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The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use and use on pregnant patients.

The CUBEScan™ BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, noninvasive system for measuring bladder volume (residual volume). The CUBEScan™ BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3Dmechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.

The provided FDA 510(k) summary for the CUBEScan™ BioCon-1100 does not contain detailed information about specific acceptance criteria for device performance, nor does it describe a clinical study conducted to prove the device meets such criteria.

Instead, the summary states:

"The subject of this premarket submission, CUBEScan™ BioCon-1100, did not require clinical studies to support substantial equivalence."

This indicates that the FDA granted clearance based on the device's substantial equivalence to a predicate device (CUBEScan™ BioCon-900, K171591) by demonstrating similar technological characteristics and adherence to non-clinical safety standards, rather than through a new clinical performance study for this specific model.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them because such a study was not presented in this document for the K200548 submission.

The document focuses on non-clinical testing for safety and compliance with various standards related to acoustic output, biocompatibility, electrical safety, and software, as summarized in Section 7: "Summary of Non-Clinical Testing Performed." However, these are not directly performance acceptance criteria related to accuracy of urine volume measurement in a clinical context.

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