(160 days)
The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices.
The Abbott Vascular StarClose 6F Dilator is a tapered plastic tube with a hub to facilitate handling and an interior channel sized to accept a 0.038 inch guidewire. The dilator goes inside one of the StarClose sheaths to provide support while gaining access to blood vessels prior to catheterization procedures.
This is a premarket notification (510(k)) for a medical device (dilator) and does not include information about artificial intelligence (AI) or machine learning (ML). Therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a 510(k) submission for a traditional medical device (StarClose 6F Dilator), not an AI/ML device. Therefore, there are no specific "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity that would be reported for an AI model.
Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. The performance is assessed through non-clinical testing to ensure:
- Biocompatibility: No new adverse effects introduced.
- Physical Properties: Appropriate for the intended use.
The document does not provide specific numerical results or acceptance criteria for these non-clinical tests within the summary. It broadly states that "Results of scientific testing have ensured that all materials are biocompatible no new adverse effects were introduced and physical properties are appropriate for the intended use."
2. Sample Size Used for the Test Set and Data Provenance:
This section is not applicable as the device is not an AI/ML system requiring a test set for performance evaluation. The testing conducted appears to be non-clinical (e.g., laboratory or engineering tests).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This is not applicable as there is no mention of a test set with ground truth established by experts.
4. Adjudication Method for the Test Set:
This is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable. There is no mention of human readers or AI assistance in this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This is not applicable as the device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used:
This is not applicable as the device is a physical medical instrument. The "truth" for this type of device is typically its physical specifications meeting design requirements and safety/biocompatibility standards, not a diagnostic outcome.
8. Sample Size for the Training Set:
This is not applicable as the device is not an AI/ML system.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as the device is not an AI/ML system.
Summary of the Study for Substantial Equivalence:
The study referenced is a premarket notification (510(k)) submission demonstrating substantial equivalence for the StarClose 6F Dilator to predicate devices (Encapsulon Vessel Dilators (K840641) and Super Sheath Introducer Sheath (K052557)).
- Objective: To show that the StarClose 6F Dilator has the same intended use, is biocompatible, and has appropriate physical properties for its intended use, thus being as safe and effective as legally marketed predicate devices.
- Methodology: The submission states that "Abbott Vascular has submitted information on indications for use, design and principle of operation, biocompatibility and performance characteristics." It further indicates that "Non-clinical testing was conducted." While details are not provided in the summary, this non-clinical testing would typically involve:
- Biocompatibility testing: To ensure the materials used do not cause adverse biological reactions (e.g., ISO 10993 series of standards).
- Physical and mechanical testing: To verify the dilator's strength, flexibility, dimensions, and other physical properties meet design specifications and are suitable for percutaneous introduction of intravascular devices.
- Conclusion: The submission concluded that the StarClose 6F Dilator "has been shown to be substantially equivalent to the Class II predicate devices upon which the dilator is based." The FDA concurred with this determination.
In essence, the "study" for this device is the collection of non-clinical, engineering, and biocompatibility tests required to demonstrate substantial equivalence under the 510(k) pathway for a traditional medical device.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).