Search Results
Found 1 results
510(k) Data Aggregation
(166 days)
CTS-310(B)
Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, neonatal cephalic, adult cephalic, and heart.
Model CTS-310B is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC). The unit allows heart, abdominal organic 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 9-inch video monitor and a special photographic unit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SIUI CTS-310B Ultrasound Imaging System, structured according to your request.
Please Note: The provided document is a 510(k) Premarket Notification Summary from 1999. In this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive, de novo clinical trials. Therefore, the information typically available for newer AI/SaMD devices (e.g., detailed study designs, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance metrics like AUC, sensitivity, specificity, etc.) is generally not present. The "acceptance criteria" here are mainly a demonstration that the new device's technical specifications match or are similar to the predicate device.
Acceptance Criteria and Device Performance Study for SIUI CTS-310B Ultrasound Imaging System
The acceptance criteria for the SIUI CTS-310B Ultrasound Imaging System and its associated transducers (EZU-PL12 and EZU-PC3A) are based on demonstrating substantial equivalence to a predicate device, the Hitachi Medical Corporation EUB-310 (K862867). The "study" proving this equivalence is a direct technical comparison.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the specifications of the predicate device (Hitachi EUB-310A). The SIUI CTS-310B is deemed to meet these criteria by demonstrating identical or comparable performance across various technical characteristics.
| Feature | Acceptance Criteria (Predicate: Hitachi EUB-310A) | Reported Device Performance (SIUI CTS-310B) | Meets Criteria? |
|---|---|---|---|
| Main Unit | |||
| Scanning Mode | Electronic linear scanning (compatible 80 elements linear probe); Electronic convex sector (compatible convex probe of 80 elements) | Electronic linear scanning (compatible 80 elements linear probe); Electronic convex sector (compatible convex probe of 80 elements) | Yes |
| Display Mode | B mode, B/B mode, M mode, B/M mode simultaneously | B mode, B/B ode, M mode, B/M mode simultaneously | Yes |
| Measurement | In B mode: distance, area, circumference; In M mode: time interval, velocity, depth, heart rate | In B mode: distance, area, circumference; In M mode: time interval, velocity, depth, heart rate | Yes |
| Calculation | 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 probe) | Linear: 104mm (3.5MHz probe) | Linear: 104mm (3.5MHz probe) | Yes |
| Scanning Width (5MHz probe) | Linear: 61mm (5MHz probe) | Linear: 61mm (5MHz probe) | Yes |
| Scanning Angle (Convex Sector) | 60° (convex sector scanning probe) | 60° (convex sector scanning probe) | Yes |
| Transmitting Voltage | Pulse height 130V | Pulse height 130V | Yes |
| Transmitting Pulse Width (3.5MHz) | 140 μs (3.5MHz) | 140 μs (3.5MHz) | Yes |
| Transmitting Pulse Width (5MHz) | 100 μs (5MHz) | 100 μs (5MHz) | Yes |
| Detecting Depth (3.5MHz) | Maximum depth: 210mm (3.5MHz probe) | Maximum depth: 210mm (3.5MHz probe) | Yes |
| Detecting Depth (5MHz) | Maximum depth: 140mm (5MHz probe) | Maximum depth: 140mm (5MHz probe) | Yes |
| Zoom (3.5MHz) | x1.0, x1.2, x1.5, x2.0 selectable + depth shift | x1.0, x1.2, x1.5, x2.0 selectable + depth shift | Yes |
| Zoom (5MHz) | x1.0, x1.5, x2.0 selectable + depth shift | x1.0, 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 | 512 x 512 x 4 bit | 512 x 512 x 4 bit | Yes |
| Coordinate transformation | Monitor can display electronic linear scanning image or convex sector scanning image | Monitor can display electronic linear scanning image or convex sector scanning image | Yes |
| Video Output | PAL or NTSC system TV signal | PAL or NTSC system TV signal | Yes |
| Power Supply | 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 250W | 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 250W | Yes |
| Monitor | 5.5" and 9" black and white monitor | 9" black and white monitor (Note: SIUI only mentions 9", Hitachi offers both 5.5" and 9". This is not a deviation that would affect substantial equivalence in operation.) | Comparable |
