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510(k) Data Aggregation

    K Number
    K241700
    Device Name
    Tenex 2nd Generation System
    Manufacturer
    Trice Medical, Inc.
    Date Cleared
    2024-11-18

    (158 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trice Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenex® 2nd Generation System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery, and Plastic and Reconstructive Surgery. The Tenex® 2nd Generation System is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.
    Device Description
    The Tenex 2nd generation system is an ultrasonic surgical instrument that fragments, emulsifies and aspirates soft and hard tissue. It also provides sharp debridement of soft and hard tissue in wounds such as neuropathic diabetic ulcers. The Tenex 2nd generation system is intended for use in an office-based setting, clinical or hospital environment. The system consists of a Console, ultrasonic MicroTips, a Foot Switch and a number of accessories. The Console includes a touch screen tablet with a graphical user interface, motors to drive diaphragm pumps in the MicroTip, ultrasonic driver electronics and Software. The Console generates the ultrasonic energy required to operate the MicroTips and manages irrigation fluids. The Console is non-sterile when used and does not require processing. The MicroTips connect to the Console for electrical power and to facilitate the transfer of irrigation fluid from the saline bag to the surgical site, and then aspirate the emulsified tissue and fluid to a collection bag incorporated into single use, disposable the MicroTip assembly. Motors in the Console couple to the diaphragm pumps in the MicroTips to control the fluid flows. The MicroTips are constructed from various biocompatible polymers and metals. The MicroTip tubing is made of biomedical grade PVC and silicone. The MicroTips are single use and sterile packaged. They are sterilized via gamma irradiation. The MicroTips are the ultrasonic surgical hand pieces that house the transducers, horns and needles with beveled tips. The Foot Switch is used by the user to remotely control the Console. It connects to the back of the Console via an electrical cable. It provides on/off functionality for cutting, irrigation, and aspiration. The Foot Switch is IPX8 rated for protection against liquids. The System includes additional components. a Packaging Hard Case is provided for shipping, handling. and storage of the Console, and a power cord is provided for connecting the Console to facility electrical power to operate the device. These items are non-sterile when used and do not require processing. Associated accessories include: a USB Flash Drive for saving procedure information, USBC-HDMI cable for connecting to an external display, and a USB-Smartphone adaptor for connecting USB output to a smartphone.
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    K Number
    K212556
    Device Name
    mi-eye 3 needlescope with cannula, mi-tablet 3
    Manufacturer
    Trice Medical, Inc.
    Date Cleared
    2021-09-15

    (33 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trice Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The mi-eye 3 needlescope™ with cannula, mi-eye tablet 3™ is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination of an interior cavity of the body through either a natural or surgical opening.
    Device Description
    The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is a portable visualization device that uses a probe with integrated camera and separate LCD monitor attached via a cable. The sterile, single-use needlescope probe includes the camera and image capture features with LED light source. The mi-eye 3 probe connects to, and is powered by, the reusable mi-tablet 3. The mi-tablet 3 includes an internal battery and power supply, along with a cable for external charging. The mi-tablet 3 LCD Monitor displays a real-time image from the probe. The Monitor is also capable of connecting to separate ultrasound transducer, linear and convex, imaging probes and displaying their visual output. The mi-eye 3 needlescope™ with cannula has a rigid shaft that extends from the handle. The distal tip of the probe contains the camera, illumination, and imaging optics. Irrigation may be provided through the distal end of the probe from user supplied solution attached to the handle. The mi-eye 3 needlescope™ with cannula is available in 75 and 95mm lengths with 0 and 25 degree viewing angles, relative to the axis of the probe is packaged with a scalpel, cannula, obturator and switching stick for use in creating and maintaining the channel for the probe. The monitor has a 12" (diagonal) screen. The probe weight is under 300 grams.
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    K Number
    K162475
    Device Name
    mi-eye 2, mi-eye 2 monitor
    Manufacturer
    Trice Medical
    Date Cleared
    2016-09-16

    (10 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trice Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The mi-eye 2 is indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
    Device Description
    The Camera Enabled Probe is a battery operated, portable, visualization device that uses a probe with integrated camera and separate LCD monitor attached via cable. The sterile, single-use probe includes the camera and image capture features with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to provide power to the probe. The probe scope extends from the handle as a rigid shaft with retractable needle and flushing port for cleaning the field of view. The distal tip of the probe contains the camera, illumination, and imaging optics. The mi-eye 2 devices are identical in design and function and available in three lengths: 50mm, 95mm, and 160mm. The monitor has a 10.8" (diagonal) screen. The entire unit weight is less than 300 grams.
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    K Number
    K141119
    Device Name
    CAMERA ENABLED PROBE
    Manufacturer
    TRICE MEDICAL, INC.
    Date Cleared
    2014-07-29

    (90 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRICE MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
    Device Description
    The Camera Enabled Probe is a battery operated, portable, visualization device that uses a probe with integrated camera and separate LCD monitor attached via cable. The sterile, single-use probe includes the camera and image capture features with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to provide power to the probe. The probe scope extends from the handle as a rigid shaft with retractable needle and flushing port for cleaning the field of view. The distal tip of the probe contains the illumination and imaging optics. The Camera Enabled Probes are identical in design and function and available in three lengths: 50mm, 95mm, and 160mm. The monitor is 220mm X 135mm X 39mm. The entire unit weight is less than 300 grams.
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