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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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