(181 days)
K 820311, K 913490, K 922489
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No
The summary explicitly states "there are no new materials, laminate manufacturing processes or technological characteristics" and there are no mentions of AI, ML, or related concepts.
No
The device is a burr hole cover used after cranial surgery, which is a supportive or reconstructive device rather than one that treats a disease or condition.
No
The device is described as a burr hole cover following cranial surgery, indicating it is an implantable device used for structural support or closure, not for identifying a disease or condition. Its comparison to existing implants further supports its role as a therapeutic or reconstructive device rather than a diagnostic one.
No
The device description clearly states the device is composed of physical materials (ePTFE and FEP) and is intended to be implanted as a burr hole cover, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used as a burr hole cover following cranial surgery." This describes a surgical implant used in vivo (within the body) during a medical procedure.
- Device Description: The device is a physical implant made of ePTFE and FEP.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant placed within the body.
N/A
Intended Use / 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.
Product codes
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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.
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.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 820311, K 913490, K 922489
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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
-
- 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.
1
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.