Butterfly Gestational Age Tool

The Butterfly Gestational Age Tool is a software application that guides trained healthcare professionals in measuring fundal height and capturing ultrasound video sweeps of a pregnant patient's abdomen using a Butterfly ultrasound probe (iQ+ or iQ3). The collected sweeps are input into a deep-learning model that outputs an estimated gestational age for singleton intrauterine pregnancies presumed to be between 16–37 weeks gestation. The tool is intended as adjunctive information only and is not intended for prenatal management or delivery planning.

The Butterfly Gestational Age Tool employs the same fundamental scientific technology and hardware as its predicate device (Butterfly iQ3 Ultrasound System, K232808) with no changes to overall system design or performance characteristics. The only addition is a new artificial-intelligence feature that automates gestational age calculation via a deep-learning model trained on over 100,000 cine loops from thousands of patients. There are no new features that change the indications for use, no impact to cybersecurity requirements, and no new accessories required.

IEC 60601-1 Ed. 3.2:2020, IEC 60601-1-11 Ed. 2.1b:2020, IEC 60601-1-12 Ed. 1.1b:2020, IEC 60601-2-5 Ed 3.0:2009-07, IEC 60601-2-37 Ed. 2.0b:2007, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971, and FDA Guidance for Software Contained in Medical Devices.