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510(k) Data Aggregation

    K Number
    K232618
    Device Name
    Aurora Surgiscope System
    Manufacturer
    Rebound Therapeutics Corporation
    Date Cleared
    2023-10-27

    (59 days)

    Product Code
    GWG, GZT
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebound Therapeutics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aurora Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
    Device Description
    The Aurora Surgiscope System consists of two components: (1) a sterile, single use, sheath with integrated illumination LEDs and camera, with an obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB). The sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the sheath for user reference. At the proximal end of the sheath is the imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob. - The LEDs provide illumination to the surgical field by directing light down the sheath, along . the instrument channel. - The camera captures video image of the surgical field. ● The proximal end of the sheath also contains a tab, which may be used to manually hold the device. To facilitate insertion of the surgical site, an obturator is provided with the device. During insertion, the obturator is fully inserted into the sheath, and the entire unit is advanced to the desired location. The distal end of the obturator is conical in shape to minimize tissue damage. In addition, the proximal handle of the obturator is designed to accommodate various stereotactic instruments for neuronavigation. Once inserted, the obturator is removed. Two sterile, single use accessories optional for use are provided with the Aurora Surgiscope System: an Irrigation Device and 12 French Suction Device. The ICB is a non-sterile device that provides three main functions in the Aurora Surgiscope System: - To power the Surgiscope LEDs and camera - . To relay the video feed captured by the Surgiscope camera to a display monitor for real-time image visualization - . To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), as well as vary the LED light output. The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The ICB is supplied with two cables: A power cable for connection to an AC wall outlet, and a display cable for connection to a high definition surgical monitor.
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    K Number
    K203745
    Device Name
    AURORA Evacuator +Coag
    Manufacturer
    Rebound Therapeutics
    Date Cleared
    2021-12-02

    (345 days)

    Product Code
    GEI, K96
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebound Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization may include laparoscopic, pelviscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.
    Device Description
    The AURORA Evacuator +Coag device is provided sterile, for single use only. It is a disposable, handheld, battery powered instrument that combines the ability to remove fluids and soft tissue, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site during minimally invasive surgical procedures. It consists of a wand and handle with connection ports for a bipolar electrode cable, vacuum source (for aspiration) and irrigation line. At the distal tip of the wand, a side aspiration window with an internally rotating whisk is provided to break up and aspirate soft tissue and fluids. The battery and motor that powers the whisk is contained in the device handle. Bipolar electrodes are located at the distal tip of the wand and can be activated to coagulate tissue when connected to an electrosurgical generator. When desired, an irrigation line may be connected to the handle and saline can be delivered to clear the surgical field as a procedural aid. Bipolar electrosurgical generator/cables, vacuum source, and irrigation source are not provided with the device. Prior to use, the device is to be connected to electrosurgical generator, external vacuum source (i.e. operating room suction) and irrigation source (i.e. drip). A green power indicator light is located on the top portion of the handle to show that power is available to the device. A suction control vent for the user to control vacuum pressure and a button for activating the whisk are located conveniently on the handle.
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    K Number
    K201840
    Device Name
    Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
    Manufacturer
    Rebound Therapeutics
    Date Cleared
    2020-11-04

    (125 days)

    Product Code
    GWG, GZT
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebound Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AURORA Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
    Device Description
    The Aurora Surgiscope System consists of two components: (1) a sterile, single use, sheath with integrated illumination LEDs and camera, with an obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB). The sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the sheath for user reference. At the proximal end of the sheath is the imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob. - . The LEDs provide illumination to the surgical field by directing light down the sheath, along the instrument channel. - The camera captures video image of the surgical field. The proximal end of the sheath also contains a tab, which serves as the location for the fixation arm to hold/fix the device. To facilitate insertion of the surgical site, an obturator is provided with the device. During insertion, the obturator is fully inserted into the entire unit is advanced to the desired location. The distal end of the obturator is conical in shape to minimize tissue damage. In addition, the proximal handle of the obturator is designed to accommodate various stereotactic instruments for neuronavigation. Once inserted, the obturator is removed. The ICB is a non-sterile device that provides three main functions in the AURORA Surgiscope System: - . To power the Surgiscope LEDs and camera - . To relay the video feed captured by the Surgiscope camera to a display monitor for real-time image visualization - . To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), as well as vary the LED light output. The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The ICB is supplied with two cables: A power cable for connection to an AC wall outlet, and a display cable for connection to a high definition surgical monitor.
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    K Number
    K201637
    Device Name
    Aurora Evacuator +Coag
    Manufacturer
    Rebound Therapeutics
    Date Cleared
    2020-08-12

