(90 days)
Not Found
Steerable stainless steel core with radiopaque marker; a jacket, and polymer/hydrophilic coating is applied over the core/coil. The quidewires are bound by the following parameters: Outside Diameter: .016" - .045" Lengths: 20 cm -- 400 cm Tips: Straight, Shapable with standard and stiff tip flexibility
Device Acceptance Criteria and Study Details:
This document describes the acceptance criteria and the study performed for a guidewire produced by Lake Region Manufacturing, Inc. (LRM). The study aims to demonstrate substantial equivalence of guidewires manufactured with a polymer/hydrophilic coating to existing predicate guidewires, specifically Terumo guidewires.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All test results were within prescribed specification limits." While specific numerical acceptance criteria ranges are not provided, the reported performance indicates successful adherence to predefined standards for each test. For the biocompatibility tests, the results explicitly state whether the material passed or met the expectations for safety.
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Lubricity | Force required for insertion/withdrawal within a catheter lumen standardized to guidewire diameter must be within specifications. | All test results were within prescribed specification limits. |
| Coating Durability | Lubricity before and after multiple catheter insertions/withdrawals must be within specifications. | All test results were within prescribed specification limits. |
| Dimensional Measurement (OD) | Outside diameter at multiple body points (dry, 10 min soak, 40 min soak) must be within specifications. | All test results were within prescribed specification limits. |
| Distal Tip Flexibility | Flexibility of the distal tip must be within specifications. | All test results were within prescribed specification limits. |
| 3-Point Bending Test | Guidewire body stiffness/flexibility must be within specifications. | All test results were within prescribed specification limits. |
| Rotational Control | Ability to place distal tip at desired location (360 degrees) when controlled from proximal end must be within specifications. | All test results were within prescribed specification limits. |
| Torsional Integrity | Torqueable strength of the guidewire must be within specifications. | All test results were within prescribed specification limits. |
| Radiopacity | Radiopacity of the distal tip must be equivalent to currently marketed hydrophilic guidewires. | All test results were within prescribed specification limits. |
| Tracking | Tractability of the guidewire must be within specifications. | All test results were within prescribed specification limits. |
| Pull Test | Strength of welded joint points must be within specifications. | All test results were within prescribed specification limits. |
| Biocompatibility Tests | ||
| Cytotoxicity | Pass assay (e.g., maximum Grade 2 cytotoxic response). | The samples evoked a mild cytotoxic response (Grade 2) when tested at a 48 hour exposure period. The test material passed the assay. |
| Hemolysis | No hemolysis should be produced. | The samples did not produce hemolysis. |
| Acute Systemic Toxicity | No signs or symptoms of systemic toxicity. | No signs or symptoms of Systemic Toxicity were observed for any of the samples. |
| Intracutaneous Test | Skin reactions should not be significant. | For all samples, skin reactions were not significant. |
| Implantation (7 Day) | Reaction not significant compared to negative control implant. | The reaction was not significant as compared to the negative control implant, for any of the samples. |
| Sensitization | Non-sensitizer. | The samples were deemed to be a non-sensitizer. |
| Pyrogen Test | No pyrogenic response. | The samples did not produce a pyrogenic response. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Sizes:
- For each of the three product groups (.018" standard, .035" standard, and .038" stiff configurations), at least 200 samples were produced (600+ total samples).
- For each individual test, either 20 or 30 samples were selected.
- Additional sets of 20 or 30 samples were used for destructive tests.
- Data Provenance: The data is prospective, as LRM manufactured "production samples" and "LRM samples" specifically for this comparative testing. The predicate Terumo product was "purchased by LRM, complete in packaging" for direct comparison. The country of origin for the data is implicitly the United States, as LRM is a U.S. company and the submission is to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts or their qualifications used to establish ground truth for the functional performance tests (Lubricity, Rotational Control, etc.). These tests appear to be objective, quantitative measurements against predefined engineering specifications.
- For biocompatibility tests, these are typically performed in specialized laboratories following established protocols, implying certified personnel, but specific expert qualifications are not detailed.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method for the test set results. The tests appear to be objective measurements compared against internal specifications or the performance of the predicate device. Therefore, it is likely that no formal adjudication was required beyond comparing the results to the established criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices where human interpretation is involved. For a guidewire, the effectiveness is assessed through its physical and performance characteristics, not through human reader interpretation of output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the studies performed were standalone in the sense that they evaluated the device's inherent physical and functional properties directly. There is no "algorithm" or human-in-the-loop component to a guidewire's fundamental performance assessment in this context. The tests measure the device's characteristics directly.
7. Type of Ground Truth Used:
- The ground truth used for the functional performance tests (Lubricity, Dimensional Measurement, etc.) is defined engineering specifications and comparative performance against a predicate device (Terumo guidewires). The goal was to show that the LRM device met its own specifications and was equivalent to the predicate.
- For the biocompatibility tests, the ground truth is established by validated laboratory protocols and reference standards, following recommendations from the FDA's "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices."
8. Sample Size for the Training Set:
- The concept of a "training set" is not applicable to this submission. The device is a physical medical instrument, not a machine learning algorithm. The manufacturing process itself could be considered "trained" through years of experience and quality controls, but there isn't a distinct "training set" of data in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established:
- As the concept of a training set is not applicable, this question is not relevant to this device submission. The "ground truth" for the manufacturing process is established through documented quality systems, engineering change order reviews, material qualification, product qualification, and process qualification. These controls ensure consistency and adherence to design specifications over time.
§ 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.