(447 days)
ENLIGHT 1810 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs.
It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm.
ENLIGHT 1810 is a non-invasive, radiation free medical device intended to provide information on the regional distribution of ventilation in a cross-sectional slice of the thorax.
As the total variation in impedance for the thorax corresponds to the total tidal volume, ENLIGHT 1810 can estimate the percentage of tidal volume in regions of interest (ROI) breath by breath, measuring the contribution of the impedance variation of that ROI to the total impedance of the lung.
Electrical impedance tomography (EIT) is a technique in which the electrical properties of tissues are estimated from surface electrode voltage measurements and used to provide information on Local Impedance Variation (LIV) within a cross section of a patient's thorax. Considerable electrical impedance variations are imposed on lung tissue by variations in the lung's air content. There is a linear relationship between the variations in air content and the percentage change in lung tissue impedance. This linear relationship is explored in Electrical Impedance Tomography, supporting its use as a tool to support the user's assessment of the variations in regional air content within a cross section of a patient's lungs.
The device may be used on adult patients undergoing either fully controlled or assisted mechanical ventilation in the ICU environment.
Acceptance Criteria and Study for ENLIGHT 1810
The ENLIGHT 1810 is a ventilatory electrical impedance tomograph intended to be an adjunctive tool to other clinical information to support the user's assessment of variations in regional air content within a cross-section of a patient's lungs. As such, the device's acceptance criteria primarily focus on its ability to qualitatively measure regional ventilation distribution and its safety and performance under various conditions.
1. Table of Acceptance Criteria and Reported Device Performance
The direct "acceptance criteria" for clinical performance are not explicitly stated in quantitative metrics (e.g., specific accuracy thresholds) for the human studies. Instead, the studies aim to demonstrate agreement and the qualitative utility of the device in assessing regional ventilation distribution compared to gold standards (CT). The bench tests, however, do have specific quantitative performance parameters.
| Acceptance Criterion (Category) | Specific Measure/Performance Parameter | Acceptance Threshold (Implicit/Explicit) | Reported Device Performance (Bench Study) | Reported Device Performance (Clinical Studies) |
|---|---|---|---|---|
| Safety & Biocompatibility | Biocompatibility (patient-contacting components) | Pass all tests (Cytotoxicity, Sensitization, Irritation, Intracutaneous reactivity, Extractables & leachables) | All tests passed | N/A (addressed in non-clinical) |
| Shelf Life/Reprocessing/Sterility | Reprocessing Validation (single patient use components) | 50 reprocessing cycles without impact on functionality | Data supported 50 reprocessing cycles did not impact device functionality | N/A (addressed in non-clinical) |
| EMC & Electrical Safety | Compliance with AAMI ANSI ES60601-1, ANSI AAMI IEC 60601-1-2 | Conformance with standards | Conformed with specified standards | N/A (addressed in non-clinical) |
| Software | Software functionality and cybersecurity | Met design, implementation, and cybersecurity specifications | Met design, implementation, and cybersecurity specifications | N/A (addressed in non-clinical) |
| Non-clinical Performance: EIT System Parameters | Signal to Noise Ratio | Not explicitly stated as acceptance, but specification: 45 dB-80 dB | 45 dB-80 dB | N/A |
| Voltage Accuracy | Not explicitly stated as acceptance, but specification: 99.45%-100% | 99.45%-100% | N/A | |
| Drift | Not explicitly stated as acceptance, but specification: Allan variance converges to zero | Allan variance converges to zero | N/A | |
| Reciprocity Accuracy | Not explicitly stated as acceptance, but specification: 93%-100% | 93%-100% | N/A | |
| Amplitude Response | Not explicitly stated as acceptance, but specification: 88%-102% | 88%-102% | N/A | |
| Position Error | Not explicitly stated as acceptance, but specification: |
§ 868.1505 Ventilatory electrical impedance tomograph.
(a)
Identification. A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing;
(ii) Real time evaluation of local impedance variation;
(iii) Plethysmogram accuracy testing; and
(iv) Use life testing of reusable components.
(3) Performance data must validate reprocessing instructions for any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Guidance for interpretation of the images generated;
(ii) A warning that the device should be removed before use of a defibrillator, or defibrillator interaction information based on defibrillator performance testing with the device;
(iii) A use life for any reusable components; and
(iv) Instructions for reprocessing any reusable components.