(87 days)
GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal: Abdominal (including renal and GYN); Pediatric: Small Organ (breast, testes, thyroid); Neonatal Cephalic: Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.
The GE Healthcare Vivid E9 Diagnostic Ultrasound System is a general-purpose ultrasound system specialized for cardiac imaging. The submission describes the device as substantially equivalent to previously cleared predicate devices (Vivid E9 K101149, Vivid i / Vivid q K102388, and 6Tc Transducer K081921).
Acceptance Criteria and Device Performance (Summary)
The documentation provided does not include specific quantitative analytical or clinical performance acceptance criteria for the device's diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to medical device safety standards. The "device performance" is implicitly considered to be equivalent to the predicate devices and compliant with the listed voluntary standards.
The table below summarizes the types of tests mentioned as being conducted to ensure device safety and effectiveness.
| Acceptance Criteria Category | Reported Device Performance Assessment |
|---|---|
| Acoustic Output Safety | Evaluated and found to conform to applicable medical device safety standards (e.g., NEMA UD 3). |
| Measurement Accuracy | Evaluated and found to conform to applicable medical device safety standards. |
| Biocompatibility | Evaluated and found to conform to ISO 10993-1. |
| Cleaning and Disinfection Effectiveness | Evaluated and found to conform to applicable medical device safety standards. |
| Thermal Safety | Evaluated and found to conform to IEC60601-1, UL60601-1, IEC60601-1-2, IEC60601-2-37. |
| Electrical Safety | Evaluated and found to conform to IEC60601-1, UL60601-1, IEC60601-1-2, IEC60601-2-37. |
| Electromagnetic Safety | Evaluated and found to conform to IEC60601-1-2. |
| Mechanical Safety | Evaluated and found to conform to applicable medical device safety standards. |
| Software Quality Assurance | Risk Analysis, Usability Analysis, Requirement Reviews, Design Reviews, Unit Testing, Integration Testing, Final Acceptance Testing, Performance Testing, Safety Testing. |
| DICOM Conformance | Complies with NEMA PS 3.1 - 3.20. |
Study Information
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Sample Size used for the test set and the data provenance:
The submission explicitly states that "The subject of this premarket submission, Vivid E9, did not require clinical studies to support substantial equivalence." Therefore, there is no mention of a defined test set of patient data or its provenance for diagnostic performance evaluation, as clinical studies were not conducted for this submission. The product's compliance was primarily based on non-clinical tests and comparison to predicate devices. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as clinical studies involving test sets and ground truth from experts were not conducted for this premarket submission. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as clinical studies involving test sets were not conducted for this premarket submission. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This submission is for an ultrasound system, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for an ultrasound system and its software features, not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as clinical studies requiring ground truth were not conducted. The "ground truth" for the non-clinical tests mentioned would be established by validated test methods and reference standards for the specific safety and performance metrics (e.g., accuracy of measurements against known physical standards, successful completion of software tests). -
The sample size for the training set:
Not applicable. The document does not describe a machine learning model requiring a training set. The device is an ultrasound system with enhanced software features, and its development followed a standard quality assurance process. -
How the ground truth for the training set was established:
Not applicable, for the same reasons as above.
§ 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.