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510(k) Data Aggregation
(225 days)
Lumax Guiding Catheter
"Intended for the intravascular introductional devices into the peripheral, including pulmonary, vasculature."
Lumax® Guiding Catheters are conduits introduced, either singly or as a coaxial pair, into a vein or artery and tracked over a wire guide to the site of a vascular lesion where interventional devices can be delivered through the guiding catheter's internal lumen for treatment. The Lumax® Guiding Catheters may include either a single guiding catheter or a coaxial catheter pair (composed of an outer guiding catheter and an inner coaxial catheter). The single guiding catheters are available in a 7.0 French outer diameter in lengths of 80 or 90 cm. They are manufactured with a multilayered braided nylon shaft, bonded Luer hub, and radiopaque tip. The guiding catheters are designed with a multipurpose (MPA) distal curve configuration. The coaxial catheter pair comprises an outer guiding catheter matched to an inner coaxial catheter. The guiding catheter component is available in an outer diameter of 8.0 French and a length of 80 cm. The inner coaxial catheter is manufactured from radiopaque braided nylon tubing and has an outer diameter of 6.0 French and a length of 100 cm. For lubricity, the distal 40 cm of the inner catheter is treated with hydrophilic coating. The Lumax® Guiding Catheters are supplied as packaged, sterile devices, intended for single-patient use.
The provided text describes the Lumax® Guiding Catheters and their acceptance criteria through various performance tests. However, it does not include a study that proves the device meets acceptance criteria for an AI/CADe device, as this device is a physical medical catheter, not a software or AI-based diagnostic tool.
Therefore, many of the requested categories for AI/CADe studies will not be applicable or present in this document.
Here's the information extracted from the document regarding the acceptance criteria and performance of the Lumax® Guiding Catheters:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Per ISO 10993-1 and FDA guidance for Cytotoxicity, Genotoxicity, Sensitization, Acute Systemic Toxicity, Intracutaneous Irritation, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, Partial Thromboplastin Time), and Thrombogenicity. | All test results met the acceptance criteria or demonstrated that the device is biocompatible. |
| Radiopacity | Not explicitly stated, but implies visibility and non-inferiority to user-defined standard. | The devices were visible, and visibility was qualitatively non-inferior to the user-defined standard. |
| Lubricity | Acceptance criteria for the comparison of means test and for the coated test articles. | The acceptance criteria for the comparison of means test and the coated test articles were met. |
| Tensile Strength | Predetermined acceptance criteria (in accordance with Annex B of BS EN ISO 10555-1). | The predetermined acceptance criteria for the studies were met. |
| Stress Cracking | Stress cracking requirements stated in ISO 80369-7. | The predetermined acceptance criteria for the study were met. |
| Dimensional Verification | Predetermined acceptance criteria. | The predetermined acceptance criteria for the study were met. |
| Visual, Dimensional, and Compatibility Verification | Internal requirements for compatibility, inner diameter, outer diameter, effective length, and visual inspection requirements of Section 4.12 of BS EN ISO 10555-1. | The predetermined acceptance criteria for the studies were met. |
| Air Leakage | Air leak requirements of BS EN ISO 10555-1. | The predetermined acceptance criterion for the study was met. |
| Liquid Leakage | Liquid leakage requirements of BS EN ISO 10555-1. | The predetermined acceptance criterion for the study was met. |
| Simulated Use | Predetermined acceptance criteria for ability to perform as intended in expected clinical use conditions. | The predetermined acceptance criteria for the study were met. |
| Particulate Testing and Coating Integrity | Not explicitly stated, but implies successful characterization. | This study successfully characterized the particulate counts and hydrophilic coating integrity of the Lumax® Guiding Catheters. |
| Rollback | Ability to be inserted through simulated tissue without signs of rollback of their tips and to meet requirements in Annex A of BS EN ISO 11070. | The predetermined acceptance criteria for the study were met. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes laboratory performance testing, not a clinical trial with a "test set" and "data provenance" in the context of an AI/CADe 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)
This information is not applicable and not provided. The testing described is performance testing of a physical device against engineering and safety standards, not an evaluation requiring expert interpretation of results to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided.
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
This is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance testing is based on established engineering standards (e.g., ISO, BS EN ISO) and pre-determined acceptance criteria for physical and mechanical properties, as well as biocompatibility.
8. The sample size for the training set
This is not applicable and not provided. This document describes the performance testing of a manufactured medical device, not the training of an AI model.
9. How the ground truth for the training set was established
This is not applicable and not provided. There is no concept of a "training set" or "ground truth" establishment for training in the context of this device's regulatory submission.
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