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510(k) Data Aggregation
(89 days)
CORDIS HYDRONOL STEERABLE GUIDEWIRE
The Cordis Hydronol Steerable Guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.
The Cordis Hydronol Steerable Guidewire is constructed from a superelastic nitinol core wire. A hydrophilic coating is applied over the guidewire. Cordis Hydronol Steerable Guidewires have a flexible, shapeable, and highly radiopaque platinum alloy coil on the distal tip.
This report describes the acceptance criteria and the study conducted to demonstrate that the Cordis Hydronol Steerable Guidewire meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) premarket notification for a medical device (guidewire) and does not contain explicit, quantitative acceptance criteria or detailed performance study results in the format typically used for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices through design, construction, indication for use, and performance characteristics.
The "performance" referred to in this document primarily relates to the device's functional integrity and safety as compared to existing, legally marketed guidewires. The key performance-related statement is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 standards for materials used. | "All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Hydronol Steerable Guidewires per ISO 10993-1." (Page 1, under "Biocompatibility") |
| Functional Equivalence: Be similar in performance characteristics to other commercially available hydrophilic steerable guidewires. | "The Cordis Hydronol Steerable Guidewire is similar in design, construction, indication for use and performance characteristics to other commercially available hydrophilic steerable guidewires." (Page 1, under "Summary of Substantial Equivalence") This is a qualitative claim of similarity rather than a quantitative performance metric. |
| Safety: Device materials and construction should not pose undue risk in clinical use. | Implied by successful biocompatibility testing and substantial equivalence claim. No specific quantitative safety metrics are reported. |
| Intended Use: Function effectively for its stated Indications for Use (introduce and position catheters/interventional devices within peripheral vasculature). | Implied by the design and comparison to predicate devices used for the same purpose. No specific quantitative performance metrics (e.g., steerability force, pushability, torque transmission, tip flexibility, coating durability) are provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of evaluating a medical device's performance through a study with specific data points or patient cases. The evaluation is based on pre-clinical testing (biocompatibility) and a declaration of substantial equivalence to existing predicate devices.
- Sample Size for Testing: Not specified for functional performance. Biocompatibility tests would involve specific samples of device materials, but the number is not detailed.
- Data Provenance: Not applicable in the context of clinical data. Biocompatibility testing is typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of submission relies on:
- Regulatory Experts: FDA reviewers (like Thomas J. Callahan, Ph.D., Director, Division of Cardiovascular, Respiratory, and Neurological Devices) make the determination of substantial equivalence based on the submitted documentation and their knowledge of medical device regulations and relevant science.
- Company Experts: The manufacturer (Cordis Corporation) employs engineers, scientists, and regulatory affairs personnel (e.g., Ms. Jacqueline Zimovan) who design the device, conduct tests, and compile the submission based on their expertise.
There's no mention of external clinical experts establishing "ground truth" for a test set in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable, as there is no described clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging devices, especially those incorporating AI, and involves multiple readers evaluating cases with and without AI assistance to measure human performance improvement. This document is for a mechanical guidewire and does not involve such an evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical, mechanical guidewire, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by existing regulatory standards and successful predicate devices.
- Biocompatibility: ISO 10993-1 provides the "ground truth" standard for safety of materials in contact with the body.
- Functional Performance: The performance of the predicate devices (Terumo Radifocus Glidewire, LRM Steerable Hydrophilic Guidewire) serves as the "ground truth" for acceptable performance characteristics, asserting that the new device is "similar."
8. The Sample Size for the Training Set
Not applicable. This submission does not involve an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment process for a training set.
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