(60 days)
The SonoScape X5 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
This SonoScape X5 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The X5 system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.
This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes.
The SonoScape X5 Digital Color Doppler Ultrasound System is compared to the predicate device, SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System (K152164), to establish substantial equivalence. The information provided outlines the comparison and the tests conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly state quantitative clinical acceptance criteria for the device's performance (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the substantial equivalence is based on the device conforming to applicable medical device standards and having similar performance characteristics to a legally marketed predicate device. The "reported device performance" is primarily demonstrated through compliance with various safety and performance standards, and comparison of technical specifications to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicit from testing/comparison) | SonoScape X5 Reported Performance (based on comparison and testing) |
|---|---|---|
| Intended Use | Same as predicate device | Same as predicate (Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology). Minor differences in specific application modes (e.g., no Trans-esoph. Cardiac, Laparoscopic on X5) are deemed not to affect safety/effectiveness. |
| Pulsed Doppler Imaging | Compliance with 21 CFR 892.1550 | Compliant (Class II, Product Code 90-IYN) |
| Pulsed Echo Imaging | Compliance with 21 CFR 892.1560 | Compliant (Class II, Product Code 90-IYO) |
| Diagnostic Transducer | Compliance with 21 CFR 892.1570 | Compliant (Class II, Product Code 90-ITX) |
| Electrical Safety | Compliance with IEC 60601-1 | Compliant with IEC 60601-1 |
| EMC | Compliance with IEC 60601-1-2 | Compliant with IEC 60601-1-2 |
| Performance (Ultrasound) | Compliance with IEC 60601-2-37 | Compliant with IEC 60601-2-37 |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Compliant with ISO 10993-5, ISO 10993-10 |
| Acoustic Output Display | Compliance with AIUM/NEMA UD3-2004 | Compliant with AIUM/NEMA UD3-2004 |
| Acoustic Output Measurement | Compliance with AIUM/NEMA UD2-2004 | Compliant with AIUM/NEMA UD2-2004 |
| Acoustic Output Levels | Below FDA limits; similar to predicate | Derated ISPTA: 720mW/cm2 max; TIS/TIB/TIC: 6.0 max; MI: 1.9 max; Derated ISPPA: 190W/cm2 max (Same as predicate) |
| Design (General) | Embedded Linux OS, autocorrelation/FFT, probe support, cine playback, image archive, USB upgrade | Same as predicate; minor difference in Digital Scan Converter resolution (1130*820 vs 800x600) deemed not to affect safety/effectiveness. |
| Operation Controls | Similar functionality and ranges to predicate | Generally similar; some differences in value range or setting (e.g., Depth Range: 1.5-40cm vs 3-24.8cm; B Dynamic range: 20-200 vs 20-280dB; Gray map: 1-16 vs 7 options) deemed not to affect safety/effectiveness. |
| Operation Modes | Includes clinical basic items, within predicate's capabilities | B, M, PW, CW, CFM, PDI, THI, PHI, Compound Imaging (Subset of predicate's broader modes which also include TDI, Color M Mode, 3D/4D, Panoramic, Trapezoid, Elastography) deemed not to affect safety/effectiveness. |
| Display Modes | Includes clinical basic items, within predicate's capabilities | B, CFM, PDI, B+CFM, B+PDI, M, PW,CW: V1/2,V1/1,V2/1,H1/1,Full (Subset of predicate's broader modes like Dual, Quad, Dual Live, Steer M) deemed not to affect safety/effectiveness. |
| Measurement Items | Includes clinical basic items, within predicate's capabilities | B, CFM, DPI: Distance, Area, Volume, Angle; M: Distance, Slope, %Sten(D), Ratio(D), Time, HR; CFM/PDI: Doppler Area, Color Flow, Flow Velocity; PW/CW: Velocity, Acceleration, Auto Trace, Time, HR, RI, PI, S/D (Subset of predicate's broader list, but covers basic items) deemed not to affect safety/effectiveness. |
| Power Supply | Same type as predicate, compliant with standards | Voltage: 100-240V~; Frequency: 50/60Hz; Power Consumption: 100-240V~, 1.5-0.75A (Similar to predicate's voltage range and power consumption, compliant with IEC60601-1) |
| Screen Size | Same type as predicate, compliant with standards | 15.6 inch LCD monitor (Similar to predicate's 15 inch LCD monitor, compliant with IEC60601-1 & IEC60601-1-2) |
| Probes Compatibility | Similar to predicate, new probes comparable to existing | Most probes (3C-A, C613, L741, 6V1, EC9-5, PWD2.0) are same or slightly adjusted frequency range; Two new probes (3P-A and 7P-B) are similar to predicate probes (2P1 and 5P1) with same clinical application and similar performance/frequency, deemed not to affect safety/effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "No clinical testing was required." Therefore, there is no test set in the sense of clinical data from patients. The "tests" conducted were primarily non-clinical laboratory tests to verify design specifications and compliance with recognized safety and performance standards. The data provenance for these non-clinical tests would be internal laboratory testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Given that no clinical testing was referenced, there were no "experts" involved in establishing ground truth for a clinical test set. The assessment relied on expert judgment of engineering, quality, and regulatory personnel to confirm compliance with standards and equivalence to the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was performed or referenced.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The submission is for a diagnostic ultrasound system and does not mention any AI components or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The submission is for a diagnostic ultrasound system, not an algorithm.
7. The type of Ground Truth Used
As per the document, "No clinical testing was required." Therefore, no specific type of "ground truth" (e.g., expert consensus, pathology, outcomes data) derived from clinical cases was used to validate the device's diagnostic performance for this 510(k) submission. The "truth" in this context is the device's adherence to regulatory standards and its demonstrated equivalence in technical characteristics and safety to an already cleared device.
8. The Sample Size for the Training Set
Not applicable, as this is not a submission for a machine learning or AI-based device requiring a training set in that context.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used or referenced for a machine learning or AI-based device.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.