(248 days)
This device is intended to be used for applications in fetal. abdominal, intraoperative (defined as the abdominal region and periphery), pediatric, small organ (defined as thyroid, breast and testes), cardiac, transrectal, transvaginal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either from the surface of the skin, transrectally, transvaginally or intraoperatively. The UF-5800A incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-5800A with optional Doppler (UF-5800DU) is a prescription device intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-5800 is intended to be used in a doctor's office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (Abdominal region and periphery), Pediatric, Small Organ (thyroid, breast, and testes), Cardiac, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The model UF-5800 is a portable, General Purpose Ultrasound Scanning System. The unit will be marketed as the UF-5800A General Purpose Ultrasound Scanner without Doppler. The addition of the optional UF-5800DU Doppler unit will add black and white Doppler capability to the UF-5800A. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on its gray scale monitor. The resulting information is displayed in M-mode, B-Mode, Doppler (both CW and pulsed) modes, or in combinations of modes on the system's 7 inch diagonal video monitor as a 16 level grayscale or black and white image.
The Fukuda Denshi FF sonic model UF-5800A is a general-purpose ultrasound scanner with an optional Doppler unit (UF-5800DU). Here's an analysis of its acceptance criteria and the study that proves it meets those criteria, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Fukuda Denshi FF sonic model UF-5800A are primarily based on demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards. The "reported device performance" section directly addresses how the device meets these criteria through various tests.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device must be as safe, as effective, and perform as well as or better than the legally marketed predicate devices (Fukuda Denshi models UF-4500 and UF-3500, and Medison SonoAce 4800). This includes technological characteristics not raising new safety/efficacy issues. | Laboratory testing was conducted to validate and verify that the UF-5800A and UF-5800DU "met all design specifications and is substantially equivalent to the currently marketed FUKUDA DENSHI models UF-4500 and UF-3500 as well as the Medison SonoAce 4800." The technological characteristics, including the microprocessor, linear and convex probes (same as predicate Fukuda Denshi devices), and acceptance of sector and CW Doppler probes (similar to Medison SonoAce 4800), were deemed not to raise new safety or efficacy issues. |
| Environmental Safety | Compliance with environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. | Environmental testing, as per the specified FDA guidance document, was performed. (Specific results are not detailed in this summary, but the conclusion states "demonstrate that the device is as safe..."). |
| Acoustic Output | Derated acoustic output limits must be below the maximums established for Track 1 devices as listed in the "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 30, 1997. Specific limits provided in the table: |
- Peripheral Vessel: ISPTA3
§ 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.