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The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.

Electrosurgical Instruments

The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery.

The ACMI® DUR-HL Laser Systems are pulsed solid-state Holmium YAG Lasers with a wavelength of approximately 2080 nm (2.1um). This wavelength is absorbed primarily by water, whereby an average penetration depth of approx. 400 um (0.4 mm). The lasers are Class IV lasers pursuant to 21CFR 1040 and designed to comply with the requirements outlined in 21 CFR 1040. The ACMI® DUR-HL Laser Systems are comprised of the following components: - Laser Unit, which includes Laser console, control and display panel . - . Fiber port for delivery systems - System microprocessor control electronics . - Covered footswitch . - . Operating software - (For use with) a variety of fiber optic delivery devices/accessories. .

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine bedy cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures. The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

The ACMI® DUR®- Digital Ureteroscope and Choledochoscope (DUR®-D) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semiconductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit. The DUR®-Digital Ureteroscope and Choledochoscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The DUR®- Digital Ureteroscope and Choledochoscope may also be used to manage biliary calculi in a choledochoscope indication. The DUR®-D System uses a Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

Intended to be a conduit for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures, such as, nephrostomy, cystoscopy, or ureteroscopy, in the urinary tract.

The UroPass Access Sheath is a single use, sterile (EtO sterilized) disposable product. The sheath is made of layers of polyurethane and PTFE with a stainless steel coil sandwiched in between (the coil provides kink resistance). The sheath has a funnel at the proximal end to ease the insertion of an LDPE dilator. The dilator is equipped with a polypropylene luer connector for injection of irrigation or contrast. The dilator is removable from the sheath by means of a clip fixed to the luer connector. The outside of the sheath has a lubricious coating for ease of insertion into the ureter. For ease of visualization, the dilator and sheath are radiopaque. Two holes (suture loops) are incorporated into the funnel to facilitate attachment to surgical drapes for stabilization of the sheath during surgery.

The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are intended for the examination/operation of the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Like the predicate ACMI® MR-Series Ureteroscopes, the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are semi-rigid endoscopes with two working channels. Flexible accessories such as stone baskets, retrievers, forceps, electrohydraulic lithotripter probes and laser fibers may be used through either working channel. The main component parts of each device include: The metal shaft, Two working channels, An eyepiece, Optical imaging fibers, Light guide connector post, A distal lens, Light carrier fibers. This Special 510(k) proposes the addition of autoclaving processes as a sterilization method, a change in shaft material from stainless steel to MP35N alloy, as well as a change in the manufacturing process to allow the shaft to be hermetically sealed using a micro-TIG and laser welding process in place of epoxy seals.

The dual lumen ureteral catheter is designed for percutaneous and THC uddi lamon aretoral os indicated as a conduit for multiple uses including, but not limited to, ureteral dilation, stone displacement, including, but not limited tial/anesthetic agents and guidewire placement.

Like the predicate Flexible Tip (open or closed) Ureteral Catheter, the Dual Lumen Catheter is a ureteral catheter with a flexible tip used for guidewire placement and for contrast injection. The Dual Lumen Catheter incorporates the same technological characteristics as the predicate device. The proposed Dual Lumen Catheter raises no new questions of safety or effectiveness. Biocompatibility testing confirms that the different materials of construction (from polyurethane to polyethylene) present no new safety concerns. The method of manufacture (extrusion) is the same for both the predicate and the proposed device. The new material used in the Dual Lumen Catheter has been used in other legally marketed devices within the same classification regulation for the same intended use and has had an established history of successful clinical application in Urology. Like the predicate device, the Dual Lumen Catheter features a hollow plastic tube placed inside the ureter, which, as in the predicate device, allows for the passage of guidewires and for the injection of fluid. Both catheters are fitted with female luer lock Tuohy-Borst adaptors, and feature soft tips to ensure protection of tissue during passage. This Special 510(k) proposes an addition of the second lumen to the catheter, a modification of the material characteristics, shortening of the working length and a change of color of the device. The indications for use, principles of operation, and diameter of the Dual Lumen Catheter remain the same as in the predicate device.

The Invisio IRL Digital Rigid Laparoscope System is intended for use, by qualified physicians, to provide access to, illumination, and visualization of body cavities, during endoscopic laparoscopic surgical procedures.

The Invisio IRL Digital Rigid Laparoscope is a standard USA Series Laparoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image replacing the rod lens system typically used in the rigid laparoscope The Invisio IRL Digital Rigid Laparoscope can be inserted into the abdomen or chest through small skin cuts allowing the surgeon to explore the whole cavity without the need of making large standard openings dividing skin and muscle.

The ACMI® INVISIO ICN (ICN) Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

Like the predicate ACMI® Electronic Video CystoNephroscope (ECN) System, the ACMI® INVISIO ICN (ICN) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. The ICN can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The ICN incorporates the same basic video imaging technology located in the endoscope as the predicate device. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit. Like the predicate device, the ICN uses the same Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera. This Special 510(k) proposes modifications in the proximal handle design, a reduction in flexible shaft outer diameter, elimination of the secondary active deflection mechanism, and a minor software algorithm modification for the ACMI® INVISIO ICN. The indications for use, principles of operation, working channel length and diameter of the ACMI® INVISIO ICN remain the same as in the predicate device.

ACMI® M4™ Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.

ACMI M4 Series Telescopes are optical devices that are used with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems. ACMI M4 Telescopes are optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures in urology and gynecology. They are designed to be inserted through an endoscopic device such as an ACMI cystourethroscope, hysteroscope, or resectoscope. M4 Telescopes are (4mm diameter, 31 cm long) rigid autoclavable optical instruments available in four directions of view: M4-0A, direct (0°), M4-12A, operative (12°), M4-30A, foroblique (30°), and M4-70A, lateral (70°), to assist the physician in visualization of the anatomy during diagnostic and surgical procedures.

The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope, CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures

The ECN Video Cystonephroscope is a flexible endoscope that incorporates video sensor technology to capture the endoscopic image, replacing the fiber optic image bundle typically used in most endoscopes. The ECN Video Cystonephroscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney