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510(k) Data Aggregation

    K Number
    K250493
    Device Name
    MotiliCap GI Monitoring System
    Manufacturer
    AnX Robotica Corporation
    Date Cleared
    2025-05-21

    (90 days)

    Product Code
    NYV
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    AnX Robotica Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MotiliCap GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders. Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined. The system measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices. Not for use in pediatric patients.
    Device Description
    The MotiliCap GI Monitoring System is comprised of the following components: - MotiliCap Capsule (Catalog Number: CP-US-7010) - Data Recorder (Catalog Number: MO-US-8001) - Computer Software (MotiliScan: V1. MO-US-8005) - Smartphone App (MotiliCap: V1. MO-US-8006) The single-use capsule consists of the pressure sensor, the pH sensor, and the temperature sensor, which separately measure the pressure, pH, and temperature in the GI tract to determine transit times of the stomach, small bowel, and colon. The system provides information that aids clinicians in the evaluation of motility-related disorders. The data recorder records biomedical data transmitted by the capsule. The MotiliScan software is installed on a general-purpose computer. Before the examination, the software can create a case to start a test. After the test is complete, the software can receive, and process downloaded test data from the data recorder and graphically display the data for easy analysis and review. The MotiliScan software analyzes data and calculates motility indices such as GET, SBTT, CTT, and WGTT. The MotiliCap App is installed on a smartphone. This App is connected to the data recorder via Bluetooth, displays the connection status, and shows information about the capsule connected to the data recorder.
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    K Number
    K233229
    Device Name
    NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
    Manufacturer
    AnX Robotica Corporation
    Date Cleared
    2024-01-05

    (99 days)

    Product Code
    NEZ, QUN
    Regulation Number
    876.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AnX Robotica Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NaviCam Small Bowel (SB) Capsule Endoscopy System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 2 years of age. The NaviCam Tether is an accessory of the NaviCam SB Capsule. It is intended to aid the capsule for visualizing the esophagus prior to the capsule's release into the gastrointestinal tract for a SB capsule endoscopy procedure in adults (≥ 22 years).
    Device Description
    The NaviCam Small Bowel Capsule Endoscopy System is an endoscopic capsule imaging system intended to obtain images of the small bowel. It is comprised of the following components: - a. Capsule: The disposable, ingestible NaviCam Small Bowel Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via an RF communication channel to the NaviCam Data Recorder located outside the body. - Data recorder: The Data Recorder is an external receiving/recording unit that receives b. and stores the acquired images from the capsule. - ESView Software: The ESView is a software application for processing, analyzing, c. storing, and viewing the acquired images collected from the NaviCam Data Recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports and a capsule endoscopy atlas. - Locator: The Locator is a handheld device that is used to turn the NaviCam Capsule d. on. It is also used for determining if the capsule is still in the body when the patient is not sure whether he/she expelled it. - e. Tether: The NaviCam Tether is a disposable product, which serves as an accessory to the NaviCam SB Capsule to allow for examination of the esophagus prior to releasing the NaviCam SB Capsule into the small bowel.
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    K Number
    K231960
    Device Name
    NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
    Manufacturer
    AnX Robotica Corporation
    Date Cleared
    2023-10-03

    (92 days)

    Product Code
    QKZ
    Regulation Number
    876.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AnX Robotica Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NaviCam Xpress Stomach Capsule is intended for visualization of the stomach of patients >= 6 years old with BMI =< 65 and a waist circumference =< 77 inches. The system can be used in clinics and hospitals, including ER settings. The NaviCam Tether is an accessory of the NaviCam Stomach Capsule. It is intended to aid the Capsule for visualizing the esophagus (not magnetically maneuvered) prior to the Capsule's release into the stomach capsule endoscopy (MCCE) procedure.
    Device Description
    NaviCam® Xpress Stomach Capsule Endoscope System enables the operator to control the capsule endoscope inside the stomach. The capsule endoscope can be moved in any direction during examination. The direction and angulation of the capsule camera head can be adjusted in real-time, hence realizing complete control of capsule endoscope movement and attitude during examination in the X left and right, Y forward and backward, Z up and down directions as well as rotation clockwise and counterclockwise.
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