(18 days)
The Wildcat 6F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline/contrast.
The Wildcat 6F Guidewire Support Catheter is a 6F sheath and 0.035" guidewire compatible over-thewire device. It consists of a catheter shaft with handle assembly at the proximal end an atraumatic distal tip. The catheter is available in two sizes with a working length of either 110 cm or 135 cm. A locking luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.
Here's an analysis of the provided text regarding the Avinger Wildcat 6F Guidewire Support Catheter, focusing on acceptance criteria and supporting studies.
Important Note: The provided text is a 510(k) Summary and FDA clearance letter. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way a clinical trial report would for drug or novel device approval.
Acceptance Criteria and Device Performance
The core of this submission is substantial equivalence to an existing predicate device (Wildcat 7F Guidewire Support Catheter). Therefore, the "acceptance criteria" are largely focused on demonstrating that the new device (Wildcat 6F) performs at least as well as the predicate device in relevant non-clinical tests and that the modifications do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Mechanical Performance (Non-Clinical) | Tensile Strength | "All data fell well within pre-determined product specifications and external standard requirements." (Implies meeting or exceeding the performance of the predicate and/or industry standards.) |
| Torque Strength | "All data fell well within pre-determined product specifications and external standard requirements." | |
| Coating Integrity | "All data fell well within pre-determined product specifications and external standard requirements." | |
| Device Compatibility (with guidewires and other devices) | "All data fell well within pre-determined product specifications and external standard requirements." (Likely means it functions as intended with 0.035" guidewires and allows passage of other interventional devices.) | |
| Biocompatibility | EN ISO 10993-1 "Biological Evaluation of Medical Devices" | "Biocompatibility testing was conducted according to EN ISO 10993-1 'Biological Evaluation of Medical Devices'. All data fell well within pre-determined product specifications and external standard requirements." (Implies the materials are safe for human contact for the intended duration.) |
| Sterility | Irradiation for sterility | "The catheter has been irradiated for sterility..." (Implies that the sterilization method used is validated and achieves the required sterility assurance level. The specific sterility assurance level (e.g., SAL of 10^-6) is not explicitly stated but is a standard requirement for sterile medical devices.) |
| Intended Use Equivalence | Supports steerable guidewires in peripheral vasculature | "The Wildcat 6F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature." (Directly aligns with the predicate's intended use and is demonstrated through non-clinical performance data and material similarity.) |
| Facilitates placement/exchange of guidewires | "It may be used to facilitate placement and exchange of guidewires and other interventional devices." (Directly aligns with the predicate's intended use.) | |
| Delivers saline/contrast | "It may also be used to deliver saline/contrast." (Directly aligns with the predicate's intended use.) | |
| Safety and Effectiveness (Overall Substantial Equivalence) | Comparison to Wildcat 7F Guidewire Support Catheter | "Based upon the product technical information, intended use, and performance data provided... the Avinger 6F catheter has been shown to be equivalent to the currently marketed Avinger 7F catheter." (This is the ultimate "acceptance criterion" for a 510(k) - demonstrating no new safety or effectiveness concerns compared to a legally marketed device, despite minor modifications like smaller profile, modified distal tip, and new working lengths.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the "design verification testing" or "biocompatibility testing." It only states that "Design verification testing was conducted." For medical device non-clinical testing, sample sizes are typically determined by statistical methods or regulatory guidance to ensure robustness and often involve multiple units tested to destruction or specific performance thresholds.
- Data Provenance: The data is generated from laboratory testing (design verification and biocompatibility testing). It is prospective in the sense that the tests were designed and executed to evaluate this specific device for regulatory submission. The country of origin for the data generation is not explicitly stated but would presumably be in the USA, where Avinger, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Specified. For non-clinical device performance and biocompatibility testing, "ground truth" is established by adherence to recognized standards (e.g., ISO 10555-1, EN ISO 10993-1) and internal product specifications. The "experts" involved would be the engineers, scientists, and technicians who perform and validate these tests, but their specific number or qualifications are not detailed in this summary. These are typically individuals with expertise in mechanical engineering, materials science, and biochemistry specific to medical devices.
4. Adjudication Method for the Test Set
- Not Applicable. Since this involves laboratory testing against established specifications and standards, there isn't a "ground truth" requiring adjudications between human observers, as would be the case in a clinical trial or image interpretation study. The test results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document describes non-clinical testing for a medical device. MRMC studies are typically performed for diagnostic imaging devices to evaluate the impact of AI assistance on human reader performance. This is not relevant to the Wildcat 6F Guidewire Support Catheter which is an interventional tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. The device's "standalone" performance is its ability to meet the non-clinical specifications independently.
7. The Type of Ground Truth Used
- Engineering/Material Specifications and Recognized Standards: The ground truth for the non-clinical tests is based on:
- Pre-determined product specifications: Internal quality and performance requirements set by Avinger, Inc.
- External standard requirements: Adherence to established international standards such as ISO 10555-1 (for intravascular catheters) and EN ISO 10993-1 (for biocompatibility).
- Performance of the predicate device: The Wildcat 7F served as a benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device that employs a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).