(84 days)
The Wildcat 7F Guidewire Support Catheter is intended to be used 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 Avinger Wildcat 7F Guidewire Support Catheter (Wildcat 7F) is a sterile, single-use, disposable catheter designed to support steerable guidewires in accessing discrete regions within the peripheral vasculature. The Avinger Wildcat 7F catheter consists of a distal tip, catheter shaft and proximal handle that allows for device manipulation and a means for flushing the catheter lumen. The catheter has a working length of 135 cm and is compatible with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and bilateral wedges. Both elements are visible through fluoroscopy and support steerable guidewires in accessing the discrete region of interest within the peripheral vasculature. Subsequent to conventional guidewire placement, athetercomy devices, PTCA catheters and/or stents may be used to provide therapeutic benefit. The Wildcat 7F catheter in and of itself does not provide any therapeutic benefit beyond simple facilitation of guidewire support.
This 510(k) summary (K083313) for the Avinger Wildcat 7F Guidewire Support Catheter focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through a traditional clinical study with acceptance criteria. Therefore, the information typically requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not directly applicable or available in this submission.
Here's a breakdown of the provided information in relation to your request, highlighting what is present and what is absent:
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) based on substantial equivalence, there are no specific "acceptance criteria" presented in terms of clinical performance metrics like sensitivity, specificity, or accuracy. Instead, the device's performance is assessed against established standards and predicate devices.
| Performance Aspect | Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Compliance with ISO10555-1 requirements for sterile, single-use intravascular catheters (tensile, torque strength, coating integrity, device compatibility). | "All data fell well within pre-determined product specifications and external standard requirements." |
| Biocompatibility | Compliance with ISO 10993 "Biological Evaluation of Medical Devices". | "Biocompatibility testing was conducted according to ISO 10993..." (implies compliance, as no issues were noted). |
| Functional Equivalence | Ability to support steerable guidewires in accessing discrete regions of the peripheral vasculature; facilitate placement/exchange of guidewires and other interventional devices; and deliver saline/contrast. Functionality similar to predicate devices (Asahi Tornus, GOPHER). | "Design analysis data confirm that the Wildcat device performs according to the stated intended use." "The Avinger Wildcat Guidewire Support Catheter is substantially equivalent to the Asahi Tornus and GOPHER support catheters." |
| Use Environment | Performance demonstrated in a relevant biological model. | "Device performance was successfully evaluated in a porcine animal model." |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/not specified. The nonclinical performance data is based on laboratory testing and an animal model, not a human clinical test set.
- Data provenance: Laboratory testing results and data from a porcine animal model. Country of origin for the lab testing is not specified, but the submission is from a US company (Avinger, Inc.). The data is prospective for the specific tests conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this is not a human clinical study, there was no "test set" requiring expert ground truth in the traditional sense of medical image or clinical outcome assessment. The evaluation relies on engineering and biological testing standards.
4. Adjudication method for the test set
- Not applicable. There was no test set requiring expert adjudication.
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 device is a guidewire support catheter, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the nonclinical performance data is based on:
- Engineering specifications and international standards: For mechanical properties (e.g., tensile strength, torque strength, ISO10555-1).
- Biocompatibility standards: For material safety (ISO 10993).
- Physiological observation: In the porcine animal model, demonstrating the catheter's ability to support guidewires and access vessels.
- Comparison to predicate devices: The functional performance is considered "ground truth" by demonstrating equivalence to devices already legally marketed and presumed safe and effective.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no concept of a training set or its ground truth for this device.
§ 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).