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510(k) Data Aggregation
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(118 days)
The Vanquish Water Vapor Ablation System is indicated for the thermal ablation of targeted prostate tissue via a transurethral approach.
The Vanquish Water Vapor Ablation System provides a method of focal thermal ablation that utilizes the high energy stored in water vapor to target prostate tissue. In a minimally invasive transurethral outpatient procedure performed under transrectal ultrasound (TRUS) guidance, sterile water is heated within the system and converted into vapor. This vapor is then delivered through small emitter holes at the distal end of a transurethral needle into the prostate tissue.
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(76 days)
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(266 days)
The BCM2 is intended for use, under the direction of a physician, for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease (ESKD) including those receiving maintenance dialysis.
The device does not generate any real-time alarms and outputs from the device should be used in the context of all clinical data to assess a patient's fluid status.
The device is intended for use in patients 18 years and older.
The BCM2 is a multifrequency bioimpedance device that can be used by a clinician for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease, including those receiving maintenance dialysis. A physician or designated healthcare professional is responsible for interpreting data from the device to determine what action is required as a result of changes in the measurements.
To assess a patient's hydration status, the BCM2 measures impedance by applying a low-level signal (50–800 µA) for less than 10 seconds at 50 different frequencies from 5 kHz to 1,000 kHz. Measurements are performed by dialysis clinicians (e.g., dialysis nurses, patient care technicians) in a healthcare environment such as a dialysis clinic or hospital.
In the normal clinical workflow, the BCM2 provides the following output parameters:
- Overhydration (OH)
- Urea distribution volume (V)
The following calculated and derived parameters are also available:
- Extracellular water (ECW)
- Intracellular water (ICW)
- Total body water (TBW)
The BCM2 system consists of the BCM2 touchscreen console and the electrode set. The BCM2 console powers and measures the bioimpedance spectroscopy frequencies to assess fluid parameters. The device can also be operated in battery mode. Battery mode provides flexibility when moving between patients. The battery charge status is shown in the upper corner of the display regardless of which power source is being used. The power supply connection is located on the rear of the console.
The Calibration Box employs different resistors to calibrate the entire range of the BCM2's measurement (5 kHz to 1,000 kHz). Impedance measurements are performed for each resistor for all frequencies and the data is verified against an expected tolerance range. After the BCM2 has been calibrated, the Test Box is used to verify that the device is functioning properly.
The BCM2 will be available in one (1) configuration for sale within the U.S.
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(152 days)
The Focal One® is indicated for transrectal high-intensity focused ultrasound (HIFU) ablation of prostate tissue.
The Focal One® consists of the Focal One® module with a software control system, an endorectal dynamic focusing probe, a leg support, and a disposable set (FocalPak) including miscellaneous single use disposables and a coupling liquid pouch.
The Focal One® module consists of a motorized and manual endorectal dynamic focusing probe positioning unit, a RF amplifier to power the transducer, a computer to control device operation, a cooling system to cool Ablasonic (coupling liquid) and built-in safety features. It also allows the user to control the treatment while providing different user interfaces: two dual touch-screens, mouse, keyboard and printer. The Focal One® energy is delivered via an endorectal dynamic focusing probe, which includes an imaging system. The high-energy ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating heat and causing the ablation of tissue within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The endorectal dynamic focusing probe is attached to a support, enabling movements in the longitudinal, transverse, vertical and angular directions, and in rotation. A coupling liquid pouch (Ablasonic®) included in the FocalPak disposable kit, attached to a stand, maintained at a controlled temperature flows continuously (via a peristaltic pump) into the balloon to preserve the rectal wall from heating associated with the treatment. The module is mounted on four multidirectional wheels allowing an easy positioning of the device in the treatment room.
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(49 days)
For telescope (27033AA)
The endoscopes when used with sheaths and obturators are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.
The Miniature Telescope for Urology (27033AA) is a semi-rigid telescope that utilizes fiber optic technology. The shaft of the endoscope consists of phynox or stainless steel. An optical fiber bundle runs through a central lumen in the shaft and transmits the image received at the distal end to the eyepiece. Other fibers illuminate the operative site by transmitting light. The Miniature Telescope for Urology (27033AA) is just an optic, without a working or irrigation channel. It is always used in combination (e.g. with sheath (or working element and sheath). Thus providing instruments access to the operative site.
The Miniature Telescope for Urology (27033AA) is available in the following:
Direction of View: 0°
Field of View: 72.5°
Diameter: 3.5Fr
Working Length: 21cm
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(269 days)
The AquaC UNO H Portable Water Purification System is a reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies.
The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. This device is intended to be a component in a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI and FDA recognized U.S. standards.
The AquaC UNO H water purification system is a microcontroller-controlled, fully automatic reverse osmosis (RO) system with heat disinfection function, which uses pretreated soft water (hereinafter referred to as "feed water") to produce highly deionized water (hereinafter referred to as "dialysis water") for use by a hemodialysis (HD) device and preparation of dialysis concentrates.
Feed water is defined as the water supplied to a water treatment system or an individual component of a water treatment system per ISO 23500-1:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements. The feed water must be of drinking water standard, filtered, free of iron and chlorine, and softened. Potentially critical limits must be monitored by regular checks. Bacterial growth in the system must be prevented by continuous operation of the system with a minimum of idle times and by preventive measures such as chemical or heat disinfection.
The dialysis water flows through the heater, across the dialysis water conductivity/temperature sensor and the dialysis water stop valve or outlet into the ring main. The ring main can be connected to a HD device or to a device used for the preparation of dialysis concentrates. Excess dialysis water flows through the check valve and back into the break tank. The concentrate flows through the concentrate drain restrictor and is either returned into the break tank or drained via the drain valve.
The system features the following operating modes:
- Standby
- Supply
- Rinse
- Module Heat Disinfection
- Ring Disinfection
- Chemical Disinfection
- Decalcification
- Isolated Standby
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