(350 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intra-Luminal, Peripheral Vascular, Other (Specify)
This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.
The Endosonics ColorFlo Option for the Oracle Imaging System is designed for use in conjunction with imaging catheters for use during diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide blood flow information. This additional flow information is provided as a color over the standard 2D echo image.
The ColorFlo technology can provide a two dimensional map of relative blood velocity which is overlayed onto the conventional black and white intravascular ultrasound image. Regions which contain faster moving red blood cells are signified by brighter colors, whereas regions of slow motion are less bright. Regions in which there is no or little motion perpendicular to the transducer are presented as clear, or non-colored. These regions appear in grey scale as in the standard display.
The ColorFlo processor detects flow of particles (red blood cells) perpendicular to the imaging plane, or along the long axis of the catheter. This is unlike conventional doppler imaging in which the blood must flow towards or away from the transducer. This is possible by utilizing ultrahigh speed electronics and Endosonics propritary algorithms.
The ColorFlo system can detect blood velocities in the following range:
The lower limit on particle detection is between 12 cm/sec and 5 cm/sec, depending on the intervening attenuation. (The higher limit is obtained with maximum tissue attenuation between the transducer and region of flow.)
The upper limit on particle detection is between 110 cm/sec and 107 cm/sec, depending on the intervening attenuation. (The lower limit is obtained with maximum tissue attenuation between the transducer and region of flow.)
The ColorFlo Option is available on the Endosonics Oracle InVision Imaging System. This option is an internal option, and no changes to the physical appearance of the system are made with the exception of an additional key on the keyboard.
The provided 510(k) summary for the Endosonics ColorFlo Option for the Oracle InVision Intravascular Imaging System does not contain explicit acceptance criteria or a dedicated study section detailing performance metrics against such criteria.
The document focuses on substantiating substantial equivalence to predicate devices and describing the technology. However, it does report specific performance capabilities of the ColorFlo system regarding blood velocity detection. We can infer these reported capabilities act as implicit performance benchmarks.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not stated, we will use the reported performance characteristics as the "reported device performance."
| Category | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance |
|---|---|---|
| Blood Velocity Detection Range | Ability to detect a usable range of blood velocities in both low and high flow scenarios, considering attenuation. | Lower Limit: Between 12 cm/sec and 5 cm/sec (depending on intervening attenuation). |
| Upper Limit: Between 110 cm/sec and 107 cm/sec (depending on intervening attenuation). | ||
| Acoustic Output (3.5F catheters) | Keep acoustic output within safe limits for specific catheter models. | I_spta = 5.89 mW/cm², I_sppa = 20.77 W/cm² |
| Acoustic Output (2.9F catheters) | Keep acoustic output within safe limits for specific catheter models. | I_spta = 1.13 mW/cm², I_sppa = 3.71 W/cm² |
| Visual Depiction of Blood Flow | Provide a clear, two-dimensional, color-coded map of relative blood velocity overlaid on the standard 2D echo image. | Provides a two-dimensional map of relative blood velocity overlaid onto the conventional black and white intravascular ultrasound image. Regions with faster moving red blood cells are signified by brighter colors, and slow motion regions are less bright. |
| Flow Detection Perpendicular to Transducer | Detect blood flow perpendicular to the imaging plane/along the long axis of the catheter. | Detects flow of particles (red blood cells) perpendicular to the imaging plane, or along the long axis of the catheter. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. There is no mention of a specific test set, its sample size, or its provenance (country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The document does not describe any expert involvement in establishing ground truth for a test set.
4. Adjudication Method
This information is not provided. There is no mention of an adjudication method, as no test set or expert review process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The summary focuses on the technical capabilities of the device itself rather than human-in-the-loop performance or comparison with human readers.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study, in the sense of an algorithm-only evaluation against a ground truth, is implicitly described through the stated velocity detection ranges and acoustic outputs. The summary outlines the technical specifications and capabilities of the ColorFlo processor and associated catheters without human interaction as part of its core description (e.g., "The ColorFlo system can detect blood velocities in the following range..."). However, it's not presented as a formal "study" with a defined methodology, test set, and reported metrics in the way modern AI device submissions typically detail.
7. Type of Ground Truth Used
The ground truth used for verifying the reported velocity detection capabilities and other technical specifications is implied to be derived from physical measurements and engineering validation. For instance, the velocity detection ranges would likely be established in controlled laboratory settings using flow phantoms or calibrated flow systems. The acoustic outputs are typically measured using standardized hydrophones. The document does not refer to expert consensus, pathology, or outcomes data as ground truth for these specific performance claims.
8. Sample Size for the Training Set
This information is not provided. The ColorFlo option utilizes "Endosonics proprietary algorithms," but there is no mention of a training set size, suggesting the algorithms were likely developed based on engineering principles and signal processing, rather than machine learning requiring a distinct training dataset in the modern sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided for the same reasons as point 8. If "proprietary algorithms" were used, their development likely relied on theoretical models, simulations, and empirical testing in laboratory environments, rather than a "training set" with established ground truth as understood in contemporary machine learning.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.