(126 days)
The LuMend Frontrunner™ CTO Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.
The LuMend Frontrunner™ is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. The Frontrunner catheter does not have a guide wire lumen.
Based on the provided text, here's an analysis of the acceptance criteria and study information for the LuMend Frontrunner™ CTO Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Standard | Reported Device Performance |
|---|---|
| In vitro tests: | All data continued to fall well within internal specification requirements. |
| - Tensile strength | All data continued to fall well within external standard requirements and predicate performance expectations. |
| - Torque strength | All data continued to fall well within internal specification requirements. |
| - Torqueability | All data continued to fall well within external standard requirements and predicate performance expectations. |
| - Tip flexibility | All data continued to fall well within internal specification requirements. |
| - Coating adherence/integrity | All data continued to fall well within external standard requirements and predicate performance expectations. |
| Biocompatibility | All data continued to fall well within internal specification requirements. |
| All data continued to fall well within external standard requirements and predicate performance expectations. | |
| Catheter compatibility | All data continued to fall well within internal specification requirements. |
| All data continued to fall well within external standard requirements and predicate performance expectations. | |
| Substantial Equivalence (Overall based on technical details & intended use) | The LuMend Frontrunner™ has been shown to be substantially equivalent to a currently marketed predicate device (LuMend Frontrunner™ CTO Coronary Catheter [K013284]). It is identical in terms of embodiment, shape, appearance, function, and mechanism of action ("blunt micro-dissection"). |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the "in vitro, in situ, and in vivo" tests. It mentions "routine device evaluation" and that the testing "continued" from previous assessments, implying ongoing quality control rather than a single limited test set.
The provenance of the data is not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document describes engineering and biocompatibility testing, not studies involving expert assessment of images or clinical outcomes.
4. Adjudication method for the test set
This information is not provided in the document. As the tests are largely engineering and biocompatibility focused, an adjudication method in the context of expert review would not typically apply.
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
There is no indication of an MRMC comparative effectiveness study involving human readers or AI in this document. The device is a physical catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in vitro tests (tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity), the ground truth was based on internal specification requirements and external standard requirements specified in FDA's Coronary and Cerebrovascular Guidewire Guidance: Document (January 1995).
For the biocompatibility and catheter compatibility tests, the ground truth would also be related to established biocompatibility standards and compatibility specifications for medical devices.
8. The sample size for the training set
This is not applicable. The device is a physical catheter, not an AI model that requires a training set. The "testing" described refers to engineering and performance verification, not algorithm training.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI model. For the device itself, the "ground truth" for its performance is aligned with the internal and external device specifications and standards.
§ 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).