(109 days)
The Aristotle 14 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 Aristotle 14 Guidewire is a 0.014" 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, from soft to support, The product is provided in 200cm and 300cm lengths. 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 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 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 is a 510(k) summary for the "Aristotle 14 Guidewire". This document summarizes non-clinical performance tests to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria for a new clinical claim or an AI algorithm.
Therefore, many of the requested elements for an AI algorithm study (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.
However, I can extract the acceptance criteria and reported device performance from the Non-Clinical Performance Tests section, focusing on the functional and biocompatibility tests.
Acceptance Criteria and Reported Device Performance for the Aristotle 14 Guidewire
The provided document details non-clinical performance tests for the Aristotle 14 Guidewire to demonstrate substantial equivalence to a predicate device (PVS 1300 Synchro® 0.014" Guidewire, K032146). The study is based on a series of laboratory and simulated use tests rather than a clinical trial with human subjects or an AI algorithm performance evaluation.
Here's a summary of the acceptance criteria (implied by the test objective and relevant standards) and the reported device performance.
1. Table of Acceptance Criteria and Reported Device Performance
Biocompatibility Tests
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity (L-929 MEM Elution) | No reactivity (Grade 0) | Cell culture treated with test sample exhibited no reactivity (Grade 0). Conclusion: Non-cytotoxic. |
| Sensitization (Magnusson-Kligman) | No erythema or edema (Grade 0) at challenge sites | Challenge sites treated with test sample exhibited no erythema or edema (Grade 0). Conclusion: Negative for dermal sensitization. |
| Irritation (Intracutaneous Toxicity) | Low mean test score (e.g., ≤1 for 0.9% Normal Saline and Sesame Oil extracts) | The mean test score in 0.9% Normal Saline extract was 0, and in Sesame Oil was 0.1. Conclusion: Non-irritating. |
| Systemic Toxicity (Acute) | No abnormal clinical signs indicative of toxicity during the 72-hour test period | No study animals were observed with abnormal clinical signs indicative of toxicity during the 72-hour test period. Conclusion: Non-toxic. |
| Material Mediated Pyrogenicity (Rabbit) | Temperature increases for all test animals not exceeding acceptable test limit for maximum individual temperature rise | Temperature increases for all test animals did not exceed the acceptable test limit for maximum individual temperature rise. Conclusion: Non-pyrogenic. |
| Hemolysis (Direct Contact and Extract) | Difference between hemolytic indices of test article and negative control within acceptable limits (e.g., ≤2% for non-hemolytic) | The difference between the hemolytic indices of the test article and the negative control was 0.00% for both direct and indirect hemolysis. Conclusion: Non-hemolytic. |
| Partial Thromboplastin Time (PTT) | Same thrombogenicity category as predicate device (minimal activator) | Both the subject device and predicate device fell within the same thrombogenicity category (minimal activator). Conclusion: Subject and predicate devices showed similar thrombogenicity. |
| Complement Activation (SC5b-9) | Amounts of SC5b-9 generated comparable to predicate device | Amounts of SC5b-9 generated by the test article and predicate device after exposure times of 30 and 60 minutes were not statistically different. The amount of SC5b-9 generated by the test article was statistically lower than that released by the predicate after 90 minutes exposure. Conclusion: Subject and predicate devices showed similar complement system activation. |
| Thrombogenicity (Dog Model) | Average thrombus score comparable to predicate device | The average thrombus score was the same for both the subject and predicate device. Conclusion: Subject and predicate devices showed similar thrombogenic potential. |
| Latex Antigenic Protein Content (LEAP) | No detectable Latex Antigenic Proteins | No Latex Antigenic Proteins were detected. Conclusion: Contains no detectable traces of latex. |
Functional Testing
| Test | Test Method & Acceptance Criteria (Implied / Explicit) | Reported Device Performance |
|---|---|---|
| Visual Inspection | ISO 11070: Absence of extraneous matter, process/surface defects, or defects that may cause trauma to vessels. | No extraneous matter, surface defects, or visible droplets of coating were present on the Aristotle 14 Guidewires. |
| Dimensional Verification | ISO 11070: All guidewires meet dimensional specifications per engineering drawings. | All guidewires met dimensional specifications. |
| Flexing Test | ISO 11070: No defects or damage / flaking of the coating after flexing. | No defects or damage / flaking of the coating were observed after flexing. |
| Tensile Strength | ISO 11070: All guidewires meet minimum force breakage requirements. | All guidewires met minimum force breakage requirements specified in ISO 11070. |
| Tip Shape, Retention | Guidewires must be shapeable and must retain shaped angle after simulated use. | All tips met shaping and shape retention requirements after simulated use. |
