(193 days)
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
The material of construction is stainless steel which is consistent with guidewires presently in commercial distribution. The wires are also manufactured using a PTFE coating. The wires are available straight, with "J" end, or moveable core. The wires range from .014" diameter through .065' diameter and lengths from 15cm. to 400cm.
The provided text describes a 510(k) premarket notification for Galt Medical's Guidewires, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested categories for a study that proves a device meets acceptance criteria cannot be extracted because such a study was not performed or detailed in the provided documents. The submission relies on non-clinical testing and comparison to predicate devices, not human or animal clinical trials with specific performance metrics for acceptance.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Functional and Performance Characteristics: | Functionality and performance characteristics are comparable to currently marketed guidewires (predicate devices). |
| - Tensile Strength | Comparable to predicate devices. |
| - Torque Strength | Comparable to predicate devices. |
| - Torqueability | Comparable to predicate devices. |
| - Flexibility | Comparable to predicate devices. |
| - Coating Adherence | Comparable to predicate devices. |
| Substantial Equivalence: | The guidewires are considered substantially equivalent to legally marketed predicate devices (Argon Medical, Cordis, Cook Acme - K920884). |
2. 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. Non-clinical tests were performed, but the number of guidewires tested for each characteristic is not detailed.
- Data Provenance: Not specified. This would be non-clinical lab data, likely from in-house testing by Galt Medical Corp. in Garland, TX, USA. It is prospective testing, as it was conducted for the 510(k) submission.
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. This was a non-clinical device performance claim, not a diagnostic or clinical efficacy study requiring expert-established ground truth. The "ground truth" for non-clinical tests would be established by industry standards, design specifications, and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical device performance claim, not a clinical study involving human judgment or adjudication.
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. This device is a guidewire, a physical medical device for interventional procedures, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a guidewire, not an algorithm. The "standalone" performance refers to the device's functional integrity as evidenced by the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable directly. For the non-clinical tests, the "ground truth" is implied by accepted engineering standards for tensile strength, torque, flexibility, and coating adherence for guidewires, as well as the performance characteristics of the legally marketed predicate devices. The focus is on demonstrating comparable physical and mechanical properties.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device 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.