(8 days)
Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, 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 and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The 7300 (MyLab30) ultrasound system is used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes. The MyLab30 system is able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the BC431 or BS230 probes, offers the possibility to also produce automatic 3D and Real Time 4D images. The 7300 (MyLab30) is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
I am sorry, but the provided text does not contain information about acceptance criteria or specific studies demonstrating device performance. This document is a 510(k) summary for the MyLab30 ultrasound system, primarily focusing on its intended use, technological characteristics, and substantial equivalence to predicate devices for regulatory clearance. It does not detail specific performance metrics, clinical trials, or validation studies with acceptance criteria, sample sizes, expert ground truth adjudication, or comparative effectiveness.
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§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.