(211 days)
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight, angled, standard and stiff configurations, in various lengths.
The provided text describes a 510(k) premarket notification for a medical device, the "Merit Hydrophilic Guide Wire." The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving novel effectiveness. Therefore, the study described is a comparative performance study against predicate devices, not an effectiveness study in the typical sense of a human-in-the-loop clinical trial or a standalone AI algorithm performance study.
Here's an analysis of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results for each criterion. It broadly states that 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."
The tests performed and their general outcomes are listed:
| Acceptance Criteria (Stated as tests performed) | Reported Device Performance (Implied by approval) |
|---|---|
| Coating Adherence/Integrity (Including Anatomical Model) | Successfully completed |
| Catheter Compatibility (Durability) | Successfully completed |
| Surface | Successfully completed |
| Fracture test | Successfully completed |
| Flex test | Successfully completed |
| Size Designation/ Dimensions | Successfully completed |
| Particulate Evaluation | Successfully completed |
| Biocompatibility testing | Successfully completed |
The general acceptance criterion is that the new Merit Hydrophilic Guide Wire performs substantially equivalently to the predicate devices in these physical and biological tests. The document declares that the device met these criteria, indicating successful performance in all listed tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document specifies that performance testing was performed on the 0.018" and 0.038" diameter wires only. These represent the "minimum and maximum wire diameters within the cleared device range." The manufacturer believes this is sufficient to demonstrate equivalence for intermediate diameters. The exact number of units or samples tested for each specific test (e.g., number of wires for flex test, number of samples for biocompatibility) is not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the applicant is Merit Medical Systems, Inc. (South Jordan, UT, USA) with a correspondent in Ireland, suggesting that the testing could be internal to the company or contracted out to labs in various locations. Given the nature of a 510(k) submission, this testing is typically controlled in a laboratory setting for regulatory purposes. It is retrospective data in the sense that the tests were conducted prior to submission for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable in the context of this device and study. The "ground truth" for a guidewire's performance is objective measurements against established engineering and biocompatibility standards, not expert evaluation of medical images or clinical outcomes. The tests evaluate physical properties, material compatibility, and biological safety, which are quantifiable against predefined acceptance limits or comparative performance with predicate devices.
4. Adjudication Method for the Test Set
This question is not applicable. The performance tests for a guidewire (e.g., fracture test, flex test, coating adherence) involve objective measurements and comparisons to engineering specifications or predicate device performance, not subjective human assessment 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
This question is not applicable. This is a 510(k) submission for a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable, as the device is a physical guidewire and not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is based on:
- Engineering specifications and performance standards: These are derived from industry standards (e.g., ISO 11070:1998, ASTM F1980-07) and FDA guidance documents (e.g., Coronary and Cerebrovascular Guide Wire Guidance January 1995).
- Biocompatibility standards: Primarily ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile FDA Memo G95-1.
- Comparative performance against predicate devices: The objective of the submission is to demonstrate "substantial equivalence" to existing, legally marketed guidewires. Therefore, the performance of the new device is compared to the established performance of the predicate devices in the listed tests.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this guidewire's regulatory submission, as it is a physical device and not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above (no training set for a physical 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.