Auto 3D Bladder Volume Tool
Butterfly Network, Inc.The Auto 3D Bladder Volume Tool by Butterfly Network is a software application integrated with Butterfly Network ultrasound systems. It uses machine learning (U-Net convolutional neural network) to automatically segment and measure bladder volume from ultrasound images, providing clinicians with noninvasive quantitative data to support diagnosis in adult patients.
Intended Use
Software application package to view, quantify and report noninvasive bladder volume measurements on Butterfly Network ultrasound systems for adult populations to support physician diagnosis.
Technology
Uses Butterfly Network ultrasound systems to acquire 25 B-mode 2D images of the bladder; employs a U-Net convolutional neural network for automatic bladder segmentation; computes bladder volume via integration of segmented imaging data; portable software tool intended for clinical use.
Performance
Software verification and validation testing conducted per FDA guidance showed the software meets design requirements and safety; a non-interventional clinical validation study demonstrated accuracy and consistency comparable to the predicate device, with balanced patient population and variability testing confirming performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/14/2020
1 month - 2
FDA Approval
6/11/2020
Other devices from Butterfly Network, Inc.
- Butterfly iQ3 Ultrasound System2024 • 510K
- Butterfly iQ/iQ+ Ultrasound System2023 • 510K
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