(226 days)
The Drivewire 24 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire 24 Guidewire is intended to facilitate the selective placement of diagnostic catheters. This device is not intended for use in the coronary arteries.
The Drivewire 24 Guidewire is a 0.024" diameter steerable guidewire with a deflectable tip to aid in accessing vasculature. The guidewire is supplied sterile (ETO sterilization) and is for single use only. The Drivewire 24 Guidewire is comprised of a stainless steel hypotube that is cut along its length to provide flexibility and tip deflection ability through control of the handle, an inner Nitinol braided flexible coil, an inner core wire, and a handle. The inner core wire runs inside the hypotube from the distal end to the handle. The distal end of the inner core wire is flattened, looped around and joined to the tip of the distal section of the hypotube, forming a deflectable tip. The hypotube is marked with fluoro-safe markers to provide visual clues to the user to initiate fluoroscopy guided insertion. In order to actuate the tip deflection in two directions, the Drivewire 24 Guidewire handle contains a tube assembly section. The handle is assembled to the proximal end of the core wire and controls the movement of the distal tip by pulling/pushing the inner moveable core wire, allowing the bending of the distal tip in two directions. The handle assembly has neutral landmarks to identify the location where the tip is straight. The Drivewire 24 Guidewire has a hydrophilic coating on its distal segment in order to reduce the friction of the guidewire while navigating. The Drivewire 24 Guidewire is provided with a torque accessory to facilitate use of the guidewire and is not intended to have patient contact.
The information provided does not describe an AI/ML device but rather a medical guidewire. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable here.
This document, K233791, is a 510(k) premarket notification for the Drivewire 24 Guidewire, a physical medical device. The submission demonstrates substantial equivalence to a predicate device (Aristotle 24 Guidewire) through non-clinical testing.
Here's an analysis of the provided information, framed to address the prompt's questions where applicable, but explicitly noting the absence of AI/ML-specific details:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Non-Clinical Testing" which outlines various bench tests, their methods, and results indicating they met acceptance criteria. While specific numerical acceptance criteria are not always stated, the results confirm successful performance.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Verification | Meet specified overall length, diameter, bend diameter, coating length; no damage. | Dimensional and visual inspection results meet acceptance criteria. |
| Tip Flexibility | Comparable to predicate device. | Tip flexibility was shown to be comparable to the predicate device. |
| Tip Deflection Force | Less than or equal to the predicate device's force. | The force applied by the tip is equal to or less than the predicate device's. |
| Simulated Use - Delivery & Retrieval Force | Less than the predicate device's force. | The delivery and retrieval forces were less than the predicate device's. |
| Simulated Use - Performance & Compatibility | Demonstrate intended use in challenging simulated conditions. | All devices met acceptance criteria in demonstrating the intended use of the guidewire in challenging simulated use conditions. |
| Usability Evaluation | Meet acceptance criteria (as determined by physicians). | The device met the acceptance criteria. |
| Torqueability | Required initial rotation to tip response equivalent to or less than predicate device. | All devices met acceptance criteria in having the required initial rotation to the point when the tip starts to respond be equivalent to or less than the predicate device. |
| Kink Resistance | Withstand clinical use scenarios without kinking. | All devices met acceptance criteria for kink resistance which represent clinical use scenarios. |
| Fracture Test | No fractures, loosening, or failures when wound around a cylinder. | All devices met the acceptance criteria of having no fractures, loosening, or failures. |
| Flexing Test | No fractures, loosening, or failures after repeated bending. | All devices met the acceptance criteria of having no fractures, loosening, or failures. |
| Tensile Force | Meet peak tensile force criteria established by delivery and retrieval force testing. | All joints met peak tensile force acceptance criteria established by delivery and retrieval force testing. |
| Tip Mechanism Durability | Withstand a predetermined number of handle actuations. | All devices met acceptance criteria of withstanding a predetermined number of handle actuations. |
| Torque Strength | Number of turns to failure no less than a predetermined value. | All devices met the acceptance criteria of having the number of turns to failure be no less than a predetermined value. |
| Torquer Performance | No damage to handle or shaft; equivalent or higher tensile force and measured torque force at slipping to predicate device. | All devices met acceptance criteria of having no damage to the handle or shaft, and equivalent or higher tensile force and measured torque force at slipping to predicate device. |
| Particulate | Particulates equivalent to or less than the predicate device. | All devices have particulates equivalent or less than the predicate device. |
| Lubricity | Maximal and average force comparable to the predicate device. | All devices met the acceptance criteria of having a maximal force and an average force comparable to the predicate device. |
| Coating Integrity | No coating separation after simulated use testing. | All devices met the acceptance criteria of having no coating separation after simulated use testing. |
| Radiopacity | Visible under fluoroscopy. | All devices were visible under fluoroscopy. |
| Corrosion | No evidence of corrosion. | The test sample did not have evidence of corrosion. |
| Biocompatibility Tests (Cytotoxicity, Irritation, Sensitization, Hemocompatibility, Pyrogenicity, Acute Systemic Toxicity, Thrombogenicity) | Meet ISO 10993 standards and specific test requirements. | All tests confirmed that the Drivewire 24 Guidewire met biological safety requirements per the ISO 10993 standard, with specific positive results for each test (e.g., no toxicity, no irritation, not sensitizers, non-hemolytic, not complement activator, nonpyrogenic, no systemic toxicity, no thrombus formation). |
| Sterilization | Achieve SAL of 10^-6 or less by EtO. | Demonstrate that the Ethylene Oxide (EtO) sterilization process will reliably sterilize the product loads to a sterility assurance level (SAL) of 10^-6 or less, according to the overkill half cycle approach and relevant standards. |
| Shelf Life and Package Integrity | Meet acceptance criteria for 1 year shelf-life. | The Drivewire 24 Guidewire device and package met all shelf life and package integrity test acceptance criteria supporting a shelf-life of one (1) year. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Tests: The specific number of devices tested for each bench test is not explicitly stated, but the results refer to "All devices," implying a sufficient sample was used to statistically validate the findings against acceptance criteria. Data provenance for bench tests is typically from the manufacturer's internal labs.
- Biocompatibility Tests: The description mentions "test article extract" or "test articles," indicating samples of the device or its materials were used according to ISO 10993 standards.
- Animal Study: The study was conducted in "domestic swine." The number of animals or devices used per animal is not specified but is implicitly sufficient for a GLP study.
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)
This question is not applicable as this is a physical medical device, not an AI/ML diagnostic system requiring expert ground truth for interpretation. The "Usability Evaluation" mentioned that "Physicians evaluated the guidewire in clinically relevant simulated use models," implying expert input, but details on their number or qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML diagnostic study requiring expert adjudication of results.
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. No MRMC study was performed as this is a physical medical device. The efficacy is demonstrated through non-clinical testing and comparison to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a guidewire, the "ground truth" is established through physical and material science measurements, functional performance testing against defined engineering specifications, and biological safety testing against established international standards (e.g., ISO 10993). In the animal study, the "ground truth" for thrombogenicity was the direct examination of devices, renal arteries, and downstream organs for thrombus absence.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML model was involved.
§ 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.