(55 days)
The Venue 50 is intended for ultrasound masurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiae (adult & pediatic); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal); Thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.
When Pinpoint GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
The Venue 50 device is a compact and portable ultrasound system consisting of a hand-carried console (tablet sized) with the ability to dock it with a Docking station or mobile Docking cart. The portable design easily fits into tight spaces. High-resolution imaging, transducer options and wide range of applications help physicians care for a broad spectrum of patients. The singlesurface screen can be disinfected and cleaned with medical grade disinfectants. Flexible data management and connectivity options, with optional DICOM, help speed image storage and archiving for physicians at the Point of Care and patient bedside.
The requested information is not available in the provided text. The document is a 510(k) premarket notification for the GE Venue 50 ultrasound system, which states that no clinical studies were required or performed to support substantial equivalence for this device. Therefore, there is no information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venue 50 K133431) based on technological characteristics and safety standards. Details include:
- Device Description: A compact and portable ultrasound system with a hand-carried console, dockable with a docking station or mobile cart.
- Intended Use: Ultrasound imaging, measurement, and analysis for various clinical applications (Ophthalmic, Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculoskeletal Conventional & Superficial, Transvaginal, Intraoperative, Thoracic/Pleural for motion and fluid detection, and imaging guidance of interventional procedures). It also includes Pinpoint GT Technology for needle tracking.
- Technology: Employs the same fundamental scientific technology as its predicate devices.
- Comparison to Predicates: The Venue 50 is considered substantially equivalent to predicate devices in intended use, imaging capabilities, technological characteristics, safety, and effectiveness.
- Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection, as well as thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards and voluntary standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, DICOM).
- Quality Assurance: Risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, performance testing, safety testing, and simulated use testing.
§ 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.