(6 days)
Ultrasound imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Antares with 4D Basic Imaging is substantially equivalent to the predicates listed herein. The Antares is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, 3D imaging, and 4D Basic Imaging on a CRT display.
The provided 510(k) summary for the Siemens SONOLINE Antares™ Diagnostic Ultrasound System does not contain information on the acceptance criteria or test study details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data sample size, or training ground truth establishment.
Instead, the document focuses on:
- Device Description: General purpose, mobile, software-controlled diagnostic ultrasound system with various imaging modes (B-Mode, M-Mode, PWD, CWD, Color Doppler, Amplitude Doppler, Harmonic Imaging, 3D, and 4D Basic Imaging).
- Intended Uses: A broad range of clinical applications including General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
- Technological Comparison to Predicate Device: The Antares system is stated to be substantially equivalent to previously cleared devices (SONOLINE Elegra Millennium Enhanced, K001400; SONOLINE G50/G60 S, K040060) by performing similar functions of transmitting ultrasound, post-processing echoes, and displaying anatomical structures and fluid flow.
- Compliance with Standards: The device has been designed to meet several product safety standards (UL, CSA, AIUM/NEMA, IEC, ISO, EN, and 93/42/EEC Medical Devices Directive).
- FDA Clearance: The document includes the FDA's letter of clearance and several "Indications for Use Forms" for the main system and various transducers, listing the clinical applications and modes of operation for which each is cleared.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about the various aspects of a study (sample size, data provenance, experts, adjudication, MRMC, standalone performance, ground truth) as this information is not present in the provided text. The submission primarily relies on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards rather than providing detailed clinical study results with specific performance metrics.
§ 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.