(23 days)
ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.
The ComboWire™/ComboTip™ Pressure/Flow Guide Wire is a steerable guide wire with a pressure transducer mounted less than 3 cm proximal to the tip and a tip mounted ultrasound transducer. The ComboWire/ComboTip measures pressure and flow when used with the ComboMap™ Pressure/Flow Instrument, a class IIa currently marketed device. The ComboWire/ComboTip is currently available in a diameter of 0.014" with a length of 185cm however, additional sensor configurations and wire length will be produced in the future to accommodate customer needs just as has been done with SmartWire, WaveWire and FloWire where up to 10 models are offered. The proximal end of the ComboWire/ComboTip is compatible with the provided ComboWire/ComboTip Connector Cable Assembly. The ComboWire/ComboTip can be torqued using the included torque device to facilitate navigation through the vasculature.
The provided text describes the Volcano Corporation ComboWire™ Pressure/Flow Guide Wire Family Special 510(k) submission (K042996). However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, nor does it include information typically associated with AI/ML device studies.
The document is a traditional 510(k) summary focused on demonstrating substantial equivalence to predicate devices (SmartWire® and FloWire®) for an updated medical device. The "Performance Data" section merely states: "Applicable testing was performed to evaluate the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire. The test results were found to be acceptable as required by the respective test plans and protocols." It does not elaborate on what these tests were, their acceptance criteria, or their results.
Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria and performance studies in the context of an AI/ML device.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states "test results were found to be acceptable as required by the respective test plans and protocols," but the specific criteria and results are not detailed. | Not specified in the document. The document states "test results were found to be acceptable as required by the respective test plans and protocols," but the specific performance metrics are not detailed. |
Missing Information (and why it's missing from this type of 510(k) submission):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. This type of detail is typically not included in a 510(k) summary for a non-AI device unless significant clinical trials with human subjects are involved. The testing mentioned would likely be bench testing (e.g., pressure accuracy, flow velocity accuracy, mechanical properties, biocompatibility).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth establishment by experts is usually for diagnostic imaging or similar AI/ML applications, which is not the nature of this device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a non-AI medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would likely refer to calibrated measurements from reference instruments during bench testing, not clinical expert assessments.
- The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Device and Performance Information Provided:
- Device Name: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of Products
- Intended Use: To measure simultaneous pressure and blood flow velocities in blood vessels (coronary and peripheral) during diagnostic angiography and/or interventional procedures.
- Technological Characteristics Comparison to Predicate: Combines functionality of two separate predicate wires (SmartWire® for pressure, FloWire® for flow) into one system. Material construction, measurement modalities, and instrument connections are stated to be the same as predecessor wires.
- Performance Data Statement: "Applicable testing was performed... The test results were found to be acceptable as required by the respective test plans and protocols." This is a general statement asserting compliance with internal testing protocols, but specific results are not disclosed in this summary.
- Conclusion: The device has the "same intended use and utilize the same fundamental scientific technology as that of the predicate devices. There are no new questions raised regarding safety and efficacy."
In essence, this 510(k) relies on the argument of "substantial equivalence" to previously cleared predicate devices, rather than presenting novel performance data for acceptance criteria as one would expect for an AI/ML system.
§ 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.