CNS INTERCHANGEABLE BIT CRANIAL DRILL

K961113 · Clinical Neuro Systems, LLC · HBG · Jun 5, 1996 · Neurology

Device Facts

• Record ID: K961113
• Device Name: CNS INTERCHANGEABLE BIT CRANIAL DRILL
• Applicant: Clinical Neuro Systems, LLC
• Product Code: HBG · Neurology
• Decision Date: Jun 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4300
• Device Class: Class 2
• Attributes: Therapeutic

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.

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.

Indications for Use

Indicated for patients requiring intracranial pressure (ICP) reduction, cerebrospinal fluid (CSF) monitoring, or temporary CSF drainage via access to the subarachnoid space or lateral ventricles.

Regulatory Classification

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)

{0}

CNS
CLINICAL NEURO SYSTEMS INC.
JUN - 5 1996
K961113
309 Commerce Drive
Exton, PA 19341-2616
[phone]
Fax [phone]

# 510(k) Summary

I
Submitted By
Clinical Neuro Systems
309 Commerce Drive
Exton Pa 19341
Phone [phone]
Fax [phone]
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.

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# 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 |