(268 days)
- The Makoto Intravascular Imaging SystemTM is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden.
c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. - The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
The Makoto Intravascular Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid corecontaining plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.
This FDA 510(k) summary describes the acceptance criteria and study results for the Makoto Intravascular Imaging System's new Automatic Border Contouring (ABC) and Guide Catheter Detection (GCD) software features.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Contour | Acceptance Criteria | ABC Performance Evaluation on Test Data | Result |
|---|---|---|---|---|
| Bland-Altman Plot Diameter Difference Limits of Agreement (95% CI) (mm) | Lumen | +/- 0.59 | [-0.37, 0.41] | PASS |
| Bland-Altman Plot Diameter Difference Limits of Agreement (95% CI) (mm) | EEM | +/- 0.74 | [-0.54, 0.52] | PASS |
| Bland-Altman Plot Area Difference Limits of Agreement (95% CI) (mm²) | Lumen | +/- 3.46 | [-2.3, 2.48] | PASS |
| Bland-Altman Plot Area Difference Limits of Agreement (95% CI) (mm²) | EEM | +/- 6.18 | [-4.5, 4.0] | PASS |
| Forward Hausdorff Distance 95% CI (mm) | Lumen |
§ 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).