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The STD Med Primo Port is a totally-implantable vascular access device designed to provide long term, repeated access to the vascular system.
The STD Med Primo Port Poly is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

The device described in this 510(k) consists of a a modified sterile, single use, implantable port, with catheter and catheter locks. The port is introduced into the vascular system and attached to the port stem using a catheter lock. The port is then sutured under the skin in the area of the subclavian fossa. The port is accessed percutancously usina a non-coring needle that penetrates a silicone rubber septum at the top of the port. The port system is the mechanism with which fluids can pass into and out of the central venous system.

The provided text is related to a 510(k) submission for a medical device called "Primo Port," a subcutaneous port and catheter. It details the device's description, indications for use, and regulatory information, including the FDA's substantial equivalence determination.

However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or the type of ground truth used.

The 510(k) summary states, "A description and summary of the verification and validation testing methods and results utilized to qualify the device modifications is included in this submission." However, these specific details are not present in the provided text.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not available in the given input.

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