(447 days)
Not Found
Not Found
No
The summary describes a device based on Electrical Impedance Tomography (EIT) and its performance is evaluated using traditional statistical methods (bias, limits of agreement). There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The studies focus on validating the EIT technology's ability to measure impedance variations and correlate them with ventilation distribution, not on training or evaluating an AI/ML model.
No
The device is described as providing "information of local impedance variation" as an "adjunctive tool" to support assessment, rather than directly treating a condition.
Yes
The device provides "information of local impedance variation within a cross-section of a patient's thorax" and presents this information "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." This function of providing information and supporting assessment of a patient's physiological state falls under the definition of a diagnostic device.
No
The device description and performance studies clearly indicate the use of hardware components for electrical impedance tomography (EIT), including surface electrodes and an acquisition module, which are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ENLIGHT 1810's Function: The ENLIGHT 1810 is a non-invasive device that measures electrical impedance variations within the patient's thorax. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it provides information of local impedance variation within a cross-section of a patient's thorax to support assessment of regional air content in the lungs. This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the ENLIGHT 1810 falls under the category of a non-invasive medical device used for physiological monitoring and assessment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QEB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electrical Impedance Tomography (EIT)
Anatomical Site
Patient's thorax / lungs
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Clinician user, medically ventilated adult patients in a hospital setting, ICU environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Animal Study:
- Study Type: Assessment of EIT to quantify ventilation distribution compared to X-ray computed tomography (CT)
- Sample Size: 7 swine animals
- Key Results: Agreement between EIT and CT for anterior/posterior (bias = -0.02 and limits of agreement = -0.09 to 0.06) and for right/left ROIs (bias = 0.04 and limits of agreement = -0.03 to 0.05%). Supported qualitative clinical performance.
Clinical Study 1:
- Study Type: Comparison between regional distribution of ventilation: EIT vs. CT
- Sample Size: 32/39 healthy volunteers (7 excluded from analysis)
- Method: EIT and CT images acquired simultaneously in supine, prone, and lateral decubitus during end-expiration and end-inspiration pause. Four thoracic regions of interest (ROI) defined: anterior, posterior, right, and left.
- Endpoints: Evaluated ventilation distribution to anterior/posterior and right/left regions of the thorax and assessed agreement with CT.
- Key Results: Anterior/posterior bias was -0.1 with limits of agreement -0.11-0.1. Right/left ROI bias was -0.02 with limits of agreement -0.09 to 0.06. Statistical evaluations were descriptive using Bland-Altman type difference plot.
Clinical Study 2:
- Study Type: Assessment of Regional Distribution of Ventilation: Right / Left
- Sample Size: 21 patients with lung transplants (11 single lung, 10 bilateral transplant)
- Method: Regional distribution of ventilation assessed with ENLIGHT during 30 cycles of regular, spontaneous breathing in five different body positions. CT scans performed at total lung capacity.
- Endpoint: Percent ventilation to the 'best lung' according to EIT.
- Key Results: Average tidal ventilation in supine position: 57±11% in bilateral transplants, 79±12% in unilateral transplants for emphysema, and 83±13% in unilateral transplants for fibrosis.
Clinical Study 3:
- Study Type: Assessment of Regional Distribution of Ventilation: Upper / Lower (Retrospective analysis)
- Sample Size: 39 patients
- Method: Evaluated regional distribution of ventilation to the anterior and posterior halves at different PEEP levels.
- Endpoint: Proportion of ventilation to the anterior region, obtained using ENLIGHT, at the highest and lowest PEEP levels.
- Key Results: Regional distribution of ventilation to the anterior half of the lung was 35 ± 6% during the highest PEEP and 62± 8% (P
§ 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.
0
DE NOVO CLASSIFICATION REQUEST FOR ENLIGHT 1810
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Ventilatory electrical impedance tomograph. 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.
NEW REGULATION NUMBER: 21 CFR 868.1505
CLASSIFICATION: Class II
PRODUCT CODE: QEB
BACKGROUND
DEVICE NAME: ENLIGHT 1810
SUBMISSION NUMBER: DEN170072
DATE OF DE NOVO: September 29, 2017
- TIMPEL Inc. CONTACT: R. Simão Álvares, 356 cj. 41 - Pinheiros São Paulo - SP, 05417-020, Brazil
INDICATIONS FOR USE
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.
LIMITATIONS
The sale, distribution, and use of the ENLIGHT 1810 are restricted to prescription use in accordance with 21 CFR 801.109.
