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The HD11 is intended for diagnostic ultrasound imaging and fluid flow analysis. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.

The HD11 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. It is substantially equivalent to other ultrasound systems including the Philips M2540A EnVisor and HDI-5000 series Ultrasound systems with transducers.

The 3D8-4 and L15-7io transducers are substantially equivalent to other Philips sector, linear and endo-cavity ultrasound transducers.

The HD11 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. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The provided text describes the Philips Ultrasound HD11 Diagnostic Ultrasound System and its transducers as substantially equivalent to predicate devices. It does not contain information about specific acceptance criteria, study methodologies, or performance metrics beyond broad claims of "safety and effectiveness."

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: No specific performance criteria or results are detailed. The document relies on substantial equivalence to predicate devices rather than proving performance against new criteria.
• Sample size used for the test set and data provenance: No test set information or data provenance is provided.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as no a ground truth establishment process is described.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned.
• Standalone performance study: No standalone performance study information is provided.
• Type of ground truth used: Not applicable, as no ground truth is described.
• Sample size for the training set: No training set information is provided.
• How the ground truth for the training set was established: Not applicable.

Summary of Device and Equivalence Claim (as provided in the document):

The Philips Ultrasound HD11 Diagnostic Ultrasound System is a diagnostic ultrasound device designed for imaging and fluid flow analysis. It is claimed to be substantially equivalent in safety and effectiveness to the Philips M2540A EnVisor and HDI-5000 series Ultrasound systems with transducers (predicate devices).

The basis for this substantial equivalence includes:

• Identical intended uses (diagnostic ultrasonic imaging and fluid flow analysis).
• Same gray-scale and Doppler capabilities.
• Essentially the same technologies for imaging, Doppler functions, and signal processing.
• Acoustic output levels below Track 3 FDA limits.
• Manufactured under equivalent quality systems.
• Manufactured with materials of equivalent biosafety.
• Designed and manufactured to the same electrical and physical safety standards.

The document lists various transducers and their specific indications for use, indicating which applications are "new indications" (N), "previously cleared by FDA" (P), or "added under Appendix E" (E) for different imaging modes (B, M, PWD, CWD, Color Doppler, Combined, Other). The modes listed under "Other" include advanced features like SonoCT, X-Res, Angio, Panoramic, 3-D/4-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging, IMT Measures, iSCAN, 2D Doppler, Color Power Angio, Fetal Heart (Spatial Temporal Image Correlation), and Real Time Biopsy (for specific transducers).

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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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