GORE SYNECOR Biomaterial

K152609 · W. L. Gore & Associates, Inc. · FTL · Dec 11, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K152609
• Device Name: GORE SYNECOR Biomaterial
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GORE SYNECOR Biomaterial device is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material.

Device Story

GORE SYNECOR Biomaterial is a composite surgical mesh for hernia and soft tissue wall repair. Device consists of three layers: a permanent PTFE knit mesh for structural strength; a non-porous bioabsorbable PGA:TMC film layer to minimize visceral adhesions; and a porous bioabsorbable PGA:TMC web layer to facilitate cellular infiltration and vascularization. Intended for single use by surgeons in clinical settings. The mesh provides reinforcement or bridging for tissue defects. Clinical benefit derived from combining permanent strength with bioabsorbable components to manage adhesion risk and support tissue integration.

Clinical Evidence

No clinical evaluations conducted. Evidence consists of bench testing and animal studies. Bench testing confirmed functional acceptance criteria for strength and shelf life. Animal study (rabbit model) compared subject device to predicate control, showing no statistical difference in fibrous tissue ingrowth and similar adhesion performance.

Technological Characteristics

Composite mesh comprising PTFE knit, non-porous PGA:TMC film, and porous PGA:TMC web. Permanent PTFE layer provides structural strength; bioabsorbable PGA:TMC layers manage adhesion and tissue integration. Single-use device.

Indications for Use

Indicated for patients requiring repair of hernias and abdominal or thoracic wall soft tissue deficiencies needing non-absorbable reinforcement or bridging material.

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

• ETHICON PHYSIOMESH Flexible Composite Mesh (K093932)
• GORE INFINIT Mesh (K081069)
• GORE BIO-A Tissue Reinforcement (K033671)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing the department's focus on people and health.

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

December 11, 2015

W.L. Gore & Associates Incorporated Ms. Barbara Smith Official Correspondent 301 Airport Road Elkton, Maryland 21921

Re: K152609

Trade/Device Name: GORE SYNECOR Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: September 11, 2015 Received: September 14, 2015

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 of medical device-related

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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" (21 CFR 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | |
| | Form Approved: OMB No. 0910-0120 |
| | Expiration Date: January 31, 2017 |
| | See PRA Statement below. |
| 510(k) Number (if known) | K152609 |
| Device Name | GORE SYNECOR Biomaterial |
| Indications for Use (Describe) | The GORE SYNECOR Biomaterial device is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material. |
| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

....

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# 510(k) Submitter

W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Regulatory contact: Barbara L. Smith Phone: [phone] Fax: [phone] E-mail: [e-mail]

# Date Prepared

September 9, 2015

## Device Names/Classification

Device Name: GORE® SYNECOR Biomaterial

Classification Name: Mesh, surgical, polymeric

Classification: 21CFR878.3300

Product Code: FTL

# Predicate Devices

.

- ETHICON PHYSIOMESH® Flexible Composite Mesh K093932 .
- K081069 GORE® INFINIT® Mesh .
- GORE® BIO-A® Tissue Reinforcement K033671 ●

# Device Description

GORE® SYNECOR Biomaterial is a composite mesh intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material. The device incorporates three distinct functional layers comprised of 1) a polytetrafluoroethylene (PTFE) knit mesh, laminated between 2) a non-porous synthetic bioabsorbable PGA:TMC film layer, and 3) a porous synthetic bioabsorbable PGA:TMC web layer. The permanent PTFE knit layer functions to provide strength when bridging a hernia or soft tissue defect. The non-porous bioabsorbable film layer is designed to limit cellular penetration which serves to minimize visceral adhesion formation to the material. The porous bioabsorbable web layer provides a scaffold for cellular infiltration and vascularization. The GORE® SYNECOR Biomaterial is for single use only.

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## Indications for Use

GORE® SYNECOR Biomaterial is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material.

## Differences in Technological Characteristics

The GORE® SYNECOR Biomaterial possesses a film layer not present in the Gore predicate devices. The primary difference between the subject GORE® SYNECOR Biomaterial device and predicate composite PHYSIOMESH is in the constituent materials.

## Summary of Performance Testing

#### Pre-Clinical

Bench study: Testing demonstrated the GORE® SYNECOR Biomaterial device met the intended functional acceptance criteria necessary for providing strength when bridging a hernia or soft tissue defect for up to the stated shelf life. Suture retention and burst strength testing was also performed to compare the GORE® SYNECOR Biomaterial to the predicate devices.

Animal study: The subject GORE® SYNECOR Biomaterial and predicate composite (control) device were studied in a rabbit model. The results demonstrated that the GORE® SYNECOR Biomaterial had no midsurface adhesions similar to the control (predicate) device. Furthermore, there was no statistical difference in the amount of fibrous tissue ingrowth for the GORE® SYNECOR Biomaterial relative to the predicate. Overall histopathology was as expected for the type and construction of both devices with organized tissue ingrowth and vascularity filling the macropores.

#### Clinical

No clinical evaluations of this product have been conducted.

#### Conclusion

Based on the information contained within this 510(k) premarket notification, W. L. Gore & Associates concludes that the subject GORE® SYNECOR Biomaterial device is substantially equivalent to the predicate devices in terms of indications for use, contraindications, construct, materials, biocompatibility, sterilization, and performance.