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The Davol® Hysteroscopy Pouch Drape and Tubing Set is intended for the collection of distention and irrigation fluids during diagnostic or operative hysteroscopy.

The Davol Hysteroscopy Pouch Drape and Tubing Set consists of a Drape and Fluid Collection Tubing. The Drape is a blue polyethylene under-buttocks sheet with a clear, funnelshaped polyethylene fluid collection pouch. The sheet has a patient adhesive strip located at the edge closest to the pouch, as well as hand cuffs to facilitate placement under the patient. The cuffs are identified as left and right. The pouch is held open by a malleable wire support located at the top outside edge and it contains a spunbonded nylon fabric filtration screen to catch large tissue debris or surgical gauze, which prevents clogging the drainage port. The drainage port, located at the bottom of the pouch, has a hinged cap. The Fluid Collection Tubing includes a Drape Suction Set and an Outflow Tubing Set. The Drape Suction Set is supplied in a Y-configuration manufactured from three pieces of polyvinylchloride (PVC) tubing joined by a PVC Y-Connector. The Ouflow Tubing Set includes an anti-siphon feature which allows air to vent into the fluid path of the outflow tubing.

Repair of Inguinal Hernia Defects.

The Proposed Device, the Bard Sperma-Tex Preshaped Mesh, is manufactured from knitted polypropylene monofilament. The mesh is cut in a thumbnail design. A patch of e-PTFE is stitched onto one side of the mesh, at the rounded corner, with polypropylene monofilament.

The Proposed HydroFlex Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy.

The modified HydroFlex HD system is designed to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy. The system distends the uterus for better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site. The modified HydroFlex HD hysteroscopic distention tubing set is intended for use with the HydroFlex Irrigation Pump Controller. Pressure in the pumping chamber is determined by the setting on the main controller which is calibrated to account for 16 inches of bag height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the intrauterine space is limited to approximately 100mmHg or 2.0 psig, by the main controller. Rate of flow is dependent upon the pumping chamber pressure. Fluid will stop flowing when the back pressure in the system equals the pressure setting on the controller. Under static pressure conditions with no outflow this will equal the intrauterine pressure. The impeller continues to spin even with flow stopped and, in this way, the selected pressure is maintained. Flow will automatically resume when system back pressure falls below the selected pressure.

The HydroFlex HD Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy.

The HydroFlex HD system is designed to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or operative hysteroscopy. The system distends the uterus for for better visualization during hysteroscopic procedures and flushes blood and tissue debris from the operative site. The HydroFlex HD hysteroscopic distention tubing set is intended for use with the HydroFlex Irrigation Pump Controller. Pressure in the pumping chamber is determined by the setting on the main controller which is calibrated to account for 16 inches of bag height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the intrauterine space is limited to approximately 100mmHg or 2.0 psig, by the main controller. Rate of flow is dependent upon the pumping chamber pressure. Fluid will stop flowing when the back pressure in the system equals the pressure setting on the controller. Under static pressure conditions with no outflow this will equal the intrauterine pressure. The impeller continues to spin even with flow stopped and, in this way, the selected pressure is maintained. Flow will automatically resume when system back pressure falls below the selected pressure. The HydroFlex HD system is driven by an impeller pump which is powered by an electronic Controller. The input pressure is determined by the user selected setting on the electronic Controller. The Controller determines the speed of the impeller pump which drives the flow of irrigant and determines the resultant static pressure. Both the HydroFlex HD and the Zimmer CDIS system contain a pressure relief valve which limits the maximum intrauterine static pressure by releasing fluid through the valve and drain tube. The HydroFlex HD system pressure relief valve relieves static pressures if the pressure reaches 150mmHg.

Reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

The proposed Composite Mesh is manufactured from knitted polypropylene monofilament with a diameter of 6 mil. The unique knitting process for the Composite Mesh produces a flat double layer of mesh. This double layer of mesh is knitted and interconnected simultaneously during the knitting process. One side of one layer of mesh is heat bonded to a single layer of expanded polytetrafluoroethylene (e-PTFF).

