tremoFlo C-100 Airwave Oscillometry System

K170185 · Thorasys Thoracic Medical Systems, Inc. · PNV · Sep 12, 2017 · Anesthesiology

Device Facts

• Record ID: K170185
• Device Name: tremoFlo C-100 Airwave Oscillometry System
• Applicant: Thorasys Thoracic Medical Systems, Inc.
• Product Code: PNV · Anesthesiology
• Decision Date: Sep 12, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). tremoFlo C-100 Airwave Oscillometry System is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.

Device Story

Portable lung function testing device; uses Forced Oscillation Technique (FOT) to assess lung mechanics. Input: patient mouth pressure and airflow response during quiet breathing. Operation: handheld unit with vibrating mesh oscillator superimposes small sinusoidal pressure waves (1-3 cmH2O) onto patient's normal breathing; connected to cradle unit. Output: respiratory system impedance (Rtot, Rinsp, Rexp, Xtot, Xinsp, Xexp, AX, fres) and breathing pattern parameters (Vt, Ti, Te, RR, Ve). Used in hospitals, clinics, and private offices by clinicians (pulmonologists, nurses, respiratory therapists). Software on external computer manages testing, analysis, and presentation. Healthcare providers use output to assess lung function; aids in clinical decision-making regarding respiratory status. Benefits: non-invasive, requires minimal patient effort/cooperation.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via comparison of impedance and breathing pattern parameters against predicate, reproducibility/repeatability testing (<2.5% variation), electrical safety (AAMI ES60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), and cleaning/disinfection validation.

Technological Characteristics

Handheld unit with vibrating mesh oscillator; piezo-resistive pressure sensors; pneumotach flow sensor. Connectivity: external computer via cradle. Power: 110-240V. Biocompatibility: ISO 10993-1. Electrical safety: AAMI ES60601-1:2005+A2012, IEC 60601-1-2:2007. Software: standalone package for management/analysis.

Indications for Use

Indicated for pediatric and adult patients 4 years of age or older to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Predicate Devices

• Resmon PRO FULL (K152585)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2017

Thorasys Thoracic Medical Systems, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K170185

Trade/Device Name: Tremoflo C-100 Airwave Oscillometry System Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: PNV Dated: August 11, 2017 Received: August 15, 2017

Dear E.J. Smith:

We have reviewed your 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. 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 statutes and regulations administered by other Federal agencies. You must comply

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Tara A. Ryan -S

2017.09.12 06:23:08 -04'00'

for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K170185

#### Device Name

tremoFlo C-100 Airwave Oscillometry System

#### Indications for Use (Describe)

The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). tremoFlo C-100 Airwave Oscillometry System is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/2/Picture/17 description: The image contains a green circle with the number 34 in black font inside of it. The number is centered within the circle. The green color of the circle is a solid, uniform shade.

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Image /page/3/Picture/0 description: The image shows the word "THORASYS" in a bold, sans-serif font. The letters are a light yellow color, and the word is slightly angled upwards from left to right. There is a small trademark symbol in the upper right corner of the image. The background is white.

# 510(k) Summary

# tremoFlo C-100 Airwave Oscillometry System

| Company Name: | THORASYS Thoracic Medical Systems, Inc. | |
|------------------------|-----------------------------------------------------------------|--|
| Company Address: | 6560 Avenue de l'Esplanade Suite #103<br>Quebec, Canada H2V 4L5 | |
| Telephone Number: | 514-384-8555 Ext. 133 | |
| Fax Number: | 514-384-8555 | |
| Contact Person: | Sebastien Jutras | |
| Date Summary Prepared: | September 8, 2017 | |
| Trade Name: | tremoFlo C-100 Airwave Oscillometry System | |
| Common/Usual Name: | Respiratory Impedance Measurement Device | |
| Classification Name: | Impedance Measuring Device Utilizing Oscillation Techniques | |
| Product Code: | PNV | |
| Device Class: | Class II | |
| Regulation Number: | 21 CFR 868.1840 | |

Predicate Device:

| Manufacturer's Name | Brand Name | 510(k) Number |
|------------------------------|-----------------|---------------|
| Medical Graphics Corporation | Resmon PRO FULL | K152585 |

