IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)

IBP cables and IBP adapter cables are passive electrical conductors that transmit electrical signals from invasive blood pressure (IBP) transducer sets to the Draeger Vista 300 Patient Monitor. The submission includes six distinct cable versions with different connectors (Becton Dickinson, Edwards, Abbott/Medex, Utah, and two Draeger adapter cables) for use in intrahospital patient monitoring.

The subject devices feature shielded copper wire with medical-grade TPU cable jackets and TPU overmolded connectors with integral strain relief. Key differences from the predicate include a fixed cable length of 3.8 m versus various standard lengths, and connector material specification (TPU versus PA overmolding). Both subject and predicate devices operate as passive signal conductors without signal modification.

IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-34 (invasive blood pressure monitoring equipment), ISO 10993-1/5/10 (biocompatibility testing including cytotoxicity, sensitization, and irritation), ISO 17664-2 (device processing for non-critical devices), and TS 60601-4-2 (electromagnetic immunity guidance).

The devices are substantially equivalent because they share identical indications for use, fundamental passive signal conduction technology, similar design and materials, identical usage pattern (reusable, non-sterile), and comparable performance across biocompatibility, mechanical, electrical, and safety testing. Both forward IBP signals unchanged to a patient monitor using passive electrical conduction with similar connector and wire specifications.