(79 days)
The LuMend Frontrunner™ GW 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™ GW CTO Catheter 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, an optional guide wire lumen 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. Guidance and tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator and/or the use of a guide wire.
The provided text describes a 510(k) submission for the LuMend Frontrunner™ GW CTO Catheter. Based on the information, here's a breakdown of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device and guidance) | Reported Device Performance (Summary from text) |
|---|---|---|
| Functional Equivalence | Substantially equivalent in embodiment, shape, appearance, function, and mechanism of action to predicate device. | "The LuMend Frontrunner™ GW CTO Catheter is substantially equivalent to the previously cleared LuMend Frontrumer™ CTO Catheter in terms of embodiment, shape, appcarance and function." |
| Intended Use Equivalence | Same indications for use as predicate device. | "It has the same indications for use..." |
| Mechanism of Action | Utilizes "blunt micro-dissection" for guide wire placement across stenotic lesions. | "...makes use of the identical mechanism of action: 'blunt micro-dissection' to facilitate placement of a guide wire across stenotic vascular lessions including Chronic Total Occlusions (CTOs)." |
| Device Specifications | Fall within internal specifications and external standard requirements. | "All data continued to fall well within internal specification requirements..." |
| Predicate Performance | Meet predicate performance expectations. | "...as well as external standard requirements and predicate performance expectations." |
| Biocompatibility | Acceptable biocompatibility. | Included in evaluation. |
| Catheter Compatibility | Acceptable catheter compatibility. | Included in evaluation. |
| Physical Properties | Tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity. | All tested "within internal specification requirements, as well as external standard requirements and predicate performance expectations." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of clinical or human performance data related to AI/algorithm assessment. The testing mentioned is for the physical and functional characteristics of the catheter, falling under in vitro, in situ, and in vivo tests. The data provenance is not explicitly stated beyond "in vitro, in situ and in vivo data," but it refers to technical performance rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or not provided in the context of an AI/algorithm study. The acceptance criteria and testing described pertain to the physical device's characteristics and its equivalence to a predicate device, not to an expert-driven assessment of an AI model's output.
4. Adjudication Method for the Test Set
This information is not applicable or not provided as there is no mention of a human-reviewed test set requiring adjudication for an AI/algorithm.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, not on evaluating human reader performance with or without AI assistance. This device is a physical catheter, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical catheter, not an AI algorithm.
7. The Type of Ground Truth Used
For the device's performance, the "ground truth" was established by internal specification requirements, external standard requirements (such as those specified in FDA's Coronary and Cerebrovascular Guidewire Guidance Document), and predicate performance expectations. This is based on objective measurements of physical and functional properties, rather than expert consensus, pathology, or outcomes data in a clinical trial setting for a diagnostic aid.
8. The Sample Size for the Training Set
This information is not applicable or not provided. Since this is a physical medical device and not an AI algorithm, there is no "training set" in the sense of data used to train a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided for the reasons stated in 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).