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The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.

The EndoFLIP® system is an endoscopically placed device that utilizes a catheter for various indications. Crospon submitted and received 510(k) clearances for the EndoFLIP® System with a number of different catheters with different indications for use. This submission is seeking to expand the indication for use for the proposed EsoFLIP® ES catheter to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. In all cases the catheters are to only be used with the EndoFLIP® system.

The EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.

The EsoFLIP® balloon dilation catheter is a modification of the predicate Crospon EndoFLIP® catheters. The EsoFLIP® is a small catheter with an inflatable balloon which is inserted into the gastro-esophageal junction of a patient with Achalasia. It is connected to the EndoFLIP® controller system (K I20997) and the catherer is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The EsoFLIP® catheter is inserted by the clinician. The proposed balloon dilation catheter, EsoFLIP®, can also make diameter measurements electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system. K 120997.

- The EndoFLIP® system is an endoscopically placed device indicated for use in patients fitted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting. - EndoFLIP® EF-620 catheter is indicated for use in measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves. - The EndoFLIP® system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity. Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test. The EF-325L has a locating LED used in conjunction with the shaft markings to locate the balloon midpoint.

The EndoFLIP® comprises a measuring system and a single use or reusable catheter to assist in measuring the lumen diameter at 16 points (EF family) or 8 points (BF family). The EndoFLIP® comprises a measuring system and catheter to assist in measuring lumens. In practice, the EndoFLIP® balloon catheter is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The deflated balloon is inserted under direct laparoscopic visualization. Once the balloon has been correctly located, it is then inflated with the diluted saline solution to a user programmed volume.

The EndoFLIP system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.

The EndoFLIP® system and catheter are identical to the predicate K092850, except the addition of the new software which permits a programmed series of inflations of the balloon in steps of volume. This feature is equivalent to a modality offered by the predicate Barostat (K991288). The device is not intended to perform a diagnostic test.

The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures. The EndoFLIP® ECD is single patient use, disposable. Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.

The EndoFLIP® ECD EF-800 External Channel Device (ECD) is an endoscopic accessory designed to provide an additional channel external to the endoscope for inserting, advancing, and removing endoscopic devices thereby preserving the working channel of the endoscope for other instruments.

The EndoFLIP® EF-900 Gastric Tube is intended for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and BF-325 catheters.

The EndoFLIP® Gastric Tube is a simple single lumen tube which acts as a support bougie for a 43 Fr lumen and may be used to aid in the EndoFLIP® catheter, K092850 and K 102214, deployment. It may also be used for drainage, suction or irrigation as it is open at both ends and features a number of side-holes at the distal end. A connector is supplied to push-on the proximal end to aid attachment to a suction system. The tube is 75 cm long and markings are provided at 20 cm and 70 cm from the distal end. The EndoFLIP® Gastric Tube is supplied non-sterile and is single patient use, disposable. An alcohol swab is provided to wipe down the tube exterior prior to use.

The EndoFLIP® EF-620 catheter is indicated for use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves. The EF-620 catheter is to be used only with the EndoFlip System.

The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the gastric sleeve. In practice, the EndoFLIP® balloon catheter is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The deflated balloon is inserted into the stomach by an anesthesiologist with placement being confirmed by the surgeon under direct laparoscopic visualization. One the balloon has been correctly located, it is then inflated with the diluted saline solution to user programmed volume. The display estimates the gastric sleeve diameter at sixteen points along the balloon. The system also allows snapshots to be taken and compared to real-time images.

The EndoFLIP® system is an endoscopically placed device indicated for use in patients fitted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting.

The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the stoma. In practice, the EndoFLIP® balloon catheter is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The deflated balloon is inserted alongside an endoscope and introduced across the gastric band under direct visualization. Where available, fluoroscopy may be used to guide the catheter since the measurement electrodes are clearly visible in the image field. Once the balloon has been correctly located, it is then inflated with the diluted saline solution to a user programmed volume. The display shows the changes in the estimated stoma diameter as the gastric band is filled. The system also allows snapshots to be taken and compared to the real-time images.