(318 days)
No
The summary describes a device that uses electrical impedance tomography to measure relative impedance variations and presents this data to the clinician. There is no mention of AI/ML algorithms being used for data processing, interpretation, or decision support. The performance studies focus on comparing the device's output to other methods and assessing regional ventilation distributions based on the impedance data, not on the performance of any AI/ML model.
No.
The device provides information for assessment of regional air content, acting as an adjunctive diagnostic tool, but does not state any therapeutic function or intervention.
Yes
The device "provides information of local impedance variations within a cross section of a patient's thorax" and "supports the user's assessment of variations in regional air content within a cross section of a patient's lungs." This information is used by the clinician to assess a patient's condition, which is a diagnostic purpose. The performance studies also show its use in assessing regional ventilation distributions in various clinical scenarios, further indicating its diagnostic utility.
No
The device description explicitly states it uses "several electrodes (16+1) placed around the patient's thorax" to assess impedance variations, indicating a hardware component is integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that AirTom "provides information of local impedance variations within a cross section of a patient's thorax" and that 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." This describes a device that measures physiological parameters directly from the patient's body (non-invasive, non-radiation) to provide information about their internal state.
- Device Description: The description reinforces this by explaining that it uses electrodes placed around the patient's thorax to assess regional impedance variations in a lung slice. It measures these variations during a breathing cycle, which are related to variations in regional air content.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
AirTom does not perform tests on samples taken from the body. It directly interacts with the patient's body to gather information. Therefore, it falls under the category of a medical device used for physiological monitoring or imaging, not an IVD.
N/A
Intended Use / Indications for Use
AirTom is a non-invasive, non-radiation medical device that provides information of local impedance variations 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 patients in a professional healthcare facility, whose chest circumference is within the range of 32 ~ 130 cm.
AirTom does not measure regional ventilation of the lungs.
Product codes
QEB
Device Description
AirTom is a ventilatory electrical impedance tomograph that uses several electrodes (16+1) placed around the patient's thorax to assess regional impedance variations in a lung slice (tomography). It provides only relative measurements about variations in local impedance.
AirTom estimates local impedance variations, occurring in a cross section of the thorax during a breathing cycle, which are linearly related to variations in regional air content within the lungs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax / lungs
Indicated Patient Age Range
Adult and pediatric patients, whose thorax perimeter is within the range of 32 ~130 cm.
Intended User / Care Setting
clinician user / professional healthcare facility (Hospital setting)
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)
A. Comparison of regional ventilation distributions: EIT vs. X-ray CT image
Methods: AirTom was used on six patients during routine clinical practice in ICU. Xray CT or chest X-ray images were acquired to identify a likely region(s) with a different amount of tidal ventilation. Tidal images from the AirTom device were assessed in terms of regional ventilation in the right (R) and left (L) lungs and also anterior (A) and posterior (P) regions.
Results: Below is a case of a 72-year-old male patient with atelectasis and pneumothorax. The patient was mechanically ventilated. Tidal ventilation in the left lung was only 4% due to atelectasis in the left-posterior/middle region and pneumothorax in the left-anterior/middle region.
B. Assessment of regional ventilation distributions: Anterior and posterior regions
Methods: This was a retrospective analysis of 53 patients (gender: male and female, age: 3 months ~ 80 years) under general anesthesia during surgery. AirTom monitoring started before induction of anesthesia and continued until the end of operation. Regional distributions of ventilation in the anterior (A) and posterior (P) halves from the 53 patients were evaluated at different PEEP levels.
Results: After induction of general anesthesia, atelectasis occurred in the posterior region (P) in most of the 53 patients in supine position. Due to this atelectasis, tidal ventilation in the anterior region (anterior proportion) increased to an average value of 72.2% at an initial low PEEP value as shown in the figure below. When PEEP was increased to a higher value, some of the collapsed alveoli in the posterior region were successfully recruited to result in larger tidal ventilation in the posterior region. Therefore, tidal ventilation in the anterior region (anterior proportion) was reduced to an average value of 59.6% at a high PEEP value.
C. Assessment of regional ventilation distributions: With and without pneumoperitoneum
Methods: This was a retrospective analysis of 28 patients (gender: male and female, age: 1 month ~ 80 years) under general anesthesia during laparoscopic surgery with pneumoperitoneum. AirTom monitoring started before induction of anesthesia and continued until the end of operation including time periods before and after CO2 insufflation. Regional distributions of ventilation were evaluated before and after CO2 insufflation and also after CO2 desufflation.
