(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Intra-operative (abdominal organs and peripheral vessel, neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans. Intraoperative application including soft tissue structures.
The SA 5500 System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, 3D or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The SA 5500 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Eleven different models of transducers are available and any two array probes along with 1 mechanical sector probe may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials are the same as those previously cleared in the predicate devices. The SA 5500 uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 10.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipital-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The SA 5500 supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
The provided text describes the SonoAce 5500 Diagnostic Ultrasound System and its various transducers. It outlines the device's technical characteristics and intended uses, drawing substantial equivalence to previously marketed devices. However, the document does not contain information about specific acceptance criteria or a study that quantitatively proves the device meets such criteria.
The document focuses on demonstrating substantial equivalence to predicate devices (SonoAce 6000C/UM 400 systems and Voluson 530D) based on:
- Technological Characteristics: Stating that the device operates identically to predicate devices in how it transmits and receives sound waves and processes signals.
- Acoustic Output Limits: Comparing the maximum range of ISPTA (720 mW/cm²) and MI (1.9) to predicate "Track 3 devices" and affirming they are the same.
- Electromechanical Safety Standards: Listing compliance with various international and national safety standards (e.g., EN 60601-1, UL 2601-1, IEC 1157, EN 60601-1-2).
- Intended Use: Showing that the clinical applications for the SonoAce 5500 and its transducers are either "new indications" (N) or "previously cleared" (P) under the predicate SonoAce 6000C/UM 400C Ultrasound System or COMBISON 530 Ultrasound System.
Therefore, I cannot populate the requested table and answer the specific questions (2-9) about sample size, data provenance, expert ground truth, adjudication, MRMC studies, or standalone performance, as this information is not present in the provided text.
The document is a 510(k) summary (Premarket Notification) to the FDA, which typically establishes substantial equivalence rather than presenting detailed performance studies with acceptance criteria and statistical analysis as might be found in a clinical trial report. The "acceptance criteria" here are implicitly meeting the performance and safety profiles demonstrated by the predicate devices and complying with relevant standards.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.