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The EMG tube is indicated for use where continuous monitoring of the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

Medtronic Xomed, Inc.'s NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are flexible, reinforced endotracheal tubes with inflatable cuffs. The NIM EMG ET Tubes are made from silicone elastomer. Each tube is fitted with electrodes on the main shaft, which are exposed only for a short distance, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and cuff are manufactured from material that allows the tube to conform readily to the shape of the patient's trachea with minimal trauma to tissues.

The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.

The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.

The NIM™ Surgeon Control Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

The NIMTM surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.

The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.

The NuVent™ Eustachian Tube Dilation Balloon is composed of a sterile, single use balloon handpiece and stopcock valve. The balloon is used in conjunction with the NuVent™ inflator, which is packaged with extension tubing to connect the inflator to the stopcock valve. The NuVent™ Inflator was cleared as a part of the NuVent™ EM Sinus Balloon Dilation System, 510(k) cleared under K132297. A pre-angled flexible balloon section promotes easy access and insertion into the Eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the Eustachian tube and surrounding tissues during insertion. The rigid shaft and handle extending to the flexible balloon section provides stability and tactile feedback when moving the balloon through the nasal passages and into the Eustachian tube canal. Mounted near the distal end of the balloon handpiece is a flexible balloon section. Once the balloon section is advanced into the target Eustachian tube the 6mm diameter/16 mm long rigid balloon is inflated using the separate NuVent™ inflator, expanding the Eustachian tube canal tissue and cartilage.

The Novapak Nasal Sinus Packing and Stent is intended for use in patients undergoing nasal/sinus surgery as a space occupying packing to: - · Separate tissue or structures compromised by surgical trauma. - · Separate and prevent adhesions between mucosal surfaces in the nasal cavity. - · Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption, and platelet aggregation. - · Act as an adjunct to aid in the natural healing process. Novapak is indicated for use as a nasal packing to treat epistaxis.

Novapak™ is a single use, nasal packing and stent for use following sinus surgery to prevent adhesions, control mild bleeding and provide a level of antibacterial effectiveness. Novapak™ is composed of formulated chitosan and cellulose ingredients in a sponge can be compressed for insertion into anatomy and can be cut to size. Novapak™ hydrates with sterile saline and forms a gel. The sponge dissolves within the nasal cavity with daily irrigation and natural mucus flow over several days. Residence time is typically 7-14 days with adequate irrigation. Alternately, the dressing may be removed through gentle aspiration at the discretion of the physician.

The NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery. The NIM Vital™ System may be used for EMG monitoring in surgical procedures including: Intracranial, Extracranial, Intratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities. The NIM Vital™ is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.

The NIM Vital™ system is an electromyography (EMG) monitor for intraoperative use during surgeries in which a motor or motor-sensory nerve is at risk. The NIM Vital™ records EMG activity from the muscles innervated by the affected nerve. The system assists in early nerve identification by providing the surgeon with tools to help locate and identify the particular nerve at risk within the surgical field. The system monitors EMG activity from the muscles innervated by the nerve at risk, alerting the surgeon when a particular nerve has been activated. Nerve monitoring involves measuring and displaying amplitudes of EMG responses as well as the latency (delay) between the stimulus and the EMG response. The system also allows an option for Automatic Periodic Stimulation (APS), allowing for EMG monitoring, nerve activity trending and alerts. This information is used throughout the procedure to determine and/or change surgical strategy in order to promote the best outcome for the patient by preserving nerve function. In addition, intraoperative monitoring can help verify the integrity of the nerve throughout the procedure. NIM Vital™ system provides detailed intraoperative nerve condition information to inspire surgical strategy and help improve patient outcomes. Proprietary technology notifies user in real time of nerve condition - visually and audibly. NIM Nervassure™ continuous monitoring technology provides real-time feedback on nerve function so surgeons can adjust course, if necessary, during thyroid surgery and other procedures affecting head and neck nerves. NIM NerveTrend™ EMG reporting enables nerve condition tracking throughout a procedure, even when using intermittent nerve monitoring. During both continuous and intermittent trending, green, yellow and status bars provide visual information and their associated tones provide audible cues to users of current nerve function and EMG trends. NIM Vital™ nerve condition information can be captured in a single, meaningful snapshot. The following components of the NIM Vital™ Nerve Integrity Monitoring System including mechanical, electrical and software design are subject of this 510(k) submission: NIM Vital™ Console NIM Vital™ Console controls the functions of the system: - Interacting with users via touch screen graphic user interface - Setting parameters for nerve stimulations - Executing stimulation procedures - Processing and displaying EMG responses - Notifying users about events by issuing audio signals - Interfacing with Patient Interface unit NIM Vital™ Patient Interface Under control of NIM Vital™ Console - Generating stimulation signals - Receiving and processing EMG responses - Connecting with Console wirelessly or via cable NIM Vital™ Accessories: - Cables allow connection between components of the system - Cart provides housing for the component of the system and allows easy movement of the Console within the Operating Room - Adaptors allow use of predicate NIM 3.0 System disposables with subject NIM Vital System The NIM Vital™ System uses sterile disposables that were developed and cleared for use with the predicate device NIM™ 3.0 and are not subject of this 510(k) submission: - Disposables: - Electrodes stimulation electrodes, return electrodes, Automatic Periodic Stimulation (APS) electrodes - Incrementing Probes In addition, NIM Vital™ System is using a Mute Probe - a non-sterile component of NIM™ 3.0 System to detect activation of electrocautery devices during surgical procedures.

