(60 days)
The Kittycat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Kittycat Catheter is contraindicated for use in the illac, coronary, cerebral or carotid vasculature.
The Kittycat 2 Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Kittycat Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.
The Kittycat Catheters consist of a Catheter Shaft with a Handle assembly at the proximal end and a rotating Distal Tip. The Kittycat Catheters have a working length of 140 cm and 150 cm for the Kittycat and Kittycat 2, respectively. A locking Luer at the proximal provides entry to a lumen that supports and facilitates movement of a guidewire. The Kittycat Catheters have been irradiated for sterility and are intended for single-use only. The Kittycat Catheters are fundamentally the same device and only differ in handle design and Distal Tip deflection mechanism: the Kittycat Catheter utilizes a slider-based Distal Tip deflection mechanism while the Kittycat 2 Catheter utilizes a pre-shaped Distal Tip.
The provided text describes the 510(k) summary for the Kittycat and Kittycat 2 Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study outlining specific acceptance criteria and device performance in a clinical or standalone setting.
Therefore, the information requested regarding acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment is largely not present in the provided text, as these are typically part of a clinical trial or a performance study to prove efficacy, which is often not required for a 510(k) submission based on substantial equivalence.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific clinical outcome. The acceptance criteria implied here are that the non-clinical testing results "fell well within pre-determined product specifications and external standard requirements." However, the specific "product specifications" and "external standard requirements" are not detailed.
- Reported Device Performance: The document states that the non-clinical testing "confirmed that the Kittycat Catheters performs according to the stated intended use" and "demonstrated that the Kittycat Catheters are substantially equivalent to the predicate device." No specific, quantitative performance values are provided (e.g., success rates, accuracy metrics).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not provided. The submission focuses on non-clinical testing, not a clinical "test set" with patients.
- Data Provenance: The "Non-Clinical Performance Data" section lists various tests conducted. These are laboratory/benchtop tests, not human data. No country of origin or retrospective/prospective designation applies here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not provided. This information is relevant for clinical studies involving human interpretation or diagnosis. For non-clinical device testing, ground truth is typically established by engineering specifications, physical measurements, and industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not provided. Adjudication methods are used in clinical trials, especially when human readers are involved in assessing outcomes.
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. This device is a percutaneous catheter, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on engineering specifications, physical and mechanical test standards, and conformity to equivalent predicate device performance. The non-clinical tests (e.g., tensile testing, torque testing, biocompatibility, tip deflection testing) are designed to verify that the device meets predefined technical requirements and performs safely and effectively in simulated environments, aligning with the predicate device.
8. The sample size for the training set:
- Not applicable/not provided. There is no "training set" as this is not an algorithm being developed. The phrase "non-clinical testing was previously conducted" implies a set of tests were run, but not in the context of a training dataset for an AI model.
9. How the ground truth for the training set was established:
- Not applicable/not provided. As there's no training set, there's no ground truth established for one.
In summary, the provided 510(k) summary is for a medical device (a catheter) seeking market clearance based on substantial equivalence to a legally marketed predicate device. It relies heavily on non-clinical (benchtop) testing to demonstrate that the new device has comparable performance and safety characteristics to the existing one. It does not contain the kind of clinical study data, AI performance metrics, or extensive human expert involvement details that would be found in a submission for a diagnostic AI 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).