SpO2 Extension Cable

The SpO2 Extension Cable is a medical device that connects pulse oximetry (SpO2) sensors placed on a patient to a monitoring device, enabling SpO2 monitoring by healthcare professionals. It consists of two separable parts: a patient cable with a 20-pin connector and an adapter with four types of pairing interfaces (DB9F-LNCS, MLNCS-MLNCS, LNOP-LNOP, RD-RD) that connects to SpO2 sensors. The device is reusable and non-sterile.

The key difference from the predicate device (K222370) is structural: the proposed device can be separated into two parts (patient cable and adapter), whereas the predicate is a non-separable complete extension cable. Both devices use shielded and unshielded copper wiring with PVC or TPE jackets, have 2m±10% cable length, and maintain identical materials and manufacturing processes. Both are compatible with Masimo Corporation sensors and monitors including the Radical-7.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization), IEC 60601-1 Edition 3.2 (electrical safety), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), ISO 80601-2-61:2017 (pulse oximeter equipment requirements), and ANSI AAMI EC53:2013/(R)2020 (ECG cables and leadwires). Compatibility testing verified no data corruption during sensor-monitor communication.

Although the structure differs (separable vs. non-separable), both devices contain identical plug, cable/leadwire, and connector components. The proposed device complies with all the same electrical safety standards (IEC 60601-1, IEC 60601-1-2), performance standards (ISO 80601-2-61), and biocompatibility standards as the predicate. Compatibility testing confirms accurate performance with the same sensors and monitors. The structural modification does not affect safety or effectiveness because the fundamental design, materials, and functional performance remain equivalent.