Enlight 2100 (TPL-E2103-0)

The ENLIGHT 2100 is a non-invasive, radiation-free electrical impedance tomography (EIT) device that measures local impedance variation in a cross-section of a patient's thorax to assess regional air content variations. It provides respiratory parameters based on spirometric monitoring and is intended for mechanically ventilated patients (adults to infants over 29 days old) with thorax perimeter 37.5–134 cm in hospital settings. The device does not measure regional ventilation directly but serves as an adjunctive tool to other clinical information.

The device uses 16–32 electrodes placed around the thorax and employs the same EIT hardware and algorithms as the predicate with no modifications to core EIT data processing. Changes include reusable electrode belt and reference cable (previously single-use), additional software parameters for Distribution Change Map normalized by driving pressure, and automated calculation of ΔEEZ and compliance loss percentages (HPCzL and LPCzL) that users could perform manually on the predicate. The operating system remains Yocto-based Linux.

ISO 10993-1 biocompatibility standard cited for patient contact characterization (surface contact, intact skin, prolonged duration up to 30 days). No other consensus standards (IEC, ASTM) explicitly referenced in the summary.

The device is substantially equivalent because it has identical indications for use, same patient population, same environment of use, and no changes to the core technological characteristics (hardware and EIT algorithms remain unchanged). Software enhancements and parameter additions are non-material—they automate calculations and display information already available to users on the predicate device or represent complementary visualization of the same underlying EIT data. The reusable accessories involve no material or hardware changes and require only cleaning instructions. Bench testing confirmed equivalent performance for all new parameters despite the predicate not having explicitly documented these values.