(29 days)
The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
The provided text describes the 510(k) premarket notification for the Mirage™ Hydrophilic Guidewire and X-pedion™ Hydrophilic Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, rather than a study on an AI/ML-based medical device.
Therefore, the information required to answer most of your questions about acceptance criteria for an AI/ML device, sample sizes for AI test sets, expert ground truthing, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not present in this document.
However, I can extract information related to the acceptance criteria and performance data for the physical medical device as described:
Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):
The document details numerous non-clinical bench tests performed to demonstrate the safety and performance of the guidewires. The results consistently state that "The Mirage™ and X-pedion™ Hydrophilic Guidewires met the acceptance criteria for [Test Name]."
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Test Category | Specific Test / Parameter | Acceptance Criteria (Implied by positive outcome) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| Chemical Characterization (Extractables/Leachables) | No risk to the patient from Chemicals of Potential Concern (COPC). | The extractables/leachables found are acceptable. | |
| Cytotoxicity | No evidence of cell lysis or toxicity; grade , and USP . | Met the acceptance criteria for bacterial endotoxin. | |
| Packaging | |||
| Terminally Sterilized Medical Devices | Met criteria per ISO 11607. | Met the acceptance criteria for packaging terminally sterilized medical devices. | |
| Performance (Bench) | |||
| Device Compatibility/Distal Access | Compatible with ancillary devices, navigates tortuous vessels. | Met the acceptance criteria for device compatibility/distal access. | |
| Distal Flexibility | Navigates through tortuous vessels. | Met the acceptance criteria for distal flexibility. | |
| Visual Fracture | Met criteria per ISO 10555-1 and ISO 11070. | Met the acceptance criteria for visual fracture. | |
| Radiopacity | Clearly visible during use. | Met the acceptance criteria for radiopacity. | |
| Tip Buckling | Withstands forces typical of clinical use. | Met the acceptance criteria for tip buckling. | |
| Tip Retention | Satisfactory tip retention. | Met the acceptance criteria for tip retention. | |
| Tip Shapeability | Satisfactory tip shapeability. | Met the acceptance criteria for tip shapeability. | |
| Torque Response | Distal tip responds to proximal manipulations. | Met the acceptance criteria for torque response. | |
| Turns to Failure | Withstands torsional forces typical of clinical use. | Met the acceptance criteria for turns to failure. | |
| Visual Inspection and Dimensional Verification | Meets specified dimensions. | Met the acceptance criteria for visual inspection and dimensional verification. | |
| Particulate | Meets criteria per USP for particulate counts and sizes. | Met the acceptance criteria for particulate counts and sizes. | |
| Friction Force | Satisfactory friction force. | Met the acceptance criteria for friction force. | |
| Flexing | Met criteria per ISO 11070. | Met the acceptance criteria for flexing. | |
| Corrosion Resistance | Met criteria per ISO 11070. | Met the acceptance criteria for corrosion resistance. | |
| Tensile Strength | Met criteria per ISO 11070. | Met the acceptance criteria for tensile strength. |
Since this is a 510(k) submission for a non-AI/ML medical device, the following information is not applicable or not provided in the document:
- Sample sizes used for the test set and the data provenance: Not an AI device, so no "test set" in the AI sense. Bench tests follow specific standards, implying sample sizes per those standards, but not explicitly stated here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth for a physical device is established via standardized physical and chemical tests, not expert human interpretation of data for AI.
- Adjudication method for the test set: Not applicable for non-AI bench testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a physical guidewire, "ground truth" is typically defined by adherence to engineering specifications, material properties, and performance under simulated clinical conditions, verified through empirical testing following established ISO and USP standards.
- The sample size for the training set: Not applicable; this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.
In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device requiring clinical validation for diagnostic or prognostic purposes.
§ 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.