(29 days)
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
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. The device 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 textured porous fibrous web surface on both surfaces composed solely of synthetic bioabsorbable poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC). In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months. The GORE® BIO-A® Tissue Reinforcement 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°. It is for single use only.
I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain the information needed to answer your request about acceptance criteria and the study that proves the device meets those criteria.
The 510(k) submission for the GORE BIO-A Tissue Reinforcement, K191773, explicitly states:
- "No bench, animal, or clinical studies were required to support the labeling modification." (Page 4, under "Summary of Performance Testing")
- The entire submission is focused on a "labeling change that is not related to any safety or effectiveness issue" and clarifies that there are "no differences in technological characteristics between the subject and predicate device." (Page 4, under "Differences in Technological Characteristics")
Therefore, the document does not discuss:
- A table of acceptance criteria or reported device performance from a new study.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
This is a regulatory clearance for a labeling change only, implying that the device itself was previously cleared or is substantially equivalent to a cleared predicate, and no new performance data was submitted or required for this specific 510(k) application.
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July 31, 2019
W.L. Gore & Associates, Inc. Barbara Smith Regulatory Associate 301 Airport Road Elkton, Maryland 21921
Re: K191773
Trade/Device Name: GORE BIO-A Tissue Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWT, OWZ, OXC, OXF Dated: June 28, 2019 Received: July 2, 2019
Dear Barbara Smith:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Nina Mezu-Nwaba, PharmD., MPH., MSc, CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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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5. 510(K) SUMMARY
510(k) Submitter
W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Regulatory contact: Barbara L. Smith, RAC Phone: 410-506-8189 E-mail: blsmith@wlgore.com
Date Prepared
June 28, 2019
Device Names/Classification
| Device Name: | GORE® BIO-A® Tissue Reinforcement |
|---|---|
| Classification Name: | Mesh, surgical, polymeric |
| Regulation: | 21CFR 878.3300 |
| Classification: | Class II |
| Product Code: | OWT, OWZ, OXC, OXF |
Predicate Devices
- K163217 GORE® BIO-A® Tissue Reinforcement ●
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. The device 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 textured porous fibrous web surface on both surfaces composed solely of synthetic bioabsorbable poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC). In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months. The GORE® BIO-A® Tissue Reinforcement 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°. It is for single use only.
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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 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
Differences in Technological Characteristics
The subject of this 510(k) is a labeling change that is not related to any safety or effectiveness issue for the GORE® BIO-A® Tissue Reinforcement. There are no differences in technological characteristics between the subject and predicate device.
Summary of Performance Testing
No bench, animal, or clinical studies were required to support the labeling modification.
Conclusion
The GORE® BIO-A® Tissue Reinforcement device is substantially equivalent to the predicate devices in terms of indications for use, design, materials, biocompatibility, sterilization, packaging, and labeling.
§ 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.