(25 days)
The PrimeWire PRESTIGE™ Pressure Guide Wire Device is indicated for use 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 for the diagnosis and treatment of blood vessel disease.
The PrimeWire PRESTIGE™ Pressure Guide Wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The PrimeWire PRESTIGE™ guide wire measures pressure when used with the SmartMap, s5 Family, and ComboMap systems. The PrimeWire PRESTIGE™ guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm and 300 cm, with straight or pre-shaped tips. The PrimeWire PRESTIGE™ guide wire is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.
Here's a summary of the acceptance criteria and study information for the PrimeWire PRESTIGE™ Pressure Guide Wire, based on the provided text:
Acceptance Criteria and Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the PrimeWire PRESTIGE™ Pressure Guide Wire. Instead, it relies on a statement of substantial equivalence to predicate devices and general performance claims.
| Acceptance Criteria Category | Specific Criteria (as inferred/stated) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Device performs pressure measurement in blood vessels (coronary and peripheral). | The device measures pressure when used with SmartMap, s5 Family, and ComboMap systems. "The PrimeWire PRESTIGE™ guide wire has the same performance specifications... as that of the predicate devices." |
| Technological Equivalence | Uses the same fundamental scientific technology as predicate devices. | "The modified PrimeWire PRESTIGE™ Pressure Guide Wire Device uses the same fundamental scientific technology... as that of the predicate device." |
| Intended Use Equivalence | Same intended use as predicate devices. | "The modified PrimeWire PRESTIGE™ Pressure Guide Wire Device... has the same intended use as that of the predicate device." |
| Safety and Efficacy (General) | Modifications do not raise new questions regarding safety or efficacy. Product is comparable to the predicate device. | "Modifications to the device do not raise any new questions regarding safety or efficacy. The test results indicate the revised product is comparable to the predicate device." |
| Design Controls Compliance | Compliance with design controls. | "The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence..." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Applicable testing was performed in accordance with the Design Verification Plan," but details about the sample size (e.g., number of devices tested, number of measurements taken) are not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing described appears to be internal device verification and validation performed by Volcano Corporation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The submission focuses on device performance compared to predicate devices and internal verification, not on clinical studies with expert-established ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None stated or implied. The document describes design verification and comparability testing to predicate devices rather than a clinical study requiring adjudication.
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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:
- No MRMC study was done or reported. This device is a medical instrument (pressure guide wire) and not an AI or imaging diagnostic device that would typically involve a multi-reader, multi-case comparative effectiveness study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical medical instrument, not a standalone algorithm. Its function inherently involves human operation and interaction with other medical systems.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The concept of "ground truth" as typically used in AI/diagnostic device validation (e.g., expert consensus, pathology, outcomes data) is not applicable in the context of this device's submission. The "ground truth" for this device's performance would be the direct measurement of physical parameters (pressure) by the device itself, validated against established reference standards or the performance of predicate devices within a controlled environment, but the specifics of these reference standards are not detailed here.
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The sample size for the training set:
- This question is not applicable as the device is a physical medical instrument, not an algorithm that requires a training set.
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How the ground truth for the training set was established:
- This question is not applicable for the same reason as above; there is no "training set" for this type of device.
§ 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.