(106 days)
The HS30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HS30 is a general purpose, mobile, software controlled, diagnostic ultrasound system, Its function is to acquire ultrasound data and to display the data as 2D mode. M mode. Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, Elastoscan Mode or as a combination of these modes. The HS30 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The HS30 uses digital multi-beam forming technology and supports a variety of Linear, Convex, Phased, Static and Volume probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz.
The acceptance criteria and study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy). Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (HS40 Diagnostic Ultrasound System, K180409) by showing that the new device (HS30 Diagnostic Ultrasound System) has similar intended use and key technological features, and that any differences do not raise new questions of safety or effectiveness.
The "performance" is implicitly demonstrated through adherence to various international and FDA guidance standards related to safety and functionality.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Intended Use | Identical to predicate, except exclusion of "Intra-Operative" application (which is deemed not to raise new safety/effectiveness concerns). |
| Technological Features | Similar to predicate (all features migrated from predicate). |
| Acoustic Output Safety | Conforms to FDA guidance and IEC60601-2-37, NEMA UD 2, NEMA UD 3. |
| Electrical Safety | Conforms to ANSI AAMI ES60601-1. |
| Electromagnetic Compatibility | Conforms to IEC60601-1-2. |
| Biocompatibility | Conforms to ISO 10993-1. |
| Reprocessing | Conforms to FDA Guidance for Reprocessing Medical Devices. |
| Software/Firmware Functionality | Evaluated using the same test criteria as the predicate for all applicable imaging modes to ensure image quality was not compromised. |
| Risk Management | Assessed per ISO 14971. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The proposed device HS30 Diagnostic Ultrasound System did not require clinical studies to demonstrate substantial equivalence." This means there was no specific clinical test set of patient data used for evaluating the device's diagnostic performance from a clinical perspective. The evaluation primarily relied on non-clinical testing and comparison to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical studies with a test set requiring expert ground truth were conducted for this submission. The determination of substantial equivalence was based on non-clinical engineering and safety testing.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies with a test set requiring expert adjudication were conducted for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states no clinical studies were required to demonstrate substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device is a diagnostic ultrasound system, not an AI algorithm intended for standalone diagnostic performance. Its functionality is to acquire and display ultrasound data for human interpretation. The "software/firmware-driven functionality" was evaluated to ensure image quality and functionality were not compromised compared to the predicate, but this is an assessment of the system's ability to produce expected outputs, not an assessment of an AI algorithm's standalone diagnostic accuracy.
7. The Type of Ground Truth Used
For the non-clinical tests conducted, the "ground truth" would be defined by the specifications and expected outputs of the various tests:
- Acoustic Output, Electrical Safety, EMC: Measured values against predefined technical limits and standards.
- Biocompatibility: Laboratory test results against established safety thresholds.
- Software Functionality: Expected system behavior and image quality output compared to the predicate device's established performance, verified through engineering tests.
8. The Sample Size for the Training Set
Not applicable. The HS30 Diagnostic Ultrasound System is a hardware and software system for generating ultrasound images, not an AI model that requires a training set in the conventional sense. Its development would involve engineering design, manufacturing, and testing processes. The "software functionality" was evaluated against the predicate device, implying a comparison against established benchmarks rather than training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no AI model requiring a training set was part of this submission for the HS30 Diagnostic Ultrasound System.
§ 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.