Results: The total impedance changes between two states (CO2 on and off) from the 28 patients are shown below. The reference time to compute the total impedance change was right after the induction of general anesthesia before CO2 insufflation.
With pneumoperitoneum by CO2 on, i.e., after CO2 insufflation, the total impedance change between end-inspiration and end-expiration decreased on average to 64.8% of the baseline value. After CO2 desufflation, i.e. CO2 off, the total impedance change between end-inspiration and end-expiration recovered to 90.1% of the baseline value.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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June 30, 2023
Bilab Eung Je Woo, Ph.D. Chief Technical Officer 5F Ubiquoss Building, 68 Pangyo-ro 255beon-gil, Bundang-gu Seongnam-si, Gyeonggi-do 13486 Korea. South
Re: K222466
Trade/Device Name: AirTom Regulation Number: 21 CFR 868.1505 Regulation Name: Ventilatory electrical impedance tomograph Regulatory Class: Class II Product Code: QEB Dated: June 28, 2023 Received: June 28, 2023
Dear Eung Je Woo, Ph.D .:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222466
Device Name AirTom
Indications for Use (Describe)
Air Tom is a non-invasive, non-radiation medical device that provides information of local impedance variations 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 patients in a professional healthcare facility, whose chest circumference is within the range of 32 ~ 130 cm.
AirTom does not measure regional ventilation of the lungs.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains a logo for "BiLab". The logo features the letters "BiLab" in a bold, sans-serif font. To the left of the text is a circular graphic with a blue gradient, suggesting a stylized atom or a sphere with a light source. The overall design is clean and modern, likely representing a technology or science-related company.
510(k) Summary BiLab's AirTom®
1. Submitter's information:
| Submitted by | BiLab
5F Ubiquoss Building, 68 Pangyo-ro 255beon-gil
Bundang-gu, Seongnam-si
Gyeonggi-do 13486, Republic of Korea |
|-------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact
person | Eung Je Woo, Ph.D.
Chief Technical Officer, BiLab
phone: +82-70-4865-0591 |
| Date prepared | June 14, 2023 |
2. Device information:
| Trade name | AirTom® |
|---|---|
| Common/Usual name | Ventilatory electrical impedance tomograph |
| Classification | |
| name | Ventilatory electrical impedance tomograph |
| 21 CFR 868.1505, FDA product code QEB, Class II |
3. Predicate device information: AirTom is substantially equivalent to the following:
| Manufacturer | Device |
|---|---|
| TIMPEL S.A. | Enlight 2100 (K211135) |
4. Device description
AirTom is a ventilatory electrical impedance tomograph that uses several electrodes (16+1) placed around the patient's thorax to assess regional impedance variations in a lung slice (tomography). It provides only relative measurements about variations in local impedance.
AirTom estimates local impedance variations, occurring in a cross section of the thorax during a breathing cycle, which are linearly related to variations in regional air content within the lungs.
4
5. Intended Use and Indications for Use
Intended Use: AirTom is intended to be used as a prescription non-invasive, nonradiological ventilatory device that provides an assessment of local impedance variations within a cross section of a patient's thorax.
Indications for Use: AirTom is a non-invasive, non-radiation medical device that provides information of local impedance variations 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 patients in a professional healthcare facility, whose chest circumference is within the range of 32 ~ 130 cm.
AirTom does not measure regional ventilation of the lungs.
6. Summary of technological characteristics compared to predicate device
Both AirTom and the predicate device are prescription devices used by clinicians in similar medical environments, have the same intended use, and are supplied and used, non-sterile.
The AirTom and predicate device systems also have a similar design configuration (composed primarily of a monitor and electrodes) and energy sources. Both systems have a touchscreen that provides user control features. The monitors are connected to electrodes for data measurements.
Ventilatory electrical impedance tomography is employed by both the AirTom and the predicate systems. In the collection of impedance data, the differences between the predicate and AirTom do not raise any questions of safety and effectiveness.
7. Non-clinical performance data provided for substantial equivalence
Technical standards: AirTom was tested and found to comply with the requirements of the technical standards applicable to medical devices (including the predicate device), as listed below.
FDA Guidances: Technical information was also provided in accordance with the recommendations of the FDA Guidances, as listed below.
