(30 days)
The Wildcat 5F Guidewire Support Catheter (Kittycat 2) 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 sàline or contrast.
The Wildcat 5F Guidewire Support Catheter (Kittycat 2) is a 5F sheath and 0.014" guidewire compatible over-the-wire device. It consists of a catheter shaft with handle assembly at the proximal end and an atraumatic distal tip. The catheter is available in a working length of 150 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.
The provided text describes the regulatory submission for the Wildcat 5F Guidewire Support Catheter (Kittycat 2) and its substantial equivalence to a predicate device. However, it does not contain a detailed study with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance. The document focuses on non-clinical performance testing to demonstrate the device's functionality and safety based on pre-determined product specifications and external standard requirements.
Therefore, many of the requested items cannot be extracted directly from the provided text.
Here is the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
The document states that "All data fell well within pre-determined product specifications and external standard requirements." However, the specific quantitative acceptance criteria and the exact reported performance values are not detailed in the provided text. The non-clinical tests conducted include:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (General Statement) |
|---|---|
| Visual and Dimensional Verification | Data fell well within pre-determined product specifications and external standard requirements. |
| Tensile Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Torque Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Guidewire advancement capability | Data fell well within pre-determined product specifications and external standard requirements. |
| Device Advancement capability | Data fell well within pre-determined product specifications and external standard requirements. |
| Tip Deflection Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Device leak testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Luer Leak Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Flexibility/Trackability | Data fell well within pre-determined product specifications and external standard requirements. |
| Spiral Blade Functional Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Coating Friction Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Biocompatibility | Data fell well within pre-determined product specifications and external standard requirements. |
| In Vitro Simulated Use Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Packaging Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Shipping Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Shelf Life Testing | Data fell well within pre-determined product specifications and external standard requirements. |
| Sterility Testing | Data fell well within pre-determined product specifications and external standard requirements. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for each test. The data provenance is not mentioned, but it refers to "non-clinical testing," which typically implies laboratory-based or in-vitro tests rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the study described is for a medical device (guidewire support catheter) and involves non-clinical performance testing, not diagnostic or image interpretation tasks requiring clinical expert review for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of non-clinical device performance testing described.
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
No such study was conducted or mentioned in the provided text, as the device is a physical medical instrument, not an AI or diagnostic application.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable, as the device is a physical medical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" would be established by the pre-determined product specifications and external standard requirements for each test (e.g., a specific tensile strength value, a certain flexibility parameter, evidence of no leaks, etc.). This is not clinical ground truth.
8. The sample size for the training set
This information is not applicable, as no AI model or algorithm requiring a training set is involved.
9. How the ground truth for the training set was established
This information is not applicable, as no AI model or algorithm requiring a training set is involved.
§ 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).