(30 days)
For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Utilizing a proprietary process, LRM produces a PTFE coated stainless steel steerable core. The proximal portion of the core wire is coated with PTFE to provide lubricity and improve wire handling. A platinum alloy coil, placed within the confines of the outer coil and over-wrapping the distal core section, provides radiopacity in the distal tip. The coils are secured in their location by solder, which is attached to the core. The proximal end of the outer coil is attached to the core with braze, and the distal end has a mid-point of the outer coil which is attached to the core with solder (applicable designs). The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are coated with MDX (silicone) or with hydrophilic coating. The guidewires are bound by the following parameters: Outside Diameter: .014", Lengths: 175cm - 300cm, Tips: Straight or shaped with various tip flexibilities, Flexibility: Floppy to Extra Support.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual/Tactile Attributes | Met established specific inspection criteria requirements. | The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices. |
| Dimensional Attributes | Met established specific inspection criteria requirements. | The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices. |
| Mechanical Attributes | Met established specific inspection criteria requirements. | The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices. |
| Hydrophilic Properties | Met criteria established for the hydrophilic properties of the guidewire (in addition to basic design criteria). | The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices. (Implied that hydrophilic properties were also found comparable given the overall statement). |
| Functional Equivalence | Device functionality and performance characteristics must be comparable to currently marketed devices. | The results of these tests demonstrated the functionality and performance characteristics of these guidewires are comparable to the currently marketed devices. |
| Biocompatibility | Acceptable biocompatibility for the device. | Biocompatibility testing has been performed on the material components of this device. This testing, along with a market history of proven biocompatibility, establishes acceptable biocompatibility for this device. |
| Design Control (21 CFR 820.30) | Conformance with design control procedure requirements. | LRM is in conformance with the design control procedure requirements as specified in 21 CFR 820.30. |
| Risk Analysis (FMEA) | All verification and validation activities result in the ability to demonstrate that the predetermined acceptance criteria were met. | Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met. |
| Material/Product/Process Qualification | Assure that each product manufactured with the hydrophilic coating remains equivalent to the predicate products, and that the changes will not have an adverse affect on the safe and effective use of the product. | LRM has formal quality systems in place to assure that each product manufactured with the hydrophilic coating remains equivalent to the predicate products, and that the changes will not have an adverse affect on the safe and effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify an exact numerical sample size for the test set used in non-clinical tests. It refers to "Test pieces" being tested.
- Data Provenance: The data provenance is not explicitly stated. The testing was conducted by Lake Region Manufacturing, Inc. (LRM), based in Chaska, MN, USA. It is implied to be internal company testing and is retrospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this submission. The "acceptance criteria" and "ground truth" discussed here refer to objective engineering and material performance tests for a medical device (guidewire), not a diagnostic or AI-driven interpretative device that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods are relevant for subjective assessments, typically found in clinical trials or diagnostic studies where multiple experts interpret data. The tests described are objective non-clinical performance and material tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the scope of this guidewire submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone algorithm performance study was not done. This submission is for a physical medical device (guidewire), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for the test set was based on established specific inspection criteria requirements for visual/tactile, dimensional, and mechanical attributes, as well as criteria established for the hydrophilic properties of the guidewire. For biocompatibility, it was based on biocompatibility testing performed on material components and a market history of proven biocompatibility. For design control and risk analysis, it was based on conformance with 21 CFR 820.30 and results of FMEA verification and validation activities. For material/product/process qualification, it was based on achieving equivalence to predicate products and ensuring no adverse effect on safe and effective use.
8. The Sample Size for the Training Set
- This information is not applicable. This submission describes the testing of a physical medical device (guidewire) to demonstrate substantial equivalence, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable. As stated above, this is not an AI/algorithm submission.
§ 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.