VENTRIO ST HERNIA PATCH

K101920 · C.R. Bard, Inc. · FTL · Mar 23, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K101920
• Device Name: VENTRIO ST HERNIA PATCH
• Applicant: C.R. Bard, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The proposed device, Ventrio ST Hernia Patch, is a sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias. The intended use for the proposed device. Ventrio ST Hernia Patch, is the same as the predicate devices. Ventrio Hernia Patch and Sepramesh IP Mesh.

Device Story

Ventrio ST Hernia Patch is a sterile, single-use, self-expanding, partially absorbable surgical prosthesis for soft tissue/hernia repair. Device consists of two layers stitched with PTFE monofilament: a top layer of knitted polypropylene mesh and a bottom layer of Sepramesh IP Mesh (co-knitted polypropylene and polyglycolic acid fibers). The visceral side features a bioresorbable hydrogel coating (sodium hyaluronate, carboxymethylcellulose, polyethylene glycol) to minimize tissue attachment; coating resorbs in <30 days. Sorbaflex Memory Technology, using an extruded polydioxanone (PDO) monofilament ring, provides stability for insertion and placement; PDO degrades via hydrolysis in 6-8 months. Used by surgeons in clinical settings. The fascial side promotes fibroblastic response and tissue ingrowth. Device facilitates surgical repair of soft tissue deficiencies.

Clinical Evidence

Bench testing and preclinical studies performed. Bench testing evaluated physical properties (weave, pore size, density, thickness, stiffness) and mechanical performance (burst strength, suture pullout, weld tensile strength, dry bond strength). Preclinical pig study evaluated peritoneal attachment, mesh contracture, tissue ingrowth, and inflammatory response. In vivo rat study evaluated degradation of coating, PGA fibers, and PDO monofilament. Biocompatibility testing conducted per ISO 10993. No human clinical trial data presented.

Technological Characteristics

Materials: Polypropylene, polyglycolic acid (PGA), polydioxanone (PDO), PTFE, sodium hyaluronate, carboxymethylcellulose, polyethylene glycol. Sensing/Actuation: Mechanical (Sorbaflex PDO ring for shape memory). Dimensions: Patch form factor. Connectivity: None. Sterilization: Sterile. Software: None.

Indications for Use

Indicated for reinforcement of soft tissue where weakness exists, including hernia repair. For prescription use only.

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

• Ventrio Hernia Patch (K100229, K081777)
• Sepramesh IP Mesh (K040868, K053066, K063739)

Submission Summary (Full Text)

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MAR 2 3 2011

# Section 8.0

# 510(k) Summary of Safety and Effectiveness

#### Submitter Information A.

| Submitter's Name: | Davol Inc. |
|-------------------|-------------------------------|
| Address: | Subsidiary of C.R. Bard, Inc. |
| | 100 Crossings Boulevard |
| | Warwick, RI 02886 |

| Telephone: | [phone] |
|----------------------|----------------|
| Fax: | [phone] |
| Contact Person: | Michelle Godin |
| Date of Preparation: | July 8, 2010 |

#### B. Device Name

Trade Name: Common/Usual Name: Classification Name:

Bard Ventrio ST Hernia Patch Surgical Mesh Surgical Mesh, Polymeric

#### ﺰ Predicate Device Name

Trade name:

Ventrio Hernia Patch (Davol Inc.) K100229, K081777

Trade name:

Sepramesh IP Mesh (Davol Inc.) K040868, K053066, K063739

#### Device Description D.

The proposed device, Ventrio ST Hernia Patch, is a self-expanding bioresorbable coated, partially absorbable, sterile prosthesis, containing 2 distinct layers stitched with PTFE monofilament, forming a positioning pocket. The top layer is knitted polypropylene mesh, 0.004" in monofilament diameter, and the bottom layer is Sepramesh IP Mesh. Sepramesh IP Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue ingrowth into the mesh. The visceral side of the mesh is a

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bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The device contains Sorbaflex Memory Technology, which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The Sorbaflex Memory Technology is comprised of an extruded polydioxanone (PDO) monofilament that is contained within a knitted polypropylene mesh tube. The extra large oval size patches contain two separate Sorbaflex PDO monofilaments. The Sorbaflex PDO monofilament fully degrades in vivo by means of hydrolysis. Absorption is essentially complete in 6-8 months.

#### E. Intended Use

The proposed device, Ventrio ST Hernia Patch, is a sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias. The intended use for the proposed device. Ventrio ST Hernia Patch, is the same as the predicate devices. Ventrio Hernia Patch and Sepramesh IP Mesh.

### F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The proposed device, Ventrio ST Hernia Patch, has the same design as the currently marketed Ventrio Hernia Patch (K100229) with the exception of the posterior polypropylene mesh laver and the single layer of expanded polytetrafluoroethylene (ePTFE). These two layers have been replaced by Sepramesh IP Mesh which is a coknitted polypropylene/PGA mesh with a bioresorbable coating. The anterior polypropylene slit mesh and PDO monofilament ring contained within a knitted tube mesh are the same as the predicate device, Ventrio Hernia Patch, as well as the interlocking stitch using polytetrafluoroethylene (PTFE) monofilament to sew the patch. The Sepramesh IP Mesh

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used in the proposed device is exactly the same as the currently marketed device, Sepramesh IP Mesh.

Laboratory bench testing was performed to verify that the proposed device's performance characteristics are similar to that of the predicate devices.

#### G. Performance Data

Bench testing was performed to assess the effects of the new characteristics of the proposed device, Ventrio ST Hernia Patch. The tests compared the proposed device against the predicate devices, Ventrio Hernia Patch and Sepramesh IP Mesh. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" (March 2, 1999), the tests included physical characteristics including mesh weave, mesh pore size, device density, device thickness, device stiffness as well as performance evaluations including burst strength, suture pullout strength, PDO ring weld tensile strength, PGA pullout strength, dry bond strength, mass/area measurements, and deployment/hydrogel disruption testing. In addition, two preclinical studies were performed. An overall performance study in pigs was performed to evaluate peritoneal tissue attachment, percent area coverage, mesh contracture, tissue ingrowth, and host inflammatory/fibrotic response. An in vivo degradation study was performed in rats to evaluate the host inflammatory/fibrotic response and absorption characteristics of the bioresorbable coating, PGA fibers, and the PDO monofilament during degradation of the material in vivo. The testing presented in this submission demonstrates that the proposed device, Ventrio ST Hernia Patch, is substantially equivalent to the predicate devices. The results of the testing can be found in Section 16.

Biocompatibility testing in accordance with the ISO 10993 standards was conducted. The results indicate that the device is biocompatible per these standards. Results are summarized in Section 15 and copies of the test reports are in Attachment 3.

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The results demonstrate that the proposed device is substantially equivalent to the currently marketed predicate devices and therefore, the proposed device, Ventrio ST Hernia Patch, is safe and effective for its intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

C.R. Bard, Inc. % Ms. Michelle Godin, MS, RAC Regulatory Affairs Project Manager 100 Crossings Boulevard Warwick, Rhode Island 02886

MAR 2 3 2011

Re: K101920

Trade/Device Name: Ventrio ST Henria Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 11, 2011 Received: March 14, 2011

Dear Ms. Godin:

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

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Page 2 - Ms. Michelle Godin, MS, RAC

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 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 Patt 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm:

Sincerely yours,

Mark N. Melkerson
Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

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

Device Name: Ventrio ST Hernia Patch

### Indications for Use:

The Ventrio ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias.

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)

Daniel Krone for MXM
(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101920