(33 days)
Cross-Pilot" Turbo elite Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.
The Spectranetics Cross-Pilot™ Turbo Elite® Support Catheters are intravascular catheters. These catheters are available in a variety of lengths and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating.
The provided document (K090913) is a Special 510(k) Premarket Notification for the Cross-Pilot™ Turbo elite® Support Catheter. This type of submission focuses on documenting that modifications to an already cleared device do not affect its safety or effectiveness, or alter its intended use. Therefore, the "study" described is a revalidation of the device's functional equivalence to its predicate, rather than a clinical trial with acceptance criteria for new performance metrics.
Here's an analysis based on the provided text, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state a table of acceptance criteria with specific numerical targets for performance metrics. Instead, it refers to "specified requirements" and implicitly relies on the predicate device's performance as the benchmark.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalence to predicate device for functional testing. | "All device functional test results for the Cross-Pilot™ Turbo elite Support Catheter met specified requirements." |
| No change in labeling, packaging, materials, and sterilization from the predicate. | "Labeling, packaging, materials and sterilization of the Cross-Pilot™ Turbo elite Support Catheter has not changed from that of the predicate devices listed above." |
| Continued ability to guide and support Spectranetics laser catheters during access of vasculature. | Indication for Use remains the same, implying continued performance in this regard. |
| Continued ability to provide a conduit for the delivery of saline solution or diagnostic contrast agents. | Indication for Use remains the same, implying continued performance in this regard. |
2. Sample size 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 general "test set" sample sizes, data provenance, or whether the testing was retrospective or prospective. It only mentions "device functional testing." In the context of a Special 510(k) for minor changes, functional testing typically involves in-vitro and bench testing, performed in a controlled laboratory environment. The "data provenance" would therefore be the manufacturer's internal testing facilities, likely in the US (Colorado Springs, CO, as per the contact information).
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 is not applicable to the described study. The study involves functional testing of a physical medical device (a catheter), not a diagnostic algorithm or image analysis requiring expert ground truth for interpretation. The "ground truth" for functional testing is typically established by engineering specifications and predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this study is about functional testing of a physical device against engineering specifications and predicate performance, not about clinical outcomes or interpretations that would require an adjudication method.
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 is not a study involving human readers, AI, or comparative effectiveness. It is a submission for a modification to a medical device and relies on functional equivalence to a predicate.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. 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" in this context is the established performance and specifications of the predicate device (K082559) and engineering design specifications for the modified device. The functional testing aims to show that the modified device performs equivalently to the predicate and meets its own internal design requirements.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI algorithm, and therefore there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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).