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    K Number
    K132337
    Device Name
    ESOFLIP BALLOON DILATION CATHETER
    Manufacturer
    CROSPON, LTD.
    Date Cleared
    2013-10-07

    (73 days)

    Product Code
    PID,PIE
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K900924,K120997
    Why did this record match?
    Device Name :

    ESOFLIP BALLOON DILATION CATHETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    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.

    AI/ML Overview

    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 MetricAcceptance Criteria (Implicit from Predicate Comparison)Reported Device Performance
    Indications for UseIdentical 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 UseHospital and surgery centers (identical to predicates).Hospital and surgery centers (identical to predicates).
    Patient PopulationPatients with Achalasia (identical to K900924).Patients with Achalasia (Identical to K900924).
    MaterialsIdentical 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 (
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