(131 days)
The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures.
Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressure measurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature.
The proposed OptoMonitor II is a new version of the OptoMonitor System that includes software modifications and new labeling to allow for the expanded indications of intravascular pressure monitoring during interventional procedures, such as with the occlusion perfusion catheter, for diagnosis and treatment within the vasculature. This device and its components are considered accessories to catheter pressure transducers and are intended for use with legally marketed catheters.
The OptoMonitor II is intended to measure pressure using specifically devoted optical pressure sensing devices. The OptoMonitor II comprises two modes of operation:
- FFR mode using an OptoWire (The FFR mode is exactly the same as the predicate device, there are no changes to FFR mode included in this submission.)
- Pressure mode using an Optical Pressure Catheter (The Pressure mode is a new modality and the subject of this submission)
The OptoMonitor II automatically switches to the proper operational mode upon connecting the device. This information is contained within the EEPROM contained in every device that connect to the OptoMonitor II.
Both modes are nearly the same with the following differences:
- The FFR mode includes the calculation and display of Pd/Pa and FFR values.
- The FFR mode includes the equalization of distal pressure against aortic pressure.
- The pressure mode includes atm (atmosphere) as pressure unit.
- The pressure mode does not allow re-zeroing the distal pressure of more than 50 mmHg when in mmHg, and of more than 300mmHg when in atm unit.
- The pressure is not output on the distal output interface when unit ATM (instead of mmHg).
The proposed OptoMonitor-II includes the Optical Unit (OU), the Display Unit (DU), The Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components are exactly the same as the cleared device hardware (K142598 cleared on 06/12/2015), software and labeling (to indicate updated software) is updated with this submission.
OptoMonitor-II is compatible with the cleared Occlusion Perfusion Catheter(OPC) devices as described in the FDA submissions K130525, K154554 & K153488. The OPC catheters are legally marketed devices that are not altered by Opsens. All sizes of Occlusion Perfusion Catheters are compatible with the OptoMonitor II device since the catheters are all within the specified pressure range and the connectors are compliant to Optomonitor requirements.
The device is a non-sterile, non-patient contact device.
The provided document is a 510(k) premarket notification for the OptoMonitor II device. The document states that the OptoMonitor II is an updated version of the OptoMonitor system, primarily involving software modifications and new labeling to expand its indications to include intravascular pressure monitoring during interventional procedures, such as with an occlusion perfusion catheter.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" against which a study directly proves the device meets. Instead, it compares the technological characteristics and performance specifications of the proposed OptoMonitor II with its predicate device (OptoMonitor K142598) to establish substantial equivalence. The overall "acceptance criterion" is implicitly that the OptoMonitor II performs comparably to the predicate device and does not raise new questions of safety or effectiveness.
Here's a table based on the "Substantial Equivalence Table" provided, highlighting key performance specifications:
| Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (OptoMonitor II) |
|---|---|---|
| Operating Temperature | 15°C to 30°C | 15°C to 30°C |
| Transport Temperature | -25°C to 60°C | -25°C to 60°C |
| Operating Relative Humidity | 10% to 85% non-condensing | 10% to 85% non-condensing |
| Storage Temperature | Room Temperature | Room Temperature |
| Operating Pressure | 70 to 106 kPa | 70 to 106 kPa |
| Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg FFR and catheter low pressure range. Distal high pressure range between -1 (-760 mmHg) atm and 20 atm (152000 mmHg) in high pressure mode. |
| 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). The high pressure range shall have an accuracy of 4% of reading or 1% of the full scale range whichever is greater. |
| 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).