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The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs.

The Digital ClarusScope System and Digital NeuroPEN System are spinal endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for spinal procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application; the other fitting is an irrigation extension tube with a female Luerlock connector.

The Digital ClarusScope System and Digital NeuroPEN System are intended for use in neurosurgery, endoscopic neurosurgery, and ventriculoscopy for visualization of ventricles and structures within the brain during neurological surgical procedures, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

The Digital ClarusScope System and Digital NeuroPEN System are neurological endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for neurological procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application: the other fitting is an irrigation extension tube with a female Luerlock connector.

The Clarus Peel-Away Introducer Sheath is intended to be used in indications requiring access through the brain into the ventricular system.

The Clarus Peel-Away Introducer Sheath is a thin-walled, cylindrical device that is placed in position so that it provides a communicating passageway through brain tissue. This is accomplished by fitting the sheath securely over an obturator, advancing both devices through the tissue together as a unit. A hole through the distal tip of the obturator aids in placement by allowing pressurized cerebrospinal fluid to egress once the ventricular system is reached. The proximal hub on the obturator is rotated, unlocking it from the sheath, and the obturator is removed from the sheath, leaving the sheath alone in the desired position acting to hold the penetrated site in an open condition. The peel away sheath is capable of being pulled apart lengthwise to allow varying insertion depths into brain tissue. The proximal end of the sheath has tab handles that are provided to facilitate grasping and tearing. At this point, a regulatorily cleared device can be inserted through the sheath for patient procedures.

FOR VISUALIZATION OF AIRWAY ANATOFILY AND INDICATED PLACING AND CONFIRMING PLACEMENT of AID IN THE To ARTIFICIAL AIRWAYS

The Model 30000-V endoscope is a tubular device with a malleable shaft. The optical element of the endoscope consists of a small diameter camera bonded into the distal tip of the endoscope shaft. The removable shaft of the endoscope is attached to the battery and video screen by means of various electrical connectors. Illumination light is provided at the tip of the endoscope for direct viewing. The removable shaft of the endoscope is soakable and can be high-level disinfected. A waterproof cap is provided to protect the connector during the cleaning/disinfection process.

The Clarus Model 21200 Nucleotome Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine. The Clarus Model 21200 Nucleotome Probe Set is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

This 510(k) submission is a modification of the existing Nucleotome devices. previously filed as K844131, K902778, K913145, K914282, K923525, K931109, K942987 and respectively found to be substantially equivalent by the FDA on November 29, 1984; October 30, 1990; December 19, 1991; December 19, 1991; February 9, 1993; March 29, 1994; and October 30, 1995. The modifications represented by this submission, is the addition of thoracic and cervical indications. The Nucleotome Discectomy Probe is intended to be used for decompression of the discs in the spine (lumbar, thoracic and cervical). The set consists of components necessary, as required for percutaneous surgical techniques. The Model 21200 consists of a Discectomy Probe, a guide needle, a straight cannula, with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. A syringe with a union connector is also included to help maintain the openness of the aspiration tubing. The Clarus Model 21200 Nucleotome Discectomy Probe, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the devices which have been previously filed with FDA under 510(k) applications K844131, K902778, K913145, K914282, K923525, K931109, K942987 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical and/or thoracic applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device. As with the previous sets, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected to offer the user a comprehensive set of instruments for disc decompression. The cannulas and dilators are manufactured of stainless steel with a molded plastic proximal end. The trephine (coring needle) is of similar construction as well. These materials are standard to the industry for surgical instruments.

The Clarus Model 1100 Laser Endoscopic Decompression Kit is intended to be used on patients with contained lumbar or cervical disc herniations or bulges. This is a identical, with the addition of cervical, to the predicate device, Model 1100 Laser Endoscopic Decompression Kit (K922881) The Clarus Model 1100 Laser Endoscopic Decompression Kit indicated for laser disc decompression in the lumbar and cervical regions of the spine, where the laser is used to remove inner disc material.