5
Image /page/5/Picture/0 description: The image contains the word "BiLab" with the "B" being stylized with a blue sphere behind it. The text is black and the sphere is a gradient of blue. The text is bolded and sans-serif.
| Testing performed/
information
provided | Tested or Information provided in accordance
with Technical Standards and/or FDA Guidances
(listed below): |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shelf life testing –
Electrode pads | ANSI/AAMI EC12:2000/(R)2015
Disposable ECG electrodes |
| Biocompatibility
information
and testing | FDA Guidance: Use of International Standard ISO 10993-1,
Biological evaluation of medical devices -Part 1:
Evaluation and testing within a risk management process,
issued 9-4-20 |
| | ISO 10993-1:2018, Biological Evaluation of Medical
Devices – Part 1: Evaluation and Testing within a Risk
Management Process |
| Software information
and testing | FDA Guidance: Guidance for Industry and FDA Staff:
Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices, issued 5-11-05 |
| Off-the-Shelf (OTS)
software information and
testing | FDA Guidance: Guidance for Industry and FDA Staff:
Off-the-Shelf Software Use in Medical Devices,
issued 9-27-19 |
| Cybersecurity
information | FDA Guidance: Draft Guidance for Industry and FDA Staff:
Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices, issued 10-18-18 |
| Electromagnetic
compatibility testing | IEC 60601-1-2 Edition 4.1, Medical Electrical Equipment -
Part 1-2: General Requirements For Basic Safety
And Essential Performance - Collateral Standard:
Electromagnetic Compatibility - Requirements And Tests |
| Electrical and Mechanical
safety testing, including:
Basic safety and essential
performance testing, | IEC 60601-1:2005 + A1:2012, Medical Electrical
Equipment - Part 1: General Requirements For Basic
Safety And Essential Performance |
| Usability testing, | IEC 60601-1-6:2010 + A1:2013, Medical Electrical
Equipment - Part 1-6: General Requirements For Basic
Safety And Essential Performance – Collateral Standard:
Usability |
| | IEC 62366-1 Edition 1.1 Medical Device-Application of
usability engineering to medical devices |
| | FDA Guidance: Content of Human Factors Information in
Medical Device Marketing Submissions, Draft Guidance,
issued 12-09-22 |
| Degrees of protection/
enclosure testing | IEC 60529:2013, Degrees of Protection Provided By
Enclosures (IP22) |
| Patient cable testing | ANSI/AAMI EC53:2013, ECG Trunk Cables
and Patient Lead Wires |
| Testing performed/
information
provided | Tested or Information provided in accordance
with Technical Standards and/or FDA Guidances
(listed below): |
| Packaging testing
(vibration and shock) | ISTA Procedure 3A: 2018, For packaged products
weighing 150 lb (70 kg) or less |
| Battery testing | IEC 62133-2:2017: Secondary cells and batteries
containing alkaline or other non-acid electrolytes -
Safety requirements for portable sealed secondary lithium cells,
and for batteries made from them, for use in
portable applications - Part 2: Lithium systems |
| Battery transport
testing | ST/SG/AC.10/11/Rev.7 Recommendations on transport
of dangerous goods/Manual of tests and criteria/Rev.6/Amend.
1 Part III, subsection 38.3 Lithium metal and lithium ion
batteries |
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Image /page/6/Picture/0 description: The image shows the logo for BiLab. The logo features a stylized "B" with a blue gradient, followed by the text "iLab" in black. The "B" is designed with a circular shape and a gradient that transitions from dark blue to light blue, giving it a modern and technological appearance.
8. Clinical performance data provided for substantial equivalence
A. Comparison of regional ventilation distributions: EIT vs. X-ray CT image
Methods: AirTom was used on six patients during routine clinical practice in ICU. Xray CT or chest X-ray images were acquired to identify a likely region(s) with a different amount of tidal ventilation. Tidal images from the AirTom device were assessed in terms of regional ventilation in the right (R) and left (L) lungs and also anterior (A) and posterior (P) regions.
Results: Below is a case of a 72-year-old male patient with atelectasis and pneumothorax. The patient was mechanically ventilated. Tidal ventilation in the left lung was only 4% due to atelectasis in the left-posterior/middle region and pneumothorax in the left-anterior/middle region.
