AirTom

K222466 · Bilab · QEB · Jun 30, 2023 · Anesthesiology

Device Facts

• Record ID: K222466
• Device Name: AirTom
• Applicant: Bilab
• Product Code: QEB · Anesthesiology
• Decision Date: Jun 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1505
• Device Class: Class 2

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.

Device Story

AirTom is a ventilatory electrical impedance tomograph (EIT) used in hospital settings by clinicians. It utilizes 16+1 electrodes placed around the patient's thorax to measure voltage and estimate local impedance variations within a lung cross-section during the breathing cycle. These impedance changes are linearly related to regional air content variations. The device features a touchscreen monitor for user control and data visualization. Clinicians use the output as an adjunctive tool to assess regional ventilation distribution, aiding in clinical decision-making regarding mechanical ventilation settings (e.g., PEEP adjustments). The device is non-invasive, non-radiation, and non-sterile.

Clinical Evidence

Clinical evidence includes a comparison of EIT vs. X-ray CT/chest X-ray in 6 ICU patients, a retrospective analysis of 53 patients under general anesthesia evaluating anterior/posterior ventilation distribution at varying PEEP levels (p < 0.01), and a retrospective analysis of 28 patients undergoing laparoscopic surgery to assess impedance changes during pneumoperitoneum (p < 0.01). Results demonstrate the device's ability to track regional ventilation changes.

Technological Characteristics

Ventilatory electrical impedance tomograph; 16+1 electrode configuration; touchscreen interface; non-sterile; surface contact (intact skin). Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6/62366-1 (usability), and ISO 10993-1 (biocompatibility). Battery-powered (lithium-ion).

Indications for Use

Indicated for mechanically-ventilated patients in a professional healthcare facility, with chest circumference 32 ~ 130 cm. Used as an adjunctive tool to support clinician assessment of regional air content variations in lung cross-sections. Contraindications include defibrillation, cardiac pacemakers, skin damage, open chest wounds, hyperhidrosis, implanted devices, body-worn devices, neonates, patients with uncontrolled body movements, pregnant/lactating women, BMI > 50, and unstable/open thorax.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the ventilatory electrical impedance tomograph is subject to the following special controls:

*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.

Predicate Devices

• ENLIGHT 2100 (K211135)

Submission Summary (Full Text)

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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 [phone] 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 | BiLab<br>5F Ubiquoss Building, 68 Pangyo-ro 255beon-gil<br>Bundang-gu, Seongnam-si<br>Gyeonggi-do 13486, Republic of Korea |
|-------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact<br>person | Eung Je Woo, Ph.D.<br>Chief Technical Officer, BiLab<br>phone: [phone] |
| Date prepared | June 14, 2023 |

#### 2. Device information:

| Trade name | AirTom® |
|------------------------|-----------------------------------------------------------------------------------------------|
| Common/Usual name | Ventilatory electrical impedance tomograph |
| Classification<br>name | Ventilatory electrical impedance tomograph<br>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.

