CNS INTERCHANGEABLE BIT CRANIAL DRILL

{0} CNS CLINICAL NEURO SYSTEMS INC. JUN - 5 1996 K961113 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 Fax 610-524-8176 Contact: Jim Meikle Preparation Date 1-12-96 II Trade Name Clinical Neuro Systems Interchangeable Bit Cranial Drill Common Name Cranial Drill Classification Name Manual Cranial Drill, Burr, Trephine, and Accessories III Predicate Device Identification PS Medical Ventriculostomy Kit: Cranial Drill Camino Laboratories Twist Drill Procedure Kit: Cranial Drill Clinical Neuro Systems Cranial Drill IV 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 guard 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. {1} # V ## 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. # VI ## 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 Bit Included with Drill | Yes | Yes | Yes | | 3. Integral Bit | Yes | Yes | NA | | 4. Adjustable Depth Guard | Yes | Yes | No | | 5. Set Screw with Hex Wrench | No | Yes | Yes | | 6. Packaging | Sterile, CSR Wrap in Peal Pouch | Sterile, CSR Wrap in Tray and Header Bag | Sterile, in Lidded 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 |