(69 days)
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™ 6 is a short-rail 40 MHz IVUS imaging catheter. It is compatible with a 0.014" guidewire, and at a minimum, a 6F guide catheter (≥ 0.064" ID). OptiCross 6 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 guidewire lumen. The proximal shaft, distal shaft, and distal guidewire 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 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 one- way 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™ 6 40 MHz Coronary Imaging Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness through extensive clinical trials. Therefore, much of the requested information regarding clinical studies, human readers, and detailed ground truth for AI algorithms is not applicable to this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific numerical targets (e.g., "measurement accuracy > 95%") alongside reported performance values. Instead, it lists the types of tests performed and states that the device met the requirements, indicating successful performance in each area.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench-top Performance | Physical integrity, functionality, and performance met standards | Demonstrated deliverability, crossability, guide catheter compatibility, lubricity, retraction capability, image resolution, image penetration, non-uniform rotational distortion, image artifact, measurement accuracy, pullback reliability, general imaging capabilities, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, catheter robustness, and simulated use structural integrity. |
| Biological Safety | Compliant with ISO 10993-1, microbial assessments met standards | Successfully passed biocompatibility, bioburden, endotoxin, pyrogenicity, and sterility assurance assessments. |
| Electrical and Mechanical Safety | Acoustic output below FDA Track 1 limits; compliant with IEC 60601-1-2 (3rd Edition) | Acoustic output test results are below FDA Track 1 limits. Electromagnetic compatibility testing demonstrated compliance to IEC 60601-1-2 (3rd Edition). |
| Packaging Validation | Met standards of ISO 11607-1 and ISO 11607-2 | Integrity of packaging configuration evaluated and met standards after sterilization, climatic conditioning, and distribution challenge. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of number of devices or data points. Bench testing involves a representative number of devices to assess performance.
- Data Provenance: Not applicable in the context of clinical data for an AI device. The data for bench and safety testing would be generated in a lab setting by the manufacturer (Boston Scientific Corporation). All testing is non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI-enabled device requiring expert ground truth for image interpretation. The testing focuses on the physical and functional performance of the catheter.
4. Adjudication method for the test set
Not applicable. This is not an AI-enabled device.
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 is not an AI-enabled device and no MRMC study was conducted. The determination of substantial equivalence is based on 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 medical device (intravascular imaging catheter), not an AI algorithm.
7. The type of ground truth used
For bench testing, the "ground truth" is the established engineering specifications, performance standards, and regulatory requirements (e.g., dimensional tolerances, image quality parameters, safety limits). For biological safety, it's compliance with ISO standards and successful completion of specific biological assessments.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study described is a non-clinical performance evaluation to demonstrate substantial equivalence to a predicate device (OptiCross™ K123621). This means the focus is on proving that the new device, OptiCross™ 6, is as safe and effective as a previously cleared device, not necessarily on proving novel clinical efficacy.
The study included:
- Bench Testing: Extensive tests to evaluate the physical integrity, functionality, and performance of the catheter across various aspects such as deliverability, image resolution, measurement accuracy, and structural integrity.
- Biological Safety Testing: Assessments for biocompatibility (in accordance with ISO 10993-1), bioburden, endotoxin, pyrogenicity, and sterility assurance.
- Electrical and Mechanical Safety Testing: Evaluation of acoustic output against FDA guidance and electromagnetic compatibility testing to ensure compliance with IEC 60601-1-2.
- Packaging Validation: Testing the integrity of the packaging configutation according to ISO 11607-1 and ISO 11607-2.
The document explicitly states: "Non-clinical performance evaluations, as described above, indicate that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device, OptiCross™ (K123621)." It also notes "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."
The "acceptance criteria" were implied by the successful completion and compliance with the various tests and standards mentioned (e.g., "Acoustic Output test results for the OptiCross™ 6 are below the FDA Track 1 limits," and "demonstrating compliance to IEC 60601-1-2"). The report concludes that based on these non-clinical data, the device meets the safety and effectiveness requirements for substantial equivalence.
§ 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).