Versatex Monofilament Mesh

K150091 · Sofradim Production · FTL · May 26, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150091
• Device Name: Versatex Monofilament Mesh
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Versatex™ Monofilament Mesh is intended for the repair of abdominal wail hemias or other fascial deficiencies that require the addition of a reinforcing material.

Device Story

Versatex™ Monofilament Mesh is a macroporous, 3D monofilament polyester textile used for soft tissue reinforcement in abdominal wall hernia repair. The device is a flat sheet mesh, available in various sizes, featuring a green-dyed (D&C Green No. 6) center marker to assist with orientation during surgical placement. It is intended for permanent implantation to reinforce fascial deficiencies. The device is used by surgeons in an operating room setting. It functions as a mechanical reinforcement scaffold to support tissue healing and prevent hernia recurrence. The device is provided sterile.

Clinical Evidence

Bench testing only. Performance characteristics assessed included mesh thickness, pore size, surface density, bursting strength, bursting distension, breaking strength, elongation at break, tear strength, and suture strength. Biocompatibility evaluated per ISO 10993-1 for permanent implants. Shelf-life and sterile barrier integrity were validated.

Technological Characteristics

Macroporous 3D monofilament polyester textile. Flat sheet design. Includes D&C Green No. 6 dye for orientation. Biocompatibility per ISO 10993-1. Sterilized for permanent implantation.

Indications for Use

Indicated for the repair of abdominal wall hernias or other fascial deficiencies requiring reinforcing material 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

• Mersilene™ Polyester Fiber Mesh (Preamendment device)
• Symbotex™ Composite Mesh (K142908)

Submission Summary (Full Text)

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

October 5, 2015

Sofradim Production % Ms. Mary Mellows Surgical solutions, a global business unit of Covidien 60 Middletown Avenue North Haven, Connecticut 06473

Re: K150091

Trade/Device Name: Versatex™ Monofilament Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: April 21, 2015 Received: April 22, 2015

Dear Ms. Mellows:

This letter corrects our substantially equivalent letter of May 26, 2015.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K150091

Device Name Versatex™ Monofilament Mesh

Indications for Use (Describe)

Versatex™ Monofilament Mesh is intended for the repair of abdominal wail hemias or other fascial deficiencies that require the addition of a reinforcing material.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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## 510(k) Summary

| Submitter Information | |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Sofradim Production (subsidiary of Covidien LLC) |
| Address | 116, avenue du Formans<br>01600 Trevoux,<br>France |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment Registration | 9615742 |
| Name of contact person | Mary Mellows<br>Senior Regulatory Specialist<br>Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared | January 15, 2015 |
| Name of device | |
| Trade or proprietary name | Versatex™ Monofilament Mesh |
| Common or usual name | Surgical Mesh |
| Classification name | Mesh, Surgical, Polymeric |
| Classification panel | General and Plastic Surgery (79) |
| Regulation | 21 CFR 878.3300 |
| Product Code | FTL |
| Legally marketed devices to<br>which equivalence is claimed | Mersilene™ Polyester Fiber Mesh - Preamendment device<br>Symbotex™ Composite Mesh – K142908 |
| Reason for 510(k) submission | To obtain market clearance of Versatex™ Monofilament Mesh. |
| Device description | Versatex™ Monofilament Mesh is made out of a macroporous three-<br>dimensional monofilament polyester textile. Largest sizes include a green<br>dyed monofilament polyester (D&C Green No. 6) marking that is<br>positioned in the center of the textile to help center and orient the mesh. |
| Intended use of the device | Versatex™ Monofilament Mesh is intended for soft tissue reinforcement<br>where weakness exists. |
| Indications for use | Versatex™ monofilament mesh is intended for the repair of abdominal wall<br>hernias or other fascial deficiencies that require the addition of a<br>reinforcing material. |

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comparing Summary devices

the The subject Versatex™ Monofilament Mesh is substantially equivalent to technological characteristics the predicate device Mersilene™ Polyester Fiber Mesh (Preamendment of the subject and predicate device) in terms of indications and design for the following technological characteristics:

- Polyester textile performance ।
- Design: flat sheet meshes with equivalent shapes and sizes.

The subject Versatex™ Monofilament Mesh is substantially equivalent to the predicate device Symbotex™ Composite Mesh (K142908) in terms of intended use and design for the following technological characteristics:

- -Same polyester materials and textiles
- -Design: flat sheet meshes with equivalent shapes and sizes.

Bench testing has been conducted in accordance with FDA's Guidance for Performance data the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the Versatex™ Monofilament Mesh. The following mesh subject characteristics were assessed: mesh thickness, pore size, surface density, bursting strength, bursting distension, breaking strength, elongation at break, tear strength, suture strength.

> The bench results demonstrate that the device is substantially equivalent to the primary predicate Mersilene™ Polyester Fiber Mesh (Preamendment device).

> Versatex™ Monofilament Mesh has the same intended use as the primary predicate Mersilene™ Polyester Fiber Mesh (Preamendment device).

> Versatex™ Monofilament Mesh is made out of materials that have been evaluated for biocompatibility in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-179).

> VersatexTM Monofilament Mesh shelf-life has been demonstrated by the stability results of the material and the ability of packaging to maintain the sterile barrier.

> In conclusion, all testing demonstrates that the subject VersatexTM Monofilament Mesh is substantially equivalent to the predicate devices.