VENTRALIGHT ST MESH

K101851 · Davol Inc., Sub. C. R. Bard, Inc. · FTL · Jul 15, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101851
• Device Name: VENTRALIGHT ST MESH
• Applicant: Davol Inc., Sub. C. R. Bard, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jul 15, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ventralight ST Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Device Story

Ventralight ST Mesh is a sterile, single-use surgical mesh for soft tissue reconstruction and hernia repair. Device consists of a co-knitted polypropylene (PP) and polyglycolic acid (PGA) fiber layer, coated on the visceral side with a bioresorbable hydrogel (sodium hyaluronate, carboxymethylcellulose, and polyethylene glycol). The PP side facilitates fibroblastic tissue ingrowth; the bioresorbable coating minimizes visceral tissue attachment and is resorbed within 30 days. This 'low profile' version of the predicate Sepramesh IP Mesh uses lighter-weight PP monofilament and modified PGA layering to allow deployment through smaller trocars during laparoscopic procedures. Surgeons place the mesh to bridge or reinforce soft tissue defects; the device provides structural support while the coating prevents adhesions during the initial healing phase.

Clinical Evidence

No human clinical trials were conducted. Evidence consists of bench testing (pullout, burst, tear, suture retention, dry bond, and hydrogel disruption strength) and a 4-week post-implantation porcine study comparing the subject device to the predicate. The animal study evaluated tissue attachment, mesh contracture, tissue ingrowth, and inflammatory/fibrotic response. Results demonstrated the device meets specifications and performs equivalently to the predicate.

Technological Characteristics

Co-knitted polypropylene (PP) and polyglycolic acid (PGA) fibers. Visceral side coated with bioresorbable hydrogel (sodium hyaluronate, carboxymethylcellulose, polyethylene glycol). Low-profile design; lighter-weight PP monofilament compared to predicate. Sterile, single-use, implantable mesh.

Indications for Use

Indicated for the reconstruction of soft tissue deficiencies, including hernia repair, in patients requiring surgical mesh.

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

• Sepramesh IP Bioresorbable Coating/Permanent Mesh (K040868, K053066, K063739)

Submission Summary (Full Text)

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# 8. 510(k) Summary

#### 510(k) SUMMARY

# KIO1851

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

| 510(k) Number: | TBD | JUL 15 2010 | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|
| Owner Name: | Davol Inc., Subsidiary of C. R. Bard, Inc. | | |
| Address: | 100 Crossings Boulevard<br>Warwick, RI 02886 | | |
| Contact Person: | Michelle Godin<br>Sr. Regulatory Affairs Associate<br>Tel: [phone]<br>Fax: [phone]<br>Email address: [e-mail] | | |
| Alternate Contact: | Thomas Hutchinson<br>Vice President, Regulatory and Clinical Affairs<br>Tel: [phone]<br>Fax: [phone]<br>Email address: [e-mail] | | |
| Date Prepared: | June 30, 2010 | | |
| Device Trade Name: | Ventralight ST Mesh | | |
| Device Common Name: | Surgical Mesh | | |
| Class: | Class II, 21 CFR 878.3300, Product Code FTL | | |

#### Predicate Device(s):

- Sepramesh IP Bioresorbable Coating/Permanent Mesh (K040868, K053066, . K063739)
### Device Description:

The Ventralight ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to

> Special 510(k) Submission for the Bard Ventralight ST Mesh

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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, encouraging complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a 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.

#### Indication for Use:

The Ventralight ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

#### Comparison to Predicate Devices:

The Ventralight ST Mesh has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the Ventralight ST Mesh are the same as the predicate device including packaging, biocompatibility, sterilization, and labeling. The technological characteristics include a co-knitted PGA and polypropylene mesh layer to allow for tissue in-growth and a bioresorbable coating to minimize tissue attachment. The only difference between the predicate device and the proposed device is that the proposed device, Ventralight ST Mesh, is a low profile version of the predicate device. Sepramesh IP Mesh. By creating a low profile version of Sepramesh IP Mesh. minimum trocar sizes can be utilized for deployment of the mesh in laparoscopic ventral hernia repairs. To create a low profile version of Sepramesh IP Mesh, two minor modifications were required. The first modification is that the polypropylene mesh layer is now constructed of a lighter weight polypropylene monofilament which is identical in the polypropylene material composition and knit pattern and differs in diameter only by .001 in. The second modification is in the PGA layer. Additional PGA was added to fill in the interlayer spaces on the top layer to pull & the co-knitted PP/PGA mesh tighter to the top layer PGA fibers and the bioresorbable

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coating. The overall knitting process remains the same. Where minor technological differences exist between the proposed device and the predicate device, performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.

# Summary of Non-Clinical Testing:

Bench testing and animal studies were performed on the Ventralight ST Mesh to support substantial equivalence. Bench testing on the proposed device included PGA pullout strength testing, burst strength testing, tear strength testing, suture retention strength testing, dry bond strength testing, and hydrogel disruption testing after laparoscopic deployment. Predicate device testing included seal strength testing, package qualification testing, and biocompatibility testing as there were no packaging or material changes to the device. A 4 week post-implantation study in a porcine model was completed on the predicate device and proposed device to evaluate tissue attachment, mesh contracture, tissue in-growth, and host inflammatory and fibrotic response for both devices. Results of testing demonstrate that the Ventralight ST Mesh design meets product specifications and intended uses.

#### Statement of Equivalence:

The Ventralight ST Mesh has the same indications for use and technological characteristics as the predicate device. Based on this and the design and engineering data provided in the Premarket Notification, the proposed Ventralight ST Mesh has been shown to be substantially equivalent to the cleared Sepramesh IP Mesh.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Davol Inc., Subsidiary of C.R. Bard, Inc. % Ms. Michelle Godin Sr. Regulatory Affairs Associate 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K101851

Trade/Device Name: Ventralight ST Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 30, 2010 Received: July 1, 2010

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

JUL 1 5 2010

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Page 2 - Ms. Michelle Godin

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 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/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/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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

for
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

JUL 1 5 2010

- KIO 1851 510(k) Number (if known):

Device Name: Ventralight ST Mesh

The Ventralight ST Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Kinnebrew XKM

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(Division Sign Off)

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

510(k) Number K10/851

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