(12 days)
The 0.035" and 0.025" Hytek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.
The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for the purpose of directing the catheter through a blood vessel.
The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to help facilitate smoother passage.
The HyTek Guidewire is available in diameters of .014" to .035, and in lengths from 80 cm to 300 cm.
The provided text is a 510(k) summary for the HyTek Guidewire. It discusses the device's substantial equivalency to predicate devices based on non-clinical tests. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically required for AI/ML-based medical devices.
Instead, this document describes a traditional medical device (a guidewire) and its regulatory clearance process, which relies on demonstrating substantial equivalence to already approved predicate devices through bench testing.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
Here's the breakdown of what can be extracted from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality and performance comparable to currently marketed predicate devices. | "The results of these tests demonstrated the functionality and performance characteristics of the guidewire are comparable to the currently marketed device." (K991898, Section 6. Non-Clinical Tests) |
| Specific performance characteristics tested (bench tests) | Torque, flexibility, and coating adherence. (K991898, Section 6. Non-Clinical Tests) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The "tests" mentioned are non-clinical bench tests. Sample sizes for these types of engineering tests are rarely specified in 510(k) summaries as they are not human subject studies. Data provenance (country, retrospective/prospective) is irrelevant for bench testing of a physical device.
3. 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 provided. "Ground truth" in the context of AI/ML usually refers to human expert annotations or clinical outcomes. For physical device bench testing, the "ground truth" is typically established by engineering specifications and direct measurement, not human experts in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication is a concept for resolving discrepancies in human expert opinions for ground truth establishment. This is not relevant for bench testing a physical device.
5. 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
- Not applicable / Not provided. MRMC studies are for evaluating the impact of AI on clinical reader performance. This device is a physical guidewire, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The "ground truth" for the bench tests would be the physical properties and performance measured against engineering specifications, which are implicitly derived from the predicate device's characteristics and industry standards.
8. The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. There is no "training set."
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The study consisted of non-clinical tests designed to demonstrate that the HyTek Guidewire's functionality and performance characteristics are comparable to the currently marketed predicate device (K943390 and K991194).
These tests specifically included:
- Torque
- Flexibility
- Coating adherence
The document states that "The results of these tests demonstrated the functionality and performance characteristics of the guidewire are comparable to the currently marketed device." This statement, along with the detailed comparisons to predicate devices in the full 510(k) submission (which is summarized here), was sufficient for the FDA to determine substantial equivalence and clear the device for market. The specific methodology, detailed results, and quantitative acceptance thresholds for these bench tests are not provided in this summary but would have been part of the full 510(k) submission.
§ 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.