Search Results

The Butterfly iQ Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Procedural Guidance, Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B- mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler.

The Butterfly iQ Ultrasound System is a general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable visualization and measurement of anatomical structures and fluid of adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode imaging the instrument also supports Color Doppler and Power Doppler imaging. The user interface includes touchscreen menus, buttons, controls, indicators and navigation icons that allow the operator to control the system and to view and measure ultrasound imagery.

The provided text describes the Butterfly iQ Ultrasound System and establishes its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or an analytical study proving that the device meets those criteria.

The document discusses:

• Indications for Use: The system is for diagnostic ultrasound imaging and measurement of anatomical structures and fluids in adult and pediatric patients for various clinical applications (Peripheral Vessel, Procedural Guidance, Small Organs, Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal, Ophthalmic).
• Technological Characteristics: It's a general-purpose diagnostic imaging system consisting of a single transducer connected to a mobile device, supporting B-mode, M-mode, Color Doppler, and Power Doppler.
• Comparison to Predicate Devices: It highlights similarities and differences with the Butterfly Poseidon Ultrasound System (K163510) and GE Venue (K170714) regarding intended use, general device description, clinical applications, target population, usage environment, energy output, regulatory classification, portability, biocompatibility, sterility, electrical and mechanical safety, product codes, transducer type, and display.
• Summary of Safety and Performance: It states that verification and validation activities were performed to demonstrate that the device meets predetermined performance specifications and lists various IEC, ISO, and NEMA standards used for evaluation (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993, NEMA UD-2).
• Conclusion of Substantial Equivalence: It concludes that the Butterfly iQ Ultrasound System is as safe and effective as the predicate, with similar intended uses, indications, technological characteristics, and principles of operation, and that minor technological differences raise no new issues of safety or effectiveness. Performance data, including software verification and validation and performance testing, are mentioned as demonstrating safety and effectiveness.

However, the document does not provide the following specific information:

1. A table of acceptance criteria and the reported device performance. While it mentions "predetermined performance specifications" and "performance data," it doesn't quantify what those specifications were or the results achieved.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human reader improvement with AI assistance. The device is an ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the prompt.
6. If a standalone (algorithm only without human-in-the-loop performance) was done. Again, the prompt describes AI/algorithm performance, which is not the focus of this 510(k) for an ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

In summary, the provided text confirms the general safety and performance evaluation undertaken for the Butterfly iQ Ultrasound System to establish substantial equivalence but lacks the detailed metrics, study design, and results typically found in a clinical study report for specific acceptance criteria.

Ask a specific question about this device