Search Results

To facilitate the placement of devices during diagnostic and interventional procedures.

Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Nitinol) with a radiopaque polymer (polyurethane) jacket and a hydrophilic coating is applied over the jacket. Guidewires are available up to 260cm length and in diameters from 0.018" to 0.038" depending on specific design requirements. Guidewires may have a straight or angled distal tip.

This document summarizes the acceptance criteria and supporting studies for the Lake Region Medical Hydrophilic Coated Guidewires (K133155). The information primarily comes from the 510(k) Summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes qualification testing to demonstrate equivalence to a predicate device, rather than explicit acceptance criteria with numerical targets and reported performance values. The tests performed are listed, implying that the device was found to be acceptable against established criteria for each test. Due to the lack of specific numerical acceptance criteria and performance data in the provided text, the table below lists the tests performed and notes that they were conducted to demonstrate equivalence and found acceptable.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for each individual bench or biocompatibility test. It states that "Test pieces were tested and inspected." This suggests a laboratory setting for testing physical and biocompatibility properties. The data provenance is presumed to be from internal lab testing conducted by Lake Region Medical ("Lake Region Medical performed testing"). The study is analogous to a pre-market, prospective validation of the device's physical and biological characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the type of testing described (bench and biocompatibility). The "ground truth" for these tests would be defined by the specified test methods (e.g., ISO standards, FDA guidance documents) and the scientific principles behind them, rather than expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As described above, the testing involves objective measurement and analysis against predefined standards for physical and chemical properties, not subjective 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

Not applicable. This device is a guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. See point 5. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the bench testing is based on:

• Established specific inspection criteria for visual/tactile and dimensional attributes.
• FDA Coronary and Cerebrovascular Guidance for certain test method development.
• ISO 11070:1998 for guidewire test methods.

For biocompatibility testing, the ground truth is based on:

• ISO 10993 series of standards.

These standards and guidance documents define the acceptable limits and methodologies for evaluating the device's physical and biological properties.

8. The Sample Size for the Training Set

Not applicable. This product is a physical medical device, not an AI model, so there is no training set mentioned or implied.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Ask a specific question about this device

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 - 400 cm, Tips: Straight or shaped with standard or long taper tip flexibility. Note: None of these guidewires are for PTCA use.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: LRM Hydrophilic Coated Guidewire

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the document describes tests conducted to demonstrate equivalence to a predicate device (Terumo guidewires) and ensure product quality. The reported performance is generally stated as "All test results were within prescribed specification limits" for engineering specifications, and specific qualitative findings for biocompatibility.

• Visual appearance (polymer tip integrity, jacket durability)
• Dimensional Measurement (Outside Diameter, Dry, after 10 min soak, after 40 min soak)
• Lubricity (force required to insert/withdraw in catheter)
• Pull Test (strength of welded joint points)
• 3-Point Bending Test (body stiffness/flexibility)
• Coating Durability (lubricity after multiple catheter insertions/withdrawals)
• Distal Tip (J) Memory (memory of shaped product)
• Kink Resistance
• Linear Stiffness (linear tip flexibility)
• Torque Control (response and rotational control)
• Torque Fatigue (torqueable strength) | Engineering Specifications:
  "All test results were within prescribed specification limits." (Implies meeting the design criteria and demonstrating equivalence to the predicate). |
  | Biocompatibility Testing (Meeting recommendations in FDA's General Program Memorandum #G95-1 and ISO-10993):
• Acute Systemic Toxicity
• Cytotoxicity (MEM)
• Hemolysis
• Intracutaneous Test
• Pyrogen (Material Mediated)
• Inhibition and Enhancement
• Sensitization
• Thrombo In-Vitro (Plate Method) | Biocompatibility Testing:
• Acute Systemic Toxicity: "No signs or symptoms of Systemic Toxicity were observed for any of the samples."
• Cytotoxicity (MEM): "The samples evoked a mild cytotoxic response (Grade 1), when tested at 48 hours. The test material passed the assay."
• Hemolysis: "The samples did not produce hemolysis."
• Intracutaneous Test: "For all samples, skin reactions were not significant."
• Pyrogen (Material Mediated): "The samples did not produce a pyrogenic response."
• Inhibition and Enhancement: "No endotoxin detected at 0.03 eu/ml."
• Sensitization: "The samples were deemed to be a non-sensitizer."
• Thrombo In-Vitro (Plate Method): "The test article was considered non-thrombogenic." |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: For each test series within the comparative test data, either fifteen (15) or ten (10) test samples were selected. Some destructive tests required additional sets of 10 or 15 samples. This applied to each of the three groups of wires (.018", .035", .038" standard configurations, including straight and shaped distal tips).
• Data Provenance:
  • Country of Origin: Not explicitly stated, but Lake Region Manufacturing, Inc. is located in Chaska, MN, USA. The "Terumo product was purchased by LRM, complete in packaging," so the Terumo product could have originated from anywhere Terumo manufactures.
  • Retrospective or Prospective: Prospective. The test samples were "produced following current manufacturing processes and procedures," and "Terumo product was purchased." "All samples were sterilized prior to testing." This indicates newly manufactured products specifically for this comparative testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of "experts" establishing ground truth in the traditional sense of clinical opinion or image interpretation. The "ground truth" for these engineering and biocompatibility tests is based on objective, quantitative measurements against predefined internal design specifications and recognized standards (e.g., ISO-10993) or established test methodologies.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements (e.g., micrometer measurements, force measurements, chemical assays). There is no subjective 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

Not applicable. This submission is for a medical device (guidewire), not an AI-powered diagnostic or interpretive tool that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications: Internal design criteria/specifications (presumably quantitative engineering limits) and a comparison to a predicate device (Terumo guidewires) presumed to be safe and effective.
• Biocompatibility: Recommendations from FDA's General Program Memorandum #G95-1 and international standard ISO-10993 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing), which specify acceptable biological responses to materials. These are based on established scientific principles and regulatory guidance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set. The "training" for the device itself would be the manufacturing process and quality system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of a physical medical device. The "ground truth" for ensuring consistent manufacturing would be the established "current manufacturing processes and procedures" and "design specifications" mentioned in the document, which are part of LRM's formal quality systems.

Ask a specific question about this device