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EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.

EZ-IO Humeral Head: The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia. The VidaPort provides intraosseous access in the proximal tibia. The EZ-IO Humeral Head provides intraosseous access in the Humeral Head. These devices are used when intravenous access is difficult or impossible to obtain.

The provided text is a 510(k) summary for the Vidacare® Needle for EZ-MIO and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head. This document does not contain information about acceptance criteria or a study proving device performance in the manner requested. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.

The key points from the document are:

• Device: Intraosseous infusion systems (needles and drivers) for providing access in the distal tibia, proximal tibia, or humeral head.
• Purpose of Submission: Extends the indications for use to include usage for up to 24 hours.
• Method of Equivalence: The submission states, "There have been no changes to the design or components of the devices cleared under 510(k) K062956, K032885 and K052408, and therefore the comparison of technological characteristics listed below are identical." This means the product's performance is assumed to be equivalent to the predicate devices because its design and components are unchanged.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies because the provided text does not contain that information. The document is a regulatory submission focused on substantial equivalence, not a detailed performance study report.

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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.

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