(55 days)
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals for ultrasound imaging, measurement and analysis of the human body and fluid. Venue Go clinical applications include the following: Abdominal (including Gynecology and Urology), Thoracic/Pleural, Ophthalmic, Fetal/Obstetrics, Small Organ (including breast, testes, thyroid), Peripheral vascular, Adult and neonatal cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adults and Pediatric), Transesophageal, Transrectal, Transvaginal, Intraoperative and Imaging guidance for interventional procedures (e.g. Nerve block, biopsy, vascular access).
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified 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.
The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Some biopsy kits are available for needle-guidance procedures.
The system has the capability for 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. 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 is available to be used as an input device. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.
The provided text is a 510(k) Premarket Notification Submission for the GE Venue Go Ultrasound System. This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device against existing ones rather than detailing a study that proves the new device meets specific, quantitative acceptance criteria for clinical performance.
The document states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This means that traditional clinical performance studies with specific quantitative acceptance criteria or comparative effectiveness studies (like MRMC studies) demonstrating improvement with AI assistance were not performed or submitted for this specific premarket notification.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Venue, LOGIQ e, LOGIQ P9) through:
- Identical or similar intended use and clinical applications.
- Similar imaging capabilities and technological characteristics.
- Compliance with applicable medical device safety standards (e.g., electrical, electromagnetic, mechanical safety, biocompatibility, acoustic output).
- Quality assurance measures applied during development (risk analysis, requirements reviews, design reviews, various levels of testing: unit, integration, performance, safety).
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study for this specific device, nor can I answer questions about sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as these types of clinical performance evaluations were explicitly not required or conducted for this 510(k) submission.
The document indicates that new indications or features are being added to the device (e.g., Intraoperative indication, new transducers and imaging modes). For these new features, substantial equivalence is established by showing that they were previously cleared on other predicate devices. For instance:
- The Intraoperative indication was cleared on LOGIQ e (K151028).
- L4-12t-RS, L8-18i-RS, and 6S-RS transducers were cleared in LOGIQ e (K151028).
- The Neonatal Cephalic application for L8-18i-RS was cleared in LOGIQ P9 (K181783).
- New applications for L4-12t-RS and 6S-RS, and new imaging modes like "Color M Doppler" and "Combined Modes" were cleared in LOGIQ P9 (K181783) or existing predicates.
In summary, the "acceptance criteria" for a 510(k) device like this are primarily demonstrated through substantially equivalent performance to existing, legally marketed predicate devices by showing similar features, technology, and compliance with recognized safety standards in non-clinical tests, rather than through new clinical performance studies with quantitative metrics.
§ 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.