(77 days)
The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only.
Clinical Neuro Systems Interchangeable Bit Cranial Drill consists of various bit sizes used during a ventriculostomy procedure. The product includes a hand drill with variable chuck, a 0.156" (3.97mm) drill bit with depth guard, a 0.209" (5.31mm) drill bit with depth guard, and a 0.25" (6.35mm) drill bit with depth guard. The depth quard allows accurate, secure, and easy to use adjustment of cranial drill depth. Cranial drill depth is selected by setting the depth guard to the required distance. The Cranial Drill allows for access to the subarachnoid space or the lateral ventricles of the brain. The Cranial Drill is supplied sterile, double CSR wrapped in a Chevron pouch.
This document describes the marketing authorization for a medical device and, as such, does not contain information about the device's acceptance criteria, study design, or performance metrics in a way that aligns with your request for AI/algorithm performance. The information provided is for a cranial drill, which is a physical surgical tool, not an AI or software-based device.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The "Test Data" section in the input only shows that standard medical device tests (Sterility, Performance, Cytotoxicity, Comparative Evaluation) were performed and found "Acceptable" for regulatory approval, but it does not detail performance metrics, sample sizes, ground truth establishment, or human reader studies relevant to an AI/algorithm.
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Image /page/0/Picture/1 description: The image shows a logo for Clinical Neuro Systems Inc. The logo consists of the letters "CNS" in a bold, sans-serif font. Below the letters, the words "CLINICAL NEURO SYSTEMS INC." are printed in a smaller, sans-serif font. Underneath the company name, there is a series of black rectangles of varying widths arranged in a row.
309 Commerce Drive
Exton, PA 19341-2616
(610) 524-9150
Fax (610) 524-8176
510(k) Summary
I
Submitted By Clinical Neuro Systems 309 Commerce Drive Exton Pa 19341 Phone 610-524-9150 610-524-8176 Fax Contact: Jim Meikle Preparation Date 1-12-96
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Trade Name Clinical Neuro Systems Interchangeable Bit Cranial Drill
Common Name Cranial Drill
Classification Name Manual Cranial Drill, Burr, Trephine, and Accessories
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Predicate Device Identification PS Medical Ventriculostomy Kit: Cranial Drill Camino Laboratories Twist Drill Procedure Kit: Cranial Drill Clinical Neuro Systems Cranial Drill
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Product Description
Clinical Neuro Systems Interchangeable Bit Cranial Drill consists of various bit sizes used during a ventriculostomy procedure. The product includes a hand drill with variable chuck, a 0.156" (3.97mm) drill bit with depth guard, a 0.209" (5.31mm) drill bit with depth guard, and a 0.25" (6.35mm) drill bit with depth guard. The depth quard allows accurate, secure, and easy to use adjustment of cranial drill depth. Cranial drill depth is selected by setting the depth guard to the required distance. The Cranial Drill allows for access to the subarachnoid space or the lateral ventricles of the brain. The Cranial Drill is supplied sterile, double CSR wrapped in a Chevron pouch.
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Intended Use
The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only.
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Technological Comparison To Predicate Devices
| Item | CNS Cranial Drill | PS Medical Kit Drill | Camino Kit Drill |
|---|---|---|---|
| 1. Hand Drill | Fiskars Twist Drill | Fiskars Twist Drill | Fiskars Twist Drill |
| 2. Drill BitIncludedwith Drill | Yes | Yes | Yes |
| 3. Integral Bit | Yes | Yes | NA |
| 4. AdjustableDepth Guard | Yes | Yes | No |
| 5. Set Screw withHex Wrench | No | Yes | Yes |
| 6. Packaging | Sterile, CSR Wrapin Peal Pouch | Sterile, CSR Wrapin Tray and HeaderBag | Sterile, inLidded Tray |
VII
Test Data
The following tests were performed to ensure acceptable performance of the Clinical Neuro Systems Interchangeable Bit Cranial Drill.
| Test | Result |
|---|---|
| Sterility | Acceptable |
| Performance | Acceptable |
| Cytotoxicity | Acceptable |
| Comparative Evaluation | Acceptable |
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§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
(a)
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.(b)
Classification. Class II (performance standards).