(77 days)
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Not Found
No
The device description and performance studies focus on the mechanical aspects and sterility of a cranial drill, with no mention of AI or ML capabilities.
No
The device is a drill, used to create access during a procedure, but it does not directly treat a disease or condition itself.
No
The device is a surgical drill used for accessing the brain, monitoring ICP, and draining CSF. These are therapeutic and monitoring functions, not diagnostic.
No
The device description clearly outlines physical components like a hand drill, drill bits, and depth guards, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a cranial drill used to create access to the subarachnoid space or lateral ventricles of the brain. This is a surgical tool used on the body, not a test performed on samples from the body.
- Intended Use: The intended use is to reduce intracranial pressure, monitor CSF, provide temporary drainage of CSF, and monitor ICP. These are all direct interventions or measurements taken within the body, not diagnostic tests performed on samples.
Therefore, this device falls under the category of a surgical instrument or medical device used for direct intervention and monitoring within the body, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
subarachnoid space or the lateral ventricles of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following tests were performed to ensure acceptable performance of the Clinical Neuro Systems Interchangeable Bit Cranial Drill.
Test: Sterility, Result: Acceptable
Test: Performance, Result: Acceptable
Test: Cytotoxicity, Result: Acceptable
Test: Comparative Evaluation, Result: Acceptable
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.
PS Medical Ventriculostomy Kit: Cranial Drill, Camino Laboratories Twist Drill Procedure Kit: Cranial Drill, Clinical Neuro Systems Cranial Drill
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
11
Trade Name Clinical Neuro Systems Interchangeable Bit Cranial Drill
Common Name Cranial Drill
Classification Name Manual Cranial Drill, Burr, Trephine, and Accessories
111
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 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.
1
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 |