(113 days)
The Comet™ Pressure Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Comet™ is a coronary and peripheral guidewire with a pressure sensor mounted approximately 3 cm proximally to the distal end of the straight tip. The optical pressure sensor is integrated within the distal region of a 0.014" guidewire to measure blood pressure gradient changes across coronary and peripheral lesions during endovascular procedures. The tip is radiopaque to help with guidewire placement and shapeable by the user. The guidewire is attached to an optical cable through a detachable connector. The optical cable has a connector on the proximal end for interface with an ancillary Boston Scientific signalprocessing module. When connected to the signal-processing module, a Boston Scientific iLab Polaris™ Multi-Modality Guidance System displays various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value calculated from the ratio of distal pressure over aortic pressure. A torque device is preloaded onto the proximal end of the wire. The pressure guidewire, optical cable, and torque device are all connected in the single use sterilized packaging. The intended use of Comet remains within the scope of the predicate intended use. The subject device features a narrower intended use (i.e., FFR) as compared to the PressureWire Certus (i.e., any physiological parameters). Narrower intended use does not raise new questions of safety and/or effectiveness.
I am unable to provide a comprehensive answer to your request based on the provided text. The document is a 510(k) summary for the Boston Scientific Comet Pressure Guidewire, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a comprehensive study report for a de novo approval.
Here's why I cannot fully address your request with the given information and what parts I can extract:
Information I CAN extract (or infer):
- Device Name: Comet™ Pressure Guidewire
- Intended Use/Indications for Use: To direct a catheter through a blood vessel and to measure physiological parameters (specifically blood pressure gradient and FFR) in the coronary and peripheral blood vessels.
- Type of Ground Truth (for the device functionality): The device is measuring physiological parameters (blood pressure gradient, FFR). The "ground truth" for its accuracy would implicitly be a highly accurate reference pressure measurement system.
- Stand-alone Performance: The device is designed to measure parameters (e.g., FFR) on its own, so a standalone performance assessment of its sensing accuracy and drift was conducted.
Information NOT present in the document (or not in enough detail to answer fully):
- Table of Acceptance Criteria and Reported Device Performance: While the document lists types of in vitro and in vivo tests performed (e.g., Sensing Accuracy, Sensing Drift), it does not provide the specific numerical acceptance criteria for these tests (e.g., "Sensing Accuracy +/- 2 mmHg") nor the quantitative reported device performance against those criteria. It only states that the results "demonstrate that the technological characteristics and performance criteria... are comparable to the predicate devices."
- Sample Size used for the test set and data provenance: The document mentions "in vitro tests" and "in vivo studies in GLP porcine model" but does not specify sample sizes (e.g., number of guidewires tested for accuracy, number of animals in the in vivo study). It also doesn't specify data provenance beyond "GLP porcine model."
- Number of experts used to establish ground truth for the test set and qualifications: This is not relevant for a device measuring physical parameters directly. The "ground truth" for pressure measurements comes from a reference standard, not expert consensus.
- Adjudication method: Not applicable as this is a device measuring physical parameters, not interpreting images or clinical outcomes requiring human adjudication.
- MRMC comparative effectiveness study: Not applicable. This device measures physiological parameters; it's not an AI system assisting human readers in interpretation.
- Standalone Performance (detailed): While implied by "Sensing Accuracy" and "Sensing Drift," the specific results of these standalone performance tests are not provided.
- Type of ground truth (detailed for specific parameters): For pressure measurements, the ground truth would be established by a highly accurate, calibrated reference pressure transducer. The document doesn't explicitly state the reference method used.
- Sample size for the training set: Not applicable. This is a physical medical device (a guidewire with a sensor), not an AI/machine learning algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable, for the same reason as above.
In summary, the provided FDA 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device by listing types of tests performed. It explicitly states, "As the indications for use and fundamental scientific technology have not changed, non-clinical performance data supports a determination that the subject device is substantially equivalent to the predicate device, and that it is at least as safe and effective for its intended use." This means the detailed quantitative data and specific acceptance criteria would likely be in the full submission, but are not openly reported in this summary.
§ 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).