(29 days)
The Siemens ACUSON X700™ and X600 ™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological 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 Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
The Siemens ACUSON X700™ and X600™ are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
This document is a 510(k) premarket notification for the Siemens Acuson X700 and Acuson X600 Diagnostic Ultrasound Systems. It does NOT describe a study that proves the device meets acceptance criteria. Instead, it justifies substantial equivalence to previously cleared predicate devices based on similarities in intended use, technological characteristics, and compliance with safety standards.
Therefore, the requested tables and information regarding acceptance criteria, sample sizes, expert involvement, efficacy studies (like MRMC), or ground truth are not present in this document.
The document focuses on demonstrating that the new devices (Acuson X700 and X600) are substantially equivalent to existing cleared devices, meaning they are as safe and effective. It does this by listing:
- Intended Use for various clinical applications (Cardiac, Abdominal, Peripheral Vessel, etc.) and various transducers (4C1, VF10-5, VF12-4, EC9-4w, 6C2, CW2, AcuNav 8F, AcuNav 10F, V5Ms, 4V1c, C7F2, EV9F4, SoundStar 10F, SoundStar eco 8F, SoundStar eco 10F, VF16-5, C6F2, C8F3, EV9F3, P8-4, MC9-4, CH5-2, C6-2, C8-5).
- Technological Characteristics like supported center frequencies (2.0 MHz to 13.0 MHz) and various imaging modes (B, M, PWD, CWD, Color Doppler, Power Doppler, combined modes).
- Features (e.g., Dynamic TCE Technology, SieClear, 3-Scape 3D Imaging, Arterial Health Package, Stress Echo, Contrast Agent Imaging).
- Compliance with safety standards: acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, referencing standards like UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601 series, EN/IEC 62304, EN/IEC 62366, and ISO 10993-1.
The document explicitly states:
- F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence. "Since the ACUSON X700 and X600 use the same technology and principles as existing devices, clinical data is not required."
Therefore, this document does not contain the information requested in points 1 through 9 of your prompt, as it is a 510(k) summary seeking equivalence rather than a report on a study demonstrating new acceptance criteria.
§ 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.