(270 days)
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.
The OptoWire and OptoMonitor System includes a pressure sensing guidewire (OptoWire), electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. The OptoWire and OptoWire cable are sterile, single-use devices; the remaining system components are reusable.
Here's a breakdown of the acceptance criteria and study information for the OptoWire and OptoMonitor System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests (bench and animal) but does not explicitly list specific acceptance criteria values alongside the reported device performance in a single section. Instead, it states that "All internal design criteria were successfully met" and the device "compared favorably to predicate devices tested" for the OptoWire mechanical/functional verification.
However, a detailed comparison table with predicate devices (Volcano Corp. PrimeWire Prestige Plus Pressure Guide Wire and ComboMap Pressure and Flow System) does provide specific performance metrics for the OptoWire and OptoMonitor System that can be inferred as criteria for substantial equivalence.
Inferred Acceptance Criteria & Reported Device Performance (from "Substantial Equivalence Comparison" table):
| Feature/Parameter | Acceptance Criteria (Inferred from Predicate/Target) | OptoWire and OptoMonitor System Performance (Reported) | Met Acceptance Criteria? |
|---|---|---|---|
| OptoWire | |||
| Guidewire OD | 0.014" (Predicate: PrimeWire Prestige Plus) | 0.014" | Yes |
| Guidewire Length | Ranges (e.g., 185 cm, 300 cm for predicate) | 175 cm | Favorable Comparison |
| Guidewire Shaft Material | Stainless Steel; Nitinol (Predicate: PrimeWire) | Stainless Steel; Nitinol | Yes |
| Guidewire Coating | Teflon; GlyDx Hydrophilic (Predicate: PrimeWire) | Teflon; Silicone | Favorable Comparison |
| Guidewire Tip Configuration | Straight, pre-shaped "J" (Predicate: PrimeWire) | Straight | Favorable Comparison |
| Guidewire Tip Length | 3.0 cm (Predicate: PrimeWire) | 3.5 cm | Favorable Comparison |
| Radiopaque Tip? | Yes (Predicate: PrimeWire) | Yes | Yes |
| Pressure Sensor Location | 3.0 cm from distal tip (Predicate: PrimeWire) | 3.5 cm from distal tip | Favorable Comparison |
| Pressure Sensing & Signal Trans | Hard wired strain gauge (Predicate: PrimeWire) | Fiberoptic sensor & fiber bundle | Favorable Comparison |
| OptoMonitor | |||
| Operating Temperature (Monitor) | 16°C to 32°C (Predicate: ComboMap) | 15°C to 30°C | Yes |
| Transport Temperature (Monitor) | -20°C to 60°C (Predicate: ComboMap) | -25°C to 60°C | Yes |
| Operating Relative Humidity | 30% to 75% (Predicate: ComboMap) | 10% to 85% non-condensing | Yes |
| Storage Temperature (Monitor) | -20°C to 60°C (Predicate: ComboMap) | Room Temperature | Favorable Comparison |
| Operating Pressure | 50 to 106 kPa (Predicate: ComboMap) | 70 to 106 kPa | Yes |
| Pressure Range | -30 to 300 mmHg (Predicate: PrimeWire/ComboMap) | -30 to 300 mmHg | Yes |
| Pressure Accuracy | +/- 1 mmHg + 1% (-30 to 50 mmHg), +/- 3% (50-300 mmHg) (Predicate: ComboMap) | +/- 1 mmHg + 1% (-30 to 50 mmHg), +/- 3% (50-300 mmHg) | Yes |
| Thermal Zero Shift |
§ 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.