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The Lumendi DiLumen C1 and EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen C1 and EZ1 consists of a sleeve with an inflatable balloon at the distal end that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The DiLumen C1 includes an attached flexible tool channel to allow endoscopic tools to be inserted through it and used in conjunction with the endoscope. The DiLumen EZ1 does not have the tool channel. The C1 and EZ1 are provided non-sterile and do not require disinfection or sterilization prior to use. The devices are intended only for single patient use. To stabilize the system during clinical use, the C1 is used with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channel to a surgical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling. As the EZ1 does not have a tool channel, the Tool Mount is not used to perform its intended functions.

The Lumendi DiLumen C² is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen C2 consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 is provided non-sterile and does not require disinfection or sterilization prior to use. The device is intended only for single patient use. To stabilize the system during clinical use, the C2 is provided with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channels to a surqical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling.

The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.

The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is inflated until it contacts the tissue near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the intestine tissue, and in combination with the Aft Balloon, creates an isolated diagnostic / therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area. The Suture Loops attached to the Fore Balloon of the DiLumen allow clinicians to manipulate tissue when used with an endoscopic clip. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflation, etc.) are unaffected by the presence of the DiLumen is designed to permit the usage of any standard tool through the endoscope working channel.

The DiLumen Endolumenal Interventional Knife ("DiLumen |ç") is a disposable monopolar electrosurgical device intended to be used for marking, cutting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.

The DiLumen Ix is a sterile, single patient use, disposable electrosurgical instrument. The DiLumen ly utilizes a pistol style handle, flexible shaft with an articulating section at its distal end, and a stainless-steel knife tip that can be extended and retracted. The handle incorporates controls that allow the clinician to rotate the shaft, extend or retract the knife tip, articulate the distal end of the shaft in a specific plane, and lock the articulation in a fixed position. The DiLumen Ik has a plug at the bottom of the handle that is used to connect the device to an electrosurgical unit. When connected to the generator, and used in combination with grounding pads, high-frequency current can be applied through the knife tip to mark, cut or cauterize tissue at the lesion site. There is also a female luer lock connector on the handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing the knife tip or to inject saline into the submucosa to lift lesions.

The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 - 14.3 mm. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.

The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area. This 510(k) notice encompasses a minor revision to the device's indications statement to specify that it can be used for tissue manipulation, as well as addition of suture loops to the Fore Balloon skirt to facilitate that functionality. The DiLumen is designed to permit the usage of any standard endoscopic tool through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) are unaffected by the presence of the DiLumen, including the sleeve, balloons, and suture loops.

The DiLumen Endolumenal Interventional Scissors ("DiLumen Is™") is a disposable monopolar electrosurgical device intended to be used for cutting, and cauterizing tissue within the digestive tract during endoscopic procedures.

The DiLumen I , is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. This allows the clinician maximum flexibility to cut, dissect and cauterize tissue during endoscopic interventions in the digestive tract. The clinician can insert the DiLumen Is into any endoscopic tool channel with a diameter of at least 6mm. With the DiLumen Is under direct visualization, the clinician can position the scissor blades as appropriate for the particular procedure using blade rotation, blade articulation, and shaft rotation as necessary. The clinician can then cut gastrointestinal tissue either with or without energizing the blades, depending on the specific need during the procedure. In addition, the DiLumen Is has a plug at the bottom of the handle. If desired by the clinician, this plug can be used to connect the device to an electrosurgical generator via a dedicated cord in order to apply monopolar electrical current through the blades to the target site in the gastrointestinal tract. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically. The DiLumen I , can also be used in conjunction with other endoscopic devices such as graspers, knives, etc. to perform endolumenal interventions.

The Lumendi DiLumen C2 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen C² consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 comes into limited (<24 hour) contact with breached or compromised surfaces of the patient. The C2 is provided sterile and intended only for single patient use. To stabilize the system during clinical use, the C2 is provided with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channels to a surgical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned and sterilized prior to each use following the instructions in the device labeling.

The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope, the endoscope and DiLumen are navigated to the target zone with the balloons deflated. Once the clinician is at the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate the two balloons with ambient air. The balloons assist in stabilizing the endoscope and the therapeutic area and are inflated or deflated independently. The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, insufflations, etc.) are unaffected by the presence of the DiLumen.