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This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

OptiCross™ 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"). OptiCross is intended for use with the BSC iLab™ imaging console (K072517) and Boston Scientific's next generation 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 guidewire 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 guidewire lumen (1.6 cm) is used to track the catheter along the guidewire 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 distal imaging window 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 quide catheter. The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs from the proximal end of the quidewire lumen to the proximal end of the imaging window. The telescoping shaft includes 16 incremental markers for lesion length assessment (1 cm apart); 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 assembly 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.

Acceptance Criteria and Device Performance Study for OptiCross™ Coronary Imaging Catheter

This device, the OptiCross™ Coronary Imaging Catheter, is a Class II diagnostic intravascular ultrasound catheter intended for the ultrasound examination of coronary intravascular pathology in patients undergoing transluminal coronary interventional procedures. Its substantial equivalence to the predicate device, iCross™ (K111043), was determined based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria with specific thresholds. Instead, it describes categories of performance evaluations that were performed and concludes that the device is "substantially equivalent to, and at least as safe and effective as the predicate device." The reported device performance is therefore presented as successful completion of these evaluations in comparison to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance evaluations (bench testing, biological safety, acoustic output, packaging validation). It does not specify a "test set" in the context of patient data or image data. The "samples" used for these tests would be manufactured devices and packaging. The number of devices or units tested for each specific bench test is not provided.

• Sample Size: Not specified for individual bench, biological, acoustic, or packaging tests.
• Data Provenance: Not applicable in terms of country of origin for patient data, as this was a non-clinical study. The studies were conducted by the manufacturer, Boston Scientific Corporation, in support of their 510(k) submission. All data is implicitly retrospective to the submission date.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The study is a non-clinical performance evaluation of a physical device, not an AI/algorithm-based diagnostic tool requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical performance evaluation, not a study involving human interpretation or adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. This device is an imaging catheter and not an algorithm or AI software for standalone performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Bench Testing: Ground truth was based on engineering specifications, physical measurements, and established performance parameters for intravascular ultrasound catheters.
• Biological Safety Testing: Ground truth was established by adherence to recognized international standards (ISO 10993-1) and regulatory requirements for biocompatibility, sterility, etc.
• Acoustic Output Testing: Ground truth was established by adherence to FDA guidance and limits for diagnostic ultrasound systems.
• Packaging Validation: Ground truth was established by adherence to recognized international standards (ISO 11607-1 and ISO 11607-2) for packaging integrity.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set with established ground truth.

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