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510(k) Data Aggregation
(29 days)
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(58 days)
The AVENTIX™ PFX System is an electrosurgical system intended to generate Pulsed Field Energy (PFE) for use with the NOVOCLEAR™ Device. The AVENTIX™ PFX System is indicated for use in small clinics, offices and/or hospital environments.
The NOVOCLEAR™ Device is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including the posterior nasal nerve distribution in patients with chronic rhinitis.
The AVENTIX™ PFX System and NOVOCLEAR™ Device include the following components:
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NOVOCLEAR™ Device - a single use, hand-held device capable of delivering pulsed field energy (PFE) to targeted tissue. The NOVOCLEAR™ Device consists of a handle, a dome-like electrode and an electrical connector. The dome-like electrode delivers PFE and is angled to approximately 60 degrees, to aid access to the targeted tissue. An electrical connector is used to connect the NOVOCLEAR™ Device to the AVENTIX™ Generator.
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AVENTIX™ Generator - generates predefined PFE output, which is delivered to the NOVOCLEAR™ Device dome-like electrode tip.
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AVENTIX™ Controller – Performs validation of the NOVOCLEAR™ Device prior to use, changes the status of the Generator between armed and disarmed, and receives and displays parameters from the generator to the user.
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Footswitch – for selective activation by the user to initiate PFE output.
The NOVOCLEAR™ Device delivers pulsed field energy (PFE) to soft tissues in the nasal airway, including the posterior nasal nerve distribution. Non-clinical testing was performed to support safety and performance for the labeled use.
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(180 days)
The Disposable Video Rhinolaryngoscope SP11A is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is used in conjunction with the Endoscopic Video Processor (Models M110B) to provide the images. The endoscope is intended for use in a hospital environment. It is designed for use in adults.
The Endoscopic Video Processor M110B is used in conjunction with corresponding Wesee endoscopes to process and display images for endoscopic procedure.
The Video Rhinolaryngoscope System consists of the Disposable Video Rhinolaryngoscope SP11A, Video Cable, Endoscopic Video Processor M110B and Accessories. To avoid risk of cross-contamination, the insertion part of the Disposable Video Rhinolaryngoscope SP11A is designed as a sterile, single use device. And other parts of the subject system are reusable device.
The endoscope has a long, thin, flexible tube to enter the patient's body, and the CMOS sensor embedded in the distal end of the endoscope is used to capture video signals of body cavity and real-time transfer the video signals to the endoscopic video processor through the video cable. The endoscopic video processor receives and processes the video signals according to the surgeon's operation on the control panel of the video image processor. Meanwhile, the light emitting diode (LED) lamp of the endoscope provides an illumination for the body cavity and the clear video is displayed on the monitor.
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(262 days)
The Disposable Biopsy Forceps FB-211D/221D/231D/241D are intended to be used to collect tissue within the upper airways in combination with a rhino-laryngoscope.
The Disposable Biopsy Forceps FB Series is comprised of four (4), sterile, single-use, disposable biopsy forceps of varying distal fenestrated cup shapes: FB-211D – Alligator jaw-step; FB-221D – Alligator jaw-step with needle; FB-231D – Oval type; and FB-241D – Oval type with needle.
The Disposable Biopsy Forceps FB Series was designed to collect tissue within the upper airways when used in conjunction with compatible rhino-laryngoscopes to collect tissues in the upper airways. The Disposable Biopsy Forceps FB Series consists of a handle and an insertion portion. The handle consists of a handle body and slider. The insertion portion consists of a covered coil sheath (stainless steel coil operating wire and polyethylene sheath), cups, and forceps cap. The slider is connected to the operating wire in the insertion portion and the cups are opened/closed by advancing/retreating the slider with the function of the connection parts.
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(330 days)
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(167 days)
The Stealth AXiS™ Surgical System, with the Stealth AXiS™ ENT clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- Functional endoscopic sinus surgery (FESS)
- Endoscopic skull base procedures
- Lateral skull base procedures
The Stealth AXiS ENT Clinical Application works in conjunction with the Stealth AXiS Surgical System, which consists of clinical software, surgical instruments, a referencing system, and platform/computer hardware. The Stealth AXiS™ ENT Clinical Application helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The system tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
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(52 days)
The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
Electric nasal aspirator (model: BC026, BC025, BC023, BC028, BC029, BC036) consists of main unit, and suction portion working together as one unit. The Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions.The motor pump is powered by a rechargeable battery. The rechargeable battery can be charged via an external power adapter(not included in this device) using the provided charging line. The user interface consists of buttons and LED display, and the user can control the air flow level through the button.
The differences between BC026, BC025, BC023, BC028, BC029 and BC036 are as follows:
- The flow rate range of BC036 at different flow levels is different from other models.
- BC025 and BC036 do not have "Light" function(used to distract and pacify the child), while other models do.
- BC026, BC028, BC029 can pause suction during the suction process, while other models do not.
- BC026, BC028, BC029 and BC023 have 4 buttons, BC025 and BC036 have 2 buttons.
- In addition, BC026, BC028, BC029, BC025, BC036 and BC023 have different Display, Size, Weight, and Appearance.
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(327 days)
The LifeVac is a non-powered, non-invasive, single-use-only airway clearance device intended to resolve choking in a victim with a complete airway obstruction when a current choking protocol has been followed without success. LifeVac should only be used to remove an object/food from a victim with a complete airway obstruction. LifeVac is intended for use on adult or pediatric choking victims who are at least 1 year of age. LifeVac can be administered by a lay person or a medical professional (18 years or older) in various settings including at home or nursing homes, restaurants, schools, and other outside environments.
LifeVac is a portable, non-powered, single-use, non-sterile device that generates suction to remove a complete foreign body airway obstruction from a choking victim after a standard choking rescue protocol has failed. The device consists of a plunger with a one-way valve. A face mask is attached prior to use. The LifeVac device with the attached mask is placed over the victim's nose and mouth creating a mask seal. The device handle is pressed down to compress the unit, which pushes the air out through the vent system on the bottom of the device and not into the patient. The handle is then quickly pulled up and negative pressure is generated to suction out the obstruction. The duration of suction is minimal. The device has a patented ball valve system which is designed to prevent any air from exiting through the mask. The valve also is designed to prevent air from pushing stuck food or foreign objects downward. This creates a one-way suction to remove the lodged object. The device is non-invasive and does not need to be placed into the oral cavity. LifeVac device is available as a Home Kit or Travel Kit. The device is the same in both kit presentations and the only difference is the Home Kit comes with 1 adult mask, 1 pediatric mask, and 1 practice mask while the Travel Kit does not include a practice mask.
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