(84 days)
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No
The device description focuses on the material composition and physical structure of a biomaterial for soft tissue reinforcement, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is indicated for soft tissue reinforcement and is absorbed by the body, which aligns with the definition of a medical device intended to affect the structure or function of the body, but it is not intended to restore health or relieve symptoms of a disease, which are common characteristics of a therapeutic device. It is a structural reinforcement.
No
The device is indicated for "reinforcement of soft tissue" and functions to "reinforce soft tissue during the phases of wound healing by filling soft-tissue deficits." This describes a therapeutic, rather than a diagnostic, function.
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," which is a physical biomaterial, not software.
Based on the provided information, the GORE® ENFORM Biomaterial is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the reinforcement of soft tissue in plastic and reconstructive surgery. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical biomaterial designed to be implanted to reinforce tissue. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the GORE® ENFORM Biomaterial is a surgical implant/biomaterial, 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, OWT, OWZ, OXC
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 soft-tissue 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
Pre-Clinical: Simulated use testing conducted as part of design verification demonstrated the GORE® ENFORM Biomaterial devices can be introduced via minimally invasive surgical procedures when used according to the instructions for use of the device. Other bench testing was leveraged from the predicate GORE® ENFORM Biomaterial device. The update to the device labeling has no impact on biocompatibility since the subject GORE® ENFORM Biomaterial is identical in material and design to the predicate GORE® ENFORM Biomaterial device.
Animal: No animal studies were required to support this change.
Clinical: No clinical data was required to support this change.
Key results: Like the predicate GORE® SYNECOR Biomaterial, GORE® ENFORM Biomaterial demonstrated acceptable performance when used in simulated minimally invasive surgical procedures.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
December 19, 2022
W. L. Gore and Associates, Inc. Barbara Smith RAc 301 Airport Road Elkton, Maryland 21921
Re: K222919
Trade/Device Name: GORE® ENFORM Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXF, OWT, OWZ, OXC Dated: September 23, 2022 Received: September 26, 2022
Dear Barbara 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. 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 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
1
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,
Deborah Fellhauer RN. BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222919
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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3
510(K) SUMMARY
510(k) Submitter
W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 USA Regulatory Contact: Barbara L. Smith, RAC Phone: 410-506-8189 E-mail: blsmith@wlgore.com
Date Prepared: December 13, 2022
Device Names/Classification
Device Name: GORE® ENFORM Biomaterial Classification Name: Mesh, Surgical, Polymeric Regulation: 21CFR 878.3300 / Surgical Mesh Classification: Class II Product Code: OXF, OWT, OWZ, OXC
Predicate Devices
K173333 GORE® ENFORM Biomaterial K152309 GORE® SYNECOR Intraperitoneal Biomaterial
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 soft-tissue 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
There are no technological differences between the subject GORE® ENFORM Biomaterial device and the predicate GORE® ENFORM Biomaterial. The predicate GORE® SYNECOR Biomaterial device possesses an additional permanent PTFE layer not present in GORE® ENFORM Biomaterial device.
Summary of Performance Testing
Pre-Clinical
Bench
Simulated use testing conducted as part of design verification demonstrated the GORE® ENFORM Biomaterial devices can be introduced via minimally invasive surgical procedures when used according to the instructions for use of the device. Other bench testing was leveraged from the predicate GORE® ENFORM Biomaterial device. The update to the device labeling has no impact on biocompatibility since the subject GORE® ENFORM Biomaterial is identical in material and design to the predicate GORE® ENFORM Biomaterial device.
Animal
No animal studies were required to support this change.
Clinical
No clinical data was required to support this change.
Conclusion
While the predicate GORE® SYNECOR Biomaterial devices possesses a technological difference compared to the subject GORE® ENFORM Biomaterial device, the difference did not raise any new or different issues of safety and effectiveness when tested using methods consistent with the predicate GORE® SYNECOR Biomaterial device. Like the predicate GORE® SYNECOR Biomaterial, GORE® ENFORM Biomaterial demonstrated acceptable performance when used in simulated minimally invasive surgical procedures. W. L. Gore & Associates concludes the subject GORE® ENFORM Biomaterial is substantially equivalent to the predicate devices.