(69 days)
The EZ-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
The EZ-IO Intraosseous Infusion System previously cleared with K132583 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are medical grade. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set catheter serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light.
Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver with needle set attached, the needle set is pressed through the soft tissue to the outer cortex of the bone. Depth markers on the catheter must be visible prior to powering driver to ensure adequate needle length for proper placement within the medullary space. Clinicians then squeeze the driver trigger and apply moderate, steady pressure. Trigger is released when a sudden "give" or "pop" is felt, which indicates entry into the medullary space; the needle set will not always be inserted to the hub. After insertion of the needle set, the driver unit is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of medications and fluids.
This submission requests the addition of the distal femur as an insertion site for the pediatric population utilizing the same insertion technique and devices previously cleared via 510(k) K132538, which includes the insertion sites of the proximal tibia, distal tibia and proximal humerus.
This document is a 510(k) premarket notification for the Vidacare EZ-IO Intraosseous Infusion System, specifically requesting an expanded indication to include the distal femur as an insertion site for pediatric patients.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a quantitative or numerical format, nor does it present device performance in such a table. Instead, the "acceptance criteria" are implied by the applicant demonstrating the safety and efficacy of the EZ-IO system for the new distal femur insertion site, with the key argument being its similarity to currently approved sites and the absence of reported complications from its use in other regions.
The document references:
- Safety: The device has been cleared in the EU since 2011 for pediatric femoral insertion with no reported complications. The target area is "relatively large" making correct insertion "easier."
- Efficacy: Anatomically and physiologically, any bone with a medullary cavity can be used for infusion. The distal femur is closer to the heart, potentially providing "quicker drug and fluid delivery." Multiple publications support the use of the distal femur in pediatric patients for intraosseous access.
2. Sample Size Used for the Test Set and Data Provenance
The document primarily relies on cadaveric studies and preclinical vascular flow studies, and references to existing literature.
- Test Set Description: "cadaveric studies" and "preclinical vascular flow studies" are mentioned. No specific sample sizes for these studies are provided in this summary.
- Data Provenance: Not explicitly stated for the cadaveric and preclinical studies. However, the document mentions that the device is cleared in 39 countries outside the US, suggesting international experience. The EU clearance for pediatric femoral insertion since 2011 implies real-world data from Europe, though details are not provided within this specific submission summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given document. The summary only refers to "cadaveric studies" and "preclinical vascular flow studies."
4. Adjudication Method for the Test Set
This information is not provided in the given document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided summary. This submission focuses on expanding the indications for an existing device, primarily by demonstrating the safety and efficacy of a new anatomical insertion site, rather than comparing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The EZ-IO Intraosseous Infusion System is a physical medical device (a needle set and driver) for intraosseous access, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable to this device. Human interaction is central to its intended use (clinicians performing the insertion).
7. The Type of Ground Truth Used
The ground truth implicitly used for the studies mentioned appears to be a combination of:
- Anatomical/Physiological Feasibility: The statement, "Anatomically and physiologically any bone that has a medullary cavity can be used to safely infuse drugs and fluids...", establishes a fundamental biological ground truth.
- Direct Observation/Measurement: Implied by "cadaveric studies" (demonstrating physical insertion and placement) and "preclinical vascular flow studies" (demonstrating fluid delivery).
- Clinical Outcomes/Absence of Complications: The lack of reported complications from EU use since 2011 serves as a form of clinical ground truth for safety.
- Expert Consensus/Literature Review: The document cites multiple publications and notes that the distal femur IO insertion site is "noted to be an option and has been used with success in pediatric patients." This relies on established medical knowledge and expert consensus in the field.
8. The Sample Size for the Training Set
The concept of a "training set" typically applies to machine learning algorithms. Since the EZ-IO Intraosseous Infusion System is a physical medical device, there is no training set in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set (see point 8), this question is not applicable.
§ 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).