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The Stryker AIM Light Source is intended to trans-illuminate anatomical structures during open or laparoscopic surgical procedures. The Stryker® AIM Light Source and SafeLight Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The Stryker® AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the Stryker® AIM Light Source and SafeLight Cable are intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. The Stryker IRIS Ureteral Kit when used with compatible Stryker is intended to trans-illuminate the ureter during surgical procedures. The catheter accepts up to 0.038" guide wire. The kit can be used for either open surgical or laparoscopic procedures.

The Stryker® Infrared Illuminating System (IRIS) is used to trans-illuminate the ureter during laparoscopic or open surgical procedures. Trans-illumination is intended to help the surgeon identify the ureter(s) during open or laparoscopic surgical procedure of lower abdomen or pelvic areas. The Stryker® Infrared Illuminating System (IRIS) consists of the following main components (herein referred to as 'proposed devices'): - A light source console. - A Ureteral Kit that consists of two catheters, one fiber assembly containing two light emitting fibers, one catheter dispenser, one light emitting fiber dispenser, two luer connectors, and two drape clips.

The InfraVision Ureteral Kit with the InfraVision IR Illuminator is intended to transilluminate the ureter during surgical procedures. The Catheter accepts up to a 0.038"-guidewire. The Kit can be used for either open surgical (with the InfraVision Detector Probe) or laparoscopic (with the InfraVision Camera) access.

The Stryker Ureteral IIIumination System IV consists of an open-ended ureteral catheter, which allows the use of a guidewire (up to 0.038" dia), is composed of Pellethane™ with a hydrophilic coating to ease insertion into the ureters and incorporates a fiberoptic light guide that is used with the InfraVision IR llluminator to transluminate the ureter during surgical procedures. It can be used for either open surgical or laparoscopic access and is distributed as a sterile, single use disposable product. The device is validated for EtO sterilization to a SAL of 10°.

The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the ureter(s) during open or laparossopic surgical procedures of the lower abdomen or pelvic areas. As a general surgery transillumination device, the Stryker Ureteral Illuminator System III replaces and is substantially equivalent to existing predicate fiberoptic light ureteral catheter transillumination devices.

The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the ureter(s) during open or laparoscopic surgical procedures of the lower abdomen or pelvic areas. The Stryker Ureteral Illuminator System III illumination source will comply with UL 544 Standard for Medical and Dental Equipment and 21 CFR 1040.10 Performance Standards for Lasers. The Stryker Ureteral Illuminator System III fiberoptic light ureteral catheter kit will be constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. The Stryker Ureteral Illuminator System III EtO sterilization processes are validated per AAMI/ANSI/ISO 11135, to a SAL of 10-6.