(32 days)
Pie Medical's Picus, Parus, Falco & Aquila Ultrasound Imaging Systems are to be used by or under the direction of a physician to perform general noninvasive and invasive diagnostic high resolution ultrasound imaging studies, to include: fetal, cardiac, transrectal, transvaginal, abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular, musculoskeletal (conventional and superficial) and wounds.
Wound imaging is a method for evaluating the extent of wounds, using high resolution ultrasound for image acquisition and applying the online measurement package of the ultrasound system to measure either the wounds' linear parameters, or the circumference and depth for volume determination. This information is used for the medical specialist to evaluate the efficacy of a particular treatment in the reduction of the wound area.
The proposed wound imaging method uses a commercially available ultrasound couplant sheet, such as the Civco's HydroScan Couplant Sheet (Class 1), to cover a wound filled with a sterile coupling gel, such as Curasol (K953450). A linear or convex array ultrasound transducer is scanned over the covered wound to image the extent of the wound. Note that it is important that the cover not be sealed with adhesive edges area, as there is a potential to cause damage to the sensitive skin area adjacent to the wound. We believe that this is a significant advantage over previously described methods which use an adhesive material on the edge of the couplant sheet, and risk damaging the sensitive skin area proximal to the wound. To prevent contamination of the wound during the scan the ultrasound probe is covered with a commercially available sterile sheath, such as those available from Civco (K970515).
The clinician can choose to perform area length or circumference measurements to evaluate the dimensions of the wound, the circumference yielding a better determination of the wounds extent in situations where the wound has an irregular geometry.
The provided 510(k) summary for the Picus, Parus, Falco, & Aquila Ultrasound Imaging Systems does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
This document primarily focuses on establishing substantial equivalence to predicate devices for the purpose of obtaining FDA clearance. It describes the device, its intended uses (clinical applications and imaging modes), and compares its general characteristics and safety features to previously cleared ultrasound systems.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth, as this information is not present in the provided text. The document states that "Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table" but does not include any performance data or a study report.
The "Indications for Use Form - Appendix F" for each system (Parus, Falco, Aquila, Picus, and specific probes like 7.5 MHz L40 and 8MHz LA DF 30C/40mm) primarily outlines the diagnostic ultrasound imaging modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, and 3D) for various clinical applications (e.g., Fetal, Abdominal, Small Organ, Wounds). It indicates if an indication is new (N) or previously cleared (P), but it does not provide performance metrics or studies to support these indications.
In summary, the provided text is a 510(k) summary for a medical device and is not a study report demonstrating adherence to specific acceptance 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.