(17 days)
Diagnostic imaging or fluid flow analysis of the human body as follows: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intra-luminal and Intra-cardiac 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 Cypress system is a multi-purpose diagnostic ultrasound system with accessories and software, and is substantially equivalent to our current product that is already cleared under 510(k) Premarket Notification number K021497. The Cypress Ultrasound System has been designed to conform to the following product safety standards: CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA 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, Safety Requirements for Medical Equipment; EN 60601-1-2; EN 60601-1-2-37; ISO 10993 Biocompatibility. The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable).
The provided text is a 510(k) summary for the Siemens ACUSON Cypress Ultrasound System and its associated transducers. This document details the technical characteristics, intended use, and substantial equivalence to predicate devices, which are typical data points in regulatory submissions for medical devices. However, it does not contain information about clinical studies with acceptance criteria or performance metrics related to specific clinical endpoints or disease detection.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies. The document focuses on regulatory compliance and technical equivalence rather than clinical performance studies.
What the document does provide:
- Device Name: ACUSON Cypress Ultrasound System
- Intended Use: Diagnostic imaging or fluid flow analysis of the human body for various applications (Fetal, Abdominal, Intraoperative, Pediatrics, Neonatal Cephalic, Cardiac, Trans-esophageal, Peripheral Vessel, Intra-luminal, Intra-cardiac applications, with specific modes of operation like B, M, PWD, CWD, Color Doppler, Amplitude Doppler).
- Technological Comparison: The Cypress system is substantially equivalent to the previously cleared ACUSON Cypress™ Ultrasound System (K021497) and ACUSON Sequoia™ Diagnostic Ultrasound System (K032114). This implies that performance is considered equivalent to these predicate devices, but no new performance data or acceptance criteria are presented.
- Product Safety Standards: Conforms to CSA C22.2 No. 601-1, AIUM/NEMA UD-2, AIUM/NEMA UD-3, 93/42/EEC Medical Device Directive, EN 60601-1 series, and ISO 10993 Biocompatibility.
- ALARA Principle: Acoustic output is in accordance with the ALARA principle (as low as reasonably achievable).
In summary, there is no information in the provided text to fulfill the request for acceptance criteria and study data on device performance against those 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.