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510(k) Data Aggregation
(88 days)
To facilitate the placement of devices during diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.
Nickel Titanium steerable core with a clear or colored, radiopaque jacket, with a polymer/ hydrophilic coating is applied over the core/jacket. The guidewires are bound by the following parameters: Outside Diameter: .018" - .038", Lengths: 150 cm - 260 cm, Tips: Straight or shaped with standard or long taper tip flexibility.
The acceptance criteria for the Hydrophilic Coated Guidewire are based on a comparison to predicate Terumo guidewires across several performance metrics. The study aims to demonstrate substantial equivalence by ensuring the new guidewires meet the same design criteria and specifications as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual | Assess for visual appearance, such as tip integrity and jacket durability (cuts, splits, seams, etc., any indication that the tip has been compromised). The implication is that the device should appear undamaged and intact. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying satisfactory visual appearance. |
| Dimensional Measurement | Outside Diameter (dry, after 10-minute soak, and after 40-minute soak in normal saline) measured by laser micrometer at multiple body points. The implication is that the dimensions should be within specified ranges and comparable to the predicate device. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying dimensional measurements were acceptable. |
| Lubricity | Measures the force required to insert and withdraw the guidewire within a catheter lumen standardized to each guidewire diameter. The implication is that the lubricity should be comparable to or better than the predicate device. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying satisfactory lubricity. |
| Pull Test | Measures the strength of materials and joints in the guidewire. The implication is that the guidewire should withstand specified tensile forces without failure. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable material and joint strength. |
| 3-Point Bending Test | Assess guidewire body stiffness/flexibility. The implication is that the stiffness/flexibility should be within specified ranges and comparable to the predicate device. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable body stiffness/flexibility. |
| Coating Durability | Measures the lubricity before and after multiple catheter insertions and withdrawals. The implication is that the coating should maintain its lubricity after repeated use, comparable to the predicate device. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying satisfactory coating durability. |
| Distal Tip (J) Memory | Assess the memory of the distal tip form of shaped product. The implication is that the shaped tip should retain its intended form after manipulation, comparable to the predicate device. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable tip memory. |
| Kink Resistance | Measures the kink resistance properties of product made from kink resistance materials or products that are designed to have kink resistance properties. The implication is that the guidewire should resist kinking under specified conditions, comparable to the predicate device. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable kink resistance. |
| Linear Stiffness | Measures the linear tip flexibility. The implication is that the tip flexibility should be within specified ranges and comparable to the predicate device. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable linear tip flexibility. |
| Torque Control | Assess guidewire torque response and rotational control to allow placement of the distal tip at a desired location in a 360-degree circle when controlled from the proximal end of the guidewire. The implication is that the guidewire should provide precise and consistent torque control. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable torque control. |
| Torque Fatigue | Assess the torqueable strength of a guidewire. The implication is that the guidewire should withstand repeated torqueing without failure, comparable to the predicate device. | Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable torqueable strength. |
| Acute Systemic Toxicity | No signs or symptoms of Systemic Toxicity were observed for any of the samples. | No signs or symptoms of Systemic Toxicity were observed for any of the samples. |
| Cytotoxicity (MEM) | The samples should not evoke a significant cytotoxic response. Specifically, the test material passed the assay for a mild cytotoxic response (Grade 1) at 48 hours. | The samples evoked a mild cytotoxic response (Grade 1), when tested at 48 hours. The test material passed the assay. |
| Hemolysis | The samples should not produce hemolysis. | The samples did not produce hemolysis. |
| Intracutaneous Test | Skin reactions should not be significant for all samples. | For all samples, skin reactions were not significant. |
| Pyrogen (Material Mediated) | The samples should not produce a pyrogenic response. | The samples did not produce a pyrogenic response. |
| Inhibition and Enhancement | No endotoxin detected at 0.03 eu/ml. | No endotoxin detected at 0.03 eu/ml. |
| Sensitization | The samples should not be a strong sensitizer, or should be deemed acceptable within a defined range. | The samples were deemed to be a weak sensitizer. |
| Thrombo In-Vitro (Plate Method) | The test article should be considered nonthrombogenic. | The test article was considered nonthrombogenic. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: For each test type, either fifteen (15) or ten (10) test samples were selected. Some destructive tests required additional sets of fifteen (15) or ten (10) samples. Within each of the three groups of guidewires (based on Terumo products of .018", .035", and .038" standard configurations), production samples were made representing the minimum (smallest size), maximum (largest size), and mode (most common size).
- Data Provenance:
- Country of Origin: Not explicitly stated, but LRM (Lake Region Manufacturing, Inc.) is based in Chaska, MN, USA. Terumo is a Japanese company, but the document states "Terumo product was purchased by LRM, complete in packaging," suggesting the predicate devices were commercially available products.
- Retrospective or Prospective: The testing was prospective, as "LRM samples were produced following current manufacturing processes and procedures," and "All samples were sterilized prior to testing." This indicates newly manufactured devices were subjected to the specified tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This device is a guidewire, and the "ground truth" for performance is established through objective, quantitative engineering and biocompatibility tests rather than expert interpretation of medical images or clinical outcomes. The tests evaluate physical properties and biological reactions against predefined specifications.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to studies where human reviewers interpret data (e.g., medical images) and their disagreements need resolution. For objective engineering and biocompatibility tests, the pass/fail criteria are instrumental, and the results are directly measured or observed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This is not an AI-powered device, nor is it a diagnostic device that involves human readers interpreting medical cases. The study focuses on hardware performance and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm or AI device. The tests performed are standalone evaluations of the guidewire's physical and biological properties.
7. The Type of Ground Truth Used:
The ground truth is established through:
- Engineering Specifications/Design Criteria: For all performance tests (e.g., visual, dimensional, lubricity, strength, stiffness, durability, memory, kink resistance, torque control, fatigue). The "prescribed specification limits" serve as the ground truth against which the device performance is measured.
- Predicate Device Performance: The primary method for establishing substantial equivalence for the performance tests was comparative testing against Terumo guidewires, implying that the performance of the Terumo guidewires (which are legally marketed) served as a benchmark for acceptability.
- Biocompatibility Standards/Guidelines: For biocompatibility tests, the ground truth is established by recognized standards like ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and the FDA's General Program Memorandum #G95-1, which define acceptable biological responses (e.g., no systemic toxicity, mild cytotoxicity acceptable, no hemolysis, non-significant skin reactions, etc.).
8. The Sample Size for the Training Set:
Not applicable. This is a medical device (guidewire), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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