K960656 · W. L. Gore & Associates, Inc. · GXR · Aug 14, 1996 · Neurology
Device Facts
Record ID
K960656
Device Name
GORE BURR HOLE COVER
Applicant
W. L. Gore & Associates, Inc.
Product Code
GXR · Neurology
Decision Date
Aug 14, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 882.5250
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Like the predicate devices, the GORE Burr Hole Cover is intended to be used as a burr hole cover following cranial surgery.
Device Story
GORE Burr Hole Cover is a cranial implant used to cover burr holes and reattach bone post-cranial surgery. Device consists of expanded polytetrafluoroethylene (ePTFE) and fluorinated ethylene propylene (FEP) laminate. FEP provides rigidity to prevent sagging; ePTFE microstructure facilitates host tissue ingrowth. Implanted by surgeons in clinical settings. Device leverages established biocompatibility and mechanical properties of ePTFE/FEP materials used in existing GORE-TEX facial implants. Benefits include structural support for cranial defects and promotion of tissue integration.
Clinical Evidence
No clinical data provided. Substantial equivalence based on extensive clinical history of GORE-TEX ePTFE medical products (over 4,000,000 applications) and comparative technological characteristics.
Indicated for covering burr holes following cranial surgery and reattaching cranial bone removed during surgery. Patient population not specified.
Regulatory Classification
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.
Predicate Devices
Holter - Hausner - Burr Hole Catheter Support (K 820311)
Porex Surgical Inc. - Medpor FLEXBLOCK Implant (K 922489)
Submission Summary (Full Text)
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AUG 14 1996
# PREMARKET NOTIFICATION SUMMARY K960656
1. **Applicant:** W. L. Gore and Associates, Inc.
3750 W. Kiltie Lane
Flagstaff, AZ 86002
Phone: (520) 779-2771
**Contact:** John W. Nicholson, Associate
Date of Preparation: February 12, 1996
2. **Applicant Device:** GORE Burr Hole Cover
**Common Name:** Burr Hole Covers
**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
4. **Applicant Device Description:**
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.
# 5. Intended Use:
Like the predicate devices, the GORE Burr Hole Cover is intended to be used as a burr hole cover following cranial surgery.
# 6. Technological Characteristics:
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.
