(181 days)
Like the predicate devices, the GORE Burr Hole Cover is intended to be used as a burr hole cover following cranial surgery.
The GORE Burr Hole Cover device is composed of expanded polytetrafluoroethylene (ePTFE) and fluorinated ethylene propylene (FEP). The same laminate construction is used to manufacture the GORE-TEX® SAM Reinforced Facial Implant indicated for plastic and reconstructive surgery, and so, there are no new materials, laminate manufacturing processes or technological characteristics.
This Premarket Notification Summary (K960656) for the GORE Burr Hole Cover device does not include the detailed information requested regarding acceptance criteria and a specific study proving device performance.
The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with detailed acceptance criteria and results. The information primarily covers device description, materials, intended use, and comparison to existing devices.
Therefore, it's not possible to populate the requested table and answer the study-related questions based on the provided text.
Here's a breakdown of why the information is missing:
- Acceptance Criteria and Reported Device Performance: The document states, "The technical, descriptive and performance data within this submission demonstrate that the applicant device is substantially equivalent to its predicate devices and that it is safe and effective for its intended use." However, it does not list specific acceptance criteria (e.g., minimum tensile strength, specific flexibility, tissue ingrowth rates, etc.) nor does it present quantitative results from a study demonstrating the device meets such criteria.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of these details are present because the submission for K960656 relies on the established safety and efficacy of the materials (ePTFE) and the substantial equivalence to predicate devices, rather than a new standalone clinical or performance study with these specific methodologies. The "extensive clinical history" mentioned refers to the general use of GORE-TEX ePTFE Medical Products over two decades for various indications, not a specific study on this particular Burr Hole Cover device that would involve the requested metrics.
In summary, the provided text is a summary of a 510(k) premarket notification, which often focuses on substantial equivalence rather than presenting an exhaustive performance study with detailed acceptance criteria as might be seen for novel or higher-risk devices.
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).