(102 days)
The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal (soft tissue), and peripheral vascular.
The Ultrasound System SONIMAGE HS1 is a portable ultrasound system for general purposes. The system provides ultrasound imaging information such as used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation. This system provides ultrasound images in all its modes of B-mode, M-mode, Color Doppler-mode, and PW Doppler-mode.
The Konica Minolta Ultrasound System SONIMAGE HS1 (K142197) is a general-purpose portable ultrasound system. Its clearance is based on substantial equivalence to a predicate device (K093171 – Viamo SSA-640A, Toshiba America Medical Systems, Inc.). This type of submission relies on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device. Therefore, the "acceptance criteria" for this device are implicitly tied to demonstrating that it meets the safety and performance standards of the predicate and other relevant safety standards.
Here's a breakdown of the information based on your request, though it's important to note that a 510(k) summary for a substantial equivalence determination often does not include a detailed "study that proves the device meets acceptance criteria" in the same way a de novo or PMA submission might, especially for performance characteristics that are considered generally well-understood for the device type.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Demonstrated Performance (via Substantial Equivalence and Bench Testing) |
|---|---|
| Intended Use Equivalence | The Ultrasound System SONIMAGE HS1 is designed to collect ultrasonic image data of the human body for diagnostic purposes, visualizing anatomic structures, characteristics, and dynamics. It offers image display, Doppler display, or Doppler sound for medical diagnosis or examination. The range of intended clinical applications (small parts, abdomen, musculoskeletal (soft tissue), and peripheral vascular) is the same as the predicate device. The system's intended use is narrowed compared to the predicate but remains within its scope. |
| Technological Characteristics Equivalence | Employs the same fundamental scientific technologies as the predicate device (K093171). |
- Operating Principle & Design: Transmits ultrasonic energy, performs post-processing of echoes for on-screen display of anatomic structures and dynamics. Laptop-shaped for portability with battery operation. Supports B-mode, M-mode, Color Doppler-mode, and PW Doppler-mode. Supports the same measurement functions.
- Transducers: Uses conventional extracorporeal transducers (Linear and Convex types), partially same as the predicate device. Specific transducers mentioned are L18-4 and C5-2. |
| Safety and Performance Standards Compliance (Non-clinical Testing) | Conforms to various standards: AAMI / ANSI ES 60601-1: 2005 and C1:2009 and A2:2010; IEC 60601-1-6: 2013; IEC 60601-1-2: 2007; IEC 60601-2-37: 2007; IEC 62304: 2006; ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010; NEMA UD 2-2004; NEMA UD 3-2004. These are stated to be the same or equivalent to those of the predicate. Devices conform to real-time display of thermal and mechanical output indices under Track 3. |
| Non-clinical Test Results | Geometric accuracy in B-mode and accuracy verification of position and velocity for Color Doppler-mode and Pulse Doppler-mode, and time for Pulse Doppler-mode were comprehensively tested as Bench-tests (except quantitative Doppler sensitivity). No quantitative claims of sensitivity regarding Color Doppler-mode and Pulse Doppler-mode were made or required. |
| Biocompatibility | Patient contact materials for human body surface were evaluated under ISO 10993 and determined acceptable. Achieves the same acceptance level for biocompatibility as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data. The evaluation for substantial equivalence relies primarily on bench testing and compliance with recognized standards. This is a common approach for ultrasound systems where the fundamental imaging technology is well-established.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As this is a 510(k) based on substantial equivalence, the "ground truth" for basic performance characteristics is often established by adherence to industry standards and engineering specifications rather than independent expert clinical review of imaging data for a "test set".
4. Adjudication Method for the Test Set
This information is not applicable/provided. No clinical "test set" requiring adjudication by experts is mentioned in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission specifically states: "The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment." This means that a direct comparison of human readers with and without AI assistance was not part of this clearance process.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device described is an ultrasound imaging system, not an AI algorithm. Its performance is inherent to the hardware and software generating the images and Doppler outputs. It is not an "algorithm only" device.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims (e.g., geometric accuracy, Doppler accuracy) would be defined by engineering specifications, phantom measurements, and adherence to international and national standards (e.g., NEMA UD 2-2004 for acoustic output and safety guidelines). The clinical "ground truth" for diagnostic efficacy is implicitly assumed to be equivalent to that of the predicate device because the underlying technology and intended use are deemed substantially equivalent.
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is an ultrasound system, not an AI algorithm that undergoes a "training set" process in the described context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reason as point 8.
§ 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.