## Device Description:

The tremoFlo C-100 Airwave Oscillometry System (AOS) is a portable lung function testing device that implements methods known per the Forced Oscillation Technique (FOT) to assess lung function in humans. The Forced Oscillation Technique (FOT) is a non-invasive test that requires minimal patient effort and cooperation and provides a full report of lung mechanics per the FOT. In general, the FOT usually consists of superimposing given external multi-frequency sinusoidal excitation small pressure waves (1-3 cmH2O peak to peak) onto the normal breathing of the patient through the device and then deriving the mechanical properties from the patient's mouth pressure and airflow response while breathing. The main outcome reported by FOT is the mechanical impedance of the respiratory system which is the complex ratio between pressure and airflow at the given excitation frequencies.

The tremoFlo C-100 Unit is a lightweight handheld device connected to a cradle unit. The handheld unit contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations which is connected to the cradle unit via a custom cable. The tremoFlo software is a complete stand-alone software package for patient management, testing, and result analysis and presentation.

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The tremoFlo C-100 system is easy to transport within a busy clinic or hospital environment. During use the operator holds the handheld device using the ergonomic handle while the patient is seated, wearing a standard nose clip and with hands on cheeks breathes quietly through the device into a standard single use Pulmonary Function Testing (PFT) filter connected at the front of the handheld unit via the PFT filter interface. Like its predicate the tremoFlo is not intended to be used as a stand-alone diagnostic device.

# Predicate Product Comparison:

# Indications for Use

| Thorasys tremoFlo C-100 Airwave Oscillometry<br>System | Resmon PRO FULL K152585 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The tremoFlo C-100 Airwave Oscillometry System<br>is intended to measure respiratory system<br>impedance using the Forced Oscillation Technique<br>(FOT). tremoFlo C-100 Airwave Oscillometry<br>System is intended for use with pediatric and adult<br>patients 4 years of age or older. The device is<br>designed to be used by pulmonologists, general<br>practitioners, nurses, respiratory therapists,<br>laboratory technologists, medical researchers and<br>similarly trained personnel in hospitals, clinics, and<br>private physician offices. | The Resmon PRO FULL is intended to measure<br>respiratory system impedance using the Forced<br>Oscillation Technique (FOT). Resmon PRO FULL is<br>intended for use with pediatric and adult patients 4<br>years of age or older. The device is designed to be<br>used by pulmonologists, general practitioners,<br>nurses, respiratory therapists, laboratory<br>technologists, medical researchers and similarly<br>trained personnel in hospitals, clinics, and private<br>physician offices. |

