(31 days)
The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.
The 0.035" diameter, 260-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are manufactured from Stainless Steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE), The coil and the core components are welded together on the distal and proximal ends, forming the guidewire. The distal ends are shaped into a double-curve.
The provided text describes a 510(k) submission for a "Pre-Formed Guidewire." This is a medical device, and the information pertains to proving its substantial equivalence to a legally marketed predicate device, rather than a study on an AI/ML powered device.
Therefore, many of the requested categories (such as human-in-the-loop performance, expert ground truth for AI, typical AI study design elements) are not applicable to this type of traditional medical device submission.
Here's an analysis based on the information provided, highlighting the applicable parts and noting the non-applicable ones:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the way one might expect for a quantitative AI performance evaluation. Instead, it lists the types of bench tests performed to demonstrate compliance with design input and substantial equivalence. The "reported device performance" is summarized as "the devices comply with the design input summary" and "resulted in the ability to demonstrate that the predetermined acceptance criteria were met."
| Acceptance Criteria (Bench Tests Performed) | Reported Device Performance |
|---|---|
| Dimensional | Complies with design input summary |
| FDA Tensile Strength | Complies with design input summary |
| FDA Tip Flexibility | Complies with design input summary |
| FDA Catheter Compatibility | Complies with design input summary |
| Packaging Study | Complies with design input summary |
| Tip Shape Retention | Complies with design input summary |
| Particulate | Complies with design input summary |
| ISO Visual | Complies with design input summary |
| ISO Fracture | Complies with design input summary |
| ISO Flex | Complies with design input summary |
| ISO Corrosion Resistance | Complies with design input summary |
| Linear Stiffness | Complies with design input summary |
| Biocompatibility Testing | No additional tests needed as materials unchanged; previously cleared. |
| GLP Animal Study | Guidewires are substantially equivalent to legally marketed device. |
2. Sample Sizes used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for each bench test. The document mentions "Test devices were manufactured and inspected."
- Data Provenance: The bench testing and animal study were conducted by Lake Region Medical, the manufacturer based in Chaska, Minnesota, USA. This is a prospective study in the sense that the tests were performed specifically for this 510(k) submission on newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the tests are for a physical medical device, not an AI/ML algorithm requiring expert ground truth for interpretation. Performance is measured objectively through physical and mechanical tests.
4. Adjudication method for the test set
- Not applicable for this type of physical device testing. Results are typically based on objective measurements against pre-defined specifications.
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/ML powered device or an AI assistance study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used
- For the bench tests, the "ground truth" or reference is the "design input summary" and "predetermined acceptance criteria" derived from engineering specifications and applicable standards (e.g., FDA, ISO standards).
- For the animal study, the "ground truth" for comparison was the performance of the currently marketed predicate device.
8. The sample size for the training set
- Not applicable. There is no AI/ML training set mentioned.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML training set mentioned.
Summary of the Study Proving Device Meets Acceptance Criteria:
The device's safety and effectiveness (and thus meeting acceptance criteria) were demonstrated through a combination of bench testing and an animal study.
- Bench Testing: Several physical and mechanical tests were conducted on manufactured test devices. These included Dimensional, FDA Tensile Strength, FDA Tip Flexibility, FDA Catheter Compatibility, Packaging Study, Tip Shape Retention, Particulate, ISO Visual, ISO Fracture, ISO Flex, ISO Corrosion Resistance, and Linear Stiffness tests. The manufacturer states that these tests demonstrated "compliance with the design input summary" and "resulted in the ability to demonstrate that the predetermined acceptance criteria were met."
- Biocompatibility Testing: No new biocompatibility tests were performed because there were no changes to the materials used from the predicate device.
- Animal Study: A GLP (Good Laboratory Practice) animal study was conducted. This study's purpose was to evaluate the safety and performance of the new guidewire compared to the currently marketed predicate device. The conclusion was that "the guidewires are substantially equivalent to the legally marketed device."
The overall conclusion is that "the conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary which shows the device is at least as safe and effective as the current legally marketed device." The changes made to the device (additional tip shape, distal core grind diameter minimum made larger) did not alter its intended use or fundamental scientific technology, supporting the claim of substantial equivalence.
§ 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.