(108 days)
Eagle Eye Platinum Digital IVUS catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature to provide an image of such vessels. This device is not currently indicated for use in cerebral vessels. The Eagle Eye Platinum Digital IVUS catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Eagle Eye® Platinum Digital IVUS Catheters incorporate a cylindrical ultrasound transducer array used to radiate acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels. The Eagle Eye" Platinum catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 rnm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The Eagle Eye Platinum catheter is introduced percutaneously or via surgical cut down into the vascular system. Two types of markers are used along the shaft length: Three radio-opaque markers applied along the length of the distal inner-shaft to aide in positioning the catheter in the vascular anatomy during an angiographic procedure. A pair of brachial and femoral (one each) shaft markers located on the outer proximal shaft aid in gauging the IVUS transducer position relative to the guiding catheter tip when introducing the EEP catheter through the guiding catheter. A hub fitting is attached to the proximal end of the catheter via an integrated strain relief and provides a channel for the ultrasound scanner leads to interface electrically with the patient interface module (PIM) connector of the imaging system. The Eagle Eye Platinum eatheters may only be used with the Volcano In-Vision imaging System, Volcano st, or Volcano s5i Imaging Systems. The catheters are designed to work with Volcano VH IVUS system software v 1.2 or higher. This catheter will not operate if connected to any other imaging system.
The provided text does not include information about specific acceptance criteria or a study proving the device meets those criteria. The document is an "Abbreviated 510(k) Summary" for the Eagle Eye® Platinum Digital IVUS Catheter, which primarily focuses on establishing substantial equivalence to a predicate device.
Here's a breakdown of why the requested information is not present in the provided text:
- No Acceptance Criteria or Performance Data: The document states "Device Design Requirements: Biocompatibility, shelf life, sterilization, package integrity, and design verification testing will be performed to prove that the materials and manufacturing processes selected for the catheter body of the Eagle Eye® Platinum catheter do not pose a significant safety risk to the patient." However, it does not provide specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for any performance aspect of the device itself (beyond general safety requirements). There is also no table of reported device performance.
- No Clinical Study Details: The document explicitly states, "The Eagle Eye® Platinum atheter is a redesign of the catheter body elements of the Eagle Eye Gold only and does not change the ultrasound signal or signal processing used for the predicate device." This indicates that the substantial equivalence argument relies on the design changes being limited to the catheter body, implying that the core imaging performance (ultrasound signal and processing) is unchanged from the predicate. Therefore, detailed clinical performance studies (such as those involving test sets, ground truth, experts, MRMC, or standalone performance) are not detailed because they are not the primary basis for this type of 510(k) submission.
Summary based on the provided text:
| Question | Answer (based on provided text) |
|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | The document states general design requirements such as "Biocompatibility, shelf life, sterilization, package integrity, and design verification testing will be performed to prove that the materials and manufacturing processes selected for the catheter body... do not pose a significant safety risk." However, it does not provide specific numerical acceptance criteria or reported device performance metrics for diagnostic accuracy, sensitivity, specificity, or other imaging performance attributes. |
| 2. Sample size and data provenance for test set | Not applicable. The document is a 510(k) summary relying on substantial equivalence, and it does not describe a clinical performance study with a test set for diagnostic efficacy of the imaging component. The changes described are to the catheter body, not the ultrasound signal or signal processing. |
| 3. Number of experts and qualifications for ground truth (test set) | Not applicable. No clinical performance study on diagnostic accuracy is described. |
| 4. Adjudication method for test set | Not applicable. No clinical performance study on diagnostic accuracy is described. |
| 5. MRMC comparative effectiveness study and effect size | Not applicable. No MRMC study is described. The submission focuses on substantial equivalence based on limited changes to the catheter body. |
| 6. Standalone (algorithm only) performance study | Not applicable. This device is an imaging catheter and is not an AI/algorithm-only device. The core imaging performance is asserted to be unchanged from the predicate device based on the limited design modifications. |
| 7. Type of ground truth used | Not applicable. No clinical performance study on diagnostic accuracy requiring ground truth is described. The device provides "an image of the vessel lumen and wall structures," but the document doesn't detail a study validating the accuracy of these images against a ground truth. |
| 8. Sample size for the training set | Not applicable. This document is for a medical device (intravascular catheter), not an AI algorithm requiring a training set in the conventional sense. The submission relies on the established performance of the predicate device's imaging system. |
| 9. How ground truth for the training set was established | Not applicable. Please see point 8. |
This document is a regulatory submission focused on demonstrating substantial equivalence of a modified device (Eagle Eye® Platinum) to a previously cleared device (Eagle Eye Gold). The modifications are specifically to the catheter body and blood-contacting materials, not to the core imaging technology or signal processing. Therefore, the detailed performance data and clinical study information usually associated with new diagnostic devices or AI algorithms are not part of this specific submission summary.
§ 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).