(318 days)
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.
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.
The provided document, a 510(k) summary for BiLab's AirTom device, focuses primarily on establishing substantial equivalence to a predicate device (TIMPEL S.A.'s Enlight 2100) rather than presenting a detailed study proving the device meets specific acceptance criteria based on quantifiable performance metrics. The summary outlines non-clinical (bench) and clinical performance data, but these are presented as comparative results to support substantial equivalence, not as formal acceptance criteria with corresponding performance against those criteria.
Therefore, the following response will extract the relevant information regarding performance and present it in a structured way that attempts to align with the request, acknowledging where explicit "acceptance criteria" (defined as specific thresholds for success) are not provided in the document.
Acceptance Criteria and Device Performance Study for AirTom
The provided 510(k) summary for AirTom focuses on demonstrating substantial equivalence to a predicate device (ENLIGHT 2100) through a comparison of technological characteristics and performance data. While explicit "acceptance criteria" with quantitative thresholds for study success are not formally stated in the document in the format typically requested (e.g., "Accuracy > 90%"), the document does list several "Performance Characteristics - Bench Test" with corresponding reported ranges for both the subject device (AirTom) and the predicate. These can be interpreted as the performance measures that were assessed to demonstrate equivalence.
The "clinical performance data" presented are descriptive and illustrative of the device's capability to assess regional ventilation, rather than a formal validation against a set of statistical acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria are not provided for the clinical studies, the table below lists the Performance Characteristics - Bench Test for which quantitative data is presented to support substantial equivalence. The "Acceptance Criteria" column is inferred from the ranges reported for the predicate device, as the goal is to show comparable performance.
| Performance Characteristic (Bench Test) | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (AirTom) | Pass/Fail (Based on documented ranges) |
|---|---|---|---|
| Signal-to-noise ratio (SNR) | 50dB - 95dB | 50dB - 80dB | Pass (within predicate's range) |
| Voltage accuracy | 80% - 100% | 90% - 100% | Pass (within or exceeding predicate's range) |
| Drift (Allan variance) | Converges below 100 pV2 | Converges within 100 pV2 | Pass (comparable to predicate) |
| Reciprocity accuracy | 95% - 100% | 90% - 100% | Pass (within comparable range, though slightly lower minimum than predicate) |
| Amplitude response | 90% - 104% | 90% - 104% | Pass (matches predicate) |
| Position error | Smaller than 4% of the radius | Smaller than 4% of the radius | Pass (matches predicate) |
| Ringing | Smaller than 0.6 | Smaller than 0.6 | Pass (matches predicate) |
| Resolution | Smaller than 0.42 | Smaller than 0.42 | Pass (matches predicate) |
| Percentage error of plethysmogram | Below 5% | Below 5% | Pass (matches predicate) |
Note: For the clinical performance sections (A, B, C), the document describes observed physiological changes in regional ventilation/impedance under different clinical conditions that are consistent with expected physiological responses or comparisons to other imaging modalities (e.g., CT). It does not provide quantitative acceptance criteria or statistical hypothesis testing results for these observations beyond p-values for differences between states.
2. Sample Sizes Used for the Test Set and Data Provenance
The document describes three clinical "assessments" that serve as a form of test set, demonstrating the device's performance in clinical settings:
-
A. Comparison of regional ventilation distributions: EIT vs. X-ray CT image
- Sample Size: 6 patients
- Data Provenance: Retrospective ("AirTom was used on six patients during routine clinical practice in ICU. X-ray CT or chest X-ray images were acquired...")
- Country of Origin: Not explicitly stated, but assumed to be where the clinical practice occurred, likely in South Korea given BiLab's location.
-
B. Assessment of regional ventilation distributions: Anterior and posterior regions
- Sample Size: 53 patients
- Data Provenance: Retrospective analysis. Patients were undergoing general anesthesia during surgery.
- Country of Origin: Not explicitly stated.
-
C. Assessment of regional ventilation distributions: With and without pneumoperitoneum
- Sample Size: 28 patients
- Data Provenance: Retrospective analysis. Patients were undergoing general anesthesia during laparoscopic surgery with pneumoperitoneum.
- Country of Origin: Not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical observations.
- For section A (EIT vs. CT), it mentions X-ray CT or chest X-ray images were acquired to identify likely regions with different tidal ventilation. This implies a clinician (likely a radiologist or intensivist) interpreted these images, but no details are provided about their number or specific qualifications.
