Ge Medical Systems Information Technologies, Inc. · Class II · Cleared Dec 12, 2024
| K-number | K243540 |
| Device name | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product code | DQK |
| Device class | Class II |
| Decision date | Dec 12, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
Mac-Lab, CardioLab, ComboLab, and MLCL Client Software are hemodynamic and electrophysiology (EP) recording systems used during interventional procedures to acquire, display, record, and transmit patient physiological data. These devices process and display real-time hemodynamic and/or EP data for multiple parameters, with data entry via manual input or interfaced devices, and are not intended to function as patient monitors or alert practitioners to status changes.
Key changes from the predicate device (K213972) include: incorporation of Diastolic Pressure Ratio (dPR) software support in Mac-Lab; addition of a 64-channel option for the Prucka 3 EP amplifier in CardioLab alongside the existing 128-channel option; introduction of PruckaStream for digital waveform streaming from the EP amplifier; expanded signal filtering, gain, and customization settings to reduce noise and improve morphology; and optional use of Barco Nexxis OR for video distribution instead of HDMI splitters and switches.
IEC 60101-1 Ed 3.2 2020-08, IEC 60601-1-2 Ed 4.1 2020-09, IEC 60601-2-27 Ed 3.0 2011-03, IEC 60601-2-34 Ed 3.0 2011-05. Additional standards used for specific feature analysis (not fully applicable): IEC 80601-2-30, IEC 80601-2-55, IEC 80601-2-56, and IEC 80601-2-61.
The proposed devices employ identical fundamental scientific technology, basic design, construction, materials, energy source, control mechanism, and operating principles as the predicate device, with no change to intended use or indication for use. The technological modifications (dPR integration, dual EP amplifier channel options, PruckaStream, enhanced filtering) do not alter the core function of recording and displaying hemodynamic and EP data. Nonclinical testing including risk analysis, design reviews, unit and system verification, safety testing, and conformance to applicable standards demonstrated no new questions of safety or effectiveness, and the device performs comparably to the predicate.
View the full FDA submission: accessdata.fda.gov