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510(k) Data Aggregation
K Number
K232618Device Name
Aurora Surgiscope System
Manufacturer
Rebound Therapeutics Corporation
Date Cleared
2023-10-27
(59 days)
Product Code
GWG, GZT
Regulation Number
882.1480Why 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
K182211Device Name
Aurora Surgiscope System
Manufacturer
Rebound Therapeutics Corporation
Date Cleared
2019-01-18
(156 days)
Product Code
GWG, GZT
Regulation Number
882.1480Why 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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