(175 days)
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, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.
The proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.
The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019).
The device is a non-sterile, non-patient contact device.
The provided text describes a 510(k) premarket notification for the OptoMonitor 3 device, which is an updated version of the OptoMonitor System. The submission aims to establish substantial equivalence to a predicate device (K192340).
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison table between the proposed OptoMonitor 3 and its predicate device, OptoMonitor (K192340), rather than explicitly listing acceptance criteria with reported performance for a new study. However, the "Technological Characteristics" section of the table effectively serves as a list of performance parameters with implied acceptance criteria being "Same" as the predicate device.
| Performance Parameter | Acceptance Criteria (Implied: Same as Predicate) | Reported Device Performance (OptoMonitor 3) |
|---|---|---|
| Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg |
| Pressure Accuracy | +/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg) | +/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg) |
| Thermal Zero Shift |
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).