(29 days)
The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The proposed device is a polypropylene dilator with a semi-threaded stainless steel tip, This stainless steel tip is used to dilate tissue surrounding an indwelling catheter or foreign object. In addition, an ergonomic handle to be used as a "drive mechanism" will be included. The device will be made with 7.0 and 9.0 French sizes. It will be supplied sterile, intended for one-time use.
The provided document describes a 510(k) premarket notification for the Cook Vascular EVOLUTION Mechanical Dilator Sheath Set. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study report with performance metrics. Therefore, many of the requested details are not present in the provided text.
Here is an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
The document lists various tests performed but does not specify the acceptance criteria for these tests or provide quantitative results for the device's performance against any set criteria. It merely states that the "results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
Since specific acceptance criteria (e.g., "Buckling force > X Newtons") and corresponding reported performance values are not provided, this table cannot be fully populated from the given text.
| Test Name | Acceptance Criteria (Not provided in text) | Reported Device Performance (Not provided in text) |
|---|---|---|
| Buckling Test | - | - |
| Binding Test | - | - |
| Bond Strength (Connector/gun) | - | - |
| Pull Testing (tip) | - | - |
| Handle Cycling Test | - | - |
| Device Performance | - | - |
Additional Information on the 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: Not specified. The document only lists the types of tests performed (Buckling, Binding, Bond Strength, Pull Testing, Handle Cycling, Device Performance) but does not provide any details on the number of units tested for each.
- Data Provenance: Not specified. The data and testing would presumably be conducted by Cook Vascular, Inc. (Vandergrift, PA, USA) as part of their internal quality and regulatory processes, but this is not explicitly stated. It is a "Special 510(k) Premarket Submission," which often relies on internal testing to demonstrate equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not mentioned. The tests described are engineering/mechanical performance tests (e.g., buckling, bond strength), not clinical studies requiring expert interpretation of results or establishment of clinical ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. This concept is relevant for clinical studies or image interpretation tasks where human readers might disagree. For the described mechanical tests, the results would typically be objectively measured against predefined engineering specifications.
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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. This is a conventional medical device (mechanical dilator sheath), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical device, not an algorithm, so this concept is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the conventional sense. The "ground truth" for the mechanical tests would be the pre-defined engineering specifications and performance requirements for the device's function (e.g., "the dilator must not buckle under X force"). The tests confirm adherence to these functional requirements.
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The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI model, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a mechanical device.
Summary of what is present:
The document serves as a 510(k) summary, which aims to demonstrate "substantial equivalence" of the EVOLUTION Mechanical Dilator Sheath Set to existing predicate devices. It lists the types of tests performed (Buckling Test, Binding Test, Bond strength, Pull Testing, Handle Cycling Test, Device Performance) as evidence of reliable design and performance. However, it does not provide specific quantitative acceptance criteria or the actual test results that would illustrate the device's performance against these criteria. The approval by the FDA (K061000) indicates that the provided information was deemed sufficient to establish substantial equivalence.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).