD, Incorporated % Ms. Stephanie Baker, BS, MBA Regulatory Affairs Project Manager 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K113229

Trade/Device Name: Ventrio™ Light Hernia Patch with TRM Antimicrobial Coating Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: July 18, 2012 Received: July 19, 2012

Dear Ms. Baker:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

JUL 20 2012

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Page 2 - Ms. Stephanie Baker, BS, MBA .

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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K 113229

INDICATION FOR USE STATEMENT

To be determined 510(k) Number (if known):

Device Name:

Ventrio™ Light Hernia Patch with TRM Antimicrobial Coating

The Ventrio™ Light Hernia Patch is indicated for use in the reconstruction of soft tissue in procedures involving soft tissue repair where weakness exists, such as for the repair of hernias. TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device.

Imgur

(Division Sign ):T) Division of Sugical, Orthopedic, and Restorative Devices

510(k) Number: K113225

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.