    (57 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebound Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open.
    Device Description
    The subject device, AURORA Evacuator +Coag, is provided sterile, for single use only. It is a disposable, handheld, battery powered instrument that combines the ability to remove fluids and soft tissue, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site during minimally invasive surgical procedures. It consists of a wand and handle with connection ports for a bipolar electrode cable, vacuum source (for aspiration) and irrigation line. At the distal tip of the wand, a side aspiration window with an internally rotating whisk is provided to break up and aspirate soft tissue and fluids. The battery and motor that powers the whisk is contained in the device handle. Bipolar electrodes are located at the distal tip of the wand and can be activated to coagulate tissue when connected to an electrosurgical generator. When desired, an irrigation line may be connected to the handle and saline can be delivered to clear the surgical field as a procedural aid. Bipolar electrosurgical generator/cables, vacuum source, and irrigation source are not provided with the device. Prior to use, the device is to be connected to electrosurgical generator, external vacuum source (i.e. operating room suction) and irrigation source (i.e. drip). A green power indicator light is located on the top portion of the handle to show that power is available to the device. A suction control vent for the user to control vacuum pressure and a button for activating the whisk are located conveniently on the handle.
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    K Number
    K191861
    Device Name
    Aurora Surgiscope System
    Manufacturer
    Rebound Therapeutics
    Date Cleared
    2019-12-06

    (148 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebound Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aurora Surgiscope System is intended for use in endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
    Device Description
    The Aurora Surgiscope System consists of two components: (1) a sterile, single use, neurological endoscope and (2) a non-sterile, reusable control unit, Image Control Box (ICB). The Aurora Surgiscope includes the following components: - Sheath - Camera - LED (Light Emitting Diodes) - Sheath Cable - Obturator The Sheath is fabricated from ABS plastic and is cylindrically shaped. It acts as both the insertion portion and instrument channel of the endoscope. Depth markers are located on both sides of the Sheath in 1 cm increments to aid with device insertion. LEDs are embedded into the interior wall of the Sheath that provide illumination of the surgical field. A larger diameter plastic ring, Camera mount (or Fixation ring), is located at the proximal end of the Sheath and may be used with fixation arm(s) to hold/fix the device. The Camera assembly is rigidly attached to the Camera Mount and positioned to produce a forward view (0° direction) of the surgical site. An optical lens and prism are also incorporated for imaging. The Surgiscope electronics are connected to the ICB by a flexible shielded Sheath Cable. The cable exits from the rear of the Camera housing and is connected to the ICB during system set-up. The Obturator is pre-loaded into the Sheath. Its distal tip is fabricated from clear plastic and is conical shaped to minimize injury to tissue during insertion. At the proximal end, a plastic handle is used for removal of the Obturator from the Sheath and has an attachment on the handle to secure stereotactic instruments for neuronavigation. A stainless steel tube connects the Obturator tip and handle. The Image Control Box (ICB) controls the real-time video image that it receives from the camera on the Surgiscope. It also delivers the real-time video to an external Display Monitor and provides isolated power to the Surgiscope LEDs and camera. The ICB is supplied with two cables: an isolated 110V power cable to be connected to an AC electrical outlet and a cable which is to be connected to the Display Monitor in the operating room. The user interface is a membrane keypad with buttons that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The connections to the Surgiscope, Display Monitor and Power are the side of the ICB as well as the ON/OFF switch.
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    K Number
    K190075
    Device Name
    Aurora Evacuator
    Manufacturer
    Rebound Therapeutics
    Date Cleared
    2019-02-12

