(154 days)
The Venue Go is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.
The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning.
The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.
The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.
A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system.
Venue Go is capable of wireless communication through a built-in Wireless LAN device. The system meets DICOM requirements to support image storage and archiving (local PACS or products such as Q-Path) and allows for output to printing devices.
The provided FDA 510(k) summary for the GE Venue Go ultrasound system does not include acceptance criteria for artificial intelligence (AI) performance or the study details to prove the device meets such criteria.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venue Go K220800) and other reference devices, based on:
- Identical fundamental scientific technology.
- Similar imaging capabilities, technological characteristics, safety, and effectiveness.
- Minor updates to the Indications for Use statement for clarity regarding operator qualifications.
- Addition of new transducers already cleared on other GE devices.
- New features/functionality such as Auto Volume Flow (AVF), Bladder Volume Tool, expanded MSK diagrams, Venue Coach, electronic software delivery, expanded Auto Inferior Vena Cava (IVC), Auto B-Lines, Real-Time ejection fraction (RT-EF), cNerve for Vscan Air CL and SL probes (which are already cleared with these AI features on predicate Vscan Air K231301 and reference LOGIQ E10s/LOGIQ Fortis K231989), and AppAPI functionality.
- Conformity to recognized performance standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.
- Quality assurance measures like risk analysis, requirements/design reviews, and various levels of testing.
Specifically, the document states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This indicates that any evaluation of "AI performance" as typically understood (e.g., using a test set with ground truth, performance metrics, and acceptance criteria) was not part of this 510(k) submission.
The AI-related features mentioned (Auto IVC, Auto B-Lines, RT-EF, cNerve) are noted as being "expanded" or already "cleared" on predicate/reference devices (K231301 Vscan Air, K231989 LOGIQ E10s/LOGIQ Fortis). This implies their performance was likely evaluated as part of those previous 510(k) submissions, and the current submission is leveraging that prior clearance for their inclusion in the Venue Go system when used with the particular probes.
Therefore, since this 510(k) does not present new AI performance study data for the Venue Go, I cannot extract the requested information. The document focuses on demonstrating that the Venue Go, with its included features, is substantially equivalent to existing cleared devices, rather than proving novel AI algorithm performance.
§ 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.