(69 days)
The CPS Courier Guidewires are intended for use in the coronary and peripheral vasculature.
The Courier Guide wire is a disposable medical device designed for single use only. It consists of a 0.014" diameter stainless steel core wire, the distal end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. The quide wire comes in 5 unique base models distinguished by their distal flexibility portions, the profile varied to provide a range of products of mixed stiffness. This reduced section is covered with a polymer coating of equivalent diameter to the main core body. Underneath the polymer at the distal tip there is a 0.010" platinum/tungsten alloy platinum coil attached to the distal tip of the core by means of solder joints. This provides greater visibility on x-ray equipment.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Equivalent to predicate device, within design parameters | - Tensile strength: Successfully completed testing. |
- Torque strength: Successfully completed testing.
- Torque response: Successfully completed testing.
- Coating performance: Successfully completed testing.
- Tip flexibility: Successfully completed testing. |
| Imaging Properties | Sufficient for visibility on X-ray equipment | - Radiopacity: Successfully completed testing. The device incorporates a 0.010" platinum/tungsten alloy platinum coil at the distal tip for greater visibility on x-ray equipment. |
| Device Compatibility | Compatible with catheters | - Catheter compatibility testing: Successfully completed testing. |
| Material/Shelf Life | Biocompatible and maintain performance over time | - Accelerated aging: Successfully completed testing. - Biocompatibility testing: Successfully completed in compliance with ISO 10993-1. |
| Overall Performance | Safe, effective, and performs as well as the predicate devices | - "The successful tests demonstrated the CPS Courier Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices." Implies meeting all relevant performance and safety benchmarks for guidewires, consistent with the predicate. |
Study Proving Acceptance Criteria are Met:
The document describes a series of performance tests. These tests collectively serve as the study demonstrating that the CPS Courier Guidewires meet the (implied) acceptance criteria, primarily by showing substantial equivalence to the predicate device and adherence to design parameters.
Detailed Information about the Study:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device (the Brivant Guidewire). The "study" in this context is a series of engineering and biocompatibility tests rather than a clinical trial involving human subjects or a diagnostic accuracy study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact sample sizes used for each individual test (tensile strength, torque response, etc.). These are typically described in detailed test reports, which are summarized here.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter, Brivant Limited, is located in Galway, Ireland, suggesting the testing was likely conducted in Ireland or by a contract lab working for them. The testing is prospective, as it's being conducted specifically to support this 510(k) submission for a new device design.
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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 in the context of this device. The CPS Courier Guidewire is a mechanical device, not a diagnostic or imaging interpretation tool that requires expert human interpretation to establish "ground truth." The ground truth for mechanical and material properties is established through standardized engineering test methods (e.g., measuring tensile strength using a testing machine) and adherence to industry standards (e.g., ISO 10993-1 for biocompatibility).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in human expert interpretation in studies involving diagnostic accuracy or image review. For physical device testing, the results are typically quantitative measurements against predefined specifications; discrepancies would involve re-testing or investigation of the test setup, not expert adjudication of interpretations.
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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:
- This question is not applicable. The CPS Courier Guidewire is a medical device (guidewire) used in procedures, not an AI-powered diagnostic or decision-support tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this submission.
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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 previously stated, this is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device is based on engineering specifications, material science principles, and established international standards. For example:
- Mechanical properties: Ground truth is defined by the physical measurement of properties (e.g., force required for tensile failure, torque applied) and comparison against design specifications and predicate device performance.
- Biocompatibility: Ground truth is established by meeting the requirements of ISO 10993-1, which involves standard tests for cytotoxicity, irritation, sensitization, etc., interpreted by toxicologists or biologists based on established scientific principles.
- Radiopacity: Ground truth is the visual confirmation of visibility under X-ray, often quantified by comparing it to known radiopaque materials or the predicate device.
- The ground truth for this device is based on engineering specifications, material science principles, and established international standards. For example:
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The sample size for the training set:
- This question is not applicable. The concept of a "training set" applies to machine learning algorithms. This device is not an AI/ML product. The tests conducted are for verification and validation of the physical device and its materials.
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How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
§ 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.