(186 days)
Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.
Merit Heparin-coated 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. A Benzalkonium Heparin coating is applied over the PTFE coating.
The Heparin-coated 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 70cm to 180cm. 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 Heparin-coated InQwire® Diagnostic Guidewire. The PTFE coating formulation has changed - PFOA has been removed as a processing aid and replaced with GenX. The oven curing process which cures the coating and flashes off the PFOA remains unchanged. The manufacturing process within Merit has not changed. 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 of both the intermediate layer and top layer of the PTFE(Polytetrafluoroethylene) coating. The removal of PFOA from Merit's non Heparin-coated InQwire® Diagnostic Guide Wires was previously assessed under Special 510(k) Premarket Notification, K133230. The only difference between the Heparin-coated InQwire® Guidewires and the non-Heparin coated InQwire® Guidewires, K133230, is the addition of a Benzalkonium Heparin coating applied over the PTFE coating. No changes have been made to the actual heparin coating. The same design and material characteristics that were qualified in K133230, also apply to the heparin-coated InQwire® Diagnostic Guidewires.
This document describes the Merit Heparin-coated InQwire® Diagnostic Guide Wire (K140608), a medical device. The information provided is for regulatory approval and focuses on demonstrating substantial equivalence to predicate devices, rather than a classical "study" proving device performance in a clinical setting with independent ground truth.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria and reported device performance with specific numerical targets and results. Instead, it states that "Performance testing…was conducted based on risk analysis," "met the acceptance criteria that were determined to demonstrate substantial equivalence," and "All test results were comparable to the predicate devices and the subject Merit Heparin-coated InQwire® Diagnostic Guide Wire met the predetermined acceptance criteria applicable to the safety and effectiveness of the device."
The tests conducted are listed as:
- Surface
- Coating Adherence/Integrity (including Fracture Test and Flexing Test)
- Coil Lubricity Test
- Catheter Compatibility
- Biocompatibility
The acceptance criteria for these tests are not explicitly detailed but are implied to be established through internal risk analysis and compliance with referenced standards. The "reported device performance" is summarized as the device successfully meeting these "predetermined acceptance criteria" and being "comparable to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the performance tests.
The document does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as the testing is described as laboratory-based performance testing rather than a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the document describes laboratory-based performance testing, not a study where expert consensus on "ground truth" would be established. The "ground truth" here is the performance specifications derived from standards and risk analysis.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of a human-adjudicated test set in a clinical context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as this is a physical medical device (guidewire) and the document focuses on its material and mechanical properties, not on diagnostic interpretation or human reader performance.
6. Standalone (Algorithm Only) Performance
This is not applicable as the device is a physical guidewire, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance testing is based on:
- Risk analysis: Identifying potential failure modes and associated performance requirements.
- Industry Standards: Compliance with documents like FDA guidance Coronary and Cerebrovascular Guide Wire (January 1995), ISO 11070:1998, ISO 11135-1:2007, ASTM F1980-07, and ISO 10993-1:2009.
- Predicate Device Performance: The subject device's performance was compared to existing predicate devices (K822586 and K133230) to establish substantial equivalence.
8. Sample Size for the Training Set
This is not applicable. The document describes performance validation of a physical medical device. There is no "training set" in the context of an AI/ML algorithm. The "training" for the device would be the design and manufacturing process, which is implicitly validated by the performance tests.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm, this is not applicable.
In summary, the document details the regulatory submission for a guidewire, focusing on demonstrating substantial equivalence through laboratory performance testing against established standards and predicate devices, rather than a clinical acceptance study with expert-derived ground truth or AI/human reader performance.
§ 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.