Sharpsite™ AC Rigid Endoscope: The Sharpsite™ AC Rigid Endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures. including thinology and endoscopic plastic and reconstructive surgery. Sharpsite™ AC Sterilization Tray: Sharpsite™ AC Endoscope Sterilization Tray is intended to provide a specific configuration to hold, organize and protect Sharpsite™ AC Rigid Endoscope during their transport, storage and sterilization prior to use in surgical procedures.

The Sharpsite™ AC endoscopes are rigid rod lens endoscopes for imaging and are available in diameters from 2.7 mm to 4.0 mm and in angles of view of 0, 30, 45 and 70 degrees. These endoscopes are reusable, autoclavable instruments and are provided non-sterile. The Sharpsite™ Rigid Ear, Nose and Throat (ENT) endoscopes provide access and allow observation during otolaryngology and head and neck procedures. The device consists of rigid rod inserted into body orifice. The endoscope includes an optical system to visualize the image by direct view or with use of a camera. The endoscopes are provided non-sterile and can be reused by multiple methods as mentioned in the IFU. Each Sharpsite™ endoscope is fitted with a commercially available removable light port adapter for use with different manufacturers light cables. Sharpsite™ AC Endoscopic sterilization tray is a container which is a reusable device that includes a base and lid. It is a single level thermoplastic instrument case designed to hold Sharpsite™ AC Rigid Endoscopes. The Sharpsite™ tray is specifically configured to organize, store, protect, transport and sterilize Sharpsite™ AC Rigid Endoscopes for use in surgical procedures.

The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-guided surgery may be necessary. When used concomitantly, these systems may be used to - locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia; or - locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia. The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated applications should be used only as an adjunct for surgical quidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The NuVent™ EM Sinus Dilation System comprises sterile, single-use instruments that combine electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects of balloon dilation technology and an inflator. Each of the three types of sinus seekers (frontal, maxillary and sphenoid) has a unique shape and angle that allows for entry into the sinus outflow tract. The inflator consists of a plunger, barrel and extension tube. Each sinus seeker is intended for use in conjunction with the Fusion software on a Medtronic computer-assisted surgery system. Inside each sinus seeker is an EM tracker. The emitter on the EM Computer-Assisted Surgery System generates a low-energy magnetic field to locate the tracker mounted inside of the sinus seeker. The software displays the location of the sinus seeker's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seekers balloon can be inflated with saline solution by using the inflator to expand the outflow of the targeted sinus.

The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction. The ALAR™ Nasal Valve Stent supports and immobilizes intranasal tissues and cartilage during the post-operative healing period following intranasal and nasal valve surgery.

The elliptically shaped fluoroplastic stent is approximately 20 mm long and 16 mm wide. Slits symmetrically spaced along the stent's lateral edges allow for left and right nostril usage. The suture and needle attached to the stent provide stent anchoring and hold cartilage plates stable during post-operative healing.

The XPS Nexus™ System is indicated for the incision/cutting, removal and drilling of soft and hard tissue and bone in head and neck/ENT, oral/maxillofacial and plastic/reconstructive/aesthetic surgical procedures.

The XPS Nexus™ System is a powered microdebrider and drill system that removes soft tissue, hard tissue and bone during surgical procedures. The system consists of a power control console, a foot control unit and assorted hand-pieces to drive various burs, blades, drills, rasps and cannulas. Hand-piece options include the StraightShot® M2 Microdebrider, the StraightShot® M4 Microdebrider and the Indigo® Otology Drill. The power control console also includes integrated irrigation pump for irrigation of blades and burs. Optional accessories include an IV pole to hold a bag(s) of irrigation solution as well as a carrying case.