(101 days)
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes – 5F, 5.5F, 7F, and 8F. All sizes of the GuideLiner V3 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, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semi-circular polymer that meets the proximal end of the full-round guide extension segment. The GuideLiner V3 catheter has two platinumiridium marker bands; the distal marker band is located at the distal tip and the proximal marker band is located near the collar. The GuideLiner V3 catheter also has two positioning marks located 95 cm (single mark) and 105 cm (double mark) from the distal tip.
This document, K172090, describes a 510(k) premarket notification for a medical device (GuideLiner V3 Catheter), not a study assessing the performance of an AI/ML-based medical device. Therefore, the information required to answer your questions regarding acceptance criteria and study proving a device meets these criteria is not present in the provided text.
The document is a clearance letter from the FDA, stating that the GuideLiner V3 Catheter is substantially equivalent to legally marketed predicate devices. It lists the types of performance and biocompatibility tests conducted to demonstrate this substantial equivalence. However, it does not provide specific quantitative acceptance criteria or detailed study results (like sample sizes, ground truth establishment, expert qualifications, etc.) that would be typical for an AI/ML device performance study.
Here's why the requested information cannot be extracted:
- Acceptance Criteria & Performance Table: The document states that "The results of the verification tests met the specified acceptance criteria," but it does not define what those criteria were (e.g., specific thresholds for kink radius, bend diameter, etc.) nor does it report the actual measured performance values for these tests.
- Sample Size and Data Provenance: This information is not provided for the various performance and biocompatibility tests mentioned. These are likely engineering and bench tests, not clinical studies with patient data.
- Experts for Ground Truth & Adjudication Method: "Ground truth" in the context of this device would likely refer to engineering specifications or established physical properties. There's no mention of experts establishing visual "ground truth" or adjudication, as this is not an image-based diagnostic AI device.
- MRMC Comparative Effectiveness Study: This is irrelevant here as the device is a physical catheter, not an AI assisting human readers.
- Standalone Performance: The performance tests mentioned are inherently "standalone" for the device's physical and mechanical properties.
- Type of Ground Truth: For a physical medical device like a catheter, "ground truth" refers to established engineering standards, material properties, and functional specifications, not expert consensus on medical images or pathology.
- Training Set Sample Size & Ground Truth Establishment: This applies to AI/ML models. The GuideLiner V3 Catheter is a physical medical device, not an AI/ML product. Therefore, there's no "training set" or "ground truth for training" in the context of machine learning.
The document confirms that various tests were performed (e.g., Kink Radius, Bend Diameter, Biocompatibility tests like Cytotoxicity, Sensitization) and that the device "passed" or "met" the specified acceptance criteria. However, it does not provide the specifics of these criteria or the numerical results.
§ 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).