## Predicate Product Comparison

| Technical<br>Feature/<br>Specification | Tremoflo C-100<br>Airwave Oscillometry<br>System | Predicate:<br>Resmon PRO FULL | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental<br>Scientific<br>Technology | Forced Oscillation<br>Technique and<br>Pneumotach per ERS<br>FOT recommendations<br>[1]. | Forced Oscillation<br>Technique and<br>Pneumotach per ERS<br>FOT recommendations<br>[1]. | Identical |
| Pneumotach Flow<br>Range | ± 2.5 L/s | ± 2 L/s | tremoFlo has a 0.5 L/s increased<br>flow range. |
| Flow Resolution | ±1.4 ml/s | ±4.6 mL/s | tremoFlo flow resolution is<br>slightly<br>better). |
| Flow Linearity | ± 2% up to 1.0 L/s | ± 2% up to 1.5 L/s | the differences are small and<br>still within ranges to provide<br>equivalent performances in both<br>devices per the bench testing. |
| Common Mode<br>Rejection Ratio | Alternate dynamic<br>software compensation | >60dB over the entire<br>range of forcing | Based on the performance<br>testing the tremoFlo |
| Technical<br>Feature/<br>Specification | Tremoflo C-100<br>Airwave Oscillometry<br>System | Predicate:<br>Resmon PRO FULL | Comparison |
| (CMRR) | signal processing<br>(derived from Farré et<br>al.[3]) | frequencies | compensation provided accurate<br>and reproducible results that are<br>equivalent to those provided by<br>the predicate. |
| Device Load to<br>Patient | 1.0 ± 5% cmH2O.s/L at<br>1 L/s | <1 cmH2O at 1L/s | the difference in resistance to<br>flow is small and within the<br>potential variation of resistance<br>for bacterial/viral filters. |
| Volume Range | ±3 Liters | ±2 Liters | tremoFlo has increased volume<br>range. |
| Volume Accuracy | <3.0% or 0.050 L<br>(whichever is greater) | <3.5% or 0.050 L<br>(whichever is greater) | the tremoFlo has a slightly<br>greater volume accuracy. |
| Mouth Pressure | Piezo Resistive | Piezo Resistive | Identical |
| Mouth Pressure<br>Linearity | 2% of full Scale up to 5<br>cm H2O | ±0.050% of full scale<br>up to 2.5 cm H2O | the differences in pressure<br>linearity are small and still<br>within ranges to provide<br>equivalent performances per the<br>bench testing and meeting the<br>ERS FOT Recommendation [1]<br>of 2 % up to 5 cmH2O. |
| Mouth Pressure<br>Resolution | 0.0053 cmH2O (0.0039<br>mmHg) | 0.015 cmH2O<br>(0.011mmHg) | Tremoflo has better resolution. . |
| Mouth Pressure<br>Range | ± 10 cmH2O | ± 2.5 cmH2O | the tremoFlo has increased Mouth<br>Pressure Range. |
| Effective Device<br>Dead Space | 35 ml | 35 ml | Equivalent. |
| Test Signal /<br>Frequency range | Sinusoidal signal at<br>specific frequencies,<br>between 5-41Hz | Sinusoidal signal at<br>specific frequencies,<br>between 5-37Hz | tremoFlo provides a sinusoidal<br>signal but with a slightly<br>increased user selectable<br>frequency range |
| Pseudo-Random<br>Noise Stimulus | 5-37 Hz, 7-41 Hz | 5-37 Hz | tremoFlo offers a slightly<br>increased frequency range |
| Single Frequency<br>Stimuli for a<br>within-breath<br>analysis of<br>respiratory<br>impedance | Can offer 5 to 41 Hz | 5,6,8 and 10 Hz | tremoFlo offers a slightly<br>increased frequency range with<br>an accuracy equivalent to the<br>predicate as per the performance<br>bench testing. The frequencies<br>are still within the medium<br>frequency range per the ERS<br>FOT Recommendation [1]. |
| Multi-Frequency | 5-11-19, 5 to 37 and 7 | 5-11-19 Hz | tremoFlo offers a slightly increased frequency range with an accuracy equivalent to the predicate as per the performance bench testing. The frequencies are still within the medium frequency range per the ERS FOT Recommendation [1]. |
| Technical<br>Feature/<br>Specification | Tremoflo C-100<br>Airwave Oscillometry<br>System | Predicate:<br>Resmon PRO FULL | Comparison |
| Stimulus for a<br>with-in breath<br>analysis of<br>respiratory<br>impedance and an<br>estimation of the<br>frequency-<br>dependence of<br>respiratory<br>impedance | to 41 Hz | | increased frequency range with<br>an accuracy equivalent to the<br>predicate as per the performance<br>bench testing. The frequencies<br>are still within the medium<br>frequency range per the ERS<br>FOT Recommendation [1]. |
| Reference<br>Resistance of the<br>calibration object | 2 cmH2O.s/L | R 2.6 cmH2O/L/s. | The difference of 0.6<br>cmH2O/L/s on the nominal<br>resistance value has no impact<br>on the calibration check<br>performance. |
| Reference<br>Reactance | The slope of X is 0.017<br>cmH2O/L/s² | The slope of X is ~0.2<br>cmH2O/L/s² | Both devices have similar<br>characteristics and both check<br>for the reactance accuracy upon<br>calibration. |
| Patient Population | pediatric and adult<br>patients 4 years or older | pediatric and adult<br>patients 4 years or<br>older | Identical |
