(29 days)
The Charter(TM) Guidewires are intended for use in the coronary and peripheral vasculature.
The Charter™ Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 43cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce various levels of support.
The distal part of the reduced section is covered with a 3cm, 0.010" platinum tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD, equivalent in diameter to the main core body.
Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessel
The provided text describes a 510(k) application for the Charter™ Guidewire. This is a medical device, not an AI/ML powered device, therefore the criteria for AI/ML powered devices cannot be fully satisfied by the provided information.
However, I can extract the acceptance criteria and the study type conducted based on the available text.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional/Mechanical | Tensile Strength | "The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device." |
| Torque Strength | "The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device." | |
| Outer Diameter measurement | "The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device." | |
| Torque Response | "The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device." | |
| Catheter Compatibility | "The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device." | |
| Coating Adherence/Coating Integrity | "The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device." | |
| Tip Stiffness | "The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device." | |
| Particulate Residue | "The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device." | |
| Overall Equivalence | Demonstration of substantial equivalence to predicate devices, ensuring no new issues of safety and effectiveness, and appropriateness for intended use. Comparability to existing devices in the range. Meeting requirements for intended use. | "Based on safety and performance testing, technological characteristics and the indications for use for the device, the proposed new Charter™ Guidewire models has been demonstrated to be appropriate for its intended use and is considered to be substantially equivalent to the original [predicate device]." |
Study Information (Based on a medical device, not an AI/ML framework):
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Sample size used for the test set and the data provenance:
- The study involved in vitro bench testing.
- The sample size for these tests is indicated as "n" (which is not a specific number but typically implies a sufficient number for statistical validity in bench testing).
- The documentation does not specify provenance like country of origin for the "data" as it pertains to physical device testing, not patient data. It is a prospective bench test conducted by the manufacturer to assess device properties.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. "Ground truth" in the context of AI/ML or diagnostic studies refers to a verified diagnosis or outcome. For a physical medical device like a guidewire, the "ground truth" is established by direct measurement and adherence to engineering specifications and performance standards through well-defined bench test methodologies.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication refers to resolving disagreements between human readers or between an AI and human readers in diagnostic tasks. The bench tests described are objective measurements against defined acceptance criteria.
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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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, often assisted by AI). The Charter™ Guidewire is a physical interventional device, not a diagnostic one.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This refers to AI algorithm performance. The Charter™ Guidewire is a physical device, and its "performance" is measured by its physical and mechanical properties described in the bench tests, not by an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on pre-defined product specifications and industry standards for guidewire performance, as outlined in the "In vitro bench testing" section, specifically referencing the "FDAs guidance document 'Coronary and Cerebrovascular Guidewire Guidance, Jan 1995'". The device's performance is measured against these objective, quantifiable criteria.
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The sample size for the training set:
- This is not applicable. There is no "training set" in the context of a physical medical device's performance testing. Training sets are used to develop and train AI/ML models.
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How the ground truth for the training set was established:
- This is not applicable as 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.