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510(k) Data Aggregation
(163 days)
The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.
The AMPLATZER Noodlewire Guidewire is a guidewire comprised of a stainless steel cable and coil. The cable wire component forms the inner body of the guidewire. The outer layer of the guidewire consists of a flat wire component coated with PTFE. The cable is placed within the coil. All components are secured together forming a single quidewire.
Acceptance Criteria and Study for the AMPLATZER® Noodlewire Guidewire
The provided document describes the 510(k) submission for the AMPLATZER® Noodlewire Guidewire. This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a feasibility clinical trial, rather than defining specific numerical acceptance criteria for a novel performance claim that would typically be evaluated in a standalone study or MRMC study.
Therefore, the structure below will reflect the type of information available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding device performance metrics for each criterion as might be seen for a new diagnostic device. Instead, the "acceptance criteria" are implied by the successful completion of various tests designed to show functional equivalence and safety. The "reported device performance" is a general statement about meeting these implied specifications.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Testing | ||
| Kink resistance | Withstand kinking forces (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Torqueability | Adequate torque transmission (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Torque strength | Withstand torsional forces (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Corrosion | Resist corrosion (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Fracture | Resist fracture (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Flexure | Demonstrate appropriate flexibility (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Tip Flexibility | Exhibit required tip flexibility (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Lubricity | Demonstrate adequate lubricity (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Pull testing | Withstand tensile forces (per ISO 11070 & FDA Guidance) | Functions according to specifications |
| Simulated Life Testing | Maintain performance under simulated in-use conditions | Documents performance under simulated, but accelerated, in-use conditions |
| Biocompatibility | Biocompatible (per ISO 10993-1) | Materials used are biocompatible |
| Clinical Performance | Safe and effective for intended use (implied by feasibility study) | Data collected as part of a feasibility clinical trial |
Conclusion from Studies: The results indicated that the AMPLATZER Noodlewire Guidewire functions according to specifications and the materials used are biocompatible. Therefore, the device is considered acceptable for human use.
2. Sample Size and Data Provenance for Test Set (Clinical Study)
- Sample Size: The document states that the AMPLATZER Noodlewire Guidewire "was used as a part of a feasibility clinical trial." It does not specify the exact sample size for this feasibility study.
- Data Provenance: The feasibility clinical trial was "conducted in the United States." This indicates a prospective study.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The clinical study mentioned is a "feasibility clinical trial," suggesting it was likely for initial safety and performance evaluation rather than establishing ground truth for a diagnostic device via expert consensus.
4. Adjudication Method for Test Set
This information is not provided as the clinical trial described is a feasibility study, not a diagnostic accuracy study requiring adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed according to the provided text. The submission focuses on demonstrating substantial equivalence through in-vitro functional testing, biocompatibility, and a feasibility clinical trial. There is no mention of a study comparing human readers with and without AI assistance for this device.
6. Standalone (Algorithm Only) Performance Study
A standalone algorithm-only performance study was not performed. The device is a physical medical device (guidewire), not a software algorithm that would have standalone performance measured.
7. Type of Ground Truth Used (Clinical Study)
The document refers to a "feasibility clinical trial" where "Specific data to the Noodlewire Guidewire was collected." While the specific nature of this ground truth is not detailed, in a feasibility study for a guidewire, the "ground truth" would likely involve objective clinical outcomes related to device performance in-vivo, such as successful navigation, ease of use, absence of complications (e.g., vessel damage, guidewire fracture), and successful facilitation of subsequent device introduction. It is not based on expert consensus for diagnostic accuracy, pathology, or traditional outcomes data in the context of diagnostic performance.
8. Sample Size for the Training Set
This information is not applicable/not provided. The device is a physical guidewire, not an AI/ML algorithm that requires a training set. The in-vitro functional testing and biocompatibility tests are not "trained" in the same sense as an algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reason as above.
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