| Torqueability | Measurement of torque response (average input to output lag) in an anatomical model; acceptable torque responses, comparable to predicate device. | All guidewires demonstrated acceptable torque responses. The torque response of the subject device was comparable to that of the predicate device. |
| Torque Strength | Torque turns to failure in an anatomical model; acceptable torque strength, comparable to predicate device. | All guidewires demonstrated acceptable torque strength. The torque strength of the subject device was comparable to that of the predicate device. |
| Tip Flexibility | Measure force to deflect guidewire tips to 45 and 90 degrees at 5mm, 10mm, and 20mm test lengths; acceptable forces & comparable flexibility to predicate. | The forces required to deflect the guidewire tips were acceptable. The flexibility of the tips of all subject devices was comparable to the tip flexibility of the predicate guidewire. |
| Fracture | ISO 11070: No signs of fracture, loosening, or failure after wrapping around mandrel. | No guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel. |
| Coating Lubricity and Durability | Frictional force of coated guidewires determined after simulated use in a tortuous path; meet specified frictional force requirements. | All guidewires met specified frictional force requirements. |
| Coating Integrity | Coating uniformity and integrity visually examined on dyed samples after simulated use in a tortuous path; acceptable coating coverage. | All samples showed acceptable coating coverage after simulated use. |
| Particulates | Particulates of various size ranges counted after simulated use in a tortuous path; comparable number of particulates to predicate. | A comparable number of particulates was recovered from subject and predicate devices following simulated use. |
| Torque Device - Introducer Testing | ISO 11070: Acceptance criteria for biocompatibility, visual inspection, corrosion resistance, tensile testing, luer taper dimensions, pouch seal strength. | Acceptance criteria of all tests were met. |
| Simulated Use Model Testing & Product Compatibility | Anatomical model to simulate neurovasculature; acceptable performance in evaluations of: Torqueability, Lubricity, Microcatheter Support & Tracking, Compatibility with accessories. | Guidewires and predicate devices were found to perform acceptably in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter. |
| Cadaver Testing | Physician evaluation of subject and predicate guidewires for performance characteristics; acceptable performance. | Subject and predicate guidewires both exhibited acceptable performance. |
| Radiopacity | Physician evaluation in human cadaver; acceptable radiopacity. | Both subject and predicate guidewires exhibited acceptable radiopacity. |
| Corrosion Resistance | ISO 11070: No signs of corrosion on guidewires after soaking in typical end-use solutions. | There were no signs of corrosion on guidewires after soaking in typical end-use solutions. |
| Chemical Compatibility | No degradation, corrosion, or physical decomposition after exposure to saline and contrast agent/saline solutions. | All guidewires showed no signs of degradation, corrosion or physical decomposition after exposure. |
| MRI Compatibility | (N/A, indicated as "MRI Unsafe") | No testing performed. Aristotle Guidewires are labeled “MRI Unsafe.” |
| Latex | ASTM D6499-07: No detectable traces of latex proteins. | No detectable traces of latex were found. |
| Package Integrity | ASTM D 4169:16, ASTM F 88-15, ASTM F 2096-11: Maintenance of integrity, affixation/legibility of labeling after transport simulation. | Following exposure to typical storage and transportation conditions, all sterile barrier pouches maintained their integrity and labeling remained affixed and legible. |
| Shelf Life | ASTM F1980: All device performance acceptance criteria met after accelerated aging conditions simulating 6 months real-time storage. | After exposure to accelerated aging conditions simulating real-time storage under ambient conditions for 6 months, all device performance acceptance criteria were met, justifying labeling the devices with a 6-month shelf life. |
| Sterilization Validation | AAMI TIR 28:2009, ISO11135:2007 Annex B: Justification for adoption into EO sterilization processing group, PCDs more difficult to sterilize than devices, bioburden enumeration performed, bacteriostasis/fungistasis tests demonstrate no inhibition of growth. | Results justified adoption into the EO sterilization processing group: Comparative and Bioburden Resistance study results demonstrated that PCDs are more difficult to sterilize than devices; Bioburden Enumeration and Extraction Efficiency tests were used to enumerate the CFUs present on devices; and Bacteriostasis/Fungistasis test results demonstrated that the product does not inhibit the growth of organisms. |
| Sterilization Validation: EO and ECH Residuals | AAMI/ANSI/ISO 10993-7: Residual traces of EO and ECH well below limits. | The residual traces of EO and ECH remaining in the Aristotle 14 Guidewire after exposure to the EO sterilization process are well below the limits specified in ISO 10993-7. |
| Sterilization Validation: Bacterial Endotoxin Levels | ANSI/AAMI ST72:2011/(R)2016, USP , and USP : LAL testing; Endotoxin levels below specified limit (e.g., |
§ 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.