(44 days)
The DC-N3/DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.
DC-N3/DC-N3S Diagnostic Ultrasound System is a general purpose, mobile. software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Color M-Mode, Free Xros M-Mode, Free Xros CM, Power/Dirpower Mode, TDI Mode, 3D/4D Mode, iScape Mode or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.
The provided 510(k) summary for the Mindray DC-N3/DC-N3S Diagnostic Ultrasound System K140030 does not contain information regarding acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy).
This K140030 submission is for a modification to a previously cleared device (K123503) and primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards for medical electrical equipment, acoustic output, biocompatibility, cleaning/disinfection, risk management, and usability.
The document explicitly states "8. Clinical Tests: Not Applicable." This indicates that for this particular 510(k) submission, clinical testing to evaluate performance against specific acceptance criteria was not required by the FDA or was not performed as part of this submission for substantial equivalence.
Therefore, requested information regarding acceptance criteria, reported performance, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be extracted from this document.
The document confirms that this device is a general-purpose diagnostic ultrasound system, and its modifications (new transducers and software options) have been compared with predicate devices (DC-N3/DC-N3S, DC-7, DC-T6, Voluson E8). The conclusion relies on the device being "substantially equivalent with respect to safety and effectiveness to devices currently cleared for market," based on adherence to standards and the consistency of intended uses and key features with traditional clinical practices and FDA guidelines.
§ 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.