(192 days)
The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac, trans-vaginal, trans-rectal and peripheral vascular applications.
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B, M, PWD, CWD, Color Doppler and 3D imaging modes.
The SIUI Apogee 1200 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD/CWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
The provided document is a 510(k) Summary for the SIUI Apogee 1200 Digital Color Doppler Ultrasound Imaging System. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a new device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study findings.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document states:
Acceptance Criteria & Study:
The "study" presented here is a demonstration of substantial equivalence to a legally marketed predicate device, the Ultrasonix Ergononix 500 Ultrasound Scanner (K042326). The core "acceptance criteria" for a 510(k) submission are that the new device is as safe and effective as the predicate device.
The document claims:
"The conclusions drawn from testing of the Apogee 1200 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device."
No specific quantitative performance metrics or studies against predefined acceptance criteria for the device's diagnostic capabilities are provided in this summary. Instead, the justification for safety and effectiveness relies on:
- Intended Use: The intended uses for the Apogee 1200 are compared and found to be substantially equivalent to the predicate device.
- Principles of Operation: Both devices operate on similar principles of ultrasound imaging.
- Technological Characteristics: The Apogee 1200's various operating modes (2D, M, Doppler, Color, 3D) and transducer types are presented as comparable to modern ultrasound systems, implying equivalence.
- Safety Considerations: The device was tested per "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 2008 FDA Guidance document) and conforms to applicable medical device safety standards (IEC 60601-1, ISO10993-5, ISO 10993-10). Acoustic output measurements were done per NEMA UD 2. These are standard safety and performance tests for ultrasound devices, but they do not report diagnostic accuracy performance.
In summary, this 510(k) document is a declaration of substantial equivalence based on technical specifications and adherence to general safety standards, rather than a clinical performance study with predefined acceptance criteria for diagnostic accuracy. Such detailed performance data showing how well the device performs clinically (e.g., sensitivity, specificity for a particular pathology) is typically not required or provided in a 510(k) summary if substantial equivalence can be demonstrated through other means.
§ 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.