(143 days)
K152609 GORE® SYNECOR Biomaterial
Not Found
No
The summary describes a physical biomaterial mesh for hernia repair and does not mention any computational or analytical functions, let alone AI/ML.
Yes
The device is a composite mesh intended for the repair of hernias and abdominal wall soft tissue deficiencies, which falls under the definition of a therapeutic device as it treats a medical condition.
No
The device is a composite mesh intended for the repair of hernias and abdominal wall soft tissue deficiencies, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a composite mesh made of physical materials (PTFE knit mesh and porous synthetic bioabsorbable web layers) intended for surgical implantation. It is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of hernias and abdominal wall soft tissue deficiencies. This is a surgical repair procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a composite mesh designed to be implanted in the body to provide structural support. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Performance Studies: The performance studies focus on the physical properties of the mesh (strength, biocompatibility, tissue response after implantation), which are relevant to an implantable surgical device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is clearly intended for surgical repair and implantation within the body.
N/A
Intended Use / Indications for Use
GORE® SYNECOR PREPERITONEAL Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
GORE® SYNECOR Preperitoneal Biomaterial is a composite mesh intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material. The device incorporates two distinct functional layers comprised of 1) a polytetrafluoroethylene (PTFE) knit mesh, laminated between 2) two porous synthetic bioabsorbable web layers. The permanent PTFE knit layer functions to provide strength when bridging a hernia or soft tissue defect. The porous bioabsorbable web layers provide a scaffold for tissue ingrowth and vascularization. The GORE® SYNECOR Preperitoneal Biomaterial is for single use only and is designed for preperitoneal placement and should be placed between tissue layers where ingrowth is desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hernias and abdominal wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-Clinical:
Bench study: Testing demonstrated the GORE® SYNECOR Preperitoneal 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. Performance data includes acceptable results for mesh thickness, density, suture retention, burst strength, and pore size relative to the predicate device. The three year shelf life is supported by the known stability of PTFE, and real time data correlated with accelerated aging data for the predicate surgical mesh device, GORE® BIO-A Tissue Reinforcement. This reference device is made of the same PGA/TMC copolymer and has similar physical and chemical properties as the bioresorbable component of GORE® SYNECOR Preperitoneal Biomaterial.
Biocompatibility: GORE has demonstrated that these materials are biocompatible in the manufacture of GORE® SYNECOR Preperitoneal Biomaterial device by conducting an extensive battery of standardized in vitro and in vivo tests according to ISO 10993 standards, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, rabbit pyrogen, genotoxicity, local effects after implantation and subchronic toxicity.
Animal study: The subject GORE® SYNECOR Preperitoneal Biomaterial was studied in a 30 day subcutaneous implant rabbit model while the predicate device, GORE® SYNECOR Biomaterial, was studied in an intraperitoneal implant rabbit model, under a separate protocol. Overall, the tissue response was similar for these constructs with the presence of organized, vascularized collagenous tissue ingrowth within the web and filling the macropores. Furthermore, the inflammatory response was as expected for a resorbable medical device in both cellular make-up and extent. Additionally, a 90 day rat subchronic toxicity study per ISO 10993 involving multiple device implants resulted in no noteworthy systemic toxicity. Finally, a 180 day subcutaneous implant study in rabbits compared the subject device against the Ethicon Physiomesh® device with an overall tissue response typical for these types of constructs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K152609 GORE® SYNECOR Biomaterial
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
W. L. Gore & Associates, Inc. Mr. Michael Titus Regulatory Associate 1505 N. Fourth Street Flagstaff, Arizona 86004
Re: K163576
Trade/Device Name: Gore Synecor Preperitoneal Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: April 12, 2017 Received: April 13, 2017
Dear Mr. Titus:
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 devicerelated 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.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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) K163576
Device Name GORE® SYNECOR PREPERITONEAL Biomaterial
Indications for Use (Describe)
GORE® SYNECOR PREPERITONEAL Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY [21 CFR 807.92]
510(k) Submitter
W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Regulatory contact: Michael J. Titus Phone: 410-506-8316 Fax: 410-506-8221 E-mail: mtitus@wlgore.com
Date Prepared
May 10, 2017
Device Names/Classification
Device Name: GORE® SYNECOR Preperitoneal Biomaterial
Common Name: Mesh, surgical, polymeric
Classification Name: Surgical Mesh
Classification: 21CFR 878.3300 Product
Code: FTL
Predicate Devices
K152609 GORE® SYNECOR Biomaterial
Device Description
GORE® SYNECOR Preperitoneal Biomaterial is a composite mesh intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material. The device incorporates two distinct functional layers comprised of 1) a polytetrafluoroethylene (PTFE) knit mesh, laminated between 2) two porous synthetic bioabsorbable web layers. The permanent PTFE knit layer functions to provide strength when bridging a hernia or soft tissue defect. The porous bioabsorbable web layers provide a scaffold for tissue ingrowth and vascularization. The GORE® SYNECOR Preperitoneal Biomaterial is for
4
single use only and is designed for preperitoneal placement and should be placed between tissue layers where ingrowth is desired.
