Rotatable Connector (5944RL)

The 5944RL Rotatable Connector is a pair of single-use, disposable surgical cables with two adaptors designed to connect a cardiovascular stimulating instrument to a cardiac pacing lead during temporary cardiac pacing procedures. It is intended for use by trained clinicians in clinical environments during lead implantation, after which it is disconnected and discarded.

Both the subject device and predicate use 22 AWG cable, male-to-female connectors with alligator clips for distal attachment, and shroud pins for proximal connection. Key differences include the subject device's rotatable lead connector (versus standard alligator clip on predicate), use of ethylene oxide sterilization (versus radiation), and higher insulation resistance specification (>1GΩ versus >1MΩ), though both meet the same dielectric withstanding voltage of 1500 volts AC.

ANSI/AAMI ES60601-1 with Amendment 2 (2021), IEC 60601-1-2 Edition 4.1, ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 11737-1 and -2 (sterilization validation), ASTM F88/F88M-21 (seal strength), ASTM F2096-11 (leak detection), ASTM D4169-22 (shipping performance), and IEC 60601-2-31 (external cardiac pacemakers).

The devices share identical indications for use, intended users, use environments, principles of operation, and fundamental technological approach for transmitting electrical signals in temporary pacing systems. Although the subject device incorporates a rotatable connector design and different sterilization method, these modifications do not raise new safety or effectiveness questions because both devices achieve equivalent electrical performance (same cable gauge, connector types, and dielectric specifications) and both comply with the same applicable safety standards for medical electrical equipment and biocompatibility.