(55 days)
The IntraMax™ guide catheter is intended for intravascular introduction of diagnostic, therapeutic and interventional* devices into the extracranial vasculature.
The IntraMax™ is single lumen devices designed to aid the physician in the access of distal vasculature with the aid of a quidewire. The IntraMax™ is a family of catheters currently manufactured in three French sizes (6, 7 and 8 FR), multiple distal stem configurations, lengths and side holes ("style features"). Per French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences within the indication for use.
The provided text describes the 510(k) summary for the IntraMax™ Guide Catheter, focusing on its substantial equivalence to a predicate device rather than a study demonstrating the device meets specific acceptance criteria in the manner you've requested (e.g., performance metrics against established thresholds).
Therefore, much of the information you've asked for (e.g., detailed acceptance criteria table with performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not available in the provided document.
The document indicates that "functional testing was performed to ensure the IntraMax™ would function according to its intended use instructions" and "All testing conducted confirmed the acceptability of the IntraMax™ for the intended purpose." However, specific quantitative acceptance criteria or detailed results of these functional tests are not provided. The focus is on demonstrating substantial equivalence to a previously cleared device (IntraTherapeutics, Inc. IntraMax™ Guide Catheter, K981191) based on identical intended use, equivalent materials, and technological characteristics.
Here's a summary of the available information based on your request, highlighting what is not explicitly stated in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Function according to intended use instructions. | "functional testing was performed to ensure the IntraMax™ would function according to its intended use instructions." and "All testing conducted confirmed the acceptability of the IntraMax™ for the intended purpose." |
(No specific quantitative performance metrics are provided, but the statement implies successful completion of functional tests.) |
| Biocompatibility in compliance with ISO 10993 and GLP requirements. | "Biocompatibility tests per ISO 10993 were also performed and were in compliance with ISO and GLP requirements."
(This indicates successful compliance with specific standards, but details of the tests and results are not given.) |
| Substantial equivalence to predicate device (K981191) in materials. | "The IntraMax™ is identical for indication for use and equivalent in materials and technological characteristics."
(No specific material composition details are provided, but equivalence to the predicate is asserted.) |
| Substantial equivalence to predicate device (K981191) in technological characteristics. | "The IntraMax™ is identical for indication for use and equivalent in materials and technological characteristics. Performance functional testing (bench) further supports a substantial equivalence claim."
(Details of the specific technological characteristics and the comparative "bench" tests are not provided, only the assertion of equivalence.) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly stated. The document refers to "functional testing" but does not provide details on the number of devices tested.
- Data provenance: The tests described (functional and biocompatibility) are laboratory/bench tests and not human clinical data. Their origin is internal to the manufacturer (IntraTherapeutics, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to the type of testing described (functional and biocompatibility bench tests) for establishing substantial equivalence. No human "ground truth" was established in this context.
4. Adjudication method for the test set
- Not applicable, as it was not a human-reader 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
- No, an MRMC study was not done. This device is a guide catheter and not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a medical device (catheter) and not an algorithm.
7. The type of ground truth used
- For functional testing, the "ground truth" would be engineering specifications and functional requirements (e.g., flow rate, flexibility, tensile strength, pushability, torqueability, lubricity, etc.), though these specific metrics are not detailed.
- For biocompatibility testing, the "ground truth" is compliance with ISO 10993 standards and Good Laboratory Practice (GLP) requirements, as determined by laboratory analysis.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the IntraMax™ Guide Catheter to a predicate device through functional and biocompatibility testing. It does not contain the detailed quantitative acceptance criteria, specific performance metrics, or study design information (like sample sizes, expert qualifications, or ground truth methods) that would be present in a submission for a novel device or a device requiring clinical performance evaluation with human data.
§ 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).