(21 days)
The Clarus Ultrasound System is a software-based ultrasound imaging system and accessories intended for use in Pointof-Care Imaging of Medical Conditions on the general public.
Point-of-Care clinical applications include:
- · Emergency triage exam to look at trauma conditions
- · Procedure guidance to guide needles into the body; and
· Other targeted diagnostic and measurement applications: fetal, fetal echo, abdominal, small organ, musculo-sketal (conventional), musculo-skeletal (superficial), urology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid
· The Clarius Ultrasound System is intended for use in environments where is provided by trained medical professionals. The device is not intended for use in emergency medical service, ambulance, or aircraft.
Users will be trained medical professionals (e.g., doctors, nurses, technicians).
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-theshelf (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 includes:
Product/Package Components:
-
- Software:
- The Ultrasound App (Clarius App) for iOS; OR
- The Ultrasound App (Clarius App) for Android ●
-
- Transducers/Scanners:
- Clarius Scanner C3 (C3 Convex Transducer); OR ●
- . Clarius Scanner L7 (L7 Linear Transducer)
-
- Accessories:
- a. Clarius-Built:
- Battery Pack (Li-ion) O
- Battery Charger O
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.
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 not intended for use in Emergency Medical Service, ambulance, or aircraft environments.
The provided text describes the Clarius Ultrasound System and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test sets or training sets, data provenance, expert ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).
The document primarily focuses on:
- Device Description: What the Clarius Ultrasound System is, its components (software, transducers C3 and L7, accessories), and how it functions as a portable, wireless diagnostic ultrasound system.
- Indications for Use: The medical conditions and applications for which the system is intended (e.g., emergency triage, procedure guidance, various diagnostic applications like fetal, abdominal, small organ, musculoskeletal, urology, gynecology, cardiac, peripheral vessel, pediatric, carotid imaging).
- Contraindications: Situations where the device should not be used.
- Substantial Equivalence: Comparing the Clarius Ultrasound System to three predicate devices (SONON Ultrasound Imaging System, Philips Lumify, and FUJIFILM SonoSite Edge II) to demonstrate that it uses the same fundamental scientific technology and has similar indications for use.
- Non-Clinical Performance Data: Listing compliance with relevant IEC and ISO standards related to medical electrical equipment safety, electromagnetic compatibility, ultrasonic medical diagnostic equipment, and biological evaluation of medical devices.
- Quality Assurance: General mention of quality assurance measures during design and development.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies based on the provided text. The document is a 510(k) premarket notification summary, which typically focuses on demonstrating substantial equivalence rather than detailing internal performance studies against specific acceptance criteria.
§ 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.