(15 days)
The DC-T6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.
DC-T6 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, Power/Dirpower Mode, TDI 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 DC-T6 Diagnostic Ultrasound System is primarily a declaration of substantial equivalence to predicate devices and outlines the device's technical specifications, intended uses, and compliance with various safety standards. It does not contain information on specific acceptance criteria for diagnostic performance, nor does it detail a study proving the device meets such criteria.
The document focusses on:
- Device Description: General purpose, mobile, software-controlled ultrasound system with various imaging modes (B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode).
- Intended Use: Broad range of clinical applications across different patient populations (adults, pregnant women, pediatric, neonates) and anatomical regions.
- Comparison with Predicate Devices: Lists several Mindray and GE ultrasound systems, stating that the DC-T6 has similar technological characteristics, safety/effectiveness features, and intended uses.
- Non-clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning/disinfection, and thermal/electrical/mechanical safety, conforming to applicable medical safety standards.
- Conclusion: Asserts substantial equivalence based on consistent intended uses with traditional clinical practices and FDA guidelines, and adherence to quality systems (21 CFR 820, ISO 9001, ISO 13485).
Therefore, based on the provided text, I cannot describe the acceptance criteria or a study proving the device meets those criteria, as such information is not present.
The document is a regulatory submission for premarket notification (510(k)), which often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical performance studies with specific acceptance criteria like those for novel AI/diagnostic software. For a traditional ultrasound system, the "performance" demonstrated for 510(k) clearance typically involves meeting technical specifications (e.g., image quality, acoustic output limits, safety standards) and proving it is as safe and effective as a predicate device for its intended uses.
The information requested in points 1-9 (acceptance criteria table, sample size, expert ground truth, etc.) is characteristic of a clinical validation study, often required for more novel or complex devices, especially those incorporating AI, to demonstrate specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC). This level of detail is not typically included in a 510(k) summary for a general diagnostic ultrasound system that relies on substantial equivalence to well-established technology.
§ 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.