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The BioCon-500 is a B-mode pulsed-echo ultrasound device. The BioCon-500 is intended to project ultrasound energy through the abdomen of the patient to obtain images of the bladder and to calculate the bladder volume non-invasively using these images. Contraindications for the BioCon-500 are fetal use and use on pregnant patients.

The BioCon-500™ is a portable ultrasound system for measuring the urine volume in a patient. BioCon-500™ transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines.

BioCon-500™ has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results.

A user can print the results using a built-in thermal printer after measurements right away.

Also using the optional CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results.

The document provided describes the BioCon-500, a portable ultrasound system for measuring urine volume. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in a structured way that would be typical for clinical validation.

The information primarily focuses on:

• Device Description: The BioCon-500 transmits ultrasound signals to the abdomen to detect bladder outlines and calculate urine volume non-invasively. It has a Pre-Scan function for bladder location.
• Indications for Use: To obtain images of the bladder and calculate urine volume non-invasively, used by qualified medical professionals. Contraindicated for fetal use and pregnant patients.
• Comparison to Predicate Devices: States that BioCon-500 is substantially equivalent to VERATHON INCORPORATED's BVI 9400 and Mediwatch Ltd.'s Multiscan.
• Safety and Performance Data: Mentions electrical, mechanical, environmental safety, and EMC testing according to UL 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001), with satisfactory results.
• FDA Clearance: Concludes the device is safe, effective, and substantially equivalent to predicate devices.

Missing Information:
Crucially, the provided text does not contain specific numerical acceptance criteria (e.g., accuracy, precision targets) for urine volume measurement, nor does it describe a study with performance data against such criteria. The "Safety, EMC and Performance Data" section refers to compliance with general safety and EMC standards, not a clinical performance study for its primary function (urine volume measurement accuracy).

Therefore, I cannot populate the requested tables and points directly from the given input. The document attests to substantial equivalence with predicate devices, which implies that the device's performance is expected to be comparable to those predicate devices, but it does not present the specific performance data for BioCon-500 itself that would allow us to fill in the requested details.

Based on the provided text, I can only state that the information requested regarding acceptance criteria and performance study details is not present. If such information were available, it would typically include a clinical study comparing the device's calculated bladder volume to a reference standard (e.g., catheterization or another validated method), along with defined accuracy or precision targets.

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