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510(k) Data Aggregation
(87 days)
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
Alight™ 16 Superselective Microwire Guides are intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Alight™ 16 Superselective Microwire Guides are 0.016 inches (0.41 mm) in diameter and are available in a variety of lengths and configurations. The core mandril of the Alight Superselective Microwire Guides is made of nitinol with a polymer coating and spans the entire length of the device to help facilitate flexibility and torqueability. The distal length of the device is covered with a hydrophilic coating.
This document describes the testing and acceptance criteria for the Alight™ 16 Superselective Microwire Guides.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Torque Response | Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be related to successful rotational response testing.) | All test articles were successfully subjected to rotational response testing and met the predetermined acceptance criteria. |
| Hydrated Lubricity | Peak force of all test articles was less than the predetermined acceptance criteria. (Specific criteria not detailed in the provided text, but implied to be a maximum force value.) | The peak force of all test articles was less than the predetermined acceptance criteria. |
| Flexing Evaluation | No flaking witnessed after testing. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be related to structural integrity after flexing.) | No flaking was witnessed after testing. The predetermined acceptance criteria were met. |
| Fracture Evaluation | All test articles underwent bending testing without showing signs of fracture. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be related to structural integrity after bending.) | All test articles underwent bending testing without showing signs of fracture. The predetermined acceptance criteria were met. |
| Torque Strength Evaluation | Device is sufficiently strong to withstand normal rotational loading for intended use. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be a minimum torque resistance.) | Testing verifies that the device is sufficiently strong to withstand normal rotational loading for intended use. The predetermined acceptance criteria were met. |
| Tensile Evaluation | Wire guide is sufficiently strong to withstand normal tensile loading for intended use in accordance with ISO 11070:2009. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be a minimum tensile strength according to the ISO standard.) | Testing verifies that the wire guide is sufficiently strong to withstand normal tensile loading for intended use in accordance with ISO 11070:2009. The predetermined acceptance criteria were met. |
| Tip Flexibility Evaluation | N/A (Tested for characterization purposes only, without a set acceptance criterion.) | The testing showed that the wire guide is sufficiently strong to withstand normal tensile loading for its intended use. |
| Biocompatibility Testing | Conformance with applicable sections of ISO 10993-1. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be acceptable results for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance.) | Device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the numerical sample size used for the test set for each individual test. It consistently refers to "all test articles" being subjected to the tests, implying that the entire batch of samples prepared for testing was used without presenting specific numerical counts.
The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text. It can be inferred that the testing was prospective as it was conducted specifically for this premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text describes performance testing of a medical device (microwire guide). For such physical and biocompatibility testing, "ground truth" is typically established through adherence to standardized testing protocols and validated measurement techniques, rather than expert consensus on interpretive data. There is no mention of experts being used to establish a "ground truth" in the way that would apply to interpretative diagnostic studies (e.g., radiologists interpreting images). The "ground truth" here is the physical measurement against set engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the tests are primarily objective performance measurements against predetermined engineering and biocompatibility criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided document relates to the premarket notification for a medical device (microwire guide), not a diagnostic or interpretative AI system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The testing described is entirely "standalone" in that it assesses the device's inherent physical and biological performance characteristics without integration into a human workflow or requiring human interpretation for its primary function. The device's performance is evaluated intrinsically.
7. The Type of Ground Truth Used
The ground truth for the performance tests described (Torque Response, Lubricity, Flexing, Fracture, Torque Strength, Tensile, Biocompatibility) is based on:
- Engineering Specifications and Predetermined Acceptance Criteria: These are set values or conditions that the device must meet, derived from design requirements, industry standards (e.g., ISO 11070:2009 for tensile evaluation, ISO 10993-1 for biocompatibility), and internal quality controls.
- Objective Measurements: Laboratory instruments and standardized procedures are used to objectively measure the device's physical properties (e.g., rotational response, peak force, absence of flaking/fracture, tensile strength).
- Standardized Biocompatibility Assays: Established biological tests (e.g., for cytotoxicity, sensitization) with predefined positive and negative controls and interpretation criteria.
8. The Sample Size for the Training Set
Not applicable. This document describes the evaluation of a physical medical device. There is no mention of a "training set" as would be used for machine learning or AI algorithms. The device's design and manufacturing processes are refined through engineering and material science, not through AI training on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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