(62 days)
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The Zura-EVO System is intended for the following applications: Cardiac and , Transesophageal. Measurement and calculation packages that provide information of anatomical structures that may be used by a physician for clinical diagnosis purposes.
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When used with the ClariTEE probe -- The episodic assessment of cardiac function using transesophageal echocardiography (TEE). It is indical for use in clinical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs.
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When used with the TTE probe is intended for imaging and assessment of Cardiac anatomy and function
The Zura-EVO Imaging System is a multi-purpose mobile, software controlled diagnostic ultrasound system. Its function is to acquire ultrasound echo data and display it in B-Mode, or Color Doppler Mode on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.
The system has an optional electrocardiography (ECG) display feature and support for a 3- lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures that provide information used for clinical diagnostic purposes. The system has measurements and calculations, image storage and review, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.
The Zura-EVO Imaging System consists of the following major components:
- Ultrasound Machine: A predicate device ultrasound machine (K102997) 2. Ultrasound Probes
a. ClariTEE Probe: A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes that enables long term use in clinical settings such as the ICU. This probe has predicate coverage under K080223 and K100969.
b. TTE probe SA4-2/24: Transthoracic probe has a predicate coverage under K102997
- Ultrasound Imaging Software: Ultrasound imaging functions are controlled via the ImaCor Zura software. The Graphical User Interface, which is the piece of software exposed to the user, communicates user inputs to the Ultrasound Imaging Platform which interfaces with the Ultrasound Transducer. The ImaCor Zura software also communicates with the probe directly to monitor the probe's lifespan. Orientation and position of the probe is controlled manually by the user.
The provided document is a 510(k) summary for the Zura-EVO Imaging System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, rather than presenting a performance study with acceptance criteria. It mentions non-clinical testing for electrical safety, sterility, aged acceleration testing, and acoustic output testing against specified standards (IEC 60601, ISO 14971, ISO 10993). However, these are general compliance tests for device safety and performance according to harmonized standards, not specific clinical performance metrics with acceptance thresholds typically seen in studies for medical device approval.
Therefore, I cannot extract the requested information from the provided text. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about test set anaysis.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies or effect sizes.
- Details on standalone algorithm performance.
- The type of ground truth used for specific clinical assessments.
- Training set sample sizes or how ground truth was established for training data.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.