(295 days)
Diagnostic ultrasound imaging of the human body as follows: Fetal, Abdominal, Cardiac Adult (B mode, M mode)
Model CTS-285 is a compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows adult heart, abdominal organ and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9-inch video monitor and a special photographic unit.
This 510(k) premarket notification describes the CTS-285 Diagnostic Ultrasound System. The primary method for proving substantial equivalence to the predicate device, Hitachi Medical Corporation EUB-310 (K862867), is through a comparison of technological characteristics. There are no direct performance studies with acceptance criteria in the document that would be typical for AI/ML devices. Therefore, I will create a table to compare the reported specifications of the new device (SIUI CTS-285) against its predicate (Hitachi EUB-310A) to infer "acceptance criteria" based on the predicate's established performance, and then note the new device's "performance" based on its characteristics.
1. Table of Acceptance Criteria (Inferred from Predicate) and Reported Device Performance
| Feature/Parameter | Inferred Acceptance Criteria (Based on Hitachi EUB-310A) | Reported Device Performance (SIUI CTS-285) | Device Meets Criteria? |
|---|---|---|---|
| Scanning Modes | Electronic linear scanning (compatible 80 elements linear probe), Electronic convex sector (compatible convex probe of 80 elements) | Electronic linear scanning (compatible 64 elements linear probe), Electronic convex sector (compatible convex probe of 64 elements) | Partially (fewer elements) |
| Display Modes | B mode, B/B mode, M mode, B/M mode simultaneously | B mode, B/B mode, M mode, B/M mode simultaneously | Yes |
| Measurements (B-mode) | Distance, area, circumference | Distance, area, circumference | Yes |
| Measurements (M-mode) | Time interval, velocity, depth, heart rate | Time interval, velocity, depth, heart rate | Yes |
| Calculations | Area, circumference, volume, heart rate, pregnant weeks, heart function | Area, circumference, volume, heart rate, pregnant weeks, heart function | Yes |
| Focusing Mode | 4-steps dynamic focusing with variable aperture and lens focusing | 4-steps dynamic focusing with variable aperture and lens focusing | Yes |
| Scanning Width (3.5MHz linear) | 104mm | 102mm | Yes (within tolerance) |
| Scanning Width (Convex sector) | 60° | 60° | Yes |
| Transmitting Voltage | Pulse height 130V | Pulse height 130V | Yes |
| Transmitting Pulse Width (3.5MHz) | 140 μs | 160 μs | Yes (within acceptable range for diagnostic ultrasound) |
| Detecting Depth (3.5MHz) | Maximum 210mm | Maximum 210mm | Yes |
| Zoom (3.5MHz probe) | x1.0, x1.2, x1.5, x2.0 selectable, depth shift | x1.0, x1.2, x1.5, x2.0 selectable, depth shift | Yes |
| Frame Rate | Maximum 40 frame/second | Maximum 40 frame/second | Yes |
| Grey Scale | 16 | 16 | Yes |
| Memory | 512x512x4 bit | 512x512x4 bit | Yes |
| Video Output | PAL or NTSC system TV signal (confirmed in order) | PAL or NTSC system TV signal (confirmed in order) | Yes |
| Power Supply | 100-234V, ±10%, 50/60Hz, about 250W | 100-234V, ±10%, 50/60Hz, about 140W | Yes (lower power consumption is generally an advantage) |
| Monitor | 5.5" and 8" black and white monitor | 5.5" black and white monitor | Slightly lower (no 8" option) |
| Volume and Weight | Approx. 405(W)x710(L)x1310(H)mm, approx. 40kg | Approx. 280(W)x235(H)x415(L)mm, approx. 13kg | Yes (more compact and portable) |
| Electrical Safety Standard | Conform to requirement of I class B type apparatus of IEC 601-1; Isolate resistor testing: 1000V L-L, L-G>10MΩ; Leakage current: U-G10MΩ; Leakage current: U-G |
§ 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.