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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/<br>information<br>provided | Tested or Information provided in accordance<br>with Technical Standards and/or FDA Guidances<br>(listed below): |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shelf life testing –<br>Electrode pads | ANSI/AAMI EC12:2000/(R)2015<br>Disposable ECG electrodes |
| Biocompatibility<br>information<br>and testing | FDA Guidance: Use of International Standard ISO 10993-1,<br>Biological evaluation of medical devices -Part 1:<br>Evaluation and testing within a risk management process,<br>issued 9-4-20 |
| | ISO 10993-1:2018, Biological Evaluation of Medical<br>Devices – Part 1: Evaluation and Testing within a Risk<br>Management Process |
| Software information<br>and testing | FDA Guidance: Guidance for Industry and FDA Staff:<br>Guidance for the Content of Premarket Submissions for<br>Software Contained in Medical Devices, issued 5-11-05 |
| Off-the-Shelf (OTS)<br>software information and<br>testing | FDA Guidance: Guidance for Industry and FDA Staff:<br>Off-the-Shelf Software Use in Medical Devices,<br>issued 9-27-19 |
| Cybersecurity<br>information | FDA Guidance: Draft Guidance for Industry and FDA Staff:<br>Content of Premarket Submissions for Management of<br>Cybersecurity in Medical Devices, issued 10-18-18 |
| Electromagnetic<br>compatibility testing | IEC 60601-1-2 Edition 4.1, Medical Electrical Equipment -<br>Part 1-2: General Requirements For Basic Safety<br>And Essential Performance - Collateral Standard:<br>Electromagnetic Compatibility - Requirements And Tests |
| Electrical and Mechanical<br>safety testing, including:<br>Basic safety and essential<br>performance testing, | IEC 60601-1:2005 + A1:2012, Medical Electrical<br>Equipment - Part 1: General Requirements For Basic<br>Safety And Essential Performance |
| Usability testing, | IEC 60601-1-6:2010 + A1:2013, Medical Electrical<br>Equipment - Part 1-6: General Requirements For Basic<br>Safety And Essential Performance – Collateral Standard:<br>Usability |
| | IEC 62366-1 Edition 1.1 Medical Device-Application of<br>usability engineering to medical devices |
| | FDA Guidance: Content of Human Factors Information in<br>Medical Device Marketing Submissions, Draft Guidance,<br>issued 12-09-22 |
| Degrees of protection/<br>enclosure testing | IEC 60529:2013, Degrees of Protection Provided By<br>Enclosures (IP22) |
| Patient cable testing | ANSI/AAMI EC53:2013, ECG Trunk Cables<br>and Patient Lead Wires |
| Testing performed/<br>information<br>provided | Tested or Information provided in accordance<br>with Technical Standards and/or FDA Guidances<br>(listed below): |
| Packaging testing<br>(vibration and shock) | ISTA Procedure 3A: 2018, For packaged products<br>weighing 150 lb (70 kg) or less |
| Battery testing | IEC 62133-2:2017: Secondary cells and batteries<br>containing alkaline or other non-acid electrolytes -<br>Safety requirements for portable sealed secondary lithium cells,<br>and for batteries made from them, for use in<br>portable applications - Part 2: Lithium systems |
| Battery transport<br>testing | ST/SG/AC.10/11/Rev.7 Recommendations on transport<br>of dangerous goods/Manual of tests and criteria/Rev.6/Amend.<br>1 Part III, subsection 38.3 Lithium metal and lithium ion<br>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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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<br>AirTom | Predicate<br>ENLIGHT 2100 | Explanation of<br>Differences |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K211135 | |
| Product<br>Classification CFR | 868.1505 - QEB | 868.1505 - QEB | No difference |
| Indications for Use | AirTom is a non-invasive,<br>non-radiation medical device<br>that provides information of<br>local impedance variations<br>within a cross section of a<br>patient's thorax. This<br>information is presented to<br>the clinician user as an<br>adjunctive tool to other<br>clinical information in order<br>to support the user's<br>assessment of variations in<br>regional air content within a<br>cross section of a patient's<br>lungs. It is intended for<br>mechanically-ventilated<br>patients in a professional<br>healthcare facility, whose<br>chest circumference is within<br>the range of 32 ~ 130 cm.<br>AirTom does not measure<br>regional ventilation of the | ENLIGHT 2100 is a non-<br>invasive, non-radiation<br>medical device that provides<br>information of local<br>impedance variation within a<br>cross-section of a patient's<br>thorax. This information is<br>presented to the clinician<br>user as an adjunctive tool to<br>other clinical information in<br>order to support the user's<br>assessment of variations in<br>regional air content within a<br>cross section of a patient's<br>lungs. It is intended for<br>mechanically ventilated<br>adult and pediatric patients<br>in a hospital setting, whose<br>thorax perimeter is within<br>the range of 37.5 -134 cm.<br>ENLIGHT 2100 does not<br>measure regional ventilation<br>of the lungs. | No difference |
| Patient population | lungs.<br>Adult and pediatric patients,<br>whose thorax perimeter is<br>within the range of 32 ~130<br>cm. | Adult and pediatric patients,<br>whose thorax perimeter is<br>within the range of 37.5 -134<br>cm. | AirTom provides<br>Epads for patients<br>with<br>chest<br>circumferences<br>from 32 to 130 cm,<br>while ENLIGHT<br>2100 provides<br>electrode belts for<br>patient with chest<br>circumferences<br>from 37.5 to 134<br>cm. |
| Prescription | Yes | Yes | No difference |
| Principles<br>of<br>operation | Electrical Impedance<br>Tomography based on<br>voltage measures to estimate<br>local impedance variation<br>within a cross section of a<br>patient's thorax. | Electrical Impedance<br>Tomography based on<br>voltage measures to estimate<br>local impedance variation<br>within a cross section of a<br>patient's thorax. | No difference |
| Contraindications | defibrillation<br>cardiac pacemakers<br>skin damage<br>open chest wounds<br>hyperhidrosis | High oxygen environment<br>MR environment<br>defibrillation<br>active implanted devices<br>pregnant or lactating women | Similar |
| | implanted devices<br>body worn devices<br>neonates<br>patients with uncontrolled body movements<br>pregnant or lactating women<br>BMI > 50<br>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.<br>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.<br>Epad is single patient use. | Cleaning and disinfection prescribed only for the device.<br>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<br>ISO 10993-1 | Surface contact<br>Intact skin | Surface contact<br>Intact skin | No difference |
| Performance Characteristics - Bench Test | | | |
| Signal-to-noise<br>ratio (SNR) | 50dB - 80dB | 50dB - 95dB | ENLIGHT 2100 has a higher maximum SNR.<br>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<br>zero (below 100pV2) | |
| Reciprocity<br>accuracy | 90% - 100% | 95% - 100% | |
| Amplitude<br>response | 90% - 104% | 90% - 104% | No difference |
| Position error | Smaller than 4% of the<br>radius | Smaller than 4% of the<br>radius | |
| Ringing | Smaller than 0.6 | Smaller than 0.6 | |
| Resolution | Smaller than 0.42 | Smaller than 0.42 | |
| Percentage error of<br>plethysmogram | Below 5% | Below 5% | |

### 10.Substantial equivalence comparison table

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