(47 days)
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of selfexpanding endoprostheses in large diameter vessels.
The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling catheter with an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh.
The provided text describes a 510(k) summary for the UnBalloon Non-Occlusive Modeling Catheter, focusing on its substantial equivalence to a predicate device and product testing. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical or algorithmic performance. The document is a regulatory submission for premarket notification, demonstrating that the device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested information points, particularly those related to a study proving device performance against acceptance criteria, cannot be extracted from this document, as such a study is not detailed.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document mentions "product performance requirements of the device specifications" and lists various tests, but it does not explicitly define specific numerical or qualitative acceptance criteria for each test (e.g., a specific tensile strength value, or a specific duration for fatigue testing without failure). It only states that the device "meets the product performance requirements."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable criteria in the document. The document asserts the device meets unspecified "product performance requirements." | Not explicitly stated with quantifiable results. The document generally states the device meets requirements without providing specific performance values for the following tests: |
| Worst case simulated use | |
| Fatigue | |
| Hemostasis | |
| Bond tensile strength | |
| Radial outward force | |
| Compatibility with endoprostheses | |
| Lubricity testing | |
| Silicone curing characterization | |
| Silicone curing process characterization study | |
| Silicone shelf life validation | |
| Bushing & seal process qualification |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided. The document refers to "product characterization and validation" and "verification activities" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.
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/Not provided. This type of information is typically relevant for studies involving human interpretation or clinical outcomes, often in the context of AI/ML device evaluations. The reported testing is primarily in-vitro/bench testing for a physical catheter, not an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. As noted above, this is not relevant for the type of product 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:
Not applicable. This device is a physical catheter, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the engineering performance tests (like fatigue, tensile strength, etc.) would be established by engineering specifications, industry standards, and validated testing methodologies against which the device's performance is measured. The document implies compliance with these without detailing them. For biocompatibility, it refers to "ISO 10993 guidelines."
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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).