(90 days)
Sternal IO Access is indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies.
The T.A.L.O.N.™ (Tactically Advanced Lifesaving IntraOsseous Needle) by Vidacare® has the same indications as the EZ-MIO Sternal, previously cleared by K063567. Both devices are for the purpose of obtaining vascular access during emergencies; both devices utilize a 15g 304 stainless steel manual needle set with a stylet and catheter that is manually inserted through the cortex of bone to the desired set depth within the medullary space to facilitate the infusion of medications and fluids.
This document is a 510(k) summary for the T.A.L.O.N.™ (Tactically Advanced Lifesaving IntraOsseous Needle) by Vidacare®. The purpose of this summary is to demonstrate substantial equivalence to previously marketed predicate devices (EZ-MIO Sternal and PYNG F.A.S.T. 1 Intraosseous Infusion System).
This is NOT a study describing acceptance criteria and device performance in the typical sense. It is a regulatory submission demonstrating substantial equivalence for a medical device. Therefore, many of the requested points are not applicable or cannot be extracted from this document, as a formal "study" with acceptance criteria and a test set (as one would evaluate an AI/software device) was not performed. Instead, the submission focuses on comparing technological characteristics and performance to predicate devices to prove safety and effectiveness.
Here's an attempt to address your points based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
| Acceptance Criteria (Implied for Substantial Equivalence to Predicates) | Reported Device Performance (Summary of Findings) |
|---|---|
| Safety and Effectiveness for Intraosseous Vascular Access in Sternal IO | "Safe and effective for gaining intraosseous vascular access through the sternum for the purpose of infusing fluids and medications." |
| Similar Indications for Use | "Identical to that of the T.A.L.O.N.™." (Referring to both predicates) |
| Similar Anatomical Sites | "Similar characteristics." |
| Similar Biocompatibility | "Similar characteristics." |
| Similar Needle Set Design Features | "Same needle set technology with a catheter of 15g stainless steel and stylet affixed to an ergonomically - designed manual driver/hub." |
| Similar Component Materials | "Similar characteristics." |
| Similar Energy Type (Manual) | "Similar characteristics." |
| Similar Environmental Specifications | "Similar characteristics." |
| Similar Ergonomics of the Patient-User Interface | "Similar characteristics." |
| Function Identically Once Inserted (Stylet Removed) | "Both predicates and the T.A.L.O.N. function identically once the needle sets are inserted into the medullary space and stylets are removed by permitting attachment of standard syringes and intravenous tubing for administration of medications and fluids." |
| Sterile and Single-Use | "All devices are sterile, single-use." |
| Improved Safety and Ease of Use (compared to EZ-MIO Sternal) | Deletion of scalpel, addition of adhesive-backed "sternal locator," precise depth control with affixed depth setting probes, securing of device, and lengthening of catheter. |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated as a numerical sample size in the context of human subjects or distinct "test cases" for performance evaluation. The "bench testing and design validation tests" likely involved multiple units of the device.
- Data Provenance: Not provided. The studies are described as "post-clinical studies, bench testing and design validation tests."
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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. This is a hardware medical device submission; the concept of "ground truth established by experts" for image interpretation or diagnosis (as in AI/software evaluation) is not relevant here. The "ground truth" for this device's performance would be its ability to consistently and safely achieve intraosseous access and allow fluid/medication administration.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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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 device is a manual intraosseous needle, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a manual medical device; there is no "algorithm" in the sense of a standalone software component. Its function inherently requires human operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is its ability to perform its mechanical function as intended – achieving safe and effective intraosseous vascular access through the sternum for fluid/medication infusion. This was likely evaluated through bench testing (functional and dimensional testing), design validation measures, and "post-clinical studies" (though details of these post-clinical studies are not provided in this summary). The ultimate "ground truth" or standard it had to meet was substantial equivalence to the predicate devices in terms of safety and effectiveness.
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model. The concept of a "training set" is not relevant.
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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).