- For sections B and C, the "ground truth" implicitly relies on established physiological understanding of lung mechanics and the expected changes under conditions like atelectasis or pneumoperitoneum, rather than a separate expert-labeled ground truth for each case for direct comparison.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth or for reviewing the outputs of the AirTom device in the context of the clinical assessments. The findings are presented as observations consistent with clinical expectations or comparisons to CT.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted or described in this document. The AirTom device is described as providing "information of local impedance variations" to the "clinician user as an adjunctive tool to other clinical information." It is not presented as an AI-powered diagnostic tool that directly assists human readers in interpreting images in a comparative setting.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The document does not describe a standalone performance study of the AirTom algorithm in isolation. The device's output (tidal images, regional distribution percentages, total impedance changes) is the direct measurement from the device, which is then interpreted by clinicians. The clinical performance data sections (A, B, C) illustrate the device's ability to capture physiological phenomena, essentially demonstrating its "standalone" measurement capabilities in a clinical context against expected physiological changes or other imaging modalities like CT.
7. The Type of Ground Truth Used
- For the bench tests (Section 9, under "Performance Characteristics - Bench Test"), the ground truth is based on engineering specifications, physical phantoms, and controlled electrical measurements.
- For the clinical performance data (Section 8):
- Section A (EIT vs. X-ray CT): The ground truth was established by comparing AirTom's visual representations of regional ventilation to X-ray CT or chest X-ray images, which are standard clinical imaging modalities for assessing lung conditions like atelectasis and pneumothorax. This represents a type of imaging ground truth.
- Sections B & C (Regional ventilation changes with PEEP, and with/without pneumoperitoneum): The ground truth is effectively physiological ground truth/clinical understanding. The studies observed the device's ability to reflect expected physiological changes in lung ventilation/impedance under known clinical interventions (e.g., induction of anesthesia and PEEP changes influencing atelectasis, or CO2 insufflation during surgery). The statistical significance of observed changes (p-values) supports that the device is reflecting these known physiological responses.
8. The Sample Size for the Training Set
The document does not specify any training set sample sizes. This device, as described, appears to be an Electrical Impedance Tomography (EIT) device that directly measures and reconstructs impedance images based on physical principles, rather than a deep learning/AI model that requires a specific training dataset (unless inherent to the image reconstruction algorithm which is not described as a deep learning model). The "clinical performance data" presented are likely used for validation/demonstration of the final product, not for training.
9. How the Ground Truth for the Training Set Was Established
As no training set is described (see point 8), the method for establishing ground truth for a training set is not applicable or detailed in this document.
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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
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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
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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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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 | BiLab5F Ubiquoss Building, 68 Pangyo-ro 255beon-gilBundang-gu, Seongnam-siGyeonggi-do 13486, Republic of Korea |
|---|---|
| Contactperson | Eung Je Woo, Ph.D.Chief Technical Officer, BiLabphone: +82-70-4865-0591 |
| Date prepared | June 14, 2023 |
2. Device information:
| Trade name | AirTom® |
|---|---|
| Common/Usual name | Ventilatory electrical impedance tomograph |
| Classificationname | Ventilatory electrical impedance tomograph21 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.
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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.
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| Testing performed/informationprovided | Tested or Information provided in accordancewith Technical Standards and/or FDA Guidances(listed below): |
|---|---|
| Shelf life testing –Electrode pads | ANSI/AAMI EC12:2000/(R)2015Disposable ECG electrodes |
| Biocompatibilityinformationand 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 MedicalDevices – Part 1: Evaluation and Testing within a RiskManagement Process | |
| Software informationand testing | FDA Guidance: Guidance for Industry and FDA Staff:Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices, issued 5-11-05 |
| Off-the-Shelf (OTS)software information andtesting | FDA Guidance: Guidance for Industry and FDA Staff:Off-the-Shelf Software Use in Medical Devices,issued 9-27-19 |
| Cybersecurityinformation | FDA Guidance: Draft Guidance for Industry and FDA Staff:Content of Premarket Submissions for Management ofCybersecurity in Medical Devices, issued 10-18-18 |
