BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)

The BD Intelliport System is an automated medication administration record-keeping system that integrates into intravenous lines to identify, measure, and document medications administered to patients during anesthesia procedures. It captures drug information from RFID-encoded syringes, measures the volume of medication delivered, and wirelessly transmits dose data to the patient's electronic medical record in hospital or surgical settings for patients weighing over 20 kg.

The subject device differs from the predicate by using RFID-labeled syringes instead of 2D barcodes, limiting compatible syringe sizes to 1–30 mL rather than 1–60 mL, changing the reader design and charger capacity from 5 to 2 bays, updating the flow algorithm to support refrigerated medications, and adding expired medication alerts. Both devices share the same intended use, fundamental technology, mechanism of action, and sterility levels.

ISO 10993-1 (biocompatibility), IEC 60601-1 and IEC 60601-2 (electrical safety and electromagnetic compatibility), ISO 80369-7 (IV port compatibility), USP 788 and ISO 8536-4 (particulate testing), and FDA guidance on human factors and usability engineering (2016).

The subject device maintains identical intended use and patient population as the predicate, with the same fundamental technology and mechanism for measuring and recording IV bolus injections. Design modifications (RFID reading, syringe size limits, updated algorithm, new alerts) were qualified through comprehensive non-clinical testing and human factors studies that demonstrate the subject device performs safely and effectively without raising different safety or effectiveness questions; testing confirms the expanded capability for refrigerated medications and improved user interface do not compromise device performance within the specified operating parameters.