(90 days)
PREDICATE™ III GUIDEWIRE are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers.
The provided document describes a 510(k) premarket notification for the Predicate III Guidewire, a Class II medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than a standalone study proving novel performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or AI-based devices, is not directly applicable or available in this submission.
However, I can extract information related to the device's qualification testing which serves to ensure it meets its design inputs and performs comparably to the predicate device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met," and "The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary." However, it does not provide a specific table listing quantitative acceptance criteria and the corresponding reported performance values for the Predicate III Guidewire. Instead, it lists the types of tests performed to ensure compliance.
| Acceptance Criteria (General Description) | Reported Device Performance (General Statement) |
|---|---|
| Visual/tactile, dimensional, and mechanical attributes | Complies with design input summary and established requirements. Test devices were manufactured and inspected according to these. |
| Compliance with design input summary (for specific tests below) | Demonstrates compliance with the design input summary and is at least as safe and effective as the current legally marketed device. |
| Biocompatibility (pre-defined acceptance criteria outlined in product Design Input Summary) | The addition of full-length coil does not affect biocompatibility, and the device is still in compliance with pre-defined acceptance criteria. |
Specific Qualification Tests Performed (acting as evidence for meeting implied acceptance criteria):
- Dimensional
- Guidewire Pull Test
- Camber Resistance
- Visual Inspection
- Wire Fracture Test
- Corrosion
- Wire Flex Test
- ISO Strength of Union
- Particulate Residue Test
- Cytotoxicity (Biocompatibility)
- Hemolysis (Biocompatibility)
- Chemical Characterization (Biocompatibility)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact sample sizes used for each of the bench tests or biocompatibility tests. It generally refers to "Test devices."
- Data Provenance: Not applicable. The data is from in-house bench and lab testing of the manufactured guidewires by Lake Region Medical. The country of origin of the data is not explicitly stated but would presumably be the United States, given the company's location (Chaska, MN). The data is generated prospectively as part of product development and verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This is a medical device (guidewire) cleared based on substantial equivalence, not a diagnostic or AI device requiring expert-established ground truth from patient data. The "ground truth" for guidewire performance is established through engineering design specifications and material science.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of device submission. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads).
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software device. Bench testing constitutes a "standalone" evaluation of the physical device's characteristics against its design specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on engineering design specifications, material properties, and established medical device performance standards (e.g., ISO standards for guidewires and biocompatibility). Compliance with these predefined technical and safety requirements serves as the "truth" that the device must meet.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.
§ 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.