| Electromagneticcompatibility testing | IEC 60601-1-2 Edition 4.1, Medical Electrical Equipment -Part 1-2: General Requirements For Basic SafetyAnd Essential Performance - Collateral Standard:Electromagnetic Compatibility - Requirements And Tests |
| Electrical and Mechanicalsafety testing, including:Basic safety and essentialperformance testing, | IEC 60601-1:2005 + A1:2012, Medical ElectricalEquipment - Part 1: General Requirements For BasicSafety And Essential Performance |
| Usability testing, | IEC 60601-1-6:2010 + A1:2013, Medical ElectricalEquipment - Part 1-6: General Requirements For BasicSafety And Essential Performance – Collateral Standard:Usability |
| IEC 62366-1 Edition 1.1 Medical Device-Application ofusability engineering to medical devices | |
| FDA Guidance: Content of Human Factors Information inMedical Device Marketing Submissions, Draft Guidance,issued 12-09-22 | |
| Degrees of protection/enclosure testing | IEC 60529:2013, Degrees of Protection Provided ByEnclosures (IP22) |
| Patient cable testing | ANSI/AAMI EC53:2013, ECG Trunk Cablesand Patient Lead Wires |
| Testing performed/informationprovided | Tested or Information provided in accordancewith Technical Standards and/or FDA Guidances(listed below): |
| Packaging testing(vibration and shock) | ISTA Procedure 3A: 2018, For packaged productsweighing 150 lb (70 kg) or less |
| Battery testing | IEC 62133-2:2017: Secondary cells and batteriescontaining alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary lithium cells,and for batteries made from them, for use inportable applications - Part 2: Lithium systems |
| Battery transporttesting | ST/SG/AC.10/11/Rev.7 Recommendations on transportof dangerous goods/Manual of tests and criteria/Rev.6/Amend.1 Part III, subsection 38.3 Lithium metal and lithium ionbatteries |
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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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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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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 | SubjectAirTom | PredicateENLIGHT 2100 | Explanation ofDifferences |
|---|---|---|---|
| 510(k) | K211135 | ||
| ProductClassification CFR | 868.1505 - QEB | 868.1505 - QEB | No difference |
| Indications for Use | AirTom is a non-invasive,non-radiation medical devicethat provides information oflocal impedance variationswithin a cross section of apatient's thorax. Thisinformation is presented tothe clinician user as anadjunctive tool to otherclinical information in orderto support the user'sassessment of variations inregional air content within across section of a patient'slungs. It is intended formechanically-ventilatedpatients in a professionalhealthcare facility, whosechest circumference is withinthe range of 32 ~ 130 cm.AirTom does not measureregional ventilation of the | ENLIGHT 2100 is a non-invasive, non-radiationmedical device that providesinformation of localimpedance variation within across-section of a patient'sthorax. This information ispresented to the clinicianuser as an adjunctive tool toother clinical information inorder to support the user'sassessment of variations inregional air content within across section of a patient'slungs. It is intended formechanically ventilatedadult and pediatric patientsin a hospital setting, whosethorax perimeter is withinthe range of 37.5 -134 cm.ENLIGHT 2100 does notmeasure regional ventilationof the lungs. | No difference |
| Patient population | lungs.Adult and pediatric patients,whose thorax perimeter iswithin the range of 32 ~130cm. | Adult and pediatric patients,whose thorax perimeter iswithin the range of 37.5 -134cm. | AirTom providesEpads for patientswithchestcircumferencesfrom 32 to 130 cm,while ENLIGHT2100 provideselectrode belts forpatient with chestcircumferencesfrom 37.5 to 134cm. |
| Prescription | Yes | Yes | No difference |
| Principlesofoperation | Electrical ImpedanceTomography based onvoltage measures to estimatelocal impedance variationwithin a cross section of apatient's thorax. | Electrical ImpedanceTomography based onvoltage measures to estimatelocal impedance variationwithin a cross section of apatient's thorax. | No difference |
| Contraindications | defibrillationcardiac pacemakersskin damageopen chest woundshyperhidrosis | High oxygen environmentMR environmentdefibrillationactive implanted devicespregnant or lactating women | Similar |
| implanted devicesbody worn devicesneonatespatients with uncontrolled body movementspregnant or lactating womenBMI > 50Unstable 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 perISO 10993-1 | Surface contactIntact skin | Surface contactIntact skin | No difference |
| Performance Characteristics - Bench Test | |||
| Signal-to-noiseratio (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 tozero (below 100pV2) | |
| Reciprocityaccuracy | 90% - 100% | 95% - 100% | |
| Amplituderesponse | 90% - 104% | 90% - 104% | No difference |
| Position error | Smaller than 4% of theradius | Smaller than 4% of theradius | |
| Ringing | Smaller than 0.6 | Smaller than 0.6 | |
| Resolution | Smaller than 0.42 | Smaller than 0.42 | |
| Percentage error ofplethysmogram | Below 5% | Below 5% |
10.Substantial equivalence comparison table
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§ 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.