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510(k) Data Aggregation

    K Number
    K192662
    Device Name
    CapsoCam Plus (SV-3) Capsule Endoscopy System
    Manufacturer
    CapsoVision, Inc.
    Date Cleared
    2020-02-14

    (142 days)

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

    CapsoVision, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CapsoCam ® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
    Device Description
    CapsoCam® Plus (SV-3) capsule is a single-use. ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing. CapsoCam® Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The system consists of the following accessories: - CapsoCam® Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa in adults and used as a tool in the detection of abnormalities of the small bowel. - CapsoView (CVV) software program, which is used to download and view CapsoCam® Plus ● (SV-3) capsule images and to generate capsule endoscopy reports. - CapsoAccess (CDAS) Capsule Data Access System, which accesses data from the ● CapsoCam® Plus (SV-3) capsules. - CapsoRetrieve (CVR1) Capsule Retrieval Kit, which is used for the collection, storage, and ● transportation of the excreted CapsoCam® Plus (SV-3) capsules. - CapsoCloud (CLD), which is a cloud-based software application used to manage procedures ● and to review and analyze images from the CapsoCam® Plus (SV-3) capsule.
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    K Number
    K183192
    Device Name
    CapsoCam Plus (SV-3)
    Manufacturer
    CapsoVision, Inc.
    Date Cleared
    2019-04-19

    (151 days)

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

    CapsoVision, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CapsoCam® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
    Device Description
    CapsoCam Plus (SV-3) capsule is a single-use, ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the capsule using the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing. CapsoCam Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible Capsule CapsoCam (SV-3), the CapsoRetrieve® (CVR1) Capsule Retrieval Kit, the CapsoAccess® Capsule Data Access System (CDAS) and the CapsoView® (CVV) software. The capsule contains a panoramic color digital video camera, two silver-oxide watch batteries, white-LED light sources, a laser diode for data download and system-control and nonvolatile flash-memory data-storage electronics.
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    K Number
    K151635
    Device Name
    CapsoCam (SV-1)
    Manufacturer
    CapsoVision, Inc.
    Date Cleared
    2016-02-09

    (237 days)

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

    CapsoVision, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CapsoCam SV-1 video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
    Device Description
    CapsoCam® SV-1 is a single-use, ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the capsule using the provided retrieval kit, and returns it to the physician who downloads and reviews the images on a personal computer (PC). The capsule is typically excreted within 3 to 30 hours after swallowing. The CapsoCam® SV-1 video capsule is a panoramic imaging system which includes a panoramic lens system and a multi-array CMOS image sensor. The CapsoCam® has four side-facing cameras arrayed about the circumference of the capsule that together image a full 360° circumference and capture high-resolution color images of the mucosa. The CapsoCam® SV-1 acquires video images while moving through the patient's gastrointestinal tract. The frame rate is 5 frames per second (FPS) for each of 4 cameras (20 FPS total) the first two hours, and then decreases to 3 FPS per camera (12 FPS total). The initial frame rate is higher because the capsule moves more quickly in the duodenum than in the jejunum or ileum. After excretion, the capsule is retrieved by the patient using CapsoRetrive, a capsule retrieval system, including a strainer which is placed in the patient's toilet to retrieve the capsule while passing fecal matter and rinse water. The patient then returns the capsule to the clinic, where a technician disinfects the capsule and retrieves the data using the CapsoAccess, Capsule Data Access System (CDAS). The CDAS is comprised of a capsule carrier for holding the capsule opener for cutting off one end of the capsule, and a docking system for forming an electrical contact to the capsule printed circuit board (PCB) through the open end. The data is transferred to the workstation over the link shown schematically in Figure 4 below, from the capsule to the docking system by a serial peripheral interface (SPI) and to the workstation by a universal serial bus (USB). The reviewing workstation is a personal computer (PC) with the Capso Vieweimage review software installed. The CapsoView@(CVV) software displays the video and employs a variety of image-enhancement, video navigation, and image analysis features to facilitate the physician's diagnosis. The software allows the physician to efficiently annotate individual frames from the video and compile a procedure report.
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