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510(k) Data Aggregation
(79 days)
The NovaCross™ Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
The NovaCross™ Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange.
The NovaCross™ Microcatheter consists of telescopic shaft, over tube, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site.
The provided text is a 510(k) summary for the NovaCross™ Microcatheter, focusing on demonstrating substantial equivalence to a predicate device. It explicitly states that the submission is a "Special 510(k) submission" to implement modifications to an already cleared device. This type of submission relies on performance testing to assure that the modified device remains as safe and effective as the predicate.
Here's an analysis of the acceptance criteria and study described:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it describes various performance tests conducted to ensure the modified device functions similarly to the predicate. The "reported device performance" is generally stated as the tests being successfully completed and demonstrating similarity to the predicate.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Simulated Use Testing | Device performs as intended during simulated use, effectively guiding, tracking, and exchanging guidewires. | "successfully completed" (implied, as it supports substantial equivalence) |
| Biocompatibility | Meets ISO 10993 standards for contact with blood and tissue (cytotoxicity, hemolysis, etc.). | Passed based on biological risk assessment, cytotoxicity, and hemolysis testing. |
| Mechanical Tests: | ||
| - Bond Strength | Sufficient bond strength to ensure device integrity during use. | "successfully completed" (implied) |
| - Visibility Test | Radiopaque markers/features provide adequate visibility under fluoroscopy. | "successfully completed" (implied) |
| - Radial Force Test | Scaffold provides appropriate radial force for anchoring without causing damage. | "successfully completed" (implied) |
| - Axial Force Test | Device maintains structural integrity and pushability/trackability. | "successfully completed" (implied) |
| GLP Animal Study | Device functions safely and effectively, demonstrating adequate scaffold deployment, anchoring, and maneuverability without adverse tissue reaction. | "successfully completed" (implied, to assess new scaffold and device characteristics) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for any of the individual tests (simulated use, mechanical, biocompatibility, or the GLP animal study).
The data provenance is within the manufacturer's testing facilities or accredited labs, as it pertains to engineering and preclinical testing of a medical device intended for regulatory submission. There is no mention of country of origin for the data or whether it's retrospective or prospective in the context of human clinical data, as this is a device modification submission based on non-clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For this type of device modification submission, which relies on engineering and preclinical testing, the concept of "ground truth" established by human experts in a clinical context is not directly applicable. The "ground truth" for these tests is defined by engineering specifications, recognized standards (like ISO for biocompatibility), and animal model observation by veterinary and scientific staff.
Therefore, the document does not mention a number of experts or their qualifications for establishing ground truth in the way it would for an AI-based diagnostic device. The expertise would be in the form of engineers, toxicologists, veterinarians, and study directors overseeing the performance and animal studies.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or evaluators assess patient data (e.g., medical images) to establish a consensus ground truth. This is not applicable to the engineering and preclinical tests described for the NovaCross™ Microcatheter. The test results are objective measurements or observations defined by the test protocols.
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 assesses human reader performance, often with and without AI assistance, and is relevant for AI-powered diagnostic devices. The NovaCross™ Microcatheter is a physical interventional medical device, not a diagnostic imaging or AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. This is relevant for AI algorithms. The NovaCross™ Microcatheter is a physical device that functions in conjunction with a steerable guidewire and is manipulated by a human operator (physician).
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests is based on:
- Engineering Specifications: For mechanical tests, the ground truth is adherence to design specifications and established performance parameters.
- Industry Standards: For biocompatibility, the ground truth is compliance with recognized standards such as ISO 10993.
- Physiological Response/Observation: For the GLP animal study, the ground truth is the objective observation of device performance in a living system and the histological assessment of tissue reaction.
- Intended Use Definition: For simulated use, the ground truth is the successful demonstration of the device's ability to achieve its intended function (e.g., guidewire exchange, access discrete regions).
8. The Sample Size for the Training Set
Not applicable. The NovaCross™ Microcatheter is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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