Image /page/6/Picture/6 description: The image shows two medical scans side by side. The scan on the left is a CT scan of a patient's lungs, showing signs of infection. The scan on the right is a tidal image, which is a type of medical imaging that is used to assess lung function. The tidal image shows the distribution of air in the lungs, with the blue areas indicating areas of good ventilation and the black areas indicating areas of poor ventilation. The image also shows the patient's vital signs, including their blood pressure (67/33) and heart rate (96/4).
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Image /page/7/Picture/0 description: The image shows the logo for BiLab. The logo consists of the letters "BiLab" in a bold, sans-serif font. The "B" is larger than the other letters and has a blue gradient effect, with the center of the "B" being the lightest shade of blue. The "iLab" part of the logo is in black. The logo is simple and modern.
B. Assessment of regional ventilation distributions: Anterior and posterior regions
Methods: This was a retrospective analysis of 53 patients (gender: male and female, age: 3 months ~ 80 years) under general anesthesia during surgery. AirTom monitoring started before induction of anesthesia and continued until the end of operation. Regional distributions of ventilation in the anterior (A) and posterior (P) halves from the 53 patients were evaluated at different PEEP levels.
Results: After induction of general anesthesia, atelectasis occurred in the posterior region (P) in most of the 53 patients in supine position. Due to this atelectasis, tidal ventilation in the anterior region (anterior proportion) increased to an average value of 72.2% at an initial low PEEP value as shown in the figure below. When PEEP was increased to a higher value, some of the collapsed alveoli in the posterior region were successfully recruited to result in larger tidal ventilation in the posterior region. Therefore, tidal ventilation in the anterior region (anterior proportion) was reduced to an average value of 59.6% at a high PEEP value.
Image /page/7/Figure/4 description: The image shows a graph with PEEP (cmH2O) on the x-axis and Anterior proportion (%) on the y-axis. There are data points connected by lines, showing the relationship between PEEP and anterior proportion. At PEEP of approximately 17 cmH2O, the anterior proportion is 59.6 ± 6.9 %, and at PEEP of approximately 5 cmH2O, the anterior proportion is 72.2 ± 6.1 %. The p-value is less than 0.01.
C. Assessment of regional ventilation distributions: With and without pneumoperitoneum
Methods: This was a retrospective analysis of 28 patients (gender: male and female, age: 1 month ~ 80 years) under general anesthesia during laparoscopic surgery with pneumoperitoneum. AirTom monitoring started before induction of anesthesia and continued until the end of operation including time periods before and after CO2 insufflation. Regional distributions of ventilation were evaluated before and after CO2 insufflation and also after CO2 desufflation.
Results: The total impedance changes between two states (CO2 on and off) from the 28 patients are shown below. The reference time to compute the total impedance change was right after the induction of general anesthesia before CO2 insufflation.
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Image /page/8/Picture/0 description: The image shows the logo for BiLab. The logo consists of the letters 'BiLab' in black font. To the left of the letters is a blue circular graphic with a white design inside.
With pneumoperitoneum by CO2 on, i.e., after CO2 insufflation, the total impedance change between end-inspiration and end-expiration decreased on average to 64.8% of the baseline value. After CO2 desufflation, i.e. CO2 off, the total impedance change between end-inspiration and end-expiration recovered to 90.1% of the baseline value.
Image /page/8/Figure/2 description: The image shows a plot of total impedance change with CO2 on and off. The y-axis represents the total impedance change, and the x-axis represents the CO2 condition (on or off). Each line represents the change in impedance for an individual, with the bold line representing the average change. The average impedance change is 64.8 ± 28.8% with CO2 on and 90.1 ± 19.4% with CO2 off, with a p-value of less than 0.01.
9. Conclusion
On the basis of the clinical and technical information, AirTom is substantially equivalent to the predicate device.
| Attributes | Subject
AirTom | Predicate
ENLIGHT 2100 | Explanation of
Differences |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K211135 | |
| Product
Classification CFR | 868.1505 - QEB | 868.1505 - QEB | No difference |
| Indications for Use | AirTom is a non-invasive,
non-radiation medical device
that provides information of
local impedance variations
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
patients in a professional
healthcare facility, whose
chest circumference is within
the range of 32 ~ 130 cm.
AirTom does not measure
regional ventilation of the | ENLIGHT 2100 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 and pediatric patients
in a hospital setting, whose
thorax perimeter is within
the range of 37.5 -134 cm.
