(48 days)
The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.
The Lake Region Hydrophilic Guidewire consists of a flexible, tapered core wire that decreases in outer diameter from the proximal to the distal end. The hydrophilic coating reduces friction during use. The radiopaque distal coil facilitates fluoroscopic visualization. The Lake Region Hydrophilic Guidewire will be available in two configuration, with either an outer diameter of 0.010" or 0.014" and 180cm long.
The provided text describes a 510(k) premarket notification for a medical device, specifically the Lake Region Hydrophilic Guidewire. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (K003084), not to prove that the device meets specific acceptance criteria through new clinical or performance studies.
Therefore, many of the requested sections related to acceptance criteria, device performance, sample sizes, ground truth, and expert adjudication are not applicable to this document as it is a substantial equivalence submission, not a de novo submission or a PMA (Premarket Approval) where new performance data would typically be generated and presented against acceptance criteria.
However, I can extract information related to the device itself and the basis for its substantial equivalence.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
This information is not applicable as this submission is for substantial equivalence to a predicate device, and no new performance acceptance criteria or testing were conducted for the proposed device itself. The document explicitly states: "As there were no changes to the device itself and Lake Region conducted the original design verification testing used to establish safety and effectiveness under Concentric Medical Hydrophilic Guidewire K003084, no further testing has been required."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. No new test set data was generated for the proposed device. The submission relies on the data that established the predicate device's safety and effectiveness.
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)
This information is not applicable. No new ground truth establishment was reported for the proposed device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No new test set data or adjudication method was reported for the proposed device.
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
This information is not applicable. This is a medical device for intravascular use (a guidewire), not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As in point 5, this is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for the proposed device directly. The "ground truth" for its safety and effectiveness was established through design verification testing conducted for the predicate device (K003084), which involved laboratory and engineering tests to ensure physical and performance specifications were met. This would typically involve objective measurements against predefined specifications, rather than expert consensus on diagnostic outcomes.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As in point 8, this is not an AI/machine learning device.
Summary of the Device and Substantial Equivalence Claim (as per the document):
The document aims to demonstrate that the Lake Region Hydrophilic Guidewire is substantially equivalent to a predicate device cleared under 510(k) K003084. The basis for this claim is that the proposed device is identical to the predicate device, which Lake Region Manufacturing (LRM) previously manufactured for Concentric Medical. LRM also conducted the original design validation testing for that predicate device.
Key points from the document supporting substantial equivalence:
- Proposed Device is the same as the Predicate Device: "The proposed device is the same device as the predicate device."
- No Changes to Core Device Attributes: The comparison table explicitly states "No change" for Raw Materials, Assembly Process, Physical Characteristics, Intended Use, Anatomical Sites, Target Population, Performance Testing, Safety Characteristics, and Biocompatibility.
- Minimal Labeling Change: "The only change to the IFU will be to the manufacturer information and the omission of the optional introducer information."
- Original Testing Suffices: "As there were no changes to the device itself and Lake Region conducted the original design verification testing used to establish safety and effectiveness under Concentric Medical Hydrophilic Guidewire K003084, no further testing has been required."
- Design Control and Validation: LRM is in conformance with 21 CFR 820.30 and states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria could be met" for the original design.
- Biocompatibility: "The materials for the proposed device are identical to the predicate device cleared under K003084 and are identically processed and sterilized. Therefore, biocompatibility testing for the proposed device is not required."
In essence, the "study" proving the device meets acceptance criteria is the original design verification and validation testing performed for the predicate device K003084, which the current device is identical to.
§ 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.