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The Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH® URO-TOUCH unit/generator for the fragmentation of renal calculi located in the kidneys and urinary bladder.

The Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH® URO-TOUCH unit/generator for the fragmentation of calculi located in the kidneys and urinary bladder. The Northgate Technologies Inc. AUTOLITH® URO-TOUCH System consists of a software controlled, electronic unit (Generator) which generates a single high-voltage pulse or a series of pulses across the tip of a flexible bipolar lithotripter probe. When discharged in 0.9% normal physiological saline solution, these pulses produce sharp, high-amplitude hydraulic shock waves that crack calculi (stones) located inside the body. They are capable of cracking calculi of virtually any size and composition. The objective is to reduce the size of the calculi so that fragments can be removed without major surgery. The AUTOLITH® URO-TOUCH System includes the following major components: AUTOLITH® URO-TOUCH Unit/Generator (K130368) Regulate the discharge voltage and repetition rate of a shot delivered to a connected extender cable and probe. Display the relative power delivered to the probe. Display the number of pulses to be delivered to the probe as requested by the operator. Automatically sense the existence of a plugged-in probe. Automatically preset start-up values for power and pulses according to the probe type. Automatically scale power range according to the probe type. Prohibit discharge of high voltage when the footswitch is activated if an extender cable/probe is not properly connected. Automatically compares the pulses delivered at the selected power levels and displays when to INSPECT or REPLACE PROBE. Displays the number of pulses delivered. Automatic AC Voltage Adjust. For use in all countries. The AUTOLITH® URO-TOUCH 9 Fr Probe is 54 cm long and is used with a transurethral scope for fragmentation of calculi in the kidneys and urinary bladder. The 9 Fr Probe, 54 cm long, was previously cleared by K914516 on January 7, 1992. The Extender Cable was cleared by K914517 on June 30, 1992.

To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to improve visualization. NEBULAE® SRS may be used in any laparoscopic surgery, as appropriate.

This 510(k) submission for the NEBULAE® SRS Laparoscopic Surgical Smoke Removal System (henceforth referred to as NEBULAE® SRS) covers the following product codes: • NEBULAE® SRS Pump (7-700-00) • NEBULAE® SRS CO₂ Gas Filtration Tubing Sets (7-510-57) The NEBULAE® SRS is intended to recirculate CO2 gas in the pneumoperitoneum whilst removing surgical smoke during laparoscopic procedures. The system consists of two parts: a Pump and dedicated singleuse, sterile Tubing Sets. The NEBULAE® SRS Pump is a microprocessor driven, mains-powered device containing a DC motor. The single-use, disposable Tubing Set consists of an integrated cartridge, containing a diaphragm pump, an in-line ultra-low particulate air (ULPA) with activated carbon filter, fluid trap(s), 10 feet of DEHP-free PVC tubing and two connectors for connecting the tubing to the trocars. The NEBULAE® SRS Pump's DC motor drives the pump head in the Tubing Set's cartridge to create the flow of CO2 gas from the patient's pneumoperitoneum, through the fluid trap(s) and filter before re-entering the patient. The NEBULAE® SRS Pump can be positioned on a level surface (e.g. a surgical trolley in the operating room) or fixed to a vertical IV pole using a dedicated bracket, which is available as an accessory (See VOLUME 011 for further information). The re-circulating CO2 gas can also be warmed by the addition of an in-line gas warmer, also available as an optional accessory.

The AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable probes for the fragmentation of renal calculi.

The AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable probes for the fragmentation of renal calculi. Both devices operate just like the legacy (predicate) AUTOLITH® device. The units are softwarecontrolled, electronic devices capable of cracking calculi of virtually any size and composition. The devices are table-top units that connect to a disposable probe that is used in the working channel of an endoscope. A surgeon places the tip of the probe near the surface of the calculus/stone under endoscopic visualization. The physician then steps on a pneumatic foot pedal to activate the device. The electronic circuitry of the device generates a single high-voltage pulse or a series of pulses across the tip of the disposable flexible bipolar lithotripter probe. The discharge (in 0.9% normal physiological saline) produces sharp, high-amplitude hydraulic shockwaves that help to fragment the calculus/stone so it can be passed or removed without major surgery.

The Nebulae™ I 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, Minimally Invasive Vessel Harvesting.

The Nebulae™ I 50 LPM Insufflator is microprocessor controlled. This CO2 (Carbon Dioxide) High Flow Insufflator has touch screen control and multiple operating modes. The System can be used for General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, and Minimally Invasive Vessel Harvesting procedures.