(73 days)
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.
This document is a 510(k) Premarket Notification for the EsoFLIP® Balloon Dilation Catheter. It outlines the device's description, indications for use, comparison to predicate devices, and a summary of non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each performance metric with specific thresholds. Instead, it states that "The results demonstrate that the EsoFLIP® has met the performance specifications." and that the device is "substantially equivalent" to predicate devices. The performance data provided is primarily a comparison to the predicate device's specifications.
| Performance Metric | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical to Cook Endoscopy Achalasia Balloon K 900924 (dilation of esophageal strictures, specifically for Achalasia patients). | The EsoFLIP® catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia. (Identical to K900924) |
| Technology (Dilation) | Maximum diameter 30 mm, working length 80 mm, use with guidewire (similar to K900924). | Balloon inflates to 30mm diameter, along a working length of 80mm. Features a guidewire tip. (Identical to K900924) |
| Technology (Measurement) | Similar measurement technique to EndoFLIP® K120997, with minor modifications (reduction in measurement points). | Provides an Estimated Diameter (Dest) of the balloon at 14 points along its length when inflated with saline solution. |
| Environment of Use | Hospital and surgery centers (identical to predicates). | Hospital and surgery centers (identical to predicates). |
| Patient Population | Patients with Achalasia (identical to K900924). | Patients with Achalasia (Identical to K900924). |
| Materials | Identical to predicate EndoFLIP® catheters, K 120997. Biocompatibility based on G95-1 and ISO 10993-1. | Patient contacting materials are identical to predicate EndoFLIP® catheters, K 120997. Considered surface contacting, mucosal membrane, limited duration ( |
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.