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510(k) Data Aggregation
(239 days)
The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY ST catheter) is intended for the intravascular ultrasound examination of coronary arteries. Intrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
The Refinity and Refinity Short Tip (ST) Rotational IVUS Imaging Catheter consists of two main assemblies: the imaging core and the catheter body. The catheter body is comprised of four sections: a distal section with a .014" compatible rapid exchange guide wire lumen and clear imaging window, a mid-shaft section, a braided proximal shaft, and a telescoping section. The distal, mid, and proximal sections comprise the usable length or working length of the catheter. The telescoping section remains outside of the guiding catheter. The telescoping section allows the imaging core to be advanced and retracted for up to 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the guidewire exit port to the proximal end of the window portion of the distal section. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a distal outward looking ultrasonic transducer. An electromechanical connector interface at the proximal end makes the connection to the patient interface module (PIM). The PIM-catheter interface consists of an integrated mechanical drive assembly and electrical connection. A flushing port with a one-way valve is used to displace the air initially present within the catheter. The catheter must be flushed with sterile heparinized normal saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way valve helps retain saline in the catheter during use. The catheter body has a distal guide wire lumen with a proximal exit port located 15.5mm (for the short tip model) or 22mm (for the standard tip model) from the distal end. One radiopaque (RO) marker band is embedded 0.5 cm from the tip. In addition, insertion depth indicators are located on the catheter body at 90 cm and 100 cm. The catheter is packaged with a sterile PIM cover, 3 cc and 10 cc syringes, and 13 in extension tubing with a 3-way stopcock. The catheter is for use with the Volcano s5 and CORE® imaging systems with software V3.x.x.
The Volcano Corporation's REFINITY Rotational Intravascular Ultrasound (IVUS) Catheter and REFINITY Short Tip Rotational IVUS Catheter underwent a series of non-clinical device performance tests to demonstrate substantial equivalence to the predicate device, the Volcano Revolution® 45MHz Rotational Intravascular IVUS Imaging Catheter.
Here's an overview of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | No visual defects (e.g., cracks, kinks, other damage) visible to the unaided eye and no extraneous surface matter using 10X magnification. | Sample catheters met product specifications. |
| Dimensional Verification | All tubing lengths and outer diameters must meet product specifications. | Sample catheters met product specifications. |
| Catheter Prep | Samples need to meet product specifications for flushing and leaks. | Sample catheters met product specifications. |
| Tensile Strength | Bond joint tensile strengths must meet product specifications. | Sample catheters met product specifications. |
| Monorail Tear Strength | The tear strength of the guide wire lumen must meet product specifications. | Sample catheters met product specifications. |
| Guide Wire Movement | Sample catheters must meet product specifications in regards to movement over a 0.014" guide wire. | Sample catheters met product specifications. |
| Torsion | Sample catheters must meet product specifications in regards to minimum turns to failure. | Sample catheters met product specifications. |
| Telescope Operation Force | Sample catheters must meet the product specification for the maximum force needed to operate the telescope after its initial opening (related to 15 cm linear movement of imaging core). | Sample catheters met product specifications. |
| Force to Overextend Telescope | The amount of force required to completely pull the telescope section out of the catheter must meet product specifications. | Sample catheters met product specifications. |
| Particulate (Hydrophilic Coating) | The number of particles counted (≥10 µm, ≥25 µm, and ≥50 µm in 50 ml of water) must meet product specifications per USP 788. | Sample catheters met product specifications. |
| Adhesion (Hydrophilic Coating) | Adhesion must meet product specifications, meaning no coating is removed by adhesive tape. | Sample catheters met product specifications. |
| Friction (Hydrophilic Coating) | The frictional force measured while pulling the catheter through pig aorta must meet product specifications. | Sample catheters met product specifications. |
| NURD (Non-Uniform Rotational Distortion) | The angular separation between diametrically opposed objects must meet product specifications. | Sample catheters met product specifications. |
| Rapid Deployment | The capacitance difference (before and after backward pull of telescope section) must meet product specifications. | Sample catheters met product specifications. |
| Tortuous Pullback | The device must continue to image per product specifications after a 15 cm pullback through a tortuous path at 1mm/sec. | Sample catheters met product specifications. |
| Image Life | The catheter must still image after completion of the Rapid Deployment and Tortuous Pullback tests. | Sample catheters met product specifications. |
| Drill Through | Device must meet product specifications in regards to Drill Through (simulated worst-case scenario with bent distal section and rotating transducer). The catheter is allowed to image for a maximum of 30 minutes or until the catheter stops imaging. | Sample catheters met product specifications. |
| Guide Catheter Compatibility | Refinity catheters must meet product specifications in regards to Guide Catheter compatibility with a 5F Guide Catheter (inner diameter 0.056"). | Sample catheters met product specifications. |
| Image Assessment | Results must meet the acceptance criteria as stated in the test protocol for axial resolution, lateral resolution, NURD, depth of image penetration, and overall image aesthetics when compared to the predicate device. | Results met the acceptance criteria as stated in the test protocol. |
| Acoustic Emissions | As defined per Track 3 of the FDA requirements document ("Information for Manufacturers Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers"). | Sample catheters met acceptance criteria. |
| Thermal Dissipation | As defined in the test protocol, performed according to EN60601-2-37. | Sample catheters met acceptance criteria. |
| B-Mode Testing | As defined in the test protocol for six relevant B-mode parameters, and qualitative visual image brightness and integrity. | Sample catheters met acceptance criteria. |
| Biocompatibility Testing | Per ISO 10993 and test protocols, including: |
- Cytotoxicity: Non-cytotoxic compared to controls.
- Sensitization: Grade of 0 at 24 and 48 hours.
- Intracutaneous Reactivity: Primary Irritation Index 0-0.4 and difference between test article and control mean score
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