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510(k) Data Aggregation
(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 | <0.3 mmHg/deg C (Predicate: PrimeWire) | <0.3 mmHg/deg C | Yes |
| Zero Drift | Unknown (Predicate: PrimeWire) | <1 mmHg/h | Met internal criteria |
| Electrical Isolation | Class 1 (Predicate: ComboMap) | Class 2 (double isolation) | Favorable Comparison |
| User Interface | Touchscreen, Remote Control (Predicate: ComboMap) | Touchscreen | Favorable Comparison |
| Auto-zeroing | Yes (Predicate: ComboMap) | Yes | Yes |
| Real Time Curves | Aortic, distal, Pa/Pd trend (Predicate: ComboMap) | Aortic, distal | Favorable Comparison |
| Real Time Numerical Values | Mean aortic, mean distal, mean Pd/mean Pa, heartbeat (Predicate: ComboMap) | Mean aortic, mean distal, mean Pd/mean Pa | Favorable Comparison |
| FFR Capability? | Yes (Predicate: PrimeWire/ComboMap) | Yes | Yes |
| FFR Viewing? | Yes (Predicate: ComboMap) | Yes | Yes |
| Basis for FFR Determination | Simultaneous acquisition of 2 pressure values | Simultaneous acquisition of 2 pressure values | Yes |
Note: "Favorable Comparison" indicates that while not identical, the performance is considered acceptable for substantial equivalence based on the technological characteristics and overall safety/effectiveness. "Met internal criteria" refers to tests where no direct predicate comparison was given for a specific metric.
2. Sample Size Used for the Test Set and Data Provenance
The document describes two types of performance testing:
- Bench Testing: The text states, "Bench testing has been performed to confirm that the OptoWire and OptoMonitor System meets predetermined acceptance criteria and is substantially equivalent to the predicate devices." It lists various tests (Tip Testing, Tensile Test, Fatigue Test, Sensor Sensitivity to Bending, Pressure and Sensor Testing, Age testing, etc.) for both the OptoWire and OptoMonitor components. No specific sample sizes (number of devices/components tested) are provided for these bench tests. The data provenance is implicitly from laboratory/engineering testing.
- Animal Testing: "Animal studies have been performed to characterize the in-vivo performance of the OptoWire and OptoMonitor System, as compared to the predicate device and other currently marketed devices with the same indications for use." No specific sample size (number of animals) is provided for the animal studies. The data provenance is from animal models.
The document does not specify a country of origin for the data for either bench or animal testing, nor does it specify if the animal study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided document does not mention the use of human experts or expert consensus to establish ground truth for any of the performance tests (bench or animal studies). The ground truth for these tests would likely be based on established engineering principles, reference measurements, and physiological standards measured during the experiments.
4. Adjudication Method for the Test Set
Since no human experts were explicitly mentioned for establishing ground truth, there is no adjudication method described for the test set. Performance was likely assessed against objective, predetermined technical specifications and direct comparisons to predicate devices.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
A Multi-reader Multi-case (MRMC) comparative effectiveness study was not mentioned in the provided document. The device is for measurement of physiological parameters (pressure, FFR), not for interpretation of images or other data by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The provided document describes the performance of the device itself, which includes the OptoWire (pressure sensing guidewire) and OptoMonitor (electronic signal processing and display units). This constitutes a standalone performance evaluation of the system's ability to accurately measure and display intravascular blood pressure and FFR values. The software within the OptoMonitor was validated "in accordance with design specifications and the system operates as intended when used for its intended use."
7. The Type of Ground Truth Used
The ground truth for the performance testing appears to be based on:
- Established engineering specifications and physical measurements: For bench testing of mechanical properties, sensor accuracy, electrical safety, etc.
- Physiological standards and comparative measurements: For animal studies, comparing the device's pressure measurements and handling characteristics against predicate devices and other currently marketed devices with the same indications for use in a living system.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for substantial equivalence.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning or AI. The OptoMonitor contains software, which was "developed, documented and validated in accordance with industry standards (IEC 62304) and FDA guidance." This type of software development and validation typically involves testing against requirements and specifications, not training with a distinct dataset in the way a machine learning model would be.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The software validation involved demonstrating that the system software operates in accordance with design specifications and performs as intended.
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