(15 days)
The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.
The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ablify to dock it with a stand or mobile cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display. It utilizes interchangeable electronic-array transducers with digital acquisition, processing and display capability operating. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking car, the Venue 40 is used primarily where portability, size and convenience are essential.
The GE Venue 40 Ultrasound device is a diagnostic ultrasound system. As a 510(k) submission, the device does not require clinical studies. The submission makes a claim of substantial equivalence to a predicate device, the GE LOGIQ e Diagnostic Ultrasound (K091374) and the GE Venue 40 Diagnostic Ultrasound (K091164).
1. Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission and clinical tests were "None required," there are no specific performance acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy derived from a clinical study.
The acceptance criteria for the device are based on non-clinical testing and comparison to the predicate device. The device is considered to meet acceptance criteria if it is found to comply with applicable medical device safety standards and is substantially equivalent to the predicate device in terms of safety and effectiveness.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-clinical Tests | Conforms to applicable medical device safety standards for: |
| Acoustic Output | Met |
| Biocompatibility | Met |
| Cleaning and Disinfection Effectiveness | Met |
| Electromagnetic Compatibility | Met |
| Thermal, Electrical, and Mechanical Safety | Met |
| Clinical Tests | None required, as per FDA guidelines. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices (GE LOGIQ e Diagnostic Ultrasound K091374, GE Venue 40 Diagnostic Ultrasound K091164) with comparable type, overall performance, characteristics, key safety and effectiveness features, physical design, general construction, materials, and intended uses/operating modes. |
2. Sample Size Used for the Test Set and Data Provenance
No clinical test set was used, as clinical tests were not required for this 510(k) submission. Therefore, there is no sample size or data provenance to report in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set requiring ground truth establishment by experts was used.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission states "Clinical Tests: None required."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable, as this device is a diagnostic ultrasound system, not an AI algorithm, and no clinical performance study was conducted.
7. Type of Ground Truth Used
Not applicable, as no clinical study requiring ground truth was performed. The device's "ground truth" for regulatory purposes relies on its demonstrated compliance with safety standards and substantial equivalence to legally marketed predicate devices, rather than a specific clinical ground truth dataset.
8. Sample Size for the Training Set
Not applicable, as this is a medical device (ultrasound system) clearance, not an AI/ML algorithm requiring a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
§ 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.