(27 days)
The FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
The FASTI™ Intraosseous Infusion System has been designed to provide alternative access of the circulatory system to intravenous infusion. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum.
The provided text is a 510(k) summary for the FAST1™ Intraosseous Infusion System. It details an expansion of the intended use population to include adult and adolescent patients (12 years and older).
Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in terms of quantitative performance metrics. The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria and results.
Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not present:
- Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a new study. The acceptance criterion for this 510(k) appears to be "Substantial Equivalence" to predicate devices.
- Reported Device Performance: The primary "performance" reported is that the device has the "same intended use and the same or similar technological characteristics as the predicate devices." (Section VII)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (FAST1™ Intraosseous Infusion System cleared under K072487 and EZ-IO Intraosseous Infusion System cleared under K052195) | The FAST1™ Intraosseous Infusion System (expansion of intended use population) has the same technological characteristics as the FAST1™ Intraosseous Infusion System cleared under K072487. The differences in technological characteristics between the modified and predicate devices do not raise issues with safety and effectiveness. |
- Sample size used for the test set and the data provenance: N/A. No specific test set or data from a performance study is described. The submission relies on the substantial equivalence to previously cleared devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No ground truth establishment by experts for a test set is described.
- Adjudication method for the test set: N/A. No test set requiring adjudication is described.
- 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: N/A. This device is not an AI-assisted diagnostic tool, but a medical device for intraosseous infusion. Therefore, an MRMC study as typically performed for AI products is not applicable here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. No ground truth is described in the context of a new performance study. The ground for decision-making is substantial equivalence.
- The sample size for the training set: N/A. No algorithm training is described.
- How the ground truth for the training set was established: N/A. No algorithm training or corresponding ground truth establishment is described.
Summary of the study that proves acceptance criteria (as per the document):
The "study" presented is a substantial equivalence argument. The manufacturer asserts that the FAST1™ Intraosseous Infusion System (with expanded intended use population) is substantially equivalent to two predicate devices:
- The original FAST1™ Intraosseous Infusion System cleared under K072487.
- The EZ-IO Intraosseous Infusion System from Vidacare Corporation cleared under K052195.
The basis for this "proof" is that the modified device has the "same intended use and the same or similar technological characteristics" as the predicate devices. The document explicitly states: "The differences in technological characteristics between the modified and the predicate devices do not raise issues with the safety and effectiveness of the modified FAST1™ Intraosseous Infusion System." This implies that prior safety and effectiveness data for the predicate devices, and the inherent similarities, are considered sufficient evidence for accepting this expansion of intended use. There is no new clinical or performance study detailed in this 510(k) summary to establish novel acceptance criteria or performance metrics.
§ 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).