(31 days)
This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
OptiCross™ HD (60 MHz Coronary Imaging Catheters) is a sterile, short rail imaging catheter. It consists of two main assemblies: 1. Imaging Core 2. Catheter Body. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 60 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end of the catheter makes the connection to the Motordrive Unit (MDU5 PLUS™). The MDU5 PLUS-catheter interface consists of an integrated mechanical drive socket and electrical connection. The catheter body is comprised of three sections: 1. Distal Imaging Window Lumen 2. Proximal Shaft Lumen 3. Telescoping Section. The distal imaging window lumen and proximal shaft lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the guiding catheter. The catheter body has a distal imaging window lumen with proximal exit 1.6 cm from the distal end. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, two insertion depth markers are located on the proximal shaft lumen at 90 cm and 100 cm from the distal tip to aid in estimating catheter position relative to the distal guide catheter tip. The proximal shaft lumen is attached to the telescoping section via a strain relief connection. The telescoping shaft (section) allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the guidewire exit port to the proximal end of the distal imaging window lumen. The telescope section has proximal markers for lesion length assessment, consisting of a series of marks spaced 1 cm apart on the telescope body. A flush port with a one-way check valve is used to flush the interior of the catheter body and maintain a flushed condition. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way check valve helps retain saline in the catheter during use.
The provided text describes the 510(k) summary for the Boston Scientific OptiCross™ HD 60 MHz Coronary Imaging Catheter. This device is not an AI-based system. It is a physical medical device (an intravascular ultrasound catheter). Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, and training sets are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a pre-clinical animal study, not through clinical trials or studies related to AI model performance.
However, I can extract the general acceptance criteria and the performance data for this device as detailed in the document, which primarily revolve around non-clinical bench testing and pre-clinical animal studies.
Here's a summary based on the provided text, adapted to the context of a physical medical device:
Acceptance Criteria and Device Performance (Non-AI Device)
The OptiCross™ HD 60 MHz Coronary Imaging Catheter's acceptance criteria and performance are established through non-clinical (bench) and pre-clinical (animal) testing to demonstrate substantial equivalence to its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Bench Testing | Physical integrity, functionality, and overall performance, including: | Bench testing was performed to evaluate physical integrity, functionality, and overall performance of the catheter. Performance criteria includes deliverability, crossability, guide catheter compatibility, lubricity, retraction capability, image resolution, image penetration, non-uniform rotational distortion (NURD), measurement accuracy, pullback reliability, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, catheter robustness and simulated use structural integrity. Results: All tests successfully completed leading to the conclusion that the device is substantially equivalent to the predicate. |
| - Deliverability | ||
| - Crossability | ||
| - Guide catheter compatibility | ||
| - Lubricity | ||
| - Retraction capability | ||
| - Image resolution (enhanced compared to predicate due to 60MHz frequency, while maintaining similar depth of penetration) | ||
| - Image penetration (similar to predicate) | ||
| - Non-uniform rotational distortion (NURD) | ||
| - Measurement accuracy | ||
| - Pullback reliability | ||
| - Dimensional requirements | ||
| - Visibility under fluoroscopy | ||
| - Interface with ancillary devices | ||
| - Environmental requirements | ||
| - User interface requirements | ||
| - Catheter robustness and simulated use structural integrity | ||
| Pre-clinical Evaluation | Support design validation and business need evaluations claims associated with in-vivo image quality. | GLP pre-clinical animal study in the porcine model was conducted to validate imaging performance. The study was performed to support design validation and business need evaluations claims associated with in-vivo image quality. Results: Successful study, reinforcing substantial equivalence. |
| Biological Safety | Meet requirements of ISO 10993-1. | Leveraged existing biocompatibility test data from commercially available OptiCross™ family of catheters (due to use of existing materials and similar manufacturing conditions). Results: Compliance to ISO 10993-1. |
| Electrical and Mechanical Safety | Acoustic Output below FDA Track 1 limits; Compliance to IEC 60601-1-2 (3rd Edition) for Electromagnetic Compatibility. | Acoustic Output for OptiCross™ HD are below the FDA Track 1 limits. Electromagnetic compatibility testing demonstrated compliance to IEC 60601-1-2 (3rd Edition). Results: Device meets safety standards. |
| Packaging Validation | Meet required product specifications. | Packaging DV results of currently available OptiCross catheters were leveraged (due to equivalent packaging). Results: Packaging meets required product specifications. |
The following questions are not applicable as the device is a physical medical device and not an AI/ML-based system:
2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI device. For the physical device, bench tests involve specific numbers of units for reliability and performance tests, but these are not defined as "test sets" in the same way as for AI. The pre-clinical study used a "porcine model" (pigs), but the specific number of animals is not detailed in the summary provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical imaging catheter's performance is established by direct physical measurements, engineering specifications, and physiological studies in animal models, not by expert consensus on image interpretation for AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study focuses on the physical performance and safety of the catheter itself, not on improving human reader performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, "ground truth" implicitly refers to:
* Engineering specifications and standards: For bench testing (e.g., precise dimensions, force measurements, image clarity metrics).
* Physiological measurements/observations: In the pre-clinical porcine model, direct observation and validation of imaging performance in a living system.
* Existing predicate device performance: The new device's performance is compared against the established performance of the legally marketed predicate.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).