(71 days)
The Verrata® PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
The Verrata® PLUS Pressure Guide Wire (hereafter referred to as the “Verrata PLUS”) is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata® PLUS measures pressure when used with the SmartMap®, ComboMap®, s5 Series™, and CORE™ Series of systems. The Verrata PLUS has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and also in straight or pre-shaped tips. The Verrata PLUS is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.
The provided text describes the Verrata PLUS Pressure Guide Wire and its performance testing to demonstrate substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection (Cable Routing) | Cable must be routed out the right side of the connector. | Sample wires and connectors were visually inspected to confirm proper routing of the cable out of the connector. Implied: Complied with acceptance criteria. |
| Visual Inspection (Pressure Sensor) | The sensor adhesive is not protruding out of the housing and the sensor is not damaged or misaligned. | Sample wires were visually inspected to confirm that the pressure sensor within the pressure housing is properly aligned, positioned and potted in place. Implied: Complied with acceptance criteria. |
| Wire Outer Diameter | The sensor housing outer diameter must meet product specifications. | The maximum diameter of the sensor housing is measured with a micrometer. Implied: Complied with acceptance criteria. |
| Zero Test and Connection Durability | The wire must successfully zero the first time and after 20 disconnect and re-connect cycles. | Wires with connectors were connected to a Volcano Pressure System and "zeroed". The pressure value on the screen of the System should read "0". Disconnect the wire from the connector and re-connect up to 20 times. After 20 disconnect and re-connects, verified that the wire still "zeros". Implied: Complied with acceptance criteria. |
| Accuracy Test | The pressure measured by the wire must meet product specifications. | The wire is connected to a test fixture and is placed in an air pressure chamber at 37℃. The pressure inside the chamber is varied and the pressure reading from the wire is compared to the pressure to which the chamber is set. Implied: Complied with acceptance criteria. |
| Drift Test | The drift over 10 minutes must meet product specifications. | The wire is connected to a test fixture and placed in saline at 37℃. The pressure reading is recorded for 10 minutes. Implied: Complied with acceptance criteria. |
| Connector to Cable Tensile Test | The tensile strength must meet product specifications. | The connector to cable connection was pull tested to assess its tensile strength. Implied: Complied with acceptance criteria. |
| Biocompatibility (ISO 10993) | Per ISO 10993 and test protocols. | Biocompatibility of the raw materials in the Verrata PLUS wire were assessed per ISO 10993. Implied: Complied with acceptance criteria. |
| Biocompatibility (Direct Hemolysis) | The difference between the hemolytic indices of the test article and negative control must be |
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.