Both the Pneumatic API system and the Battery API system are designed to provide controlled pulsatile irrigation to a joint during arthroscopic surgical procedures. The pulsatile action of the pump irrigation and mechanical debridement of tip brush help to remove blood, tissue debris, loose bodies, and foreign matter from the joint cavity. When connected to a suction source the device's can be used to aspirate fluids and debris from the joint cavity. The device's will be provided as sterile single patient use devices. The Pneumatic API System, Battery API System, Simpulse Plus Suction Irrigator System and the Simpulse SOLO Suction Irrigator System are jet lavage devices intended to provide controlled powered pulsatile irrigation for the cleansing and debridement of surgical sites (the Simpulse Plus and Simpulse SOLO also have the extended indication of providing irrigation to wound/burns). When connected to a suction source, the devices can be used to aspirate fluids and debris from the surgical site. The API Irrigation/Brush tip and the Davol Femoral Canal Irrigation Brush Tip are both intended to provide pulsatile irrigation for the cleansing and debridement of orthopaedic surgical sites. In addition ,both of these tips and the Acufex Microsurgical Rasp are intended to provide mechanical debridement of surfaces during orthopaedic surgical procedures. The API Suction Tip and the Davol Arthroscopic Outflow Cannula are intended to allow for the outflow of fluid and debris from the joint space during arthroscopic surgical procedures.

Both the Pneumatic API system and the Battery API system are designed to provide controlled pulsatile irrigation to a joint during arthroscopic surgical procedures. The pulsatile action of the pump irrigation and mechanical debridement of tip brush help to remove blood, tissue debris, loose bodies, and foreign matter from the joint cavity. When connected to a suction source the device's can be used to aspirate fluids and debris from the joint cavity. The device's will be provided as sterile single patient use devices. The major components of the systems are as follows: Pneumatic Arthroscopy Pulsed Irrigator System: The Pneumatic Arthroscopy Pulsed Irrigator (API) system consists of the Davol Simpulse Plus Handle with the API Irrigation/Brush Tip and the API Suction Tip. The Pneumatic API System functions by means of a pneumatically activated pump membrane (diaphragm) contained within the pump assembly to generated the pulsating fluid output. The pump membrane is activated by pressure from an air/nitrogen source. Battery Arthroscopy Pulsed Irrigator System: The Battery Arthroscopy Pulsed Irrigator System consists of the Davol Simpulse SOLO Handle with the API Irrigation/Brush Tip and the API Suction Tip. The Battery API system uses a mechanical pumping system to generate the pulsating fluid output. It is powered with four (4) standard AA alkaline batteries with an output amperage of approximately 1.8 amperes, with a voltage of 6 volts, dc (direct current). The batteries power a motor which activates movement of a bellows pump. The pumping system and power source are housed in the device's handle which will be manufactured from cyrolite (acrylic polymer). The batteries are contained in a battery enclosure within the device's handle.

To be connected to suction / vacuum assemblies to filter smoke particulates / aerosols, and retain aqueous fluids generated during laparoscopic electrosurgery or laser surgery.

Hydrophobic multilayered filter with vacuum tubing for attachment to wall vacuum or suction source.

The HydroFlex LI System is designed to provide controlled irriqation during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid in visualization. It may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage. The Davol HydroFlex LI system and the Davol Endo-Flo are intended to provide controlled irrigation during laparoscopic procedures. The devices flush blood and tissue debris from the operative site during laparoscopy to aid in visualizatior and may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.

The HydroFlex LI System is designed to provide controlled irriqation during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid in visualization. It may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage. The HydroFlex LI disposable Fumping Chamber/Tubing Set is intended for use with the HydroFlex irrigation pump Controller. Pressure in the pumping chamber is determined by the setting on the main Controller which is calibrated to account for two feet of baq height above the outflow. Maximum static pressure (all outflow closed and no fluid flow) applied to the pre-attached probe tip is limited to approximately 500 mmHg, or 10.C psig, by the main controller. The controller defaults to gravity at an input pressure less Rate of flow is dependent upon pressure than 70mmHq. selection on the controller and probe tip selection. Fluid will not flow when the back pressure in the system equals the pressure setting on the controller, e.g., when the in the off position. Under static pressure probe is conditions with no outflow, this will equal the controller setting. The impeller continues to spin even with flow stopped, and, in this way, the selected pressure i s maintained. Flow will automatically resume when system back pressure falls below the selected pressure, e.q., when the probe is open to flow. The HydroFlex LI system is driven by an impeller pump which is powered by an electronic Controller (electromechanical control is similar to U.S. Endoscopy Group's Laparoscopic Irrigation System and Suction Irrigation Tubing Set and the Linvatec Apex™ Universal Irrigation The input pressure is determined by the user System). selected setting on the electronic Controller. The Controller determines the speed of the impeller pump which drives the flow of irrigant. In addition, the design of the HydroFlex system reusable main Controller is such that it can be used as a multipurpose fluid irrigation system (dependent on the disposable Pump Tubing set used with the Controller). Both systems contain fluid contact components made from cyrolite and polyvinylchloride. Other materials of the HydroFlex LI system differ from the Endo-Flo system.