(30 days)
The SonoScape S8 Exp device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
The SonoScape S8 Exp Portable 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
The SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System is a general-purpose integrated, preprogrammed color ultrasound imaging system intended for diagnostic imaging.
The device's performance aligns with the predicate device, SonoScape S9 Portable Digital Color Doppler Ultrasound System (K131088).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Predicate: SonoScape S9) | Reported Device Performance (SonoScape S8 Exp) |
|---|---|---|
| Intended Use | Identical | Identical |
| Classification | Identical | Identical |
| Product Code | Identical | Identical |
| Regulation Number | Identical | Identical |
| Panel | Identical | Identical |
| Class | II | II |
| Acoustic Track | TRACK 3 | TRACK 3 |
| Design | Embedded Linux System, 128 channel full digital beam former, Autocorrelation for color processing, FFT for pulse and CW Doppler, Supports Linear, Curve linear, and Phase array probes (2-15 MHz), Cine playback, Image archive, Software upgrade via USB, Digital Scan Converter 800x600 | Identical (except for panel type) |
| Panel Type | Touch-screen panel | Full keyboard panel |
| Operation Control | TGC 8 slider, Depth Range: 3-32 cm, Image sector size: 32 lines to full B (256 lines), Image Sector position: Steering within full maximum, B orientation flip: L/R key with marking on screen, B Dynamic range control: 14 preset curves over 140 dB, Gray Scale Control: 7 Settings, Focal Number: 12, B persistence: 0-95%, Image Processing: Smoothing, edge enhancement, PW sweeping speed 2 4 6 8, PW Wall filter setting: 16 settings (25-750 HZ), PW sample volume: 0.5-20 mm, PW/B update: with UPDATE key, PW cursor steering: Steer soft key, PW angle correction: 0-80 degree user control, PW spectrum dynamic range: 10 preset curve over 15-48 dB, Spectrum baseline shift and invert, Color ROI setting: trackball and set key to control size and position, Color steering on flat probe: ±20 ±160, Color Wall Filter: 16 selection (25-750 of PRF), Color priority-B priority soft menu, Color Packet size: preset per Exam, Zoom adjustable, Freeze control: Toggling freeze key, Cine control: step, play backward, play continuously | Identical |
| Operation Mode | B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image, 3D/4D Mode, Color M Mode | Identical |
| Display Modes | Dual B, Quad Display, B and M, B and Doppler, B + Color, Dual B(Flow), Triplex mode, Dual B and Color in real time, Compound Imaging, Panoramic Imaging, Trapezoid Imaging | Identical |
| Measurement Items | Distance; area; circumference; calipers; volume, velocity, HR, PI, RI. Cardiac. OB/GYN, Urology, Vascular and small part package | Identical |
| Cine Loop | Automatic review/ manual review, Review speed adjustable | Identical |
| Power Supply | Voltage: 110-240 VAC, Frequency: 50/60 Hz, Power Consumption: 110-240V AC, 2.7-1.2A | Identical |
| Operating Condition | Temperature: 10-40°C, Relative humidity: 30-75%, Air pressure: 700hPa-1060hPa | Identical |
| Storage Condition | Temperature: -20-55°C, Relative humidity: 20-90%, Air pressure: 700hPa-1060hPa | Identical |
| Screen Size | 15 inch Widescreen LCD monitor | 15 inch Widescreen LCD monitor |
| Measurement Accuracy | Display depth: Max 32.9 cm; ±3%, Distance: 0-31.0 cm; ±3%, Area: Max. ≥855 cm²; ±7%, Angle: 10-193°; ±3%, Circumference: 200 cm; ±3%, Volume: Max. 25000 cm³; ±10%, M-Mode time: 2,4,6,8 S; ±1%, Heart Rate: 8-1000 beats/sec; ±3%, Slope: 1300 cm/s; ±3%, Velocity (PW): 0.04-2940 cm/s; Angle ≤60°, ≤5%, Velocity (CW): 0.12-3795 cm/s; Angle ≤60°, ≤5%, Velocity (Color): 1-298 cm/s; Angle ≤60°, ≤5% | Identical |
| Acoustic Output | Track 3:MI, TIS, TIC, TIB, Derated ispta: 720Mw/cm² maximum. TIS/TIB/TIC: 6.0 Maximum, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190W/cm² max | Identical |
| Electrical Safety | -IEC 60601-1 | -IEC 60601-1 |
| EMC | -IEC 60601-1-2 | -IEC 60601-1-2 |
| Performance | -IEC 60601-2-37 | -IEC 60601-2-37 |
| Biocompatibility | -ISO 10993-5, -ISO 10993-10 | -ISO 10993-5, -ISO 10993-10 |
| Level of Concern of Software | Moderate level of concern system | Moderate level of concern system |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "No clinical testing was required." Therefore, there is no information on a test set, sample size, or data provenance from clinical data. The testing mentioned in the submission focuses on laboratory testing to verify design specifications and compliance with safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical testing was required, there is no mention of experts being used to establish a ground truth for a test set.
4. Adjudication Method for the Test Set
As no clinical testing was required, there is no adjudication method described.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was mentioned in this submission. The submission focuses on comparing the proposed device to a predicate device based on technical specifications and compliance with standards, not on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an ultrasound system and not an AI algorithm. Therefore, the concept of standalone performance of an algorithm without human-in-the-loop is not applicable in the context of this submission. The performance assessment is related to the imaging capabilities of the hardware and software as a complete diagnostic tool used by a physician.
7. The Type of Ground Truth Used
Given that no clinical testing was required, the "ground truth" for demonstrating device performance relied on:
- Compliance with Industry Standards: NEMA UID 2: 2004, NEMA UD3: 2004, IEC 60601-1: 2005, IEC 60601-1-2: 2007, IEC 60601-2-37: 2008, ISO 10993-5, ISO 10993-10.
- Comparison to Predicate Device Specifications: The primary method for proving substantial equivalence was a direct comparison of technical specifications, intended use, and performance parameters (e.g., measurement accuracy, acoustic output) against the previously cleared predicate device (SonoScape S9, K131088).
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this device, as it is a diagnostic ultrasound system and not an AI/machine learning algorithm requiring a training phase with a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/machine learning algorithm was involved.
§ 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.