This 510(k) submission is a modification of the existing Clarus Model 1100 Laser Endoscopic Decompression Kit, previously filed as K922881, and found to be substantially equivalent by the FDA on November 16, 1992. The K922881 510(k) device is intended for lumbar disc decompression in the spine. The modifications, represented by this submission, is the addition of cervical indications. The Clarus Model 1100 Laser Endoscopic Decompression Kit intended use is to be endoscopic laser decompression of discs in the spine (lumbar and cervical). The kit consists of components necessary for endoscopic laser surgery where visualization and laser surgical techniques are required. The Model 1100 consists of a deflectable endoscope with a fixed laser fiber, a flexible trocar, straight and curved cannulas with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. The cervical LASE is identical to the Clarus Model 2180 Spinescope (previously cleared for cervical visualization, K011454) with a shorter working length and the addition of a fixed laser fiber. The fixed laser fiber is identical to Clarus Model 1150 Laser Fiber (previously cleared for cervical soft tissue, K022610). The Clarus Model 1100 Laser Endoscopic Decompression Kit, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the device which have been previously filed with FDA under 510(k) application K922881 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device As with the previous kits, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected by Clarus to offer the user a comprehensive set of instruments for endoscopic laser disc decompression. The cannulas and dilators are manufactured of stainless steel with a molded plastic proximal end. The trephine (coring needle) is of similar construction as well. These materials are standard to the industry for surgical instruments.

The Clarus Model 1150 Straight Firing Laser Fiber may be used both intraoperatively and percutaneously through regulatory cleared delivery systems. The Clarus Model 1150 Straight Firing Laser is for use in general, urological, OB-GYN, orthopedic (including lumbar and cervical), and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

Model 1150 Clarus Straight Firing Laser Fiber

The Clarus Straight Firing Laser Fiber and the Clarus Side Firing Lasers Fiber are for use in general, urological, OB-GYN, orthopedic, and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

This 510(k) submission is a modification of the existing Clarus Model 1150 Lascr Fiber previously filed as K922881 and found to be substantially equivalent by the FDA on November 16, 1992. The original 510(k) device was a single-use, straight firing laser fiber with a fiber indicated for laser disc decompression where the laser is used to remove inner disc material. The laser fiber core ranges from 380 -- 600 microns. The modifications represented by this submission are the addition of a reusable fiber, a side firing version (Model 1160), increased indications for any soft tissue application for which Ho:YAG lasers have been cleared, and an increased laser fiber core size range from 200 – 1000 microns. The Model 1150 Clarus Straight Firing Fiber is identical in materials, methods of manufacture, sterilization, and dimensions to the currently marketed Clarus Model 1150 Laser Fiber (K922881) with the following exceptions. These exceptions are: making the fiber assembly reusable, increasing the range of the laser fiber core size from 380 - 600 microns to 200 - 1000 microns, and the indications for use. The distal end is polished flat and the laser energy is transmitted in a forward direction. The low OH fiber is terminated on the proximal end with a standard compatible laser connector. These devices consist of an optical fiber, which may be contained in a catheter tube, cannula. needle, handpiece or handle. The Model 1160 Clarus Side Firing Laser Fiber is built identical to the Model 1150 Clarus Straight Firing Fiber listed above with the following exceptions. The exceptions being that the entire working length of the fiber is in a protective sheath and the distal end is polished at an angle, and then terminated in a quartz. cap. The distal tip includes an exit beam indicator that is easily visible to the operator when the fiber is placed through an endoscope. On the proximal end, the low OH fiber is terminated with a standard compatible laser connector. The Clarus Model 1150 Straight Firing and the Clarus Model 1160 Side Firing Laser Fibers are supplied sterile (ETO) and are intended for reuse. The Clarus Straight Firing and the Clarus Side Firing Laser Fibers may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.