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510(k) Data Aggregation
(107 days)
Go2Wire Guide Wire
The Merit GO2WIRE™ is intended to facilitate the placement and exchange of devices during peripheral diagnostic and interventional procedures.
The Merit Go2Wire guide wire will consist of 0.035" guide wire configurations available in 145, 175, 210, 260, and 300cm. The distal tip flex configurations are Floppy, Standard and Intermediate (Modified J). The distal tip shapes are either straight or modified J.
The wire is composed of a stainless-steel core wire, a PTFE coated coil, a white PTFE sleeve, a platinum-tungsten marker coil, and an optional extension system connector. The wire's proximal end is covered by a white PTFE sleeve that terminates at 100cm from the distal tip. The distal 100 cm of the wire is covered with a green PTFE pre-coated coil. The PTFE coated coil and platinum-tungsten coil are welded to the core on the very distal tip. The distal tip is shapeable and radiopaque. A torque device is included to facilitate wire steering within the vascular anatomy.
An 0.035" extension wire consisting of PTFE coated stainless steel 155cm in length to extend the length of the wire to allow initial usage with a short wire and then extendable to allow catheter exchanges when required.
This document is a 510(k) premarket notification for a medical device called the "Go2Wire Guide Wire." It is not an AI/ML device, therefore, the information requested about acceptance criteria and study proving device meets it (including multi-reader multi-case studies, standalone algorithm performance, and training/test set details for AI/ML models) is not applicable or present in this document.
The document discusses the substantial equivalence of the Go2Wire Guide Wire to a predicate device based on various performance and biocompatibility tests.
Here's the relevant information that can be extracted, addressing the spirit of the request as much as possible for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with numerical acceptance criteria and reported numerical performance values. Instead, it states:
| Acceptance Criterion Category | Reported Device Performance |
|---|---|
| Performance Testing-Bench | "All test results were comparable to the predicate devices and the subject Merit Go2Wire Guide Wire met the predeterminded acceptance criteria." |
| Specifically, the device was tested for: Size Designation, Radiodetectability, Surface, Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Fracture test, Flex test, Torturous Path Lubricity, Corrosion Resistance, Tip Shape Testing Validation, Catheter and Needle Compatibility Validation, Guidewire Clinical Use in Model Validation, Extension System Clinical Use in Model Validation, Particulate. | |
| Biocompatibility | "All test results were comparable to the predicate devices and the subject Merit Go2Wire Guide Wire met the predeterminded acceptance criteria." |
| Specifically, the device was tested for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemolysis, Thrombogenicity, Complement Activation. |
2. Sample sized 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 sizes used for each test or the provenance of the data. The tests are described as "Performance Testing-Bench" and "Biocompatibility," indicating laboratory testing of the physical device rather than data from clinical studies.
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 is not applicable as this is a physical medical device (guide wire), not an AI/ML system requiring expert interpretation for ground truth. The "ground truth" for this device would be established by validated test methods and passing results according to engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML study involving human readers or interpretation requiring adjudication.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance is established by:
- Reference to industry standards and FDA guidance documents for medical device testing (e.g., ISO 11070:2014, FDA Guidance for Guidewires, ISO 10993-1:2018 for biocompatibility).
- Predetermined acceptance criteria derived from these standards and comparison to a legally marketed predicate device (Wholey Guide Wire System [K120863]).
- Bench testing and biocompatibility testing results.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" in the context of AI/ML.
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