(269 days)
For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. Insertion sites: ADULTS (≥22 years): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur
The EZ-IO System previously cleared with K14117 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).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core change addressed by this submission is the expansion of the "EZ-IO Intraosseous Vascular Access System" indications for use from up to 24 hours to up to 48 hours. Therefore, the primary acceptance criteria revolve around demonstrating the safety and effectiveness of the device for this extended dwell time.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility for Prolonged Contact (up to 48 hours) | Materials of construction evaluated according to ISO 10993-1 for prolonged contact duration (>24 hours to ≤ 30 days) for all relevant components (EZ-IO Needle Set, EZ-Connect extension tubing set, EZ-Stabilizer dressing). Results indicated the materials are biocompatible for this duration. |
| Maintenance of Physical Performance for Extended Use | Performance requirements for physical parameters (tensile strength, torsion strength, bend strength, leak, burst pressure) are not time-dependent and the materials are unchanged. The performance data from the predicate device (K141117) for 24-hour use is considered applicable for 48-hour use without additional testing. |
| Safety of Intraosseous Catheter Retention for 48 Hours | Primary endpoint of the clinical study was the absence of serious complications from IO catheter retention over a 48-hour period. No serious Adverse Events (AEs) or complications were reported for any subjects randomized into the study during a 30-day follow-up. The study concluded that IO access can be maintained for 48 hours without significant risk of serious adverse events. |
| Manageability of Pain during 48-hour Dwell and Infusion | The clinical study demonstrated that pain associated with catheter dwell and infusion can be well-managed. |
| Maintenance of Patency for 48 Hours | The clinical study noted that a slow infusion of 30 mL/hour maintained patency for 48 hours. |
| Identification and Mitigation of Risks for Extended Use | Identified limitations of the study (comparison to actual use, literature limitations) led to restricted Indications for Use (only when alternate IV access is unavailable/unreliable, and only in patients ≥12 years old for the extended duration). "CAUTION" statements were added to the Instructions for Use regarding increased risk for patients with comorbidities, increased risk with longer dwell times, and the importance of frequent monitoring. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): 121 evaluable subjects.
- 79 healthy volunteers
- 39 with diabetes only
- 3 with diabetes and renal insufficiency
- Data Provenance: US single-site, prospective clinical IDE trial.
- Sample Size (Test Set): 121 evaluable subjects.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The study involved clinical trial procedures and observations, including physical examinations and x-rays, but the specific number or qualifications of "experts" establish ground truth in the sense of a diagnostic consensus is not detailed. The "ground truth" here is the clinical outcome (complications, pain, patency) observed in the subjects under the study protocol.
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Adjudication method for the test set:
- Not explicitly stated in detail for all events. However, adverse events were assessed for relatedness to the device, implying a review process. The primary endpoint was the "absence of serious complications," suggesting a clear definition of what constitutes a serious complication and its determination by the study team.
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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. This is not an AI/imaging device. It is a medical device for vascular access.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/algorithm device.
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The type of ground truth used:
- Clinical outcomes data: The ground truth was based on the presence or absence of serious complications, pain reports, patency, and other observed adverse events during the 48-hour indwelling period and subsequent 30-day follow-up of human subjects. This also included objective measures like IO aspirate cultures and x-rays.
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The sample size for the training set:
- N/A. This is a medical device approval, not an AI model requiring a training set. The "development" of the device was based on prior predicate devices and engineering principles, with the clinical study serving as a validation of the extended use.
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How the ground truth for the training set was established:
- N/A. As above, no training set in the AI sense was used.
§ 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).