(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.
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PREMARKET NOTIFICATION SUMMARY K960656
- Applicant: W. L. Gore and Associates, Inc. 1. 3750 W. Kiltie Lane Flagstaff, AZ 86002 Phone: (520) 779-2771
- Contact: John W. Nicholson, Associate Date of Preparation: February 12, 1996
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- Applicant GORE Burr Hole Cover Device:
Common Burr Hole Covers Name:
Classification Name: Burr Hole Covers
3. Predicate Device:
For the purposes of determining substantial equivalence, GORE cites the following as predicate devices:
- Holter Hausner Burr Hole Catheter Support K 820311 .
- Phoenix Bioengineering Phoenix Burr Hole Button K 913490 .
- Porex Surgical Inc. Medpor FLEXBLOCK Implant K 922489 .
Applicant Device Description: 4.
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.
PTFE is extremely inert and has excellent chemical and thermal stability. The carbon-fluorine bond is one of the strongest bonds known among organic compounds. The highly electronegative fluorine atoms form a protective sheath enveloping the chain of carbon atoms. GORE-TEX products are characterized by solid nodes of PTFE interconnected by a latticework of PTFE fibrils. By staggering the density of the node and fibril structure, the degree and the celerity with which host tissue attachment occurs can be determined.
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The FEP material is sandwiched between layers of PTFE and, because of its nonporous nature, FEP adds rigidity to the device which prevents it from sagging into the burr hole defect. The open microstructure of the ePTFE material allows for host tissue ingrowth. The Instructions for Use presented in Attachment 3 provide basic implanting instructions.
Intended Use: 5.
Like the predicate devices, the GORE Burr Hole Cover is intended to be used as a burr hole cover following cranial surgery.
Technological Characteristics: 6.
The Table below presents some of the basic comparative characteristics of the applicant device and its cited predicate devices.
| Material | Origin | Intended Use | Target Population | Path to Market | |
|---|---|---|---|---|---|
| GORE Burr Hole Cover | ePTFE | Synthetic | Used to cover burr holes following cranial surgery and to reattach cranial bone removed during surgery | Not Specified | Class II Under review |
| Holter - Hausner | Silicone Elastomer | Synthetic | Inserted into burr holes to provide for ventricular shunting | Not Specified | Class II K 820311 |
| Phoenix Bio-Engineering | Silicone Elastomer | Synthetic | Used to plug burr holes and to secure cranial bones following cranial surgery | Not Specified | Class II K 913490 |
| Porex Surgical Inc. | Porex Surgical Inc. | Synthetic | For covering burr holes drilled into the skull during surgery | Not Specified | Class II K 922489 |
For the past two decades, GORE-TEX® ePTFE Medical Products have been implanted in more than 4,000,000 clinical applications for a broad range of indications. This extensive clinical history has demonstrated that the devices possess the requisite structural, biocompatibility and mechanical characteristics to function safely and effectively. 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.
§ 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).