(36 days)
Esaote's MyLabSix ultrasound system is a mainframe ultrasound svstem used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal Cardiac. Peripheral Vascular. Neonatal Cephalic. Adult Cephalic. Small Organs. Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), XView, Multi View (MView). Trapezoidal View (TP View), Tissue Velocity Mapping (TVM), RF-based Quality Intima Media Thickness (QIMT) ,Color Flow Mapping (CFM) and Pulse Wave Doppler.
The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown.
A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.
The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes.
The MyLabSix is equipped with an internal Hard Disk and with an DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.
The MyLabSix is manufactured under an ISO 9001:2008 and ISO 13485:2003 certified quality system.
The provided 510(k) summary for the MyLabSix Esaote Europe Ultrasound System explicitly states: "No clinical tests were performed." Therefore, there is no information in this document regarding acceptance criteria or a study proving that the device meets such criteria through clinical performance.
The submission focuses entirely on demonstrating substantial equivalence to predicate devices (MyLabSeven and MyLabFive) and conformity to non-clinical safety and performance standards. The information provided heavily emphasizes the technological characteristics and intended uses being equivalent to already cleared devices, rather than presenting a performance study with specific acceptance criteria.
§ 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.