(176 days)
The VidaPort provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.
The VidaPort (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a preset depth within the bone marrow. The driver then separates from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringes and IV lines for administration of drugs and fluids.
The provided text is a 510(k) premarket notification for the VidaPort Intraosseous Infusion System. It describes the device, its indications for use, and a comparison to a predicate device (Bone Injection Gun, K981853). However, it does not contain information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or expert involvement as typically found in clinical trials or performance studies for AI/software devices.
This document is a regulatory submission for a simple mechanical device and focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a rigorous standalone study. The "Testing" section mentions various types of testing (Electrical Safety, Electrical Emissions, Mechanical, Animal Body) but doesn't provide the details needed to fill out the requested table and study information.
Therefore, I cannot extract the requested information from the provided text. The document is not structured to provide these details for the following reasons:
- Type of Device: The VidaPort is a mechanical intraosseous infusion system (like a drill) for emergency access, not a diagnostic AI or imaging device. The types of performance metrics and studies required are vastly different.
- Regulatory Pathway: A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device. This often involves comparing technological characteristics and showing that the new device does not raise new questions of safety or effectiveness. It does not typically require a standalone clinical trial with detailed performance metrics and ground truth establishment in the same way an AI diagnostic tool would.
- Content Focus: The document focuses on describing the device, its indications, and a high-level comparison to the predicate device, asserting "similar technological characteristics" and equivalence across several domains. It mentions "Testing" but provides no specifics on methodologies, acceptance criteria, or results.
To answer your request, if this were an AI or software device, the required information would typically be found in a well-documented performance study, clinical trial report, or validation report that would be part of a more comprehensive regulatory submission (e.g., a PMA or a more detailed 510(k) for an AI device).
Given the provided text, I can only state that the document does not contain the specific information required to complete the table and answer the study-related questions. It indicates that various tests (Electrical Safety, Electrical Emissions, Mechanical, Animal Body) were performed to demonstrate equivalence, but it does not detail their methods, acceptance criteria, or results.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).