| Volume and Weight | 405(W) X 710(1) X 1310(h)mm, approx. 40kg | 395 (W) x 1180 (H) x 728 (L)mm, approx. 65 kg (Note: Physical dimensions and weight differ, but this is not typically a performance-based acceptance criterion for image quality or safety for substantial equivalence.) | Comparable |
| Cursor Shift | By joystick on keyboard | By trackball on keyboard (Note: Different interface, but achieves same function. Not a performance or safety issue.) | Comparable |
| 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≤500μA, P-G≤100μA; 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≤500μA, P-G≤100μA; Voltage resistance testing: L-G, P-G 1500V 2mA, no sparking or arcing in 1 minute; Work normally when voltage changes ± 10% | Yes |
| Probe Ultrasound | |||
| EZU-PL12 (Transmitting Freq) | 5MHz (Hitachi EZU-PL12) | 5MHz (SIUI EZU-PL12) | Yes |
| EZU-PL12 (Scanning Width) | 61mm (Hitachi EZU-PL12) | 61mm (SIUI EZU-PL12) | Yes |
| EZU-PC3A (Transmitting Freq) | 3.5MHz (Hitachi EZU-PC3A) | 3.5MHz (SIUI EZU-PC3A) | Yes |
| EZU-PC3A (Scanning Angle) | 60° (Hitachi EZU-PC3A) | 60° (SIUI EZU-PC3A) | Yes |
| Operation Environment | Temperature 5-40°C, relative humidity 30-85% (no water drop) | Temperature 5-40°C, relative humidity 30-85% (no water drop) | Yes |
| Storage Environment | Temperature -10-60°C, relative humidity 30-95% (no water drip) air pressure 700-1060mB | Temperature -10-60°C, relative humidity 30-95% (no water drop) air pressure 700-1060mB | Yes |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: This submission does not describe a clinical test set in the way a modern AI/SaMD submission would. The "test" for substantial equivalence is primarily a technical comparison of specifications and intended use against a legally marketed predicate device. No patient data or image datasets are mentioned as being used for testing.
- Data Provenance: Not applicable, as no clinical test set data is described. The comparison is based on the published technical specifications of the predicate device (Hitachi EUB-310A) and the manufacturer's own specifications for the SIUI CTS-310B, along with a demonstration of compliance with relevant electrical safety standards (IEC 601-1).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No "ground truth" establishment using experts or patient data for a test set is described in this 510(k) submission. Substantial equivalence relies on comparing technical specifications and intended use.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a 1999 510(k) for a conventional ultrasound system, not an AI/SaMD. Such studies are not part of the substantial equivalence pathway for this type of device.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
- Not applicable. This device is a diagnostic ultrasound system operated by a human, not an algorithm providing standalone interpretations.
7. Type of Ground Truth Used
- Not applicable in the context of an AI/SaMD. For this ultrasound system, the "ground truth" for demonstrating substantial equivalence is the set of established technical specifications and performance characteristics of the predicate device. The SIUI CTS-310B's own technical specifications were compared against these.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/SaMD. No machine learning training set is involved.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set is described.
Summary of the "Study" for Substantial Equivalence:
The "study" conducted for the SIUI CTS-310B Ultrasound Imaging System to meet acceptance criteria was a technical comparison against a predicate device, the Hitachi EUB-310A. The manufacturer presented detailed technical specifications for their device and demonstrated that these specifications were either identical or acceptably comparable to those of the predicate. This comparison supported the claim that the new device has the same fundamental scientific technology, materials, design, safety features, and performance characteristics, and the same intended use as the predicate device, thus establishing "substantial equivalence" as required for 510(k) clearance by the FDA. The "acceptance criteria" were met by showing that the proposed device performed within the operational and technical parameters established by the predicate. Regulatory compliance for electrical safety (IEC 601-1) was also a critical component.
Ask a specific question about this device
Page 1 of 1