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510(k) Data Aggregation
(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-G<500 μA, P-G<100 μA; Voltage resistance testing: L-G, P-G 1500V 2mA, no sparking or arcing in 1 minute; Work normally when voltage changes ±10% | 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-G<500 μA, P-G<100 μA; Voltage resistance testing: L-G, P-G 1500V 2mA, no sparking or arcing in 1 minute; Work normally when voltage changes ±10% | Yes |
| Operation Environment | Temperature 5-40°C, relative humidity 30-85% (no water drop) | Temperature 5-40°C, relative humidity 30-50% (no water drop) | Yes (within range, but narrower humidity) |
| Storage Environment | Temperature -10-60°C, relative humidity 30-95% (no water drop), air pressure 700-1060mB | Temperature -10-60°C, relative humidity 30-95% (no water drop), air pressure 700-1060mB | Yes |
Summary of Device Performance Assessment:
The SIUI CTS-285 Diagnostic Ultrasound System demonstrates substantial equivalence to the Hitachi EUB-310A. Crucially, all core imaging and measurement capabilities (display modes, measurements, calculations, focusing, detecting depth, frame rate, grey scale, memory, video output, and electrical safety standards) meet or are comparable to the predicate device.
Minor differences exist:
- The SIUI device has fewer elements in its linear and convex probes (64 vs 80), which might slightly impact image resolution or field of view, but this is not considered a critical difference for substantial equivalence in this context, especially given the intended uses.
- The SIUI device is more compact and lighter, representing an improvement in portability.
- Its power consumption is lower.
- It offers only a 5.5" monitor compared to the predicate's 5.5" and 8" options.
- Its operational humidity range is narrower, but still within acceptable clinical conditions.
The document argues that these differences do not raise new questions of safety or effectiveness, therefore establishing substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This is a medical device premarket notification (510(k)) based on substantial equivalence, not an AI/ML device study. Therefore, there is no "test set" in the sense of a dataset for algorithmic performance evaluation. The "test" for substantial equivalence is primarily a comparison of the device's technological characteristics, intended use, and safety/effectiveness profile against a legally marketed predicate device.
The data provenance for the comparison is the specifications provided by the manufacturer of the SIUI CTS-285 and the publicly available specifications of the Hitachi EUB-310A (predicate device). This is considered retrospective in the sense that existing device specifications are being compared. The country of origin of the new device is China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no "test set" or algorithmic performance evaluation in this 510(k) submission, no experts were used to establish ground truth for a test set. The "ground truth" for substantial equivalence is the established performance and safety of the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of an algorithm's performance evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for the substantial equivalence of a diagnostic ultrasound system based on its physical and functional specifications, not a study evaluating human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a traditional ultrasound imaging system; it does not feature an AI algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is the established safety and effectiveness profile, and technical specifications, of the legally marketed predicate device (Hitachi Medical Corporation EUB-310, K862867). The new device is deemed substantially equivalent if its differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device. There is no "training set" or ground truth for such a set.
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