| Energy Type | 110-240 V / 47-63Hz | 100-240 V / 50-60Hz | Equivalent. |
| Compatible<br>Bacterial/Viral<br>Filter and nose<br>clip | Single use,<br>Given 510(k) cleared<br>PFT Filter (K111587)<br>and nose clip | Single use,<br>Specification of<br>standard Filter, nose<br>clip and optional<br>Mouthpiece as<br>provided by the User | Both devices use a single use<br>filter and nose clip. |
| Patient Contact/<br>Biocompatibility | Externally<br>communicating<br>(Indirect), Tissue,<br>limited duration<br>Surface, Skin, limited<br>duration for nose clip<br>and inlet of filter. | Externally<br>communicating<br>(Indirect), Tissue,<br>limited duration<br>Surface, Skin, limited<br>duration for nose clip<br>and inlet of filter. | Only the nose clip and filter<br>come in contact with the patient. |
| Calculated<br>Impedance<br>Parameters | Total Resistance (Rtot)<br>Inspiratory Resistance<br>(Rinsp)<br>Expiratory Resistance<br>(Rexp)<br>Total Reactance (Xtot) | Total Resistance (Rtot)<br>Inspiratory Resistance<br>(Rinsp)<br>Expiratory Resistance<br>(Rexp)<br>Total Reactance (Xtot) | The provided parameters are<br>identical with the tremoFlo<br>providing additionally AX,<br>which is derived from the<br>reactance curve, and also<br>providing R5-R20 in addition to<br>R5-R20. The performances |
| Technical<br>Feature/<br>Specification | Tremoflo C-100<br>Airwave Oscillometry<br>System | Predicate:<br>Resmon PRO FULL | Comparison |
| | Inspiratory Reactance<br>(Xinsp)<br>Expiratory Reactance<br>(Xexp)<br>deltaXrs<br>R5-R19, R5-R20 | Inspiratory Reactance<br>(Xinsp)<br>Expiratory Reactance<br>(Xexp)<br>deltaXrs<br>R5-R19 | were substantially equivalent as<br>per bench testing. |
| | AX<br>fres (frequency when<br>Xtot=0) | fres | |
| Calculated<br>Breathing Pattern<br>Parameters | Tidal Volume (Vt)<br>Inspiratory Time (Ti)<br>Expiratory Time (Te)<br>Respiratory Duty Cycle<br>(Ti/Ttot)<br>Respiratory Rate (RR)<br>Mean Inspiratory Flow<br>(Vt/Ti)<br>Mean Expiratory Flow<br>(Vt/Te)<br>Ventilation (Ve) | Tidal Volume (Vt)<br>Inspiratory Time (Ti)<br>Expiratory Time (Te)<br>Respiratory Duty<br>Cycle (Ti/Ttot)<br>Respiratory Rate (RR)<br>Mean Inspiratory Flow<br>(Vt/Ti)<br>Mean Expiratory Flow<br>(Vt/Te)<br>Ventilation (Ve) | The provided parameters are<br>identical with substantially<br>equivalent performances as per<br>bench testing. |
| Breathing Circuit | Includes a pneumotach<br>for the flow. A breathe-<br>through low resistance<br>Vibrating Mesh<br>(patented) is placed in<br>series with the<br>pneumotach and used to<br>generate the stimulus<br>during the test. | Includes a pneumotach<br>for the flow<br>measurement in series<br>with a low-resistance<br>and high-inertance<br>tube. A woofer<br>loudspeaker, protected<br>by a silicone<br>membrane, is used to<br>generate the stimulus<br>during the test. An air<br>blower flushes fresh<br>air inside the circuit to<br>avoid rebreathing. | No substantial differences. The<br>low dead space offered by the<br>compactness of the tremoFlo<br>does not necessitate a blower to<br>flush air out of the breathing<br>pathway. |
| Test duration | A minimum of 3<br>measurements with a<br>minimum duration of 20<br>seconds each and 2 valid<br>breaths minimum per<br>measurements for a total<br>of 60 seconds and 6<br>breaths minimum per test. | One measurement with 5<br>valid breaths minimum<br>when used for single of<br>multi frequency input<br>waveforms, or from 30<br>seconds measurement<br>period when used for<br>pseudo-random noise<br>input waveforms. | Similar - tremoFlo minimum of 6<br>breaths/60 seconds, as compared to<br>in the predicate's 5 breaths<br>minimum (single of multi<br>frequency input) or 30 seconds<br>measurement period (pseudo-<br>random noise input). |
| Technical<br>Feature/<br>Specification | Tremoflo C-100<br>Airwave Oscillometry<br>System | Predicate:<br>Resmon PRO FULL | Comparison |
| Hardware | tremoFlo Handheld and<br>Cradle Units<br>Laptop or desktop<br>computer | Resmon PRO FULL<br>Head<br>Stand | Both devices provide a user<br>interface and computer that are<br>embedded for the Resmon<br>device, and for the tremoFlo<br>alternately hosted on an external<br>computer. |
| Electrical Safety<br>Electromagnetic<br>Compatibility | Compliant with<br>ES60601-1:2005 +<br>A2012 (IEC60601-1,<br>Edition 3.1)<br>IEC 60601-1-2:2007 | Compliant with<br>ES60601-1:2005<br>(IEC60601-1, Edition<br>3.0)<br>IEC 60601-1-2:2007 | Equivalent. |
| Cleaning/<br>Disinfection | Non-Critical device<br>with validated and<br>labelled cleaning and<br>low-level disinfection<br>method. | Non-Critical device<br>with validated and<br>labelled cleaning and<br>low-level disinfection<br>method. | Equivalent. |

