(37 days)
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging in B-mode, M-mode, Color Doppler, Power Doppler, and Combined (B+M; B+Color Doppler; and B+Power Doppler). It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), fetal echo, peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
The Clarius Ultrasound System is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off the-shelf (COTS) iOS or Android device. The Clarius Ultrasound System comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices.
Piezoelectric material in the systems transmits high frequency, non-ionizing sound waves to the designated region of the body and converts the subsequent echoes detected to electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external (COTS) iOS or Android viewing device on which the image can be displayed. The transducer houses a battery and power generator, multichannel beam former, pre-scan converter, and Wi-Fi components. The battery is removable and comes with a separate charger. Communication between the transducer and the compatible viewing device will be via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.
The Clarius Ultrasound System product/package components include:
- Software:
The Ultrasound App (Clarius App) for iOS; OR
The Ultrasound App (Clarius App) for Android. - Transducers/Scanners:
Clarius C3 Scanner (C3 Convex Transducer);
Clarius C3 Scanner (C3 Convex Transducer) with Clarius C3-L Clip-on;
Clarius C7 Scanner (C7 Convex Transducer); OR
Clarius L7 Scanner (L7 Linear Transducer). - Accessories:
a. Clarius-Built:
Battery Pack (Li-ion); and
Battery Charger.
b. OEM/Off-The-Shelf Product(s):
Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics, USA; Model Number ME20A1203B02; Approved in the US); and
Aquasonic 100 Ultrasound Transmission Gel (Off-the-shelf ultrasound gel from Parker Laboratories Inc., USA; Approved in the US).
The concept of the Clarius Ultrasound System transducers and software is primarily to provide an easy to use, high-performance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound System is intended for use in professional healthcare facilities where healthcare is provided by trained medical professionals. The device is also intended for use in Emergency Medical Service, ambulance, or rotary aircraft environments.
The provided text describes a 510(k) premarket notification for the Clarius Ultrasound Scanner, indicating that clinical testing was not required to establish substantial equivalence.
Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving the device meets those criteria. Specifically, it states:
"The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence." (Page 14)
As a result, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- Information about an MRMC comparative effectiveness study or its effect size.
- Information about standalone performance (algorithm only).
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to predicate devices (FUJIFILM SonoSite Edge Ultrasound System K133454 and previous Clarius Ultrasound System K163138) through comparison of technical specifications, intended uses, and modes of operation, and compliance with various nonclinical performance standards like IEC and ISO.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.