(25 days)
For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases up to 24 hours. For patients ≥ 12 years old, the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.
The EZ-IO Intraosseous Vascular Access System previously cleared with K202492 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 biocompatible. 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 serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).
The provided document is an FDA 510(k) clearance letter for the EZ-IO Intraosseous Vascular Access System. It describes a Special 510(k) submission, which means the device being submitted is very similar to a previously cleared predicate device, with only minor changes. In this case, the only change is the sterilization of the EZ-IO Power Driver.
Therefore, the document does not describe a study involving AI performance, human reader improvement with AI assistance, or the establishment of ground truth by expert consensus for an AI-based device. It focuses on demonstrating the substantial equivalence of the modified (now sterile) power driver to the existing non-sterile one through non-clinical performance testing.
Consequently, much of the requested information (related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth for AI) is not applicable to this document.
However, I can extract the information relevant to the provided text:
Acceptance Criteria and Device Performance (for the change in sterility of the driver)
The acceptance criteria for this 510(k submission are not directly stated as clinical performance metrics for the device's indications for use. Instead, they are related to demonstrating that the change (sterilization of the power driver) does not negatively impact the safety and effectiveness compared to the predicate device. The performance is demonstrated through non-clinical testing.
Table 1: Acceptance Criteria (Implied) and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device remains substantially equivalent to the predicate device. | The proposed device is identical to the predicate device in design, materials, functional performance, principles of operation, manufacturing, packaging, sterilization (for other components), and shelf life, except for the sterility of the power driver. |
| Sterilization process effectiveness. | ISO 11135:2014 (Ethylene oxide sterilization standard) was met, ensuring a sterility assurance level (SAL) of 10^-6. |
| Packaging integrity and sterility maintenance. | Met ASTM F1886/F1886M-16, ASTM F2096-11 (2019), and ISO 11607-1:2019 standards. |
| Biocompatibility of materials. | Biocompatible materials were used per ISO 10993-1. |
| Functional performance of the Power Driver after sterilization. | EZ-IO Power Driver RPM and Insertion Testing and Useful Life Testing were performed, meeting previously established acceptance criteria for the predicate device. |
| Safety and effectiveness are maintained. | "The results of the bench tests demonstrate that the EZ-IO Power Driver is as safe and effective as the predicate device." |
Detailed Information as per Request:
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A table of acceptance criteria and the reported device performance: See Table above.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in terms of clinical patient numbers. The testing appears to be primarily bench/laboratory testing on physical devices and packaging.
- Data Provenance: Not specified, but generally, such non-clinical testing for FDA submissions would be conducted in controlled laboratory environments, likely within the US or by certified labs adhering to international standards. The tests are prospective in nature as they evaluate the manufacturing process and design changes.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth in the context of expert consensus for AI models is not relevant here. The ground truth for this submission is established through adherence to recognized international standards for sterilization, packaging, and functional performance testing, which are objectively measurable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments by multiple human readers, often in the context of AI performance evaluation. Here, the "truth" is determined by objective measurements against established engineering and sterilization standards.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not done as this clearance is not for an AI-enabled device or one that involves human interpretation of medical images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is not for an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on engineering standards, validated sterilization processes, and functional performance specifications of the medical device components (specifically, the power driver). It is objective and measurable, rather than being derived from subjective expert consensus, pathology, or clinical outcomes data in the context of a diagnostic or treatment outcome.
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The sample size for the training set:
- Not applicable. This submission does not involve an AI model or a training set.
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How the ground truth for the training set was established:
- Not applicable. This submission does not involve an AI model or a training set.
§ 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).