(52 days)
Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.
InQwire® Diagnostic Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The quide wires have a continuous PTFE (Polytetrafluoroethylene) coated coil, inside core wire and a safety wire. The core wire is fixed at the proximal end only and extends to a specified distance from the distal end. The distal segment of the core wire has a profiled taper. The core wire enhances the stiffness of the guide wire. The safety wire extends the full length of the guide wire and is welded at both the distal and proximal end. The safety wire is designed to provide integrity and ensures that the guide wire components remain together.
The InQwire® Diagnostic Guide Wires are offered in 0.035 inch or 0.038 inch outer diameter with different tip configurations (straight or J-tip), single ended or double ended (either end of the wire can be placed into the patient), standard or firm shaft, and are available in lengths from 50cm to 260cm. The wire is placed inside a loop flush dispenser, also referred to as a hoop. The dispenser has a female Luer connection which facilitates solution flushing through the hoop to hydrate the guide wire. The guidewires are secured in the hoop dispenser by a locking J-tip straightener.
This modification details a supplier process change relating to removal of perfluorooctanoic acid (PFOA), used in the manufacture of the PTFE (Polytetrafluoroethylene) coating. More specifically PFOA is a processing aid used for the polymerization process of PTFE, which is flashed off during the oven curing process and therefore not part of the finished InQuire® Diagnostic Guidewire. Due to environmental concerns relating to PFOA, the U.S. Environmental Protection Agency has instructed that all processors of PTFE no longer make, buy or use PFOA(2010/2015 PFOA Stewardship Program). PFOA material is used in the manufacture both the intermediate layer and top layer of the PTFE(Polytetrafluoroethylene) coating.
This document describes the 510(k) summary for the Merit InQwire® (IQ) Diagnostic Guide Wire, specifically addressing a change in the PTFE coating manufacturing process.
Here's an analysis of the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface | Not explicitly stated, but implied to be comparable to the predicate device. | All test results were comparable to the predicate devices. |
| Coating Adherence/Integrity | Not explicitly stated, but implied to be comparable to the predicate device. | All test results were comparable to the predicate devices. |
| * Fracture Test | Not explicitly stated, but implied to be comparable to the predicate device. | All test results were comparable to the predicate devices. |
| * Flexing Test | Not explicitly stated, but implied to be comparable to the predicate device. | All test results were comparable to the predicate devices. |
| * Coil Lubricity Test | Not explicitly stated, but implied to be comparable to the predicate device. | All test results were comparable to the predicate devices. |
| Catheter Compatibility | Not explicitly stated, but implied to be comparable to the predicate device. | All test results were comparable to the predicate devices. |
| Biocompatibility | Not explicitly stated, but implied to be comparable to the predicate device, likely adhering to ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile G95-1. | All test results were comparable to the predicate devices. The device met the predetermined acceptance criteria applicable to the safety and effectiveness of the device. |
The document states that "Performance testing of the subject Merit InQwire® Diagnostic Guide Wire was conducted based on risk analysis. A battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) submission for a device modification (supplier process change), the tests would primarily be laboratory-based verification and validation.
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 to the provided document. The study described is a series of engineering and biological performance tests, not a clinical study involving expert interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical trials where multiple readers assess cases. This document describes laboratory-based performance testing of a medical device.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to the 510(k) submission for a guide wire, which is a physical medical device, not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This document is about a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The "ground truth" for this device's performance is established by the specifications and measurable outcomes of the engineering and biological tests conducted against established industry standards and FDA guidance. The "truth" is whether the device meets the predetermined physical and chemical parameters.
8. The sample size for the training set
This information is not applicable. This is not a study involving machine learning or AI, so there is no training set in that context.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for an AI/machine learning model in this context.
§ 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.