(162 days)
The FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult patients requiring vascular administration of drugs or fluids to facilitate emergency resuscitation
The modified FASTI™ Intraosseous Infusion System is very similar to the FAST1™ Intraosseous Infusion System previously cleared under 510(k) K970380. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the sternum of the patient, the target/strain-relief patch, protector dome and sharps plug. The minor difference is that the infusion tube of the modified FAST1™ Intraosseous Infusion System can be removed from the patient's sternum by directly pulling on the infusion tubing, whereas the predicate device utilizes a remover tool to remove the infusion tube from the patient's sternum.
Both products are single use, hand-held, manually operated passive devices, (it has no internal energy source). Both products have an infusion tube with a sharp stainless steel tip, a flexible shaft and a standard Luer connector. For both products the user grasps an introducer handle attached to the infusion needle, and pushes the needle tip through the skin and overlying tissue into the sternum of the subject. Fluids or drugs are delivered through the needle to the marrow space of the sternum, and flow out the emissary veins of the sternum into the venous circulation.
Both devices use the same pusher handle and method to insert the infusion needle to the correct penetration depth in the sternum; a mechanism inside the introducer handle disconnects the handle from the infusion needle, preventing the user from pushing the needle any further. The principal of the mechanism is identical for both devices in that it detects the position of the anterior surface of the cortical bone of the sternum, and relates the position of the tip of the infusion needle to the surface of the cortical bone.
Both devices utilize the same adhesive patch which is applied to the top of the patient's chest which the user aligns with the supra-sternal notch of the patient. The position of the recommended insertion site is the same for both devices and is marked on the patch to aid in land marking. Also, the same patch and an associated cover for both devices provide protection and strain-relief to the site and the installed Infusion Tube.
The provided text is a 510(k) summary for the FAST1™ Intraosseous Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device, specifically highlighting a minor modification related to the removal mechanism of the infusion tube. It does not contain specific acceptance criteria, a detailed study description with performance metrics, or information related to AI or ground truth establishment in the context of medical device performance studies.
Therefore, many of the requested details cannot be extracted from the provided input. The document is primarily a regulatory submission for a device modification, not a standalone performance study report.
Here's a breakdown of what can be inferred and what is missing, based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document focuses on demonstrating substantial equivalence to a predicate device, which implies the modified device should perform at least as safely and effectively as the predicate.
- Reported Device Performance: Not quantified. The study conclusion states "The verification and validation conducted and conclusions demonstrate that the modified FAST1™ Intraosseous Infusion System is as safe and effective as the predicate device K970380." This is a qualitative statement of equivalence, not a report of specific performance metrics.
2. 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 mentioned.
- Data Provenance: Not mentioned.
- Retrospective/Prospective: Not mentioned.
3. 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)
- This information is not applicable and not provided. The study is a comparison of a modified mechanical device to a predicate device, not an assessment of diagnostic performance requiring expert interpretation or ground truth establishment in that typical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided.
5. 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
- MRMC Study: No, an MRMC study was not done. The device is a direct-use medical device, not a diagnostic or AI-assisted tool involving human readers.
- AI Improvement Effect Size: Not applicable, as the device does not involve AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical sense. The "ground truth" for this device's performance would likely involve mechanical testing, simulated insertion/removal tests, and potentially human factors assessments to confirm the modified removal mechanism's efficacy and safety. These details are not provided.
8. The sample size for the training set
- Not applicable, as this device does not use machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
- 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).