(154 days)
Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).
The Medtronic Stedi™ Extra Support Guidewire (herein after referred as Stedi Guidewire) is design for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR) procedures.
The Stedi Guidewire has a 0.035" diameter and is 275cm in length and composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil and the ground core are joined in two locations: a proximal bond and a distal weld. The distal end of the Stedi Guidewire is comprised of a preformed 540° curved tip is available in 2 sizes (3cm and 4cm). The Stedi Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity.
The Stedi Guidewire is sterilized using ethylene oxide, nonpyrogenic, disposable, and for single use only.
Based on the provided FDA 510(k) clearance letter for the Medtronic Stedi Extra Support Guidewire, here's a detailed breakdown of the acceptance criteria and the study information.
It's important to note that the provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. For medical devices like guidewires, the "studies" primarily consist of non-clinical (bench) performance testing to ensure the new device meets established safety and performance requirements, rather than clinical trials with human subjects in the way AI/software devices typically undergo. Therefore, many of the questions related to human readers, ground truth, and training sets are not applicable in this context.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Medtronic Stedi Extra Support Guidewire are demonstrated through various non-clinical (bench) performance tests. The FDA guidance "Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019)" was utilized to establish these tests. The conclusion states that the device "met all design input requirements based on the intended use."
Here's a table summarizing the types of tests conducted, which imply the acceptance criteria were met by the device's performance in these areas:
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Dimensional Verification | Met applicable design and performance requirements |
| Visual Inspection | Met applicable design and performance requirements |
| Tensile Strength (Proximal & Distal Bond) | Met applicable design and performance requirements |
| Torque Strength | Met applicable design and performance requirements |
| Lubricity/Pinch Force | Met applicable design and performance requirements |
| Kink Resistance | Met applicable design and performance requirements |
| Tip Flexibility/Spiral Tip Compression | Met applicable design and performance requirements |
| Flex Test | Met applicable design and performance requirements |
| Fracture Test | Met applicable design and performance requirements |
| Three-Point Bend Test | Met applicable design and performance requirements |
| Material/Biocompatibility: | |
| Coating Integrity | Met applicable design and performance requirements |
| Corrosion Resistance | Met applicable design and performance requirements |
| Particulate Evaluation & Chemical Characterization | Met applicable design and performance requirements |
| Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity) | Compliant with ISO 10993-1 requirements |
| Sterility/Packaging: | |
| Sterilization Validation | Compliant with ISO 11135 requirements |
| Packaging Design Verification Testing | Compliant with ISO 11607 requirements |
| Durability: | |
| Shelf Life Testing | Met applicable design and performance requirements |
| Simulated Use: | |
| Simulated Use/Compatibility | Met applicable design and performance requirements |
| Radiopacity | Met applicable design and performance requirements |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each non-clinical test. However, it indicates "samples were analyzed according to predetermined acceptance criteria" for the various bench tests. In medical device bench testing, sample sizes are typically determined statistically to ensure sufficient power to detect differences or to demonstrate compliance with specifications.
- Data Provenance: The data is generated from non-clinical bench testing performed by Medtronic Inc. This is not clinical data (i.e., no patient data is involved). It is prospective in the sense that the tests were designed and executed to evaluate the new device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. For this type of medical device (guidewire), ground truth is established through engineering specifications, material science standards (e.g., ISO standards), and performance benchmarks derived from predicate devices and historical data. It does not involve human expert consensus in the diagnostic sense. The "experts" are the engineers, material scientists, and testers who design and conduct the tests and interpret the results against predetermined specifications.
-
Adjudication method for the test set:
- N/A. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human interpretation of data (e.g., image analysis). For bench testing of a guidewire, results are quantitative or qualitative against predetermined engineering specifications, and "adjudication" typically refers to the pass/fail criteria established for each test.
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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 physical medical device (guidewire), not an AI/software device that assists human readers/clinicians, so an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm. The "standalone" performance is the device's performance in the bench tests, independent of its use in a patient for the initial testing and FDA clearance.
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The type of ground truth used:
- The "ground truth" for each test is based on pre-established engineering specifications, material standards (e.g., ISO), and performance characteristics derived from the predicate device and FDA guidance documents. For example, the "ground truth" for tensile strength is a minimum force value, for biocompatibility it's compliance with ISO 10993, and for dimensions it's adherence to specified tolerances.
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The sample size for the training set:
- N/A. This is a physical medical device undergoing non-clinical testing, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- N/A. As there is no training set for a physical device, this question is not applicable.
§ 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.