ENLIGHT 2100 does not
measure regional ventilation
of the lungs. | No difference |
| Patient population | lungs.
Adult and pediatric patients,
whose thorax perimeter is
within the range of 32 ~130
cm. | Adult and pediatric patients,
whose thorax perimeter is
within the range of 37.5 -134
cm. | AirTom provides
Epads for patients
with
chest
circumferences
from 32 to 130 cm,
while ENLIGHT
2100 provides
electrode belts for
patient with chest
circumferences
from 37.5 to 134
cm. |
| Prescription | Yes | Yes | No difference |
| Principles
of
operation | Electrical Impedance
Tomography based on
voltage measures to estimate
local impedance variation
within a cross section of a
patient's thorax. | Electrical Impedance
Tomography based on
voltage measures to estimate
local impedance variation
within a cross section of a
patient's thorax. | No difference |
| Contraindications | defibrillation
cardiac pacemakers
skin damage
open chest wounds
hyperhidrosis | High oxygen environment
MR environment
defibrillation
active implanted devices
pregnant or lactating women | Similar |
| | implanted devices
body worn devices
neonates
patients with uncontrolled body movements
pregnant or lactating women
BMI > 50
Unstable or open thorax | | |
| Environment of Use | Hospital setting | Hospital setting | No difference |
| Duration of Use | Up to 30 days, with Epad change each 24 hours. | Up to 30 days, with Addere change each 48 hours. | Epad needs to be changed every 24 hours, whereas Addere needs to be changed every 48 hours. |
| Useful life | AirTom has 5 years of useful life. | ENLIGHT 2100 has 7 years of useful life. | AirTom has a shorter useful life. |
| Shelf life | Epad has 1 year of shelf life. | Electrode Belt has 1 year of shelf life.
Addere has 2 year of shelf life. | No difference (AirTom does not use an Addere.) |
| Non-sterile | There are no sterile components or accessories. | There are no sterile components or accessories. | No difference |
| Cleaning methods | Cleaning and disinfection prescribed only for the device.
Epad is single patient use. | Cleaning and disinfection prescribed only for the device.
Accessories are single patient use. | No difference |
| Features | | | |
| Available sizes | Epad sizes 4XS, 3XS, 2XS, XS, S, M, L, XL | Electrode Belt sizes P0, P1, P2, 4S, 5S, XXS, XS, S, M, L, XL | AirTom offers 8 Epad models, whereas ENLIGHT 2100 offers 11 electrode belt models. |
| Shape | Monitor-like device, transportable | Monitor-like device, transportable | No difference |
| Patient contact per
ISO 10993-1 | Surface contact
Intact skin | Surface contact
Intact skin | No difference |
| Performance Characteristics - Bench Test | | | |
| Signal-to-noise
ratio (SNR) | 50dB - 80dB | 50dB - 95dB | ENLIGHT 2100 has a higher maximum SNR.
AirTom and ENLIGHT 2100 have similar performances in other performance metrics. |
| Voltage accuracy | 90% - 100% | 80% - 100% | |
| Drift | Allan variance ( $AV_v^2$ ) converges within 100 pV2 | Allan Variance converges to
zero (below 100pV2) | |
| Reciprocity
accuracy | 90% - 100% | 95% - 100% | |
| Amplitude
response | 90% - 104% | 90% - 104% | No difference |
| Position error | Smaller than 4% of the
radius | Smaller than 4% of the
radius | |
| Ringing | Smaller than 0.6 | Smaller than 0.6 | |
| Resolution | Smaller than 0.42 | Smaller than 0.42 | |
| Percentage error of
plethysmogram | Below 5% | Below 5% | |
10.Substantial equivalence comparison table
9
Image /page/9/Picture/0 description: The image shows the logo for BiLab. The logo consists of the letter B in a blue, glowing orb, followed by the letters "iLab" in black. The logo is simple and modern, and the blue orb gives it a sense of technology and innovation.
10
Image /page/10/Picture/0 description: The image shows the logo for BiLab. The logo features a stylized "B" in a blue gradient, followed by the text "iLab" in black. The "B" is enclosed in a circle, giving it a modern and tech-oriented appearance.
11
Image /page/11/Picture/0 description: The image contains the word "BiLab" in a stylized font. The "B" is larger and has a blue gradient, giving it a three-dimensional appearance. The "iLab" part of the word is in black and a smaller font size. The logo appears to be for a company or organization called BiLab.