(9 days)
TrailBlazer™ Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TrailBlazer™ Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The TrailBlazer™ Support Catheter is an over-the-wire (OTW) single lumen catheter with an atraumatic tapered tip. The catheter system is offered in 9 models that are 0.014", 0.018", and 0.035" guidewire compatible and have working lengths of 65 cm, 90 cm, 135 cm, 150 cm. The distal catheter shaft has three radiopaque markers that aid in positioning the catheter. The distal 40 cm portion of the catheter has a hydrophilic coating. The manifold provides a proximal lumen which transitions to the catheter shaft and terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. All models are 5 Fr compatible.
The provided text describes a 510(k) summary for the TrailBlazer™ Support Catheter. It focuses on demonstrating substantial equivalence to predicate devices through bench testing. The information required for all sections of your request (1-9) about acceptance criteria and a study proving a device meets those criteria is not explicitly available in the provided document, as it pertains to AI/algorithm performance studies.
However, I can extract information regarding the device's performance assessment based on the provided text's scope, which is primarily about bench testing for substantial equivalence, rather than clinical acceptance criteria or AI study data.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way one would define them for an AI medical device (e.g., target sensitivity, specificity). Instead, it relies on "bench testing" to demonstrate substantial equivalence to predicate devices. The "reported device performance" is essentially that it performed comparably in these bench tests.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Conformance to requirements for intended use | "Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." |
| Similar fundamental scientific technology | Met |
| Similar operating principle | Met |
| Similar flow rate | Met |
| Similar crossing profiles | Met |
| Similar catheter lengths | Met |
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 refers only to "Bench testing." There is no mention of a "test set" in the context of patient data or algorithm evaluation. Data provenance is not applicable as it's not a clinical study.
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)
Not applicable. This is a medical device clearance based on substantial equivalence and bench testing, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of an algorithm or diagnostic study.
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 an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be engineering specifications and standards for catheter performance (e.g., flow rate measurements, material strength tests, dimensional accuracy, etc.), implicitly established by standard engineering practices.
8. The sample size for the training set
Not applicable. There is no training set for an AI/algorithm involved.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the context of an AI device.
Summary of what is present in the document:
The TrailBlazer™ Support Catheter received 510(k) clearance based on demonstrating substantial equivalence to two predicate devices: Spectranetics Quick-Cross™ Support2 Catheters (K072750) and Vascular Solutions Minnie™ Support Catheter (K082337). This equivalence was established through bench testing, which assessed similarities in:
- Fundamental scientific technology
- Operating principle
- Flow rate
- Crossing profiles
- Catheter lengths
The document does not detail the specific parameters or results of the bench tests beyond stating that they provided assurance of conformance to intended use requirements and demonstrated similarities to predicate devices. It is a traditional medical device clearance, not involving AI or machine learning algorithms, and therefore discussions of test sets, ground truth, experts, or training sets in the context of AI are not present.
§ 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).