(164 days)
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).
The GuideLiner Coast catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in four sizes - 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner Coast catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, hydrophilic coated guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.
This device is a GuideLiner Coast catheter, intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, facilitate placement of interventional devices, and assist in crossing de novo coronary chronic total occlusions (CTO).
The submission focuses on establishing substantial equivalence to a predicate device (K212211, GuideLiner V3 catheter and TrapLiner catheter) by evaluating technological differences, specifically a new hydrophilic coating material, a reduction in coating length, and cosmetic changes to the hub. The information provided does not describe a clinical study involving human patients or the use of AI. Instead, it relies on a series of bench tests and biocompatibility tests. Therefore, many of the requested sections regarding clinical study design, ground truth, and AI performance are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Deliverability | Device samples passed |
| Hydrophilic Coating Evaluation | Device samples passed |
| Tensile Strength | Device samples passed |
| Hub Markings | Device samples passed |
| Biocompatibility (Cytotoxicity) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Sensitization) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Irritation) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Systemic Toxicity) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Material Mediated Pyrogenicity) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Hemolysis) | Device samples passed (in accordance with ISO 10993-1) |
| Biocompatibility (Complement Activation) | Device samples passed (in accordance with ISO 10993-1) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for each bench test. The term "device samples" is used. The data provenance is from bench testing, meaning it's laboratory-generated data, not patient data from a specific country, and is not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for bench tests is typically established by engineering specifications, material science standards, and established test methodologies, not by expert medical opinion.
4. Adjudication Method for the Test Set
Not applicable. As this is bench testing, there is no adjudication process involving multiple human evaluators of test results in the way described for clinical data.
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 submission does not involve an AI device or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI device.
7. The Type of Ground Truth Used
The ground truth for the performance tests (Deliverability, Hydrophilic Coating Evaluation, Tensile Strength, Hub Markings) is based on engineering specifications and established test methods for medical devices.
The ground truth for biocompatibility tests is based on ISO 10993-1 standards for biological evaluation of medical devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device, so there is no training set or associated ground truth establishment process.
§ 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).