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The All Safe Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The All Safe Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries. The All Safe Huber Safety Infusion Sets are also indicated for power injection of contrast media into the central venous system with implanted vascular ports indicated for power injection. The maximum recommended infusion rate at 11.8 cps is 5 ml/sec for 19 and 20 gauge. Maximum pressure is 325 psi for all gauge sizes.

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I am sorry, but the provided text from the FDA 510(k) summary for the "All Safe Huber Safety Infusion Set" does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the specific details outlined in your request (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, or training set information).

The document is primarily a notification of a substantial equivalence determination by the FDA for a medical device. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It details the device's indications for use and classification.

To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a more detailed 510(k) summary that includes information about specific performance tests and their results against predefined acceptance criteria.

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The AllSafeTM Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The AllSafeTM Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries.

All Safe Huber Safety Infusion Sets

This is a 510(k) premarket notification letter from the FDA regarding a medical device called "All Safe Huber Safety Infusion Sets". It is not a study report and therefore does not contain the information requested about acceptance criteria, device performance, study design, or ground truth establishment.

A 510(k) letter primarily indicates that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not provide details of performance studies in the way a clinical trial report or a scientific publication would.

To answer the prompt, one would need access to the actual studies conducted by Nexus Medical, LLC to support their 510(k) submission, which are not provided in this document.

Ask a specific question about this device