1
WARNINGS AND PRECAUTIONS
- . Remove the Shaper and open the Electrode Belt prior to patient defibrillation. Protection circuitry of the device mav draw part of the energy delivered by the defibrillator if all electrodes are attached to the patient.
- To avoid an electric shock do not touch the Electrode Belt during the ● defibrillation discharge.
- . ENLIGHT 1810 should not be used on pregnant or lactating women since the safety and efficiency for such cases have not been verified.
- ENLIGHT 1810 should not be used on patients with active implantable devices, . such as pacemakers, cardioverter defibrillators, or neurostimulators. There is no scientific evidence of safety for the use of this device on patients with active implantable devices.
- . ENLIGHT 1810 should not be used in environments with elevated levels of ambient oxygen (such as hyperbaric chambers) oxygen-enriched environments or in the presence of flammable anesthetic gases or any flammable agent. The device may, however, be used in patients receiving oxygen-enriched ventilation.
- ENLIGHT 1810 is MR unsafe.
- ENLIGHT 1810 should not be used in areas of explosion hazard. .
- Do not apply the Electrode Belts or Reference Electrode on injured areas of the . skin (e.g., burns, open wounds, rashes, etc.).
- . Do not reuse the Electrode Belts. They are disposable and single patient use. Reusing Electrode Belts on a new patient may result in cross-infection.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
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.
2
The system components are shown below:
Image /page/2/Figure/1 description: This image shows a medical setup with a patient connected to various devices. The devices include a Spirometer Flow Sensor, an Addere and Electrode Belt, a Shaper, and a Reference Cable, all connected to the patient's body. On the right side, there is a computer, a Pneumotachograph, a Bioimpedance Measurement System, a Power Supply, and a Device Cart, indicating a comprehensive monitoring and measurement system for the patient's respiratory and physiological functions.
Figure 1. ENLIGHT 1810 System Components
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
ENLIGHT 1810 includes components (flow sensor) that have externally communicating patient contact via gas pathway for permanent duration. The electrode belt, and shaper have surface contact, intact skin.
The complete device in its final, finished form was subjected to biocompatibility testing in accordance with the FDA guidance document, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."" The following tests were conducted to assess biocompatibility of the device for the externally communicating components for permanent duration:
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
- Intracutaneous reactivity ●
- Extractables and leachables testing with a risk assessment .
All tests passed. The results demonstrated the biocompatibility of the device.
SHELF LIFE/REPROCESSING/STERILITY
The following components are single patient use only: the electrode belt, shaper, flow sensor, and reference cable. The Addere and reference electrode are single use only and
3
must be disposed each time after use.
The surface of the ENLIGHT 1810 hardware undergoes low level cleaning, usually with disinfecting wipes similar to equipment in the ICU. No components are provided sterile.
The cleaning procedures for the single patient use were validated following the recommendations of the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Data supported that 50 reprocessing cycles did not impact device functionality.
ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY
The ENLIGHT 1810 was tested in accordance with the following consensus standards and conformed with the following electromagnetic compatibility (EMC), electrical, mechanical and thermal safety standards:
- AAMI ANSI ES60601-1:2005/(R)2012 And A1:2012 C1:2009/(R)2012 And ● A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- ANSI AAMI IEC 60601-1-2:2007/(R)2012 Medical Electrical Equipment Part . 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3)
- The device was also tested for safe exposure to known sources of EMI with ● medical devices such as MRI, diathermy, and RFID.
MAGNETIC RESONANCE (MR) COMPATIBILITY
The device has not been tested for MRI compatibility and should not be used in an MRI suite.
SOFTWARE
The De Novo request provided adequate software documentation consistent with a "Moderate" level of software concern as discussed in the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005.
Software validation and verification testing demonstrated that the device met its design, implementation, and cybersecurity specifications.
PERFORMANCE TESTING - BENCH
The non-clinical testing for the device consisted of verification and validation testing of hardware and software.
The following bench tests were performed:
- Verification of the following specifications of the EIT system was performed . based on experimental saline phantom (proposed by Yasin M et al. (2011).
4
Evaluation of EIT system performance. Physiological measurement, 32(7), 851), The following performance characteristics were studied using an acrylic cylindrical tank filled with saline and the performance computed using experiments with contrast objects placed in this tank:
- о Signal to Noise Ratio: 45 dB-80 dB,
- Voltage Accuracy: 99.45%-100%, O
- Drift: Allan variance converges to zero, o
- o Reciprocity accuracy: 93%-100%,
- Amplitude response: 88%-102%, о
- Position error: