(60 days)
The iSight™ Imaging 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.
The iSight™ imaging catheter consists of two subassemblies: Catheter body and Imaging core. The catheter body is comprised of three sections: Distal section - Guidewire lumen and Imaging Core lumen, Proximal section - Imaging Core lumen only, and Telescoping section - Imaging Core lumen only. The distal section has a guidewire lumen and an imaging core lumen. The guidewire lumen is lined with polytetrafluoroethylene (PTFE) and a hydrophilic coating [Bioslide™ BL] is applied to the distal section. A radiopaque (RO) marker is embedded in the catheter tip. The catheter sheath gradually tapers from 2.5F to 1.5F. The proximal section is a single lumen tube with attached molded strain relief. An insertion depth indicator is located on the proximal section. The working length is 135 cm. The iSight™ catheter is 5F guide catheter compatible. The telescoping section remains outside the guide catheter and allows for 15 cm of linear translation of the imaging core. It contains a flush port with a one-way valve. The telescope section has 16 gold marks, spaced at 1-cm increments. The imaging core is composed of a flexible, rotating drive cable with an outward looking 40 MHz ultrasonic transducer at the distal end. An electromechanical connector interface at the proximal end connects to the Motor Drive Unit (MDU). The iSight™ catheter is compatible with the MD-4 and MD-5 Motor Drive Units and the ClearView Ultra™, Galaxy™ , Galaxy 2 ™ , and iLAB™ systems.
The Boston Scientific Corporation iSight™ Imaging Catheter underwent a series of non-clinical tests to demonstrate its safety and effectiveness and its substantial equivalence to the predicate device, the Atlantis™ SR Pro2 Coronary Imaging Catheter.
1. Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Device must exceed performance requirements in physical integrity, functionality, and performance. | Performed a variety of tests including dimensional testing, bond tensile testing, and performance testing of the sheath and telescoping assembly, imaging core assembly, and final sterile device. The device "exceeds the performance requirements." |
| Biological Safety Testing | Catheter must be acceptable for its intended use based on biocompatibility and microbiological assessment. | Subjected to biocompatibility tests per EN ISO 10993 and microbiological assessment (bioburden, pyrogen/endotoxin, sterility assurance, latex testing). Results "demonstrate that the catheter is acceptable for its intended use." |
| Acoustic Output Testing | Acoustic output must be below FDA Track 1 limits as described in the FDA Guidance for Diagnostic Ultrasound Systems and Transducers (September 30, 1997). | Acoustic Output test results for the iSight™ Imaging Catheter "are below the FDA Track 1 limits." |
| Packaging Validation | Packaging system must meet predetermined acceptance criteria for integrity per EN 868. | "Test results demonstrate that the packaging met all of the pre-determined acceptance criteria." |
2. Sample Size and Data Provenance for Test Set:
The provided documentation does not specify a separate "test set" in terms of patient data or clinical images for evaluating the device's diagnostic performance. The evaluation was primarily based on non-clinical (bench, biological, acoustic, and packaging) testing. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable here as no clinical studies are referenced for performance evaluation.
3. Number and Qualifications of Experts for Ground Truth:
Not applicable. The ground truth for the non-clinical tests was established by comparison to engineering specifications, biological safety standards (EN ISO 10993), FDA guidance documents for acoustic output, and packaging integrity standards (EN 868). There were no experts establishing ground truth in the context of interpreting medical images or clinical outcomes for a test set.
4. Adjudication Method for Test Set:
Not applicable. As described above, there was no expert adjudication involved as the tests were non-clinical and based on objective measurements against established standards and specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The device's substantial equivalence was established through non-clinical testing comparing its characteristics and performance to a predicate device.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance):
This device is an imaging catheter (hardware), not an AI algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluated was of the physical device and its components.
7. Type of Ground Truth Used:
The ground truth for the non-clinical tests was based on:
- Engineering Specifications: For dimensional, bond tensile, and other performance aspects of bench testing.
- International Standards (e.g., EN ISO 10993, EN 868): For biological safety and packaging validation.
- Regulatory Guidance (FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers): For acoustic output limits.
- Predicate Device Characteristics: The modifications to the iSight™ Imaging Catheter were compared to the Atlantis™ SR Pro2 Coronary Imaging Catheter to ensure maintenance or enhancement of performance through non-clinical means.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI model or algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as point 8.
§ 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).