(29 days)
The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional device is not intended for use in the coronary vasculature.
The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Scientia Vascular's Aristotle 18 Guidewire and Aristotle 24 Guidewire are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only, in the following diameters, stiffness profiles, and lengths:
Aristotle 18 Guidewire
Diameter: 0.018"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300 cm
Aristotle 24 Guidewire
Diameter: 0.024"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300 cm
The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body.
The provided text is a 510(k) summary for the Aristotle 18 Guidewire and Aristotle 24 Guidewire. This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a full clinical study with a defined test set and ground truth.
Therefore, many of the requested details about acceptance criteria, test set, expert adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device clearances or more complex clinical effectiveness studies) are not applicable to this 510(k) submission.
This submission relies on:
- Similarities in indications for use, intended use, operating principles, design, materials, packaging, and sterilization processes to predicate devices.
- Bench testing data from predicate/reference devices to support the performance of the new models, particularly noting that the added length (100 cm) is at the proximal end and does not impact the distal end's features or dimensions.
- Biocompatibility and sterilization data from reference devices which are deemed applicable due to material and process commonality.
- A risk assessment (ISO 14971) concluding that no new questions of safety or effectiveness are raised and no additional testing is necessary.
Since this is a guidewire, the "performance" typically refers to physical characteristics rather than diagnostic accuracy like an AI/ML product.
Here's a breakdown based on the information provided, highlighting what is and is not present:
1. Table of acceptance criteria and the reported device performance
No explicit acceptance criteria table is provided as this is a substantial equivalence claim, not a de novo or PMA where specific performance targets might be set and then measured against. The "performance" is implicitly demonstrated through the similarity to predicate devices and the lack of new safety/effectiveness concerns due to the minor modification (increased length at the proximal end).
The document states:
- "The subject devices have the following similarities to the previously cleared predicate devices:
- The same indications for use,
- The same intended use,
- The same operating principle,
- The same basic guidewire design,
- The same materials, and
- The same packaging materials and sterilization processes."
- "The bench performance testing conducted for the reference devices (K222347, K173235) and the predicate 200 cm long models of the subject guidewires cleared under K183608 and K192783, support the performance of the subject devices (300 cm) because they use the same materials, processes, components, and dimensions within the range of the previously cleared predicate and reference devices."
- "Following the risk assessments conducted in accordance with ISO 14971, no additional testing was deemed necessary to support the substantial equivalence of the subject device models."
2. Sample size used for the test set and the data provenance
- No specific "test set" in the context of an AI/ML model for diagnostic accuracy is described. The studies referenced are bench performance testing, biocompatibility, and sterilization, which are standard for guidewire manufacturing and safety.
- The provenance of data for the bench testing and biocompatibility is not explicitly stated (e.g., country of origin) but would typically be from the manufacturer's internal testing.
- The studies were retrospective in the sense that they relied on pre-existing data from predicate and reference devices (K222347, K173235, K183608, K192783) and did not generate new clinical data for this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission does not involve diagnostic interpretation or human reader performance, so there's no "ground truth" establishment by experts in the sense of image annotation or disease diagnosis. The "ground truth" for guidewire performance comes from engineering specifications and bench testing.
4. Adjudication method for the test set
- Not applicable. No human adjudication of results is mentioned or required for this type of device and submission.
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 instrument, not an AI/ML diagnostic or image-assisted tool for human readers. No MRMC study was performed.
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.
7. The type of ground truth used
- For the performance assessment, the "ground truth" for the guidewire's characteristics (e.g., diameter, stiffness, coating, radiopacity) is based on engineering specifications, material science properties, and established bench testing methods to ensure the physical device meets its design intent and functions as expected within the vasculature. This is not a "ground truth" in terms of disease presence or absence like in diagnostic studies.
8. The sample size for the training set
- Not applicable. 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. There is no "training set" or corresponding ground truth to establish for this type of device.
§ 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.