Indications for Use
GORE® SYNECOR Preperitoneal Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of nonabsorbable reinforcing or bridging material.
Differences in Technological Characteristics
Materials of construction are identical for the two devices but the GORE® SYNECOR Preperitoneal Biomaterial possesses two PGA/TMC porous web layers and no PGA/TMC film layer. The predicate device. GORE® SYNECOR Biomaterial, has one PGA/TMC porous web layer along with a PGA/TMC film layer. This PGA/TMC porous web layer is composed of the same materials that comprise the previously cleared GORE® BIO-A Tissue Reinforcement. Relative to the GORE® BIO-A Tissue Reinforcement device, the PTFE mesh knit is unique to the SYNECOR devices as an additional material, and as an implanted material. Substantial equivalence of the packaging components and the initial shelf life data were based on the predicate device testing.
Summary of Performance Testing
Pre-Clinical
Bench study: Testing demonstrated the GORE® SYNECOR Preperitoneal 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. Performance data includes acceptable results for mesh thickness, density, suture retention, burst strength, and pore size relative to the predicate device. The three year shelf life is supported by the known stability of PTFE, and real time data correlated with accelerated aging data for the predicate surgical mesh device, GORE® BIO-A Tissue Reinforcement. This reference device is made of the same PGA/TMC copolymer and has similar physical and chemical properties as the bioresorbable component of GORE® SYNECOR Preperitoneal Biomaterial.
Biocompatibility: While the GORE® SYNECOR Preperitoneal Biomaterial device is composed of materials (i.e., PTFE, PGA, TMC) that have long-standing histories of safe clinical use, GORE has demonstrated that these materials are biocompatible in the manufacture of GORE® SYNECOR Preperitoneal Biomaterial device by conducting an extensive battery of standardized in vitro and in vivo tests according to ISO 10993 standards, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, rabbit pyrogen, genotoxicity, local effects after implantation and subchronic toxicity.
Animal study: The subject GORE® SYNECOR Preperitoneal Biomaterial was studied in a 30 day subcutaneous implant rabbit model while the predicate
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device, GORE® SYNECOR Biomaterial, was studied in an intraperitoneal implant rabbit model, under a separate protocol. Overall, the tissue response was similar for these constructs with the presence of organized, vascularized collagenous tissue ingrowth within the web and filling the macropores. Furthermore, the inflammatory response was as expected for a resorbable medical device in both cellular make-up and extent. Additionally, a 90 day rat subchronic toxicity study per ISO 10993 involving multiple device implants resulted in no noteworthy systemic toxicity. Finally, a 180 day subcutaneous implant study in rabbits compared the subject device against the Ethicon Physiomesh® device with an overall tissue response typical for these types of constructs.
Clinical
No clinical evaluations were required to support this submission.
Conclusion
Based on the information contained within this 510(k) premarket notification, W. L. Gore & Associates concludes that the subject GORE® SYNECOR Preperitoneal Biomaterial device is substantially equivalent to the predicate device in terms of indications for use, contraindications, construct, materials, biocompatibility, sterilization, and performance.