Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

The Nasal Alar SpO2 Sensor is a disposable, single-patient pulse oximetry sensor that attaches to the nasal ala region to continuously monitor blood oxygen saturation (SpO2) and pulse rate in adult and pediatric patients (≥4 years, ≥15 kg) who are well or poorly perfused. It connects via DB-9 cable to compatible Philips FAST SpO2 pulse oximetry monitors in healthcare settings under professional supervision.

The device uses spectrophotometric transmissive-mode pulse oximetry to measure SpO2 and pulse rate (30–240 bpm ± 3 bpm) with an accuracy range (ARMS) of ≤3% across 70–100%. Key differences from the predicate include new glue formulation, updated heat-shrink tubing colorants, new coverlay material, minor LED chip adjustment for improved yield, and an improved ingress protection rating (IP34 versus predicate's IPX1), all maintaining established specifications.

ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, implantation, systemic toxicity); ISO 14971 (risk management); IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 (electrical safety and EMC); ISO 80601-2-61 (pulse oximeter equipment); ISO 14155 (clinical investigation); ASTM F1980 (shelf-life aging).

The Nasal Alar SpO2 Sensor is substantially equivalent to the Xhale Assurance Nasal Alar SpO2 Sensor (K171423) because it shares the same intended use, operating principles, measurement method, sensor specifications (single-patient use, 7-day wear, ≤3% ARMS, 30–240 bpm accuracy), and contact classification. Minor material and component changes do not raise new safety or effectiveness questions, and comprehensive V&V and clinical testing (SpO2 accuracy per ISO 80601-2-61) confirm technological equivalence.