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The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only. The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

The Entuit PEG (subject device) includes a silicone enteral feeding tube (PEG tube) available in 24 Fr or 20 Fr, with site preparation components, introduction components, adapters, and connectors. The device is supplied sterile and is intended for single use in adults. Entuit PEGJ (subject device) includes a polyurethane enteral feeding tube (PEGJ tube) that is available in 12 Fr or 9 Fr. The Entuit PEGJ tube is for direct access to the jejunum. The 12 Fr PEGJ tube is designed to be inserted through the 24 Fr PEG tube and the 9 Fr PEGJ tube is designed to be inserted through the 20 Fr PEG tube such that the distal end extends into the jejunum and the proximal end extends out of the existing PEG tube. There are several feeding adapters for use with the PEG and PEGJ tubes. The PEG kit has one feeding adapter that is ENFit compatible and two feeding adapters that are compatible with Christmas tree/slip tip giving sets and syringes (Non-ENFit). The PEGJ tubes are also available with either ENFit compatible or Christmas tree compatible feeding adapters (Non-ENFit). The Entuit PEG is provided as a kit to facilitate either push or pull techniques of placement. In addition, the Entuit PEG kits are available in standard, safety, and international versions. The Entuit PEGJ is sold as a separate kit and available in standard versions.

The TeslaTome Bipolar Sphincterotome is intended for cannulation of the ductal system and sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP (endoscopic retrograde cholangiopancreatography). Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts. The Tesla Bipolar Active Cord is used to connect the TeslaTome to compatible electrosurgical generators.

The TeslaTome Bipolar Sphincterotome is an endoscopic electrosurgical accessory composed of a single stainless steel drive wire within a triple-lumen polymer catheter. The proximal end of the catheter/wire assembly terminates in a handle, held by the physician or assistant during ERCP procedures and fulfills three (3) functions: connection to an electrosurgical generator, injection of diluted contrast, introduction of an endoscopic wire guide and manipulation of the cutting wire. The distal end contains a stainless steel cutting wire and ink and band markings. Half of the cutting wire is insulated with a non-conductive polymer coating. The device allows for short-wire, distal wire guide exchange through the separation of a weakened wall in the wire guide lumen that separates with manual control. The device is also compatible with traditional long wire guides. The TeslaTome Bipolar Sphincterotome is available in eight model numbers reflecting cutting wire length of 20 or 25 mm, and a .035" Acrobat II wire guide in either 260 cm or 450 cm length, and an optional rotatable handle. The Tesla Bipolar Active Cord (TESLA-ACU-B) is used to facilitate connection to an Electrosurgical generator (ESU). It uses a magnetic connection at the sphincterotome alignment but facilitates connection with ERBE generators on the distal end with conventional ESU-compatible plugs. The Active cord is non-sterile and reusable.

This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.

The Gastrointestinal Injection Needles (subject devices) are sterile, single use devices that consist of a needle on an inner catheter fitted inside an outer catheter sheath featuring a luer slip/adjustment wheel handle with either a plastic or metal hub used as an injection port at the proximal end of the device. The devices are compatible with endoscopes with a minimum accessory channel of 2.0 mm or 2.8 mm. The Gastrointestinal Injection Needles have catheters which ranges in length from 195 to 315 cm, outer diameters of 5.4 FR and 6.9 FR, and needle gauges of 21, 23 and 25. Some configurations of the Gastrointestinal Injection Needles include ink marks at the distal end of the device to aid endoscopic visualization.

The AcuSnare Polypectomy Snare - Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

The AcuSnare Polypectomy Snare - Duckbill (ASDB) is a sterile, single use device compatible with the accessory channel of endoscope. This type endoscopic polypectomy device is designed to connect to an electrosurgical unit via an active cord accessory and the drive cable delivers energy through the snare head to cut and/or cauterize tissue as described in the instructions for use. The device consists of a handle, sheath, drive cable and wire loop snare head. The sheath is comprised of polytetrafluoroethylene (PTFE) and is offered in 7 Fr. (2.3 mm) diameter and 240 cm length models. The snare head is available in the shape of a duckbill configuration and offered in a 15 mm or 25 mm width. The stainless-steel drive cable and snare head pass through the sheath and the three ring (polycarbonate) handle allows the user to extend and retract the snare through the distal tip of the sheath.

Used for collection of cells in the biliary system.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush (subject devices) represent modifications made to the Wilson-Cook Double Lumen Biliary Cytology Brush and Fusion® Cytology Brush (predicate devices) cleared to market via 510(k) K171573 by Wilson-Cook Medical, Inc. The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes consist of a nylon brush on a stainless-steel drive wire with a stainless-steel tip, a double lumen catheter with ink markings, radiopaque markers, wire guide access via a wire guide hub or an IDE port, a detachable extension line with a leur lock for optional flushing of the wire guide hub and a pinvise handle. The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes are used by passing the device through an endoscope over a prepositioned wire guide to a target location. The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.

The Glo-Tip® Spray Catheter (subject device) is a sterile, single use device compatible with the accessory channel of an endoscope. The device consists of a long, thin polytetrafluoroethylene (PTFE) tube (catheter) with a stylet (metal wire) that together are introduced into the ductal area or elsewhere in the GI tract. Fluid (e.g., water or saline) can be injected through the catheter to spray the tissue that needs cleaning. The Glo-Tip® Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).

Howell D.A.S.H.® Sphincterotome with Dome Tip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP. Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy. Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy. Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy. Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

The sphincterotomes described in this submission are a sterile, single use devices compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. The active cords are accessories to sphincterotomes so that a sphincterotome can be connected to an electrosurgical unit.

This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

The Fusion® OMNI Sphincterotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high- frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

Endoscopic removal of stones in the biliary system and foreign bodies.

The Non-Lithotripsy Extraction Basket is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament or multifilament metal wires joined at the distal and proximal ends, and is advanced out of and retracted into the single or double lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter.

The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps. This device is indicated for adult use only.

The Captura® Disposable Hot Biopsy Forceps is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel forceps cups joined to a spool handle by a Pebax-coated stainless steel coilspring catheter and stainless steel drive cable. The handle's spool actuates the opening and closing of the forceps cups and its brass electrosurgical pin is intended for connection to an electrosurgical generator.