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510(k) Data Aggregation
(238 days)
The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Imperative Care's X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014", 0.018" and 0.024" diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device.
This document is a 510(k) clearance letter for a medical device and therefore does not contain acceptance criteria and study data in the format typically found in clinical efficacy studies for AI/software devices. The acceptance criteria and "study" described herein relate to the safety and performance of the physical guidewire device (X-Wire Guidewire) based on bench testing, biocompatibility testing, sterilization validation, and shelf-life testing, rather than a clinical study evaluating the performance of an AI algorithm.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the performance testing done in Table 2: Summary of Bench Tests and Performance Specifications and Table 3: Biocompatibility Test Summary – X-Wire Guidewire.
Table: Acceptance Criteria and Reported Device Performance (Synthesized from document)
| Test Attribute | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensional Verification | All defined guidewire dimensions are within the specified tolerances. | Pass |
| Visual Inspection | The guidewire shall be free of visual defects when removed from packaging. | Pass |
| Torqueability | The guidewire shall transmit rotation from the proximal end to the distal tip to allow users to select branches of the vasculature and reach the target location. | Pass |
| Torque Strength | Device shall not fail under expected torsional input when distal end is unable to move/rotate. | Pass |
| Tip Flexibility | Tip of guidewire shall not cause vessel damage; defined by ability to buckle to reduce contact pressure and prevent perforation. | Pass |
| Tensile Strength and Tip Pull | Guidewire shall withstand tensile forces expected in clinical use without breaking. | Pass |
| Kink Resistance | Guidewire shall be able to traverse through clinically relevant bends without kinking. | Pass |
| Coating Integrity | Coating shall remain intact during clinical use. | Pass |
| Coating Lubricity | Coating shall be lubricious to reduce frictional forces for navigation. | Pass |
| Particulate Evaluation | Guidewire shall not generate particles at a level greater than the range generated by the predicate. | Pass |
| Corrosion Resistance | Guidewire shall not corrode from time of manufacture through its shelf life. | Pass |
| Radiopacity | Opacity to x-ray shall allow physicians to visualize guidewire under fluoroscopy. | Pass |
| Simulated Use | Guidewire must be able to reach anatomical locations and deliver catheters and other interventional devices used in common neurovascular procedures. | Pass |
| Cytotoxicity | Test article extracts must yield grade 2 or lower. | Pass, Noncytotoxic |
| Sensitization | Overall pattern, intensity, duration, character of reactions compared to control conditions. | Pass, Nonsensitizer |
| Irritation or Intracutaneous Reactivity | Difference between test extract mean score and corresponding control mean score ≤1. | Pass, Nonirritating |
| Acute Systemic Toxicity | None of the animals treated with test article extracts must show significantly greater biological reactivity than control-treated animals. | Pass, Non-toxic (acute systemic) |
| Material Mediated Pyrogenicity | Test article extract must yield <0.5°C rise of individual animal baseline temperature. | Pass, Nonpyrogenic |
| Hemocompatibility – Hemolysis | Test article extract must result in hemolytic index of <2%. | Pass, Nonhemolytic for both Direct and Extract Methods |
| Hemocompatibility - SC5b-9 Complement Activation | SC5b-9 concentration of the test article is similar to both the activated NHS and negative controls. | Pass, Hemocompatible |
| Hemocompatibility – In vivo thromboresistance | Test article performs similarly to the predicate. | Pass, Hemocompatible |
| Sterilization Assurance Level | 1 x 10^-6 (implicit) | Achieved (via validated EO process) |
| Shelf Life (Accelerated Aging) | Device, accessory, and packaging performance maintained for stated shelf life. | Supports 8-month shelf life. |
Important Note: This document describes a physical medical device (guidewire), not a software/AI device. Therefore, many of the subsequent questions related to AI studies (test sets, ground truth, experts, MRMC studies, standalone performance, training sets) are not applicable to this 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the typical sense of a clinical study. The testing here refers to physical guidewire samples subjected to bench tests and biological evaluations. The specific number of devices tested for each attribute (e.g., number of guidewires for torqueability, number of animal subjects for biocompatibility) is not detailed in this summary, but would be found in the full test reports.
- Data Provenance: N/A for clinical data. The data is generated from laboratory (bench and biocompatibility) testing of the physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for the physical device performance (e.g., whether a guidewire kinks or corrodes) is established by objective measurements and standardized test protocols, not by expert consensus in a clinical diagnostic sense. However, for the biocompatibility testing, an "expert evaluation" is mentioned as confirming that the device met biological safety requirements. The number and qualifications of this expert(s) are not specified.
4. Adjudication Method (for the test set)
- Adjudication Method: Not applicable in the context of an AI study. For the bench and biocompatibility tests, "adjudication" would refer to the interpretation of raw test data against predefined acceptance criteria by qualified laboratory personnel, which is inherent in the "Pass" results reported.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This is a physical guidewire device, not an AI or software device that would typically involve human reader performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Bench Testing: Objective physical measurements, engineering specifications, and performance defined by established standards (e.g., ability to transmit torque, resistance to kinking, coating integrity). Performance is compared against similar predicate devices and general industry standards.
- Biocompatibility Testing: Established by standardized biological assays (e.g., ISO 10993 series) that measure cellular response, material-mediated effects, and systemic reactions in vitro/in vivo, compared to predefined safety thresholds.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for an AI model.
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