(81 days)
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.
It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended tc be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.
This document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for their M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System.
Based on the provided text, the device in question is a general diagnostic ultrasound system, and the submission is for the addition of a new transducer, P8-2s, to an already cleared system (K210416).
Therefore, the performance data provided is not for a new AI/ML-driven medical device requiring extensive clinical or standalone performance studies against set acceptance criteria, but rather for a modification to an existing device.
The document explicitly states:
"8. Clinical Studies Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
This indicates that a formal study proving the device meets specific acceptance criteria in the way a novel AI/ML device would is not present in this submission. Substantial equivalence for this modification is based on non-clinical tests and comparison to a predicate device.
Given this, I cannot provide the detailed information requested regarding acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these types of studies were not deemed necessary for this particular 510(k) submission.
The "acceptance criteria" for this submission are fundamentally satisfied by demonstrating:
- Technological Characteristics Similarity: The new P8-2s transducer has comparable design principles and parameters to existing transducers.
- Safety Compliance: The device and the new transducer comply with recognized electrical, physical, and acoustic safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6).
- Biocompatibility: Materials used are biocompatible (specifically Valox 3706, MLG-34-G/MLG-34-N, RTV162, RTV167 for the P8-2s probe shell, acoustic lens, and mucilage glue).
- Cleaning, Disinfection, and Sterilization Effectiveness: The design allows for effective reprocessing.
- Acoustic Output: The acoustic output is below the FDA limits (Ispta.3
§ 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.