Search Results

The CUBEScan BioCon-900S is a B-mode pulsed-echo ultrasound device. The BioCon-900S 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-900S 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-900S are fetal use and use on pregnant patients.

CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides crosssectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) premarket notification summary for the CUBEScan BioCon-900S.

The summary states that "The subject of this premarket submission, CUBEScan BioCon-900S, did not require clinical studies to support substantial equivalence." This means that no clinical studies were performed to establish performance metrics like accuracy, sensitivity, or specificity against a ground truth.

The document primarily focuses on:

• Device Description and Intended Use: The CUBEScan BioCon-900S is a B-mode pulsed-echo ultrasound device for non-invasively measuring urine volume in the bladder, intended for use by qualified medical professionals in hospitals and healthcare facilities.
• Comparison to Predicate Device: The device is considered substantially equivalent to a previously cleared predicate device (CUBEScan BioCon-900, K171591) based on the same indications for use and fundamental scientific technology.
• Non-Clinical Testing: The device underwent non-clinical testing for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

Ask a specific question about this device