(293 days)
Model 2120 NeuroPen Endoscope by Clarus Medical, Model 2125 MurphyScope by Clarus Medical, Catalog No. 82-6570 NEUROGUIDE Endoscopic Shunt Placement Kit by J & J
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No
The summary describes a standard endoscopic device with optical and fluid channels. There is no mention of image processing, AI, ML, or any data analysis capabilities that would suggest the use of such technologies. The performance studies focus on biocompatibility and physical characteristics.
Yes.
The device is intended for "endoscopic intraoperative intracranial neurosurgical shunt placement procedures" which is a medical procedure. The device includes a "shunt," which is a device implanted to divert bodily fluids, and an "endoscope" used for visualization during the procedure, classifying it as a therapeutic device.
No
The device is primarily intended for endoscopic intraoperative intracranial neurosurgical shunt placement procedures, indicating a surgical and interventional purpose rather than a diagnostic one. While it is an endoscope and can visualize the intracranial area, its primary intended use as described is for the placement of a shunt, which is a treatment/interventional procedure.
No
The device description clearly details a physical endoscope with hardware components like fiber optic bundles, lenses, and fluid channels. 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:
- Intended Use: The intended use is for "endoscopic intraoperative intracranial neurosurgical shunt placement procedures." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is an endoscope and a shunt. These are instruments used for visualization and placement within the body, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like CSF in this case, even though it's contacted), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used during a procedure.
N/A
Intended Use / Indications for Use
The Clarus Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit is intended for endoscopic intraoperative intracranial neurosurgical shunt placement procedures where cerebrospinal fluid (CSF) may be contacted. The endoscope and the shunt are supplied sterile and are intended for single use.
Product codes
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Device Description
The Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit contains an endoscope designed and manufactured by Clarus Medical and a FDA cleared shunt.
The Model 2121-XXX NeuroPEN endoscope is manufactured using medical grade biocompatible materials. The design of and materials used are the same as those used in other Clarus Series 2100 and Series 2200 Endoscopes. Further, the sizes and configurations of the endoscope are equivalent as well. The Model 2121-XXX endoscope is a tubular device with molded plastic connectors. The optical element of the endoscope consists of a fiber optic image bundle with a distal lens and a fiber light guide. The endoscope also has a separate fluid irrigation channel. The light and image guides are terminated with standard connectors designed to interface with light cables and video cameras. The fluid irrigation channel is terminated with a standard Luer-Lok™ connector.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Intracranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies
Biocompatibility testing was performed on the materials used in the construction of the endoscopes. All materials passed biocompatibility testing and are suitable for this application.
Physical testing of the endoscope included: dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, distal tip temperature study and fluid flow. All testing of the product yielded acceptable results.
Key Metrics
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Predicate Device(s)
Model 2120 NeuroPen Endoscope by Clarus Medical, Model 2125 MurphyScope by Clarus Medical, Catalog No. 82-6570 NEUROGUIDE Endoscopic Shunt Placement Kit by J & J
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
DEC 2 4 1996
K960915
510(k) Summary
Model 2121-XXX NeuroPen Endoscopic Shunt Placement Kit
| General Information | |
|---|---|
| Classifications | Class II |
| Trade Name | Clarus Model 2121-XXX NeuroPEN™ Endoscopic Shunt |
| Placement Kit | |
| Submitter | Clarus Medical Systems, Inc. |
| 1000 Boone Avenue North #100 | |
| Minneapolis, Minnesota 55427 | |
| Contact | John Vanden Hoek |
| Director - Research and Development | |
| (612) 525-8400 |
Predicate Devices
Model 2120 NeuroPen Endoscope by Clarus Medical Model 2125 MurphyScope by Clarus Medical Catalog No. 82-6570 NEUROGUIDE Endoscopic Shunt Placement Kit by J & J
Device Description
The Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit contains an endoscope designed and manufactured by Clarus Medical and a FDA cleared shunt.
The Model 2121-XXX NeuroPEN endoscope is manufactured using medical grade biocompatible materials. The design of and materials used are the same as those used in other Clarus Series 2100 and Series 2200 Endoscopes. Further, the sizes and configurations of the endoscope are equivalent as well. The Model 2121-XXX endoscope is a tubular device with molded plastic connectors. The optical element of the endoscope consists of a fiber optic image bundle with a distal lens and a fiber light guide. The endoscope also has a separate fluid irrigation channel. The light and image guides are terminated with standard connectors designed to interface with light cables and video cameras. The fluid irrigation channel is terminated with a standard Luer-Lok™ connector.
1
Intended Use
The design, materials used and intended use of the Clarus 2121-XXX Endoscope Shunt Placement Kit is substantially equivalent to the Johnson #B2-6570 Endoscopic Shunt Placement Kit.
The Clarus Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit is intended for endoscopic intraoperative intracranial neurosurgical shunt placement procedures where cerebrospinal fluid (CSF) may be contacted. The endoscope and the shunt are supplied sterile and are intended for single use.
Testing
Biocompatibility testing was performed on the materials used in the construction of the endoscopes. All materials passed biocompatibility testing and are suitable for this application.
Physical testing of the endoscope included: dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, distal tip temperature study and fluid flow. All testing of the product yielded acceptable results.
Summary of Substantial Equivalence
The Clarus Model 2121-XXX NeuroPEN Kit endoscopes are constructed of the same materials as other Series 2100 and Series 2200 endoscopes and Models 1100 and 1102 Laser Endoscopic Disc Decompression Kits as well as other Clarus products. The sizes and configurations available along with the packaging and sterilization methods are also equivalent.
The clinical indications for use of the Model 2121-XXX NeuroPEN Kit are equivalent to those of the NEUROGUIDE Endoscopic Shunt Placement Kit marketed by Johnson & Johnson. The sizes and configurations available along with the packaging and sterilization methods are also equivalent.
Therefore, due to the similarity of materials to other predicate devices, the test results and the equivalent indications for use to other predicate devices. Clarus believes these products do not raise any new safety or effectiveness issues.