(88 days)
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.
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.
This document describes the GORE® SYNECOR Biomaterial, a surgical mesh. The provided text is a 510(k) premarket notification summary and does not contain information about studies proving a device meets acceptance criteria using a test set that generates performance metrics for AI/ML algorithms. Instead, it focuses on the substantial equivalence of the GORE® SYNECOR Biomaterial to predicate devices based on pre-clinical (bench and animal) testing.
Therefore, many of the requested categories related to AI/ML device performance and testing (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and ground truth for training set) cannot be answered from the provided document.
However, I can extract information regarding preclinical performance testing.
Acceptance Criteria and Reported Device Performance (Bench Study)
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Acceptance Criteria for Strength | 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 | Suture retention testing was performed to compare the GORE® SYNECOR Biomaterial to the predicate devices. (Specific performance values or direct comparison results (e.g., "was comparable to" or "X N vs Y N") are not detailed in this summary.) |
| Burst Strength | Burst strength testing was performed to compare the GORE® SYNECOR Biomaterial to the predicate devices. (Specific performance values or direct comparison results are not detailed in this summary.) |
| Midsurface Adhesions (Animal Study) | The GORE® SYNECOR Biomaterial had no midsurface adhesions similar to the control (predicate) device. |
| Fibrous Tissue Ingrowth (Animal Study) | There was no statistical difference in the amount of fibrous tissue ingrowth for the GORE® SYNECOR Biomaterial relative to the predicate. |
| Overall Histopathology (Animal Study) | Histopathology was as expected for the type and construction of both devices (GORE® SYNECOR Biomaterial and predicate) with organized tissue ingrowth and vascularity filling the macropores. |
Study Details (Pre-clinical)
- 1. A table of acceptance criteria and the reported device performance: See table above.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Bench Study: Not specified.
- Animal Study: A rabbit model was used. The number of animals or specific details of their use are not provided. Data provenance is not specified beyond "Pre-Clinical."
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is pre-clinical testing, not expert-based ground truth for interpretation. Histopathology would have been assessed by a pathologist, but specific numbers or qualifications are not mentioned in this summary.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to pre-clinical bench and animal studies in this context.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe the use of AI/ML.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe the use of AI/ML.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Study: Engineering and material science measurements (e.g., strength, suture retention, burst strength).
- Animal Study: Histopathology and direct observation (for adhesions).
- 8. The sample size for the training set: Not applicable. This document does not describe the use of AI/ML.
- 9. How the ground truth for the training set was established: Not applicable. This document does not describe the use of AI/ML.
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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 (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 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 | |
| Indications for Use | |
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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 | |
| PRAStaff@fda.hhs.gov | |
| "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: 410-506-8189 Fax: 410-506-8221 E-mail: blsmith@wigore.com
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.
§ 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.