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The iO-Tome Device is used for cutting bone for the purpose of removing a facet joint (facetectomy) of the spinal column.

The iO-Tome Device is a design modification of the iO-Flex MicroBlade Shaver. It is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting bone for the purpose of removing a facet joint (facetectomy) in the lumbar spinal column. The flexible cutting platform is comprised of two parallel cutting elements that run along a flat flexible metallic substrate. The metallic substrate has two plastic protectors that temporarily cover the parallel cutting elements during introduction of the device into the foramen and protect the underside of the cutting platform during bimanual reciprocations. After the device is introduced and positioned within the foramen with the use of the iO-Flex System accessories and connected to the iO-Wire and Distal Handle, the user pulls up on the handles thereby exposing the parallel cutting elements. The user can then proceed with bimanual reciprocations cutting through the targeted facet joint.

The Baxano Inc. MicroBlade Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The MicroBlade Shaver device is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting and biting soft tissue and bone. The Probe Accessory is comprised of a telescoping proximal handle, cannula, and deployable catheter used to access the decompression site and place the accessory iO-Flex® Wire. The Distal Handle Accessory is comprised of a handle to accommodate the iO-Flex Wire using a wire locking mechanism and wire capture receptacle and allows manual control of the MicroBlade Shaver and Neuro Check® devices. This 510(k) pre-market notification describes a modification solely to the iO-Flex Wire. The modifications include an additional surface finish process that employs heat treatment and a subsequent chemical etching process applied to the proximal wire section intended to improve the fatigue stress resistance. There were no changes in the wire material and a small change to one nominal dimension. The modified iO-Flex Wire is manufactured from nickel-titanium ("Nitinol") and is designed to connect to the distal end of the Neuro Check Device and MicroBlade® Shaver device for placement and allows manual control of the MicroBlade Shaver and Neuro Check devices in the neural foramen. The iO-Flex Wire is packaged with the Neuro Check Device and available as a separately packaged accessory device. The Baxano Inc. MicroBlade Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column. The MicroBlade Shaver is designed to be flexible, with a low profile to allow access to compromised neural areas in the spinal column. The accessories include a Probe, Distal Handle and the iO-Flex Wire. The fundamental scientific technology and operating controls remain unchanged from the predicate iO-Flex Wire design.

The Baxano Neuro Check™ Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.

The Neuro Check Device is designed to be pulled into the neural foramen by the iO-Flex Wire to enable the surgeon to direct a stimulus signal from a commercial EMG system to electrodes on the device enabling nerve root location prior to using a Baxano cutting and biting device. The Neuro Check Device is manufactured from biocompatible Pebax® tubing and stainless steel with a handle molded from ABS. The proximal end of the device handle has a pair of wires that connect to commercially available EMG systems. The iO-Flex Wire is manufactured from nickel-titanium wire and connects to the distal end of the Neuro Check Device for placement in the neural foramen. No changes were made to the previously cleared iO-Flex Wire design (K100958) other than packaging modifications to include it within the Neuro Check Device packaging for surgeon convenience. Since the previous clearance of the Neuro Check Device (K092729; October 2, 2009) changes were made to the physician labeling (the Instructions For Use) intended to provide compatibility with enhanced output stimulus signals of commercially-available intra-operative electromyography (EMG) neuromonitoring systems for motor nerve localization. Specifically, the maximum allowable EMG stimulation current amplitude to the Neuro Check Device was increased from 30 milliamps to 50 milliamps and the maximum current pulse width from 300 microseconds to 500 microseconds to support the stimulation parameters of commercially available EMG systems. There were no design modifications of the Neuro Check Device necessary to conform to the new electrical stimulation specifications. In addition, several design modifications were implemented since the last Neuro Check Device clearance. These modifications include integrating the separate Switch Box into the Neuro Check Device handle, eliminating the need for this external accessory. The handle itself is now molded from ABS plastic instead of being machined from the same material. Two radiopaque platinum-iridium marker bands were added to the distal flexible section to assist with fluoroscopic positioning of the device. A slight bend is made in the distal flexible segment to assist in orienting the Neuro Check Device as it is positioned with respect to the patient. Lastly, the iO-Flex Wire was added to the Neuro Check Device package for user convenience.

The iO-Flex Catheter is for continuous or intermittent preoperative, perioperative or post-operative delivery of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management. The catheter may also be used perioperatively during open spinal procedures to irrigate, aspirate or inject a bolus of fluid or medication. The iO-Flex Catheter is designed for use with the iO-Flex Wire.

The iO-Flex Catheter is comprised of two primary components: (1) Y-Adapter with a rotating hemostasis valve (RHV) and (2) a flexible catheter body. The Y-Adapter consists of two ports: (1) a central guidewire port with rotating hemostasis valve and (2) a side port for connection of a standard syringe for the irrigation, injection and / or aspiration of fluids at the surgical site. The central guidewire port with RHV allows for insertion of the iO-Flex Catheter over the Baxano iO-Flex Wire. The flexible catheter shaft contains external markers for depth adjustment by the clinician.

The Baxano, Inc. MicroBlade, Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The modified MicroBlade Shaver device is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting and biting soft tissue and bone. The modified Probe Accessory is comprised of a telescoping proximal handle, cannula, and deployable catheter used to access the decompression site and place the GuideWire. The Distal Handle Accessory is comprised of a handle to accommodate the GuideWire using a wire locking mechanism and wire capture receptacle and allows manual control of the MicroBlade Shaver and Neuro Check devices.

The Baxano, Inc. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.

A switch directs the stimulus signal so that the nerve can be located relative to the Neuro Check Device. The Neuro Check Device assists in the localization of nerve roots during spinal column surgery where visualization is limited as an alternative to removing additional bone for direct visualization.

The Baxano, Inc. Neural Localization Probe is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.

The Neural Localization Probe is based on the Baxano Standard Probe (for use with the Ultra Low Profile Rongeur and the Baxano Microblade Shaver) with the modification of circumferential bipolar electrodes. The Neural Localization Probe provides the surgeon additional feedback for localizing the nerve root instead of removing additional bone to improve visualization within the spinal column. A Switch Box directs the stimulus signal so that the nerve can be located on the top, bottom, left or right of the Neural Localization Probe. The Neural Localization Probe is made of stainless steel shaped to enable the surgeon to utilize both direct visualization and tactile feedback in order to evaluate foraminal bone and soft tissue landmarks during placement of Baxano cutting devices. The Switch Box allows energy to be directed from a commercial EMG system to one of four pair of bipolar electrodes so that the surgeon gets feedback as to the relative location of the nerve root to the probe placement.

The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The ULP Rongeur and accessory devices are used to access the neural foramen and decompress targeted areas. The Rongeur attaches to a needle wire and is pulled into the foramen with the distal handle also attached to the needle wire. Tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The accessories include a probe, guide and needle wire, which are used to explore the foramen, and position the needle wire through soft tissue and the skin.

The Baxano, Inc. Microblade Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The Microblade Shaver and Accessories are used to access the neural foramen and decompress targeted areas. The Microblade Shaver is pulled into the foramen with the Distal Handle and tissue is removed by pulling up on the distal handle to cut the targeted soft tissue and bone. The Accessories include a Probe, Guide, Needle Wire and Distal Handle. The Microblade Shaver is made of stainless steel and is flexible, with a low profile, to allow access to compromised neural areas when exposure is otherwise difficult to obtain.

The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The ULP Rongeur and Access Tools are used to access the neural foramen and decompress targeted areas. The Rongeur is pulled into the foramen with the distal handle and tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The Access accessories include a probe, guide and needle wire.