    (27 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebound Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AURORA Evacuator is a powered instrument with a handpiece intended for removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/ Otolaryngological.
    Device Description
    The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures. The AURORA Evacuator consists of a stainless-steel suction wand connected to a plastic handle with an exiting vacuum tube. A barb connector at the end of the exiting vacuum tube is intended to connect to operating room suction. The suction wand is configured with an aspiration window near its distal end for fluid and soft tissue to enter. Internal to the suction wand is a rotatable shaft with wire loops. The wire loops are aligned with the aspiration window and are intended to physically break-up soft tissue. The rotatable shaft is connected to a battery powered motor. The motor and batteries are housed in the ergonomically designed handle. A green power indicator light is located on the top portion of the handle to show that power is available to the device. The handle also contains a suction control vent for user vacuum control and a motor control button for user activation of the rotating wire loops. The AURORA Evacuator is shipped in a non-functional state that requires removal of a pull tab from the handle to initiate power to the device.
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    K Number
    K182211
    Device Name
    Aurora Surgiscope System
    Manufacturer
    Rebound Therapeutics Corporation
    Date Cleared
    2019-01-18

    (156 days)

    Product Code
    GWG, GZT
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebound Therapeutics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aurora Surgiscope System is intended for use in endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
    Device Description
    The Aurora Surgiscope System consists of two components: A sterile, single use, neurological endoscope called the Aurora Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB). The Aurora Surgiscope includes the following parts: - Sheath - Camera - LED (Light Emitting Diodes) - Sheath Cable - Obturator The Sheath is fabricated from plastic and shaped like a hollow cylinder. It acts as both the insertion portion and instrument channel of the endoscope. LEDs are embedded into the Sheath's distal end for illumination. The Sheath's proximal end incorporates a larger diameter plastic ring with a fixation tab. The Camera is rigidly attached to the plastic ring and positioned to produce a forward view of the surgical site. The Sheath's electronics are connected to the ICB by a flexible shielded cable. The cable exits from the rear of the Camera housing and connects to the ICB during system set-up. The Obturator is pre-loaded into the Sheath. Its distal tip is fabricated from clear plastic and is conical shaped. It has a plastic handle at the proximal end to facilitate removal. A cannulated steel post connects the Obturator tip and handle. The Image Control Box is supplied with two cables; one for power and the other for connection to a 3rd party external HD Monitor. The ICB delivers power to the LEDs and Camera, transfers the video image to the HD Monitor, and allows a user to turn knobs that digitally adjust image quality and orientation.
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    K Number
    K180372
    Device Name
    Aurora Evacuator
    Manufacturer
    Rebound Therapeutics
    Date Cleared
    2018-04-09

    (56 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rebound Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AURORA Evacuator is a powered instrument with a handpiece intended for removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/ Otolaryngological.
    Device Description
    The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures. The AURORA Evacuator consists of a stainless-steel suction wand connected to a plastic handle. The stainless-steel suction wand is configured with an aspiration window, near its distal end, for fluid and soft tissue to enter. Internal to the suction wand is a shaft with a whisk-shaped configuration at its distal end. The whisk-shaped configuration is aligned with the aspiration window. The proximal end of the shaft is connected to a battery powered motor in the handle. The interior of the plastic handle contains the battery powered motor, batteries, electrical circuitry and the suction tubing. The suction tubing connects the stainless-steel suction wand to operating room vacuum. On the exterior of the handle is a tear-dropped shaped vent for user control of vacuum strength, a green light that illuminates when power is available, and a button for user activation of the motor. The AURORA Evacuator is shipped in a non-functional state that requires removal of a pull tab from the handle to initiate power to the device. There are three (3) configurations of the AURORA Evacuator; AURORA Evacuator -13, AURORA Evacuator -10 and AURORA Evacuator -7. All configurations are fabricated from the same materials and electrical components. The only difference among the configurations is the working length of the wand component. The wand working lengths are 13cm, 10cm, and 7cm, respectively.
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