(173 days)
Intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal angioplasty (PTA), in peripheral arteries including but not limited to femoral, popliteal arteries. This guide wire may also be used with compatible interventional devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
The Heraeus Peripheral Guidewire is a guidewire constructed using a steel core with an optional nitinol alloy tip encapsulated by polymer and lubricious outer layer. The distal polymer includes a radiopaque loading, and the distal polymer section has a hydrophilic coating.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Heraeus Peripheral Guidewire." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials against pre-defined acceptance criteria for diagnostic performance (such as those associated with AI/ML-based devices).
Therefore, many of the specific questions about acceptance criteria for diagnostic performance, and detailed study methodologies (like sample sizes for test sets, expert adjudication, MRMC studies, standalone performance of an algorithm, and ground truth establishment for training sets) do not directly apply to this type of regulatory submission and the device described.
This document describes a guidewire, which is a physical medical instrument, not a diagnostic algorithm or AI system. The "performance testing" mentioned is bench testing to ensure physical and material properties meet established standards for similar devices.
However, I can extract and present the information that is relevant to the document's content:
Acceptance Criteria and Device Performance (Bench Testing for Physical Properties)
The document states that the Heraeus Peripheral Guidewire met all predetermined acceptance criteria through in vitro bench tests. While the specific numerical acceptance criteria values are not explicitly detailed in this summary, the types of performance characteristics evaluated are listed. The "reported device performance" is summarized by the statement: "The Heraeus Peripheral Guidewire met all predetermined acceptance criteria and compared favorably with the predicate."
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category (Type of Test) | Reported Device Performance |
|---|---|
| Biocompatibility Testing: | Met criteria per ISO 10993-1:2018 and 2016 FDA guidance. |
| - Cytotoxicity | Passed |
| - Sensitization | Passed |
| - Intracutaneous Reactivity | Passed |
| - Acute Systemic Toxicity | Passed |
| - Pyrogenicity Testing | Passed |
| - Hemolysis | Passed |
| - In-Vivo Thrombogenicity | Passed |
| - Coagulation | Passed |
| - Platelet Activation | Passed |
| - Haematology | Passed |
| - Complement Activation | Passed |
| Material/Physical Properties: | Met criteria. |
| - Corrosion resistance | Met criteria. |
| - Dimensional inspection | Met criteria. |
| - Sterile package integrity testing | Met criteria. |
| - Tensile strength | Met criteria. |
| - Tip flexibility | Met criteria. |
| - Torque strength | Met criteria. |
| - Torqueability | Met criteria. |
| - Kink/Fracture Resistance | Met criteria. |
| - Kink resistance | Met criteria. |
| - Radiopacity | Met criteria. |
| - Coating Integrity, Lubricity | Met criteria. |
| Functional/Simulated Use: | Met criteria. |
| - Track/Simulated Use | Met criteria. |
| - Particulate Evaluation | Met criteria. |
Study Details (as applicable to a 510(k) for a physical device):
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Sample sizes used for the test set and the data provenance:
- The document mentions "in vitro bench tests" and "test data," but does not specify the sample sizes (e.g., number of guidewires tested for each parameter).
- Data Provenance: The tests were conducted to demonstrate equivalence with reference to "FDA Guidance - Coronary and Cerebrovascular Guidewire Guidance - January 1995." The data would originate from Heraeus Medical Components, LLC's internal testing facilities. The provenance is implied to be laboratory-based (in-vitro bench tests). The document does not specify country of origin for the direct test data, but the company is in Plymouth, Minnesota, USA. It's retrospective in the sense that the tests were performed and compiled for the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" here refers to pre-defined engineering and material specifications, not clinical diagnostic interpretations. The "experts" would be the engineers and quality assurance professionals performing and evaluating the bench tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert interpretations of clinical data, which is not what was done for this device. The evaluation of bench tests typically relies on meeting pre-defined quantitative or qualitative engineering specifications.
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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 a physical guidewire, not a diagnostic imaging/AI device. Therefore, no MRMC study looking at human reader improvement with AI assistance was conducted or would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for proving performance equivalence is based on established engineering specifications, material standards (e.g., ISO 10993-1), and comparative testing against the predicate device's known characteristics. It is not clinical "ground truth" like pathology or outcomes data.
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The sample size for the training set:
- Not applicable. This concept relates to machine learning models. This device underwent bench testing, not a machine learning training process.
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How the ground truth for the training set was established:
- Not applicable. As above, there was no machine learning training set for this 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.