(249 days)
The Hunter™ Super Soft and Soft guide wires with phosphorylcholine (PC) coating are intended to facilitate the placement of PTA and/or PTCA balloon catheters within the peripheral and coronary vasculature. This guide wire is 0.014-inch size and designed for safe use within appropriately sized balloon catheters. This device is not for use in the cerebral vasculature.
The Hunter guide wires are coated with a high molecular weight phosphorvicholine ("PC") polymer. The core wire and spring coils are coated with phosphorylcholine (PC). The PC coating aids in the prevention of thrombus formation on the guide wire tip during short-term clinical use. While the PC coating has been shown to resist thrombus accumulation during PTCA procedures, a clinical significance of this reduction has not been demonstrated. The guide wires are full-length core wire design having a distal 30cm long spring coil. PC-coated guide wires are available in 175cm and 300cm lengths with distal radiopaque platinum/fungsten spring coil lengths of 4cm and 30cm.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Soft Guide Wires with PC Coating:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria for the device. Instead, it describes the effectiveness of the PC coating in terms of its ability to reduce protein adsorption and thrombus formation, comparing it to a predicate device.
However, based on the "Safety and Effectiveness" section, we can infer the performance metrics reported:
| Acceptance Criterion (Inferred) | Reported Device Performance (PC-Coated Guide Wires) |
|---|---|
| Reduction in Fibrinogen Binding | Less than that to other common guide wire coating materials (demonstrated in vitro). |
| Resistance to Thrombus Formation | Effectively resisted thrombus deposition under variable conditions of clinical PTCA (demonstrated in a clinical study examining 50 PTCA procedures using Scanning Electron Microscopy). The text notes that "a clinical significance of this reduction has not been demonstrated" for the prevention of thrombus formation specifically, implying that the study demonstrated reduction in accumulation rather than prevention of a clinically relevant event. It also states the PC coating "aids in the prevention of thrombus formation...during short-term clinical use." |
| Reduction in Protein Adsorption | A fundamental characteristic, described as "reduction of protein adsorption (e.g. fibrinogen)." |
| Decrease in Platelet Adhesion | A fundamental characteristic, described as "decrease in platelet adhesion (and therefore activation and aggregation)." |
| Durability / Adherence | A "stable and durable polymer coating adheres to the otherwise hydrophobic substrate." |
| Sterilization Compatibility | Sterilizable by gamma radiation. |
| Biocompatibility | Implied by the lack of adverse findings and the nature of the K970938 approval for marketing. (No specific study details on biocompatibility are provided beyond the general safety and effectiveness statement). |
Study Information
Due to the nature of a 510(k) summary, specific, detailed study protocols are not included. However, we can extract the following:
1. Sample sizes used for the test set and the data provenance:
- Clinical Study:
- Sample Size: 50 clinical PTCA procedures.
- Data Provenance: The text refers to "clinical PTCA procedures," implying prospective human use data. The country of origin is not specified, but the submission is to the US FDA, so studies conducted in the US are highly probable, or at least accepted by the FDA.
- In Vitro Study:
- Sample Size: Not specified.
- Data Provenance: In vitro, laboratory setting.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the clinical study using Scanning Electron Microscopy (SEM): The text does not specify the number of experts or their qualifications who interpreted the SEM images or assessed thrombus deposition. It simply states the results "demonstrated the effectiveness."
- For the in vitro study on fibrinogen binding: No information on "experts" or "ground truth establishment" is applicable in the human expert sense, as this would be a laboratory measurement.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not mention any adjudication method for either the clinical or in vitro studies.
4. 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 device is a medical device (guide wire with coating), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance for human readers was not performed.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical device. It does not involve a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study: The ground truth for "resistance to thrombus deposition" was established through Scanning Electron Microscopy (SEM) examination of guide wires after use in 50 clinical PTCA procedures. This can be considered a direct observational "ground truth" of material performance in vivo.
- For the in vitro study: The ground truth for "fibrinogen binding" was established through laboratory measurements using an unspecified assay.
7. The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" in the context of device approval of this nature.
8. How the ground truth for the training set was established:
- Not Applicable. As above, there is no training set for this type of device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.