(120 days)
Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage.
Vscan Air supports Black/ white (B-mode), Color flow (Color doppler), Combined (B + Color Doppler) and Harmonic imaging modes with both the curved and linear array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS devices, and a probe which uses wireless technology for communication.
Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.
The provided document indicates that the Vscan Air device did not require clinical studies to support substantial equivalence. Therefore, there is no detailed information regarding acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria.
The document primarily focuses on non-clinical tests to demonstrate substantial equivalence to predicate devices. These non-clinical tests pertain to acoustic output, biocompatibility, cleaning and disinfection, as well as thermal, electrical, electromagnetic, mechanical safety, and wireless communication. The device was found to conform to applicable medical device safety standards.
Summary of Non-Clinical Tests and Conformance:
| Test Category | Standards/Requirements Conformed To |
|---|---|
| Acoustic Output | IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017. Acoustic power levels are below FDA applicable limits. |
| Biocompatibility | ISO 10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition, 2009. Probe materials are biocompatible. |
| Cleaning & Disinfection | Evaluated |
| Electrical Safety | AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance, 2005/A2:2012. IEC 60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015. IEC 60601-1-11 and IEC 60601-1-12 for home and EMS environments. |
| Electromagnetic Safety | IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014. |
| Mechanical Safety | Evaluated |
| Wireless | Evaluated (uses Wi-Fi direct) |
| Risk Management | ISO 14971, Application of risk management to medical devices, 2012. |
Key takeaway regarding clinical studies:
- Clinical Studies: "The subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence."
Therefore, the requested information regarding a study proving acceptance criteria for clinical performance is not available in the provided text. The submission relied on non-clinical testing and comparison to predicate devices to establish substantial equivalence.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.