(164 days)
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No
The summary describes a passive biomaterial device for soft tissue reinforcement and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
The device is a therapeutic device because its intended use is for the reinforcement of soft tissue, including applications like hernia repair, muscle flap reinforcement, and general tissue reconstructions, which directly treat or manage a disease or condition.
No
Explanation: The device is indicated for use in the reinforcement of soft tissue, functioning as a bioabsorbable scaffold to fill soft tissue deficits during wound healing. It is a therapeutic device, not a diagnostic one, as it does not gather or interpret data to identify a medical condition.
No
The device description clearly states it is a "porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure," indicating it is a physical biomaterial, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- GORE® ENFORM Biomaterial Function: The description clearly states that GORE® ENFORM Biomaterial is a material implanted into the body to reinforce soft tissue during wound healing. It is a physical device used in surgical procedures.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is structural support and tissue regeneration.
Therefore, GORE® ENFORM Biomaterial falls under the category of a surgical implant or medical device used for tissue reinforcement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
GORE® ENFORM Biomaterial is indicated 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® ENFORM Biomaterial may be used include hernia repair as suture line reinforcement, muscle flap reinforcement, and general tissue reconstructions.
Product codes
OXF, OXC, OWT, OWZ
Device Description
As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling softtissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Soft tissue, hernia, muscle flap
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Biocompatibility: Biocompatibility evaluation appropriate for a tissue contacting implant with permanent duration of exposure was conducted according to "Use of International Standard /SO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Guidance for Industry and Food and Drug Administration Staff. June 16, 2016".
Bench study: The bench testing conducted but was not limited to evaluation of surgical manipulation, suture needle penetration, stiffness, tensile strength. Results demonstrated that both configurations of the GORE® ENFORM Biomaterial met the performance criteria established for the indicated uses of the device.
Animal study: Animal studies were conducted to compare the performance of the ENFORM Biomaterial to the predicate control devices with respect to visceral protection, tissue ingrowth and tissue response.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 5, 2018
W.L. Gore & Associates, Inc. Barbara Smith Regulatory Associate 1505 N. Fourth Street Flagstaff, Arizona 86004
Re: K173333
Trade/Device Name: GORE ENFORM Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXF, OXC, OWT, OWZ Dated: October 20, 2017 Received: October 23, 2017
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 adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3
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
2
Indications for Use
510(k) Number (if known) K173333
Device Name GORE® ENFORM Biomaterial
Indications for Use (Describe)
GORE® ENFORM Biomaterial is indicated 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® ENFORM Biomaterial may be used include hernia repair as suture line reinforcement, muscle flap reinforcement, and general tissue reconstructions.
| 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) 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
October 20, 2017
Device Names/Classification
| Device Name: | GORE® ENFORM Biomateria |
|---|---|
| Classification Name: | Mesh, surgical, polymeric |
| Regulation: | 21CFR 878.3300 |
| Classification: | Class II |
| Product Code: | OXF, OWT, OWZ, OXC |
Predicate Devices
- . K163217 GORE® BIO-A® Tissue Reinforcement
- K152609 GORE® SYNECOR Intraperitoneal Biomaterial ●
- K143380 BARD® Phasix™ ST Mesh
Device Description
As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling softtissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.
4
Indications for Use
GORE® ENFORM Biomaterial is indicated 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® ENFORM Biomaterial may be used include hernia repair as suture line reinforcement, muscle flap reinforcement, and general tissue reconstructions.
Differences in Technological Characteristics
The GORE® ENFORM Biomaterial with film configuration, a fully absorbable device, contains a visceral protection film layer not present in the predicate GORE® BIO-A® Tissue Reinforcement. However, the GORE® SYNECOR Intraperitoneal predicate possesses a visceral protection film comprised of the same material as the GORE® ENFORM Biomaterial with film. (The permanent PTFE knit middle layer of the predicate GORE® SYNECOR is not present in the GORE® ENFORM Biomaterial devices and therefore, was not compared.) The predicate PHASIX™ ST, also a fully absorbable device, possesses a visceral protection layer comprised of a different material (hvdrogel barrier).
Summary of Performance Testing
Biocompatibility: Biocompatibility evaluation appropriate for a tissue contacting implant with permanent duration of exposure was conducted according to "Use of International Standard /SO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Guidance for Industry and Food and Drug Administration Staff. June 16, 2016".
Bench study: The bench testing conducted but was not limited to evaluation of surgical manipulation, suture needle penetration, stiffness, tensile strength. Results demonstrated that both configurations of the GORE® ENFORM Biomaterial met the performance criteria established for the indicated uses of the device.
Animal study: Animal studies were conducted to compare the performance of the ENFORM Biomaterial to the predicate control devices with respect to visceral protection, tissue ingrowth and tissue response.
Conclusion
The information and test results contained within this 510(k) premarket notification demonstrate that the subject GORE® ENFORM Biomaterial device is substantially equivalent to the predicate devices in terms of indications for use, design, materials, biocompatibility, sterilization, packaging, and performance.