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The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) 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 AcuNay diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode, Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

This document is a 510(k) Summary for the Acuson Sequoia Diagnostic Ultrasound System Signature II. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The 510(k) summary focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices, primarily through adherence to safety standards and a comparison of technological features. It does not include performance metrics or a study demonstrating the device's efficacy or accuracy against specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance for market clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Applications listed include: Ophthalmic, Fetal, Abdominal, Intra-operative (vascular/epicardial, Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, breast, Prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Gynecological, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Fetal Cardiac, Peripheral vessel, Musculo-skel (conventional), Musculo-skel (superficial), Pelvic.

Modes of Operation include: B, M, PWD, CWD, Color Doppler, Combined (Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color), Other (Angio, Panoramic, Harmonics (Tissue & Contrast), 3-D Imaging, Directional Angio Imaging, Doppler Tissue Imaging, Amplitude Doppler).

The M2540 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. The M2540 system and transducers function in a manner identical to all ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system.

The provided document is a 510(k) premarket notification for the Philips Medical Systems M2540 Diagnostic Ultrasound System and its associated transducers. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through a clinical study with detailed performance metrics against acceptance criteria.

Therefore, the document does not contain the requested information regarding acceptance criteria, a specific study proving the device meets those criteria, or details about ground truth, expert adjudication, or comparative effectiveness studies.

Instead, it asserts substantial equivalence based on similarities in:

• Intended Use: Diagnostic ultrasound imaging and fluid flow analysis.
• Technological Characteristics: Gray-scale and Doppler capabilities, imaging, Doppler functions, and signal processing.
• Safety Standards: Acoustic output levels below Track 3 FDA limits, manufacturing under equivalent quality systems, and use of bio-safe materials.

The tables presented in the document are "Indications for Use Forms," which specify the clinical applications and modes of operation for each transducer (e.g., Fetal, Abdominal, Cardiac, Peripheral Vessel, modes like B-mode, M-mode, PWD, CWD, Color Doppler). The 'N' in these tables indicates a new indication for that specific transducer/system combination, meaning it is being proposed for these uses, and its substantial equivalence is being argued based on the general device characteristics. It does not represent a performance metric or study result.

The letter from the FDA (page 2-4) confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed, but it does not detail a study proving specific performance acceptance criteria. It also mentions a "postclearance special report" required for acoustic output measurements, which is a regulatory compliance step, not a performance study proving clinical efficacy.

In summary, based on the provided text, the device's acceptance criteria and a detailed study proving it meets those criteria are not available. The submission is a regulatory clearance based on substantial equivalence to existing devices.

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