(142 days)
The GORE BIO-A™ Fistula Plug device is intended for use in the reinforcement of soft tissue for repair of anorectal fistulas.
The GORE BIO-A™ Fistula Plug is a surgical mesh supplied in a preformed three-dimensional shape (disk with attached tubes) and comprised of a porous structure of synthetic bioabsorbable PGA/TMC copolymer fiber, degraded via a combination of hydrolytic and enzymatic pathways. The PGA:TMC material is bioabsorbable and has been demonstrated to be both biocompatible and non-antigenic. It is not derived from animal or human tissues. The GORE BIO-A™ Fistula Plug is a tailorable, bioabsorbable material intended to reinforce soft tissue during the phases of wound healing by initially occupying the fistula defect and at the same time eliciting a physiological tissue response which fills the fistula defect with native tissue as the fistula plug gradually absorbs. The GORE BIO-A™ Fistula Plug is provided sterile for single use only.
The provided text is a 510(k) summary for the GORE BIO-A™ Fistula Plug. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics in the way a new, novel device might.
Therefore, the specific information requested about acceptance criteria, performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this type of regulatory submission.
Here's an analysis based on the provided text, explaining why those details are missing:
Analysis of the GORE BIO-A™ Fistula Plug 510(k) Summary (K083266):
The 510(k) process is primarily a premarket notification where a manufacturer demonstrates that their device is "substantially equivalent" in terms of safety and effectiveness to a legally marketed predicate device. This typically involves comparing technological characteristics and intended use, rather than conducting new clinical trials to establish de novo performance criteria.
Therefore, a table of acceptance criteria with reported device performance, information on sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance studies are not typically included or required in a 510(k) submission unless the device is truly novel or has significantly different technological characteristics from its predicates.
Here's a breakdown of what can be extracted or inferred:
- Device Name: GORE BIO-A™ Fistula Plug
- Intended Use: Reinforcement of soft tissue for repair of anorectal fistulas.
- Predicate Devices:
Regarding the requested information:
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A table of acceptance criteria and the reported device performance:
- Not present. The document states: "A variety of in vitro and in vivo tests and comparisons demonstrate that the GORE BIO-A™ Fistula Plug device is substantially equivalent in intended/indications for use, performance, materials and technology to the predicate devices." It does not report specific acceptance criteria or performance metrics for the GORE BIO-A™ Fistula Plug, but rather asserts its equivalence to the performance of the predicate. To understand the "performance" considered, one would need to refer to the 510(k) summaries or other regulatory documents for the predicate devices (K050337 specifically for "performance").
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. Detailed study designs, including sample sizes for specific in vitro or in vivo tests, are not provided in this summary.
-
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/Not present. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation for AI algorithms). For a physical medical device like a fistula plug, "ground truth" would relate to objective measurements of biocompatibility, degradation, mechanical properties, and potentially clinical outcomes if clinical trials were performed (which are not detailed here as part of the substantial equivalence argument). The 510(k) summary does not mention expert review in this context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not present. See point 3.
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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/Not present. This device is a physical implant, not an AI or imaging-based diagnostic tool. Therefore, MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. This device is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred based on "in vitro and in vivo tests": For a physical device, ground truth would typically refer to objective measurements of material properties (e.g., tensile strength, pore size, degradation rate), biocompatibility assessments (e.g., histological analysis of tissue response), and potentially animal model outcomes related to fistula healing or tissue integration. The summary mentions biocompatibility and bioabsorbability as key characteristics. Specific details are not provided.
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The sample size for the training set:
- Not applicable/Not present. This concept is for AI/machine learning models.
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How the ground truth for the training set was established:
- Not applicable/Not present. This concept is for AI/machine learning models.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It relies on comparisons to predicate devices and general statements about in vitro/in vivo testing rather than detailing specific studies with acceptance criteria and performance metrics relevant to an AI/diagnostic device.
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W. L. Gore & Associates, Inc. GORE BIO-A™ Fistula Plug Section 5. 510(k) SUMMARY
K083266
pg 1 of 2
510(k) SUMMARY
Applicant:
W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21922 USA
MAR 2 7 2009
Contact:
Barbara L. Smith Regulatory Associate
Common Name: Fistula Plug
Classification: 21CFR878.3300
Classification Name: Surgical Mesh
FDA product code: FTL
Device Class: II
Device Predicates:
-
- 510(k)#: K033671 Predicate Device name: Gore Bioabsorbable Mesh Manufacturer: W. L. Gore & Associates, Inc.
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- 510(k) #: K050337 Predicate Device Name: SIS Fistula Plug Manufacturer: Cook Biotech Incorporated
Device Description:
The GORE BIO-A™ Fistula Plug is a surgical mesh supplied in a preformed threedimensional shape (disk with attached tubes) and comprised of a porous structure of synthetic bioabsorbable PGA/TMC copolymer fiber, degraded via a combination of hydrolytic and enzymatic pathways. The PGA:TMC material is bioabsorbable and has been demonstrated to be both biocompatible and non-antigenic. It is not derived from animal or human tissues. The GORE BIO-A™ Fistula Plug is a tailorable, bioabsorbable material intended to reinforce soft tissue during the phases of wound healing by initially occupying the fistula defect and at the
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K083266
pg 2 of 2
W. L. Gore & Associates, Inc. GORE BIO-A™ Fistula Plug Section 5. 510(k) SUMMARY
same time eliciting a physiological tissue response which fills the fistula defect with native tissue as the fistula plug gradually absorbs. The GORE BIO-A™ Fistula Plug is provided sterile for single use only.
Statement of Intended Use:
The GORE BIO-A™ Fistula Plug device is intended for use in the reinforcement of soft tissue for repair of anorectal fistulas.
Technological Characteristics:
The GORE BIO-ATM Fistula Plug device is comprised of the same material, technology and three-dimensional disk with tubes mesh design as the predicate GORE Bioabsorbable Mesh hernia plug device. The indications for use and performance of the GORE BIO-A™ Fistula Plug are substantially equivalent to the predicate Cook SIS Fistula Plug.
Substantial Equivalence:
A variety of in vitro and in vivo tests and comparisons demonstrate that the GORE BIO-A™ Fistula Plug device is substantially equivalent in intended/indications for use, performance, materials and technology to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
CES
Public Health Service
Image /page/2/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W.L. Gore & Associates, Inc. % Ms. Barbara L. Smith Regulatory Associate 301 Airport Road Elkton, Maryland 21922
MAR 2 7 2009
Re: K083266
Trade/Device Name: GORE BIO-A™ Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 18, 2009 Received: March 19, 2009
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 Fed-ral 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Ms. Barbara L. Smith
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
L. Airm D. for
Matk . Melkerson Ditector Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _
Device Name:GORE BIO-A™ Fistula Plug
Indications for Use:
The GORE Fistula Plug device is intended for use in the reinforcement of soft tissue for the repair of anorectal fistulas.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for mxin 3/27/09
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K083266
§ 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.