← Product Code [HBG](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG) · K961113 # CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113) _Clinical Neuro Systems, LLC · HBG · Jun 5, 1996 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K961113 ## Device Facts - **Applicant:** Clinical Neuro Systems, LLC - **Product Code:** [HBG](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG.md) - **Decision Date:** Jun 5, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4300 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for 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. ## Device Story Manual cranial drill system for ventriculostomy procedures; includes hand drill with variable chuck and interchangeable drill bits (0.156", 0.209", 0.25"). Features adjustable depth guard for secure, accurate cranial penetration. Used by neurosurgeons in clinical settings to access subarachnoid space or lateral ventricles. Facilitates placement of external drainage/monitoring systems to manage ICP and CSF. Supplied sterile for single-use. Mechanical operation; no power source required. ## Clinical Evidence Bench testing only. Performance testing, sterility validation, and cytotoxicity testing yielded acceptable results. Comparative evaluation against predicate devices confirmed functional equivalence. ## Technological Characteristics Manual hand drill (Fiskars Twist Drill) with variable chuck. Includes interchangeable steel drill bits with adjustable depth guards. Sterile, double CSR wrapped in Chevron pouch. No electronic components or software. ## Regulatory 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. ## Predicate Devices - PS Medical Ventriculostomy Kit: Cranial Drill - Camino Laboratories Twist Drill Procedure Kit: Cranial Drill - Clinical Neuro Systems Cranial Drill ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 | --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K961113](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K961113) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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