PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
GANSHORN Medizin Electronic GmbHThe PowerCube+ Series by GANSHORN Medizin Electronic GmbH is a medical device designed for professional healthcare settings to measure lung function in patients 5 years and older. It performs multiple pulmonary function tests such as Spirometry, Body Plethysmography, Lung Diffusion, Occlusive Resistance, and Respiratory Muscle Strength measurements. These tests help clinicians obtain detailed physiological parameters used to diagnose and monitor lung conditions. The device uses ultrasound technology for flow measurement, an air-tight chamber for body plethysmography, and gas analyzers to assess lung diffusion capacity. It supports electronic medical record integration, providing accurate and reliable data for respiratory assessment.
Intended Use
The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician. The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.
Technology
The device includes a spirometry flow meter using ultrasound transit-time sensors for flow measurement; an air-tight plethysmograph chamber with pressure sensors measuring pressure changes applying Boyle's Law for lung volume estimation; gas analyzers measuring helium and carbon monoxide concentrations for lung diffusion capacity assessment; and a shutter mechanism with pressure sensors for occlusive resistance and respiratory muscle strength measurements. The device runs on a PC with LFX software module handling signal processing and user interface, with support for EMR connectivity.
Performance
Bench testing demonstrated performance compliance with multiple standards including ATS/ERS guidelines, ISO 23747:2015 for peak expiratory flow meters, ISO 26782:2009 for spirometers, and 2017 ERS/ATS standards for single-breath carbon monoxide uptake. Comparative testing against an FDA-cleared predicate device (MasterScreen) showed measurements within 5% deviation for key parameters. The device passed electromagnetic compatibility, electrical safety, software/cybersecurity verification and validation, biocompatibility, cleaning validation, and shelf-life testing. Clinical testing was not deemed necessary given substantial equivalence and bench validation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/14/2024
9 months - 2
FDA Approval
12/9/2024
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