GORE BIO-A Tissue Reinforcement

K163217 · W. L. Gore & Associates, Inc. · OXF · Feb 10, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163217
• Device Name: GORE BIO-A Tissue Reinforcement
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: OXF · General, Plastic Surgery
• Decision Date: Feb 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include: -Hernia repair as suture line reinforcement -Muscle flap reinforcement -General tissue reconstructions

Device Story

GORE BIO-A Tissue Reinforcement is a porous, fibrous, bioabsorbable surgical mesh; composed of synthetic polyglycolide/trimethylene carbonate copolymer. Device functions as a scaffold for tissue ingrowth; fills soft tissue deficits during wound healing; elicits physiologic tissue response; gradually absorbs in vivo (complete by 6-7 months). Surgeon trims flat sheet to desired shape at time of use. Used in plastic and reconstructive surgery; provides soft tissue reinforcement. Benefits patient by facilitating native tissue replacement of the deficit.

Clinical Evidence

No clinical or bench testing performed for this notification. Evidence consists of an animal study comparing the synthetic PGA:TMC scaffold to a Cook SIS collagen-based scaffold, demonstrating equivalent performance and tissue response.

Technological Characteristics

Porous, fibrous flat sheet web structure. Material: synthetic bioabsorbable polyglycolide / trimethylene carbonate (PGA:TMC) copolymer. Sterilization: gamma irradiation (SAL 10^-6). Single-use. Dimensions: variable, trimmable by surgeon.

Indications for Use

Indicated for patients requiring soft tissue reinforcement in plastic and reconstructive surgery, including hernia repair (suture line reinforcement), muscle flap reinforcement, and general tissue reconstructions.

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

• Cook SIS Plastic Surgery Matrix (K034039)
• Gore Bioabsorbable Mesh (K033671)
• MESO Bilayer Surgical Mesh (K132025)

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

February 10, 2017

W.L. Gore & Associates, Inc. Ms. Barbara L. Smith, RAC Regulatory Affairs 1505 N. Fourth Street Flagstaff, AZ 86004

Re: K163217

Trade/Device Name: GORE BIO-A Tissue Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXF, OWT, OWZ, OXC Dated: November 15, 2016 Received: November 16, 2016

Dear Ms. Smith:

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 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

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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. Jennifer R. Stevenson -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) K163217

Device Name GORE® BIO-A® Tissue Reinforcement

Indications for Use (Describe)

GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery.

Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include: -Hernia repair as suture line reinforcement -Muscle flap reinforcement -General tissue reconstructions

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

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) Submitter

W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 USA Regulatory contact: Barbara L. Smith

## Date Prepared

November 15. 2016

## Device Names/Classification

| Device Name: | GORE® BIO-A® Tissue Reinforcement |
|----------------------|-----------------------------------|
| Classification Name: | Mesh, surgical, polymeric |
| Classification: | 21CFR878.3300 |
| Product Code: | OXF, OWT, OWZ, OXC |

## Predicate Devices

| x | K034039 | Cook SIS Plastic Surgery Matrix |
|---|---------|---------------------------------|
| x | K033671 | Gore Bioabsorbable Mesh |
| x | K132025 | MESO Bilayer Surgical Mesh |

#### Device Description

The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web structure that functions as a surgical mesh for soft tissue reinforcement while providing a scaffold for tissue ingrowth. It is used to reinforce soft tissue during the phases of wound healing by filling soft tissue deficits. It elicits a physiologic tissue response which fills the deficit with native tissue and gradually absorbs the device. The implanted GORE® BIO-A® Tissue Reinforcement is a porous, fibrous flat sheet web structure composed solely of synthetic bioabsorbable polyglycolide / trimethylene carbonate copolymer. In vivo studies indicate the bioabsorption process should be complete by six to seven months. The device is available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The device is sterilized by gamma irradiation validated to an SAL of 10-6. It is for single use only.

## Indications for Use

GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and

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reconstructive surgery. Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include: Hernia repair as suture line reinforcement, Muscle flap reinforcement, and General tissue reconstructions

#### Differences in Technological Characteristics

The information provided in this premarket notification supports that the difference in material between the subject and predicate mesh devices (synthetic polymer vs. porcine tissue) raises no new issues of safety or effectiveness when used for the expanded indication in patients requiring soft tissue reinforcement in plastic and reconstructive surgery.

#### Summary of Performance Testing

No bench or clinical testing was used to support this 510(k) premarket notification. The animal study presented in this submission demonstrated equivalent performance when comparing Gore's synthetic PGA:TMC scaffold to a Cook's SIS collagen-based scaffold structure. The two materials performed as intended in an equivalent manner and raised no new questions of safety or effectiveness.

## Conclusion

W. L. Gore & Associates concludes that the subject GORE® BIO-A® Tissue Reinforcement device is substantially equivalent to the predicate devices in terms of intended/indications for use, design, materials, function, biocompatibility, and sterilization.