(10 days)
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician 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 Imagino".
The Acuson S2000™ has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUMNEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1
- EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
The provided text is a 510(k) summary for the Acuson S2000™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the intended uses and safety standards. It does not contain information about acceptance criteria for specific device performance metrics, nor does it describe a study proving the device meets particular performance acceptance criteria.
The document lists:
- Safety standards the device has been designed to meet (e.g., UL 60601-1, IEC 60601-2-37). These are general design and manufacturing standards, not specific performance acceptance criteria for clinical efficacy or accuracy.
- Intended Use for various clinical applications and the ability to measure anatomical structures.
- Predicate Device: Acuson Antares Ultrasound System. This indicates that the new device is compared to an existing one for substantial equivalence, but the details of that comparison or specific performance outcomes are not within this summary.
- List of Transducers and their cleared clinical applications and modes of operation.
Therefore, requested information regarding specific acceptance criteria, device performance, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone performance studies cannot be extracted from this document. The document's purpose is to state intended use and demonstrate compliance with general safety and regulatory standards through substantial equivalence to a predicate device, rather than to detail performance studies against numerical acceptance criteria.
In summary, none of the specific information requested about acceptance criteria and a study proving their fulfillment is present in the provided document.
§ 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.