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The Clarus 6000 SITEtrac Discectomy System is intended for surgical use in the lumbar spine. It is supplied non-sterile and is intended for reuse. The Model 6020 Dilators and Model 6021 Retractors are intended to be used to dilate then retract the tissue in the region of the lumbar spine. This will provide an access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine. This will provide as access point to apply surgical techniques through the tubular retractor under endoscopic visualization. These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(****) MicroEndoscopic Discectomy System" The comparisons of these devices are shown in Table I These retractors and dilators will be sold as a kit (See Kit Certification- Attachment F). Cleaning and sterilization procedures for the, dilators, retractors, and spinal needle, are contained in the Directions for Use ( See Attachment A).

The 2600 endoscope is intended for accessing and visualizing the spinal nerve root, foramina, intervertebral disc, and the surrounding tissues of the lumbar spine. The endoscope has a working channel intended for the passage of surgical instruments indicated for use in this area. Surgical instrumentation may be used for discectomy procedures, bone and osteophyte removal, procedures associated with ruptured or herniated discs such as, retrieval of extruded disc fragments and retrieval of free fragments. The Model 2600 also has an irrigation channel for sterile fluid flush or aspiration.

The Model 2600 Neuro Endoscope is manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the Model 1103 Laser Endoscopic Disc Decompression Kit, the Model 2230 Neuro Endoscope, and the Model 2125 Endoscopic Ball Probe. Further, the sizes and configurations of the endoscope and accessories are equivalent as well. The Model 2600 Neuro Endoscope is a rigid fiber optic endoscope with a molded proximal handle. The optical element of the endoscope consists of a fiber optic image bundle with a distal lens and a fiber light guide. The endoscope has a working channel and 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. The working channel has a proximal port to allow the passage of surgical instruments.

The Model 2127-900 Series Endoscope Adapter is an accessory for the Clarus Medical Systems Model 2127 Endoscope. It is intended to be reusable. It is used to temporarily clamp or hold the endoscope when mounting to an airway catheter. MOUNT AND 450 ENDOSCOPE ACCESSORY TEST PORARILY 00 USED AIRWAY CATHETER APPRODUATE TOGETHER ENDOSECHE ADD AN

The Model 2127-900 Series Endoscope Adapter is a machined or molded plastic piece used to hold an endoscope and airway catheter together. The endoscope adapter has a machined or molded tapered hub designed to fit firmly into the proximal end of various airway catheters. Additionally the endoscope adapter has a central hole designed to fit the outside diameter of the shaft on the appropriate legally marketed Clarus Model 2127 Endoscope.

The Clarus Model 5197 SightLite is intended as a illumination source for endoscopes. These endoscopes would be legally marketed Clarus Medical Systems devices. The SightLite is intended for multiple use. It is sold non-sterile.

The Clarus Model 5197 SightLite is a hand held illumination device for endoscopy. The device has a means of attaching a legally marketed optical assembly manufactured by Clarus Medical Systems that is sold separately. The image connector on the endoscope attaches to the optical assembly. The male illumination receptacle on the endoscope attaches to the female receptacle on the Model 5197 SightLite. The power source is four 1.5 volt AA lithium batteries. The illumination source is a Tungsten Halogen lamp. The SightLite is intended for multiple use. It is sealed for cleaning and disinfecting. The optical assembly used with the SightLite endoscopic light source is a separate, legally marketed, Clarus Medical Systems device that can be attached to the SightLite by means of a machined clasp that is an intrical part of the SightLite.

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.

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.

The Clarus Model 2126 SpinePEN is intended for diagnostic accessing and visualizing tissue during cranial sinus, laryngopharyngeal and bronchial procedures. It is not intended for intraoperative or percutaneous use. The endoscope is reusable and is packaged with five disposable cannulae.

The Clarus Model 2127 Endoscopes will be manufactured using medical grade biocompatible materials. The materials to be used are the same as those used in other Clarus Series 2100 Flexible Endoscopes and other Clarus Series Endoscopes. Further, the sizes and configurations of the endoscope are equivalent as well. The Model 2127 Endoscope is a flexible tubular device with plastic and stainless steel connectors. The optical element of the endoscope consists of a fiber optic image element with a distal lens and fiber light guide. The endoscope also has separate cannulae. Passive deflection allows the physician to move the endoscope's tip through the curved cannula tube during mounting and also allows the physician to bend the endoscope to the desired shape while the endoscope is attached to the The light and image guides are terminated with standard connectors cannula. designed to interface with light cables and video cameras. The basic design of the Clarus Model 2127 Endoscope is, and materials used are, equivalent to the Clarus Model 2126, Model 2125, Model 2240, and Model 2120 Endoscopes. The diameter of the Endoscope is 1 mm to 2 mm and the working length varies for the different model dash numbers available. The working length for nasolaryngeal procedures requires a cannula of 10.4. The working length for the cannula which would also pass the larynx and into the bronchi would be of 25.0 to 30.0 cm length.