(28 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™ X is a short-rail 40 MHz IVUS imaging catheter. It is compatible with a 0.014" guidewire, and at a minimum, a 5F guide catheter (≥ 0.058" ID). OptiCross X is intended for use with Boston Scientific's (BSC)'s iLab™ equipment and BSC's latest motor drive unit, MDU5 PLUS™. When used together, the catheter, motor drive unit (MDU), and iLab equipment form a complete imaging system that allows for ultrasonic examination of coronary intravascular pathology. The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal quidewire lumen. The proximal shaft, distal shaft, and distal quidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter. The distal quidewire lumen (1.6 cm) is used to track the catheter along the quidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the guide catheter. The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs within the imaging window from 2 to 17 cm from the distal tip of the catheter. The telescoping shaft includes 16 incremental markers (1 cm apart) for lesion length assessment; the 5-cm, 10-cm, and 15-cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm). The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a oneway check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The drive cable and PZT transducer rotate independently of the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive in to transmittable acoustic energy. Reflected ultrasound signals are converted back to electrical impulses, returned to the motor drive unit, and are ultimately processed by the iLab equipment for visualization.
The provided text describes a 510(k) premarket notification for the OptiCross™ X, 40 MHz Coronary Imaging Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch. Therefore, the information provided focuses on non-clinical performance evaluations and comparisons to the predicate device.
Based on the provided document, the following points regarding acceptance criteria and study information can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document lists "Performance criteria" for bench testing but does not provide a quantitative table of specific acceptance limits alongside the achieved device performance. Instead, it states that "Bench testing was performed to evaluate physical integrity, functionality, and overall performance of the catheter" and lists the categories of performance criteria evaluated.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Deliverability | Evaluated (Implied to meet requirements for substantial equivalence) |
| Crossability | Evaluated (Implied to meet requirements for substantial equivalence) |
| Guide Catheter Compatibility | Evaluated (Specifically mentioned as compatible with a minimum 5F guide catheter (≥ 0.058" ID)) |
| Lubricity | Evaluated (Hydrophilic coating enhances lubricity) |
| Retraction Capability | Evaluated (Telescope assembly allows advancement/retraction) |
| Image Resolution | Evaluated (Implied to meet requirements for substantial equivalence to predicate) |
| Image Penetration | Evaluated (Implied to meet requirements for substantial equivalence to predicate) |
| Non-Uniform Rotational Distortion (NURD) | Evaluated (Implied to meet requirements for substantial equivalence to predicate) |
| Image Artifact | Evaluated (Implied to meet requirements for substantial equivalence to predicate) |
| Measurement Accuracy | Evaluated (Implied to meet requirements for substantial equivalence, with 1 cm incremental markers for lesion length assessment) |
| Pullback Reliability | Evaluated (Implied to meet requirements for substantial equivalence) |
| Dimensional Requirements | Evaluated (Specifically mentions narrowed proximal sheath and imaging window profiles for 5F compatibility, compared to predicate's 6F) |
| Visibility under Fluoroscopy | Evaluated (Radiopaque marker band included) |
| Interface with Ancillary Devices | Evaluated (Compatible with Boston Scientific's iLab™ equipment and MDU5 PLUS™ motor drive unit) |
| Environmental Requirements | Evaluated (Implied) |
| User Interface Requirements | Evaluated (Implied) |
| Catheter Robustness | Evaluated (Implied) |
| Simulated Use Structural Integrity | Evaluated (Implied) |
| Biological Safety | Passed (Tests in accordance with ISO 10993-1, including microbial assessments (bioburden, endotoxin), pyrogenicity, and sterility assurance) |
| Acoustic Output | Evaluated (Below FDA Track 1 limits) |
| Electromagnetic Compatibility | Compliant (to IEC 60601-1-2 (3rd Edition)) |
| Packaging Validation | Evaluated (In accordance with ISO 11607-1 and ISO 11607-2, on fully packaged units after electron beam sterilization, climatic conditioning, and distribution challenge conditioning) |
2. Sample sizes used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of catheters tested) for each non-clinical performance evaluation. It broadly states "Bench testing was performed."
- Data Provenance: The data is from non-clinical (bench-top) performance evaluations, packaging validation, biological safety, electromagnetic compatibility, and acoustic output testing. The geographic origin of this testing is not specified, but it would typically be conducted by the manufacturer (Boston Scientific Corporation, Fremont, California) or their designated testing labs. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the evaluation for this 510(k) relies on non-clinical (bench) testing, not human interpretation of medical images or expert consensus on a test set. Therefore, there is no "ground truth" derived from expert review in the context of this submission.
4. Adjudication method for the test set:
Not applicable. As there is no "test set" in the context of human interpretation of medical images, there is no adjudication method described.
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 device is an imaging catheter and is not an AI-powered diagnostic tool requiring MRMC studies to evaluate human reader performance with or without AI assistance. The submission is based on demonstrating substantial equivalence through non-clinical performance data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device (catheter) used for intravascular ultrasound imaging, not a standalone algorithm. Its performance is evaluated through its physical and imaging capabilities as part of a system (catheter + MDU + iLab equipment), not as an algorithm performing a diagnostic task independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance evaluations, the "ground truth" is defined by engineering specifications, material standards, and regulatory limits. For example, the "acoustic output" ground truth is defined by FDA Guidance limits, "biological safety" by ISO 10993-1 standards, and "electromagnetic compatibility" by IEC 60601-1-2. For physical performance characteristics like dimensions, deliverability, or image quality, the ground truth is established by the device's design specifications and the performance of the predicate device.
8. The sample size for the training set:
Not applicable. This is a hardware device submission; there isn't a "training set" in the machine learning sense. The device design and manufacturing processes are developed based on engineering principles and existing knowledge, not through a "training set" of data.
9. How the ground truth for the training set was established:
Not applicable. As there is no "training set" for a hardware device, there is no ground truth established for it in this context. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and regulatory standards.
§ 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).