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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 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(s):
K042055 (August 16, 2004) cleared as Cypress™ Ultrasound System .
K021497 (July 9, 2002) cleared as Cypress™ Ultrasound System .
K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System .
K991872 (June 16, 1999) cleared as Lynx Ultrasound System .
K982800 (September 22, 1998) cleared as Ecton Lynx Ultrasound System .
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)

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, results of any study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC comparative effectiveness studies, standalone performance, ground truth types, or training set details. This document is a 510(k) summary for an ultrasound system, primarily focusing on its regulatory classification, predicate devices, device description, and intended uses, along with various transducer-specific indications. It states that the device is "substantially equivalent" to previously cleared predicate devices but does not provide details of any new study conducted to demonstrate this.

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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.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intra-Operative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Trans-esophageal, Peripheral Vascular, Other (Intra-Luminal), and Other (Intra-Cardiac) Indications.

The Acuson Cypress Ultrasound System is an ultrasound imaging platform which is designed for use with a variety of internal and external transducers. The Acuson Cypress System is a compact and portable diagnostic ultrasound system with a fold-up keyboard, an integrated LCD type display, and interchangeable electronic transducers. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) summary for the Acuson Cypress Ultrasound System, focusing on substantial equivalence to predicate devices and listing intended uses for new transducers. It does not contain performance metrics, study designs, or details on how the device's accuracy or effectiveness was evaluated against specific criteria.

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