(20 days)
Ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vessel, Laparoscopic, Musculo-skeletal (Conventional and Superficial) applications, and intended uses as defined in the FDA guidance document. 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 Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number: K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound System. The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUMNEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic Ultrasound; AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; 93/42/EEC Medical Device Directive; Safety and EMC Requirements for Medical Equipment; EN 60601-1, EN 60601-1-1, EN 60601-1-2; ISO 10993 Biocompatibility. The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable).
The provided document is a 510(k) summary for the ACUSON® Sequoia Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device and discussing the intended uses and safety standards. It does not contain information about acceptance criteria for device performance, or details of a study (test set, training set, ground truth, expert qualifications, etc.) that proves the device meets specific performance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a regulatory submission, not a performance study report.
The tables in the document (pages 5-31) are "Indications for Use" tables for various transducers, listing the clinical applications for which each transducer is cleared, and the imaging modes (A, B, M, PWD, CWD, Color Doppler, Power Doppler, Color Velocity Imaging, Combined, Harmonic Imaging) that can be used for those applications. The 'P' indicates that these indications and modes were "previously cleared by the FDA under premarket notifications #K033650 and #K033196." This shows that the current submission is for modifications to an existing and cleared device, and not a de novo submission requiring extensive new performance validation data to establish 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.