(119 days)
OptiCross™ 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
OptiCross™ 18 is a short-rail 30 MHz IVUS imaging catheter. It is compatible with a 0.018" guidewire, and at a minimum, a 6F guide catheter (≥ 0.068" ID). OptiCross 18 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 peripheral 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 in length) 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.
Here's a breakdown of the acceptance criteria and the study information for the OptiCross 18 30 MHz Peripheral Imaging Catheter, based on the provided document:
This document describes a 510(k) submission for a medical device seeking substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed here relate to non-clinical performance and safety metrics, rather than a clinical trial's primary and secondary endpoints often seen with novel device submissions. The "study" refers to a series of non-clinical evaluations and a pre-clinical animal study.
1. Table of Acceptance Criteria and Reported Device Performance
The document details numerous performance criteria and states that bench testing was performed to evaluate them. However, it does not provide specific numerical acceptance criteria or quantitative performance results for each individual parameter. Instead, it makes a general statement that "Bench testing was performed... 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." The conclusion for all these tests is that they support substantial equivalence.
Therefore, a table with specific numerical values cannot be created from this document. The reported device performance is that it met the unspecified criteria for each test, demonstrating substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document does not specify the sample sizes used for each of the bench tests (e.g., how many catheters were tested for deliverability, image resolution, etc.).
- Pre-clinical Evaluation (Animal Study): The document states this study was done "in the porcine model." It does not specify the number of animals (sample size) used in this pre-clinical study.
- Data Provenance:
- Bench Testing: Conducted in a lab setting. The country of origin is not explicitly stated but can be inferred to be within the US, given the submission to the FDA by Boston Scientific Corporation, Fremont, CA. This is a retrospective analysis of device performance against internal specifications.
- Pre-clinical Evaluation: In vivo animal study. Country of origin not specified, but likely US-based given the submitter. This is a prospective study (for the animal model).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Bench Testing: Not applicable in the context of expert-established ground truth. These tests would involve objective measurements and comparisons to engineering specifications.
- Pre-clinical Evaluation (Animal Study): The document does not specify the number of experts or their qualifications involved in evaluating the in-vivo image quality from the porcine model. Image quality assessment would typically involve trained personnel, potentially veterinarians or scientists with expertise in imaging interpretation.
4. Adjudication Method for the Test Set
- Given that the primary evidence cited is non-clinical bench testing and a pre-clinical animal study, adjudication methods like 2+1 or 3+1 (common in clinical image review) are not applicable or described in this context. These tests rely on objective physical measurements and established protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data." Therefore, there is no information on how human readers improve with or without AI assistance. This device is purely an imaging catheter, not an AI-driven interpretive device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Yes, in a functional sense, this is a standalone device. The "performance" described (image quality, deliverability, etc.) refers to the device's inherent capabilities without human interpretation influencing its mechanical or imaging production efficacy. The device's ability to produce images (image resolution, penetration, NURD) is evaluated on its own. It's a diagnostic tool that produces imaging data, not an AI algorithm performing interpretation.
7. Type of Ground Truth Used
- Bench Testing: Engineering specifications, physical measurements, and established testing protocols serve as the "ground truth" to determine if the device performs as intended and meets design requirements.
- Pre-clinical Evaluation: The "ground truth" for evaluating image quality in the porcine model would be the actual anatomical structures and pathologies within the animal, as observed or confirmed by other means (e.g., histology post-mortem, comparison to established imaging standards for IVUS in animals). The purpose was to "support acute performance and design validation claims associated with in-vivo image quality."
8. Sample Size for the Training Set
- Not applicable. This document describes a medical device undergoing 510(k) clearance based on substantial equivalence, primarily through non-clinical testing and a pre-clinical animal study. It is not an AI/ML-based device that requires a "training set" in the computational sense. The device itself is the product.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/ML device that uses a "training set."
§ 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).