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[1]: Oostveen E, MacLeod D, Lorino H, et al. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J 2003.

# Discussion of Technological Differences

Both the Resmon PRO FULL and the tremoFlo C-100 employ Forced Oscillation Technique (FOT) as established in the literature (European Respiratory Society, ERS, Task Force on Respiratory Impedance Measurements to Characterize Lung Function Of The Respiratory System, Oostveen et al., Eur Respir J 2003). The technique relies on the reproducible relationship between pressure and flow of the respiratory system. The bench test data, comparing the performances of the Resmon PRO FULL and the tremoFlo demonstrated substantially equivalent accuracy and repeatability meeting the ERS Task Force FOT Guidelines.

The main difference is that the oscillator technology to impose the pressure waves in the Resmon PRO FULL is an acoustical loudspeaker. The tremoFlo also produces sinusoidal pressure waveforms of known amplitude and discrete frequencies but alternately uses a vibrating mesh oscillator. Both methods induce similar excitations on the patient's airway during normal breathing allowing for computation of impedances in accordance with the ERS Task Force FOT Guidelines.

The tremoFlo also alternately uses a resistive mesh in its flow pathway to provide a certain impedance to prevent that the produced oscillations leak outside of the flow pathway. This ensures that the resulting oscillatory flow and pressure signals have a sufficient signal-to-noise ratio to ensure repeatability and accuracy of measurements. Comparatively the Resmon PRO FULL uses a high inertance tube instead of the resistive mesh to keep sufficient flow and pressure signals in the flow pathway. As shown by the performance results, both breathing circuits are substantially equivalent in meeting the recommended ERS Task Force FOT Guidelines.

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While the Resmon PRO FULL is a standalone device with integrated touch display and computing as compared to the tremoFlo which is used in conjunction with a computer to host the software and provide display and review management of the measurement results, both are substantially equivalent with respect to the computer display type of technology used.

# Performance Data:

- Device measurement performance –testing to compare the performance specifications (impedance and breathing pattern parameters) between the predicate and the tremoFlo device.
- Reproducibility and Repeatability 3 units were tested with repeated measurements and the results demonstrated consistency between the different devices and for multiple measurements with variations < 2.5%. This was within performance specifications.
- PFT filter (K111587) validation for pediatric use testing/validation of dead space, resistance, port sizes and filtration efficiency.
- Electrical safety and Electromagnetic Compatibility as per standards AAMI ES60601-1:2005 +A2012 and IEC 60601-1-2 ed. 3.0 (2007).
- Biocompatibility testing Based upon ISO 10993-1 and the related FDA Guidance; Use of . International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2016), testing was performed to verify acceptable VOC, Carbon Monoxide, Carbon Dioxide, Ozone and particulate matter (Particulate Matter 2.5 microns) levels from the breathing pathways of the device per the indirect patient contact mode.
- Cleaning/Disinfection Validation Testing validated as per the FDA guidance; Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (2015).
- · Hardware performance validation tests bench test conducted to validate that hardware requirements are met.
- Software verification and validation testing Unit, integration, system, and validation tests (per FDA Guidances: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document, May, 2005; Off-The-Shelf Software Use in Medical Devices, September 1999; Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2014).

## Clinical Study:

No clinical study was conducted.

## Conclusion:

Based on the above, the tremoFlo C-100 Airwave Oscillometry System is as safe and as effective as the predicate, Resmon PRO FULL.