(30 days)
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 Aristotle 24 Guidewire is a modification of Scientia Vascular's Aristotle 18 Guidewire. It is a 0.024" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has 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 guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The provided text describes the 510(k) premarket notification for the Aristotle 24 Guidewire. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Aristotle 18 Guidewire) rather than acting as a traditional clinical study report with detailed acceptance criteria and performance data for a novel AI/software device.
Therefore, many of the requested details, such as those related to AI algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details), are not applicable to this document as it pertains to a physical medical device (guidewire) and its mechanical/biocompatibility testing, not an AI/ML algorithm.
However, I can extract the relevant information regarding the acceptance criteria and the "study" (functional and non-clinical performance tests) that prove the device meets these criteria as described in the provided text for this specific medical device.
Here's an interpretation based on the provided document, addressing the applicable points and noting where information is not relevant to this specific clearance:
Acceptance Criteria and Device Performance for Aristotle 24 Guidewire (Based on 510(k) K192783)
The Aristotle 24 Guidewire is a physical medical device, and its "acceptance criteria" are demonstrated through non-clinical performance and design characteristic comparisons to a predicate device. The goal is to show substantial equivalence, not to prove clinical efficacy through a comparative effectiveness study involving human readers or AI algorithms.
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like a guidewire, the "acceptance criteria" are implicitly met when the device successfully passes a battery of functional, dimensional, and biocompatibility tests, demonstrating performance consistent with its intended use and safety profile, and comparable to a predicate device. The tables below outline the tests conducted and their general "results" as stated in the document.
| Acceptance Criteria Category | Specific Test/Characteristic | Test Method Summary (as described) | Reported Device Performance (as described) |
|---|---|---|---|
| Biocompatibility | In-vitro Blood Flow Thrombogenicity Study | Not detailed | Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate. |
| MEM elution | Not detailed | Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate. | |
| Toxicological risk assessment | Not detailed | Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate. | |
| ASTM Hemolysis (direct contact and extract) | Not detailed | Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate. | |
| Partial Thromboplasting Time | Not detailed | Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate. | |
| Compliment Activation | Not detailed | Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate. | |
| Sterilization | Sterility Assurance Level (SAL) | 100% Ethylene Oxide (EO) to achieve SAL of at least 10^-6, adopted into EO sterilization processing group in accordance with AAMI TIR 28:2016. | Aristotle 24 and Aristotle 18 are similar regarding device and packaging characteristics affecting sterilization ability. Implied successful sterilization to SAL 10^-6. |
| Functional Testing | Dimensional Verification | Tests per ISO 11070; Dimensional inspection per engineering drawings. | The Aristotle 24 Guidewires met testing acceptance criteria. |
| Tensile Strength | Tensile testing per ISO 11070. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Flexing Test | Tests per ISO 11070; Inspection for defects and damage or flaking of the coating after flexing. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Fracture | Tests per ISO 11070; Inspection for fracture, loosening, or failure after wrapping around mandrel. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Torqueability | Measurement of torque response (average input to output lag) in an anatomical model. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Torque Strength | Torque turns to failure in an anatomical model. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Tip Flexibility | Measure force to deflect guidewire tips to 45 and 90 degrees at 5mm, 10mm, and 20mm test lengths. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Tip Shape, Retention | Guidewires must be shapeable and must retain shaped angle after simulated use. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Particulate | Particulates of various size ranges counted after simulated use in a tortuous path. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Coating Lubricity and Durability | Frictional force of coated guidewires was determined after simulated use in a tortuous path. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Coating Integrity | Coating uniformity and integrity visually examined on dyed samples after simulated use in a tortuous path. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Simulated Use Model Testing and Product Compatibility | Anatomical model designed to simulate the tortuous anatomy of the neurovasculature used for simulated use testing. | The Aristotle 24 Guidewires met testing acceptance criteria. | |
| Usability Evaluation | Physicians evaluated subject and predicate guidewires for various performance characteristics in a human cadaver. | The Aristotle 24 Guidewires met testing acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
For the functional testing of the guidewire, specific sample sizes are not explicitly stated in the document. The testing involves physical samples of the Aristotle 24 Guidewire. The provenance of this "data" is the non-clinical bench testing conducted by Scientia Vascular LLC. This is not a retrospective or prospective clinical study, but rather laboratory testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The concept of "experts establishing ground truth" in the context of an AI algorithm is not applicable here. For a physical device like a guidewire, "ground truth" is established by adherence to engineering specifications, national/international standards (e.g., ISO 11070), and validated test methods.
However, for the "Usability Evaluation," it states "Physicians evaluated subject and predicate guidewires."
- Number of experts: Not specified (plural "Physicians" indicates more than one).
- Qualifications of experts: Explicitly stated as "Physicians." No further details on their years of experience or specialization are provided within this document.
4. Adjudication Method for the Test Set
This concept (e.g., 2+1, 3+1) is typically relevant for expert review of images or data in AI/diagnostic studies to establish a consensus ground truth. It is not applicable to the functional and mechanical testing of a physical medical device. The "adjudication" for mechanical tests is whether the device passes or fails predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI system on human reader performance, which is not relevant for the clearance of a guidewire.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done.
Not applicable. This device is a physical guidewire, not an algorithm.
7. The Type of Ground Truth Used
For the functional and biocompatibility testing, the "ground truth" is defined by:
- Adherence to internal engineering specifications and design parameters.
- Compliance with recognized industry standards (e.g., ISO 11070:2014 for guidewires, EN ISO 14971:2012 for risk management, AAMI TIR 28:2016 for sterilization).
- Equivalence to the performance characteristics of the predicate device (Aristotle 18 Guidewire) as established by its clearance and prior testing.
For the "Usability Evaluation," the "ground truth" was likely subjective feedback and performance metrics collected from the evaluating physicians using the device in a cadaver model.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML algorithm that requires a "training set."
Summary of the Study Proving Acceptance Criteria:
The "study" conducted for the Aristotle 24 Guidewire was a series of comprehensive non-clinical performance tests, including:
- Biocompatibility Testing: Confirmed the safety of the device's materials by assessing blood compatibility and cytotoxicity. This was supported by the fact that the materials are identical to those used in the cleared predicate device.
- Sterilization Validation: Demonstrated the effectiveness of the Ethylene Oxide (EO) sterilization process to achieve a required sterility assurance level (SAL).
- Functional Testing: Evaluated various mechanical and physical properties of the guidewire (e.g., dimensional accuracy, tensile strength, flexibility, torqueability, tip retention, particulate generation, coating lubricity/integrity) in accordance with ISO 11070:2014 and FDA guidance. These tests were stated to "meet testing acceptance criteria," implying successful performance against pre-defined engineering and performance specifications.
- Simulated Use Model Testing: Used an anatomical model to simulate tortuous neurovasculature for assessing device performance and compatibility during simulated use.
- Usability Evaluation: Involved physicians evaluating the device in a human cadaver model for performance characteristics.
The overarching goal of these tests was to demonstrate that the Aristotle 24 Guidewire is substantially equivalent to the predicate Aristotle 18 Guidewire, despite minor technological differences (larger O.D., two centering coils, one bushing). The document explicitly states that these differences "do not result in new materials used or new questions of safety or effectiveness, nor do they result in new risks for the subject device," and that "testing of the subject device has been performed, demonstrating the safety and effectiveness of the 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.