(392 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 Aristotle 18 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 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 Volo 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 Zoom Wire 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's Aristotle 14, Aristotle 24, Volo 14, and Zoom Wire 14 Guidewires ("the guidewires") 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 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm
Aristotle 18 Guidewire: Diameter 0.018", Stiffness Profiles Soft, Standard, Support, Length 200 cm
Aristotle 24 Guidewire: Diameter 0.024", Stiffness Profiles Soft, Standard, Support, Length 200 cm
Volo 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm
Zoom Wire 14 Guidewire: Diameter 0.014", Stiffness Profiles Support, Extra Support, Lengths 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.
This document concerns the 510(k) premarket notification for five guidewires: Aristotle 14 Guidewire, Aristotle 18 Guidewire, Aristotle 24 Guidewire, Volo 14 Guidewire, and Zoom Wire 14 Guidewire. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria are not explicitly stated as numerical thresholds for performance metrics. Instead, the document indicates that the devices "met acceptance criteria" or "passed" various tests, implying successful adherence to pre-defined standards for each test. The study's focus is on demonstrating similar performance and safety to predicate devices, particularly given a change in the PTFE coating.
| Test Category | Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Non-cytotoxic | Pass: Non-cytotoxic |
| Pyrogenicity | Non-pyrogenic | Pass: Non-pyrogenic | |
| Sensitization | Non-sensitizing | Pass: Non-sensitizing | |
| Irritation | Non-irritant | Pass: Non-irritant | |
| Acute Systemic Toxicity | No evidence of toxicity | Pass: No evidence of acute systemic toxicity | |
| Hemocompatibility | Non-hemolytic | Pass: Non-hemolytic | |
| Complement Activation of SC5b-9 | Similar to comparator device | Pass: The test article complement activation was similar to the comparator device. | |
| Partial Thromboplastin Time | Similar to comparator device | Pass: The test article clotting time was similar to the comparator device. | |
| In Vitro Thrombogenicity | Thromboresistant | Pass: Thromboresistant | |
| Latex Detection | Latex not detected | Pass: Latex was not detected | |
| Sterilization | Sterilization Assurance Level (SAL), EO/ECH residuals, Bacterial Endotoxin Levels | SAL of 10^-6, acceptable residual levels | Achieved SAL of 10^-6, appropriate levels of residuals and endotoxins confirmed (implied from "existing validated sterilization cycle uses 100% EO to achieve a sterilization assurance level (SAL) of 10-"). |
| Bench Performance | Visual Inspection and Dimensional Verification | Met ISO 11070 requirements | Acceptance criteria met |
| Coating Integrity Assessment | Met ISO 11070 and FDA guidance | Acceptance criteria met | |
| Corrosion Resistance | Met ISO 11070 requirements | Acceptance criteria met | |
| Agent Compatibility | Met ISO 11070 requirements | Acceptance criteria met | |
| Simulated Use | Met performance in anatomical model | Acceptance criteria met | |
| Particulate | Acceptable particulate count | Acceptance criteria met |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of guidewires tested for coating integrity). It only mentions that "performance testing was performed on the subject devices" and "testing and evaluation... of the subject devices has been performed".
- Data Provenance: The data provenance is internal to the manufacturer (Scientia Vascular, Inc.) and is prospective testing conducted specifically for this 510(k) submission. There is no mention of country of origin for the data other than it being part of an FDA submission from a U.S.-based company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission pertains to a medical device's physical and biological performance, not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. Therefore, these details are not applicable. The "ground truth" for the tests mentioned (biocompatibility, sterilization, bench performance) is based on established, standardized test methods (e.g., ISO standards, FDA guidance documents).
4. Adjudication method for the test set:
- Not applicable, as this is not a diagnostic AI/software study involving human interpretation that requires adjudication of expert opinions. The performance is assessed against objective technical specifications and standards.
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 is not an AI/software device that involves human readers or an AI assistance component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device (guidewire) and does not involve an algorithm or AI.
7. The type of ground truth used:
- The "ground truth" for the various tests conducted is based on:
- Standardized Test Methods: Adherence to defined protocols from ISO 10993 series, ISO 14971:2019, ISO 11070:2014, and FDA guidance documents.
- Objective Measurements: E.g., cell culture observations for cytotoxicity, temperature rise for pyrogenicity, measurement of physical dimensions, observation of material integrity.
- "Pass/Fail" Criteria: Compliance with established thresholds or qualitative assessments as defined by the standard test methods (e.g., "Non-cytotoxic," "Non-hemolytic," "Acceptance criteria met").
8. The sample size for the training set:
- Not applicable. As this is not an AI/software device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/software algorithm.
§ 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.