(106 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular. Intended for use in military field settings in addition to hospital/clinic settings.
The TERATECH Model 2000 is a portable ultrasound imaging system with grayscale or brightness (B-Mode) imaging. The Model 2000 consists of a laptop computer and a 3 MHz linear array ultrasonic probe.
This document is a 510(k) premarket notification for the TERATECH Model 2000 Imaging System, a diagnostic ultrasound system from 1999. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way contemporary AI/ML medical devices do.
Here's an analysis based on the provided text, highlighting what is (and isn't) present as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
This type of information is not present in the provided document. For a 510(k) submission of a diagnostic ultrasound system from 1999, the "acceptance criteria" primarily revolved around demonstrating that the device meets safety standards (electrical safety, acoustic output) and performance specifications that are comparable to legally marketed predicate devices, rather than clinical performance metrics typical of AI/ML or more advanced diagnostic devices today.
The "reported device performance" in this context refers to the technical specifications of the device itself, such as:
| Specification | TERATECH Model 2000 Performance |
|---|---|
| System Frequencies | 2-4 MHz |
| Frame Rate | 15-30 fps (imaging only) |
| Number of Ultrasound Lines per Frame | 128 |
| Fields of View | 2-27 cm |
| Mode of Operation | 2D imaging |
| Image Display | Rectangular and trapezoidal |
| Video | S-VHS Output, External VGA Monitor |
| LCD Size | 14.1" |
| Gray Shades | 256 |
| Image Magnification | 1X-4X, probe dependent |
| Image Presentation | black/white, left/right, up/down |
| Image Processing | gamma correction, dynamic range, speckle noise reduction |
| Input Power | 115 VAC, A/C adapter rated @ 60 W |
| Power Consumption |
§ 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.