(74 days)
Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.
The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure that the guide wire components remain together The outside coil is PTFE coated and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated.
The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch outer diameter with a 7cm straight tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length.
The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices.
The provided text describes a 510(k) premarket notification for a medical device, the "InQwire Amplatz Super Stiff Guide Wire." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.
Based on the document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document states that performance testing was conducted based on risk analysis and in accordance with protocols based on guidances and industry standards. It explicitly says: "these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." And "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
However, the document does not provide a specific table detailing numerical acceptance criteria and a corresponding column for reported device performance values. It lists the types of tests performed but not the quantitative results or specific thresholds.
Table of Performance Tests Conducted (Acceptance Criteria and Numerical Performance Not Specified):
| Performance Attribute | Met Acceptance Criteria (Reported) |
|---|---|
| Size Designation | Yes (comparable to predicate) |
| Tip Flexibility | Yes (comparable to predicate) |
| Surface | Yes (comparable to predicate) |
| Radiopacity | Yes (comparable to predicate) |
| Coating Adherence/Integrity | Yes (comparable to predicate) |
| Fracture Flex | Yes (comparable to predicate) |
| Particulate Evaluation | Yes (comparable to predicate) |
| Tensile Strength | Yes (comparable to predicate) |
| Catheter and Needle Compatibility | Yes (comparable to predicate) |
| Torque Strength | Yes (comparable to predicate) |
| Lubricity | Yes (comparable to predicate) |
| Biocompatibility | Yes (comparable to predicate) |
| Corrosion | Yes (comparable to predicate) |
| Packaging | Yes (comparable to predicate) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the performance tests. It also does not mention data provenance such as country of origin of the data or whether the studies were retrospective or prospective. The testing appears to be primarily bench testing (in vitro) rather than human or animal studies, given the type of device and tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes performance testing of a physical medical device (guide wire), not an AI/ML algorithm that requires expert "ground truth" for interpretation of images or other clinical data. The "ground truth" here is the physical performance of the device against engineering and material standards.
4. Adjudication method for the test set
This is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-AI reader studies. The performance tests described measure physical properties and do not involve human interpretation.
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. The device is a guide wire, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study involving human readers and AI assistance would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance testing is based on engineering standards, in vitro testing protocols, and comparison to legally marketed predicate devices. This includes:
- FDA guidance (e.g., Coronary and Cerebrovascular Guide Wire Guidance January 1995)
- Industry standards (e.g., ISO 11070:2014, ISO 11135-1:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006)
- Bench testing methodologies to evaluate physical and material properties (e.g., tensile strength, flexibility, radiopacity, coating adherence, biocompatibility, corrosion).
8. The sample size for the training set
This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as #8.
§ 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.