Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

The Spectrum IQ Infusion System with Dose IQ Safety Software is a large-volume peristaltic infusion pump for controlled delivery of pharmaceutical drugs, blood, and blood products through intravenous, arterial, subcutaneous, or epidural routes. It includes guided programming and automation features to reduce pump programming errors, intended for use by trained healthcare professionals in hospitals and outpatient care settings.

The subject device uses linear peristaltic pumping with continuous and intermittent delivery modes, a color LCD display, AC power input (100-240 VAC), wireless capability (802.11a/b/g/n), flow rates from 0.5 to 999 mL/hr, and a real-time clock with 7-year battery life. The Dose IQ software supports up to 5000 drugs, 32 care areas, 400 clinical advisories, and configurable dosing limits. All specifications are identical to the predicate device K230041.

IEC 60601-1-8 standards are cited for alarm requirements. The document does not provide detailed references to specific testing standards beyond this.

The subject device is substantially equivalent because it maintains identical design and performance specifications to predicate K230041 across all technical characteristics: same pumping mechanism, delivery modes, routes, power specifications, wireless security, infusion modes, dose modes, volumetric accuracy, and Dose IQ software capacity. Non-clinical testing comparing the subject device to a previous version (K173084) met all acceptance criteria. The submission addresses only software design and labeling changes to remedy prior recalls, with no modifications to fundamental pump function or safety features.