(25 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 - 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.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Engineering Specifications (Implied to be equivalent to predicate and within internal design criteria): |
- 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.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.