The tremoflo C2 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). The tremoflo C2 Airwave Oscillometry System is intended for use with pediativ 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 Description

The tremoflo C2 Airwave Oscillometry System (tremoflo C2) is a portable lung function testing device that implements methods known per the Forced Oscillation Technique (FOT), or oscillometry, to assess lung function in humans. The Forced Oscillation Technique (FOT) is a non-invasive test that 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) 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 main tremoflo C2 Unit is a lightweight handheld device. It contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations. The tremoflo software is a complete standalone software package for patient management, testing, result analysis, and presentation.

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. To perform the test, the patient then breathes quietly through the device into a standard single use Pulmonary Function Testing (PFT) filter connected at the front of the C2 Unit via the PFT filter interface. The tremoflo C2 is not intended to be used as a stand-alone diagnostic device.

AI/ML Overview

The provided text describes the Thorsys tremoflo C2 Airwave Oscillometry System and its substantial equivalence to a predicate device (tremoFlo C100 Airwave Oscillometry System) as determined by the FDA. The document outlines changes made to the device and provides performance data to support its claims.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" against "reported device performance" in the typical sense of numerical thresholds for clinical endpoints. Instead, it focuses on demonstrating equivalence to a predicate device, primarily through technical specifications and verification/validation testing against established standards and recommendations.

However, based on the "Performance Data" section and the comparison table, we can infer some criteria and reported performance:

Acceptance Criterion (Inferred from testing)	Reported Device Performance (tremoflo C2)
Fundamental Scientific Technology	Identical to C100 (Forced Oscillation Technique and Pneumotach per ERS FOT recommendations)
Pneumotach Flow Range	Identical to C100 (± 2.5 L/s)
Flow Resolution	Identical to C100 (±1.4 ml/s)
Flow Linearity	Identical to C100 (± 2% up to 1.0 L/s)
Common Mode Rejection Ratio (CMRR)	Identical to C100 (Dynamic software compensation signal processing)
Device Load to Patient	Modified: 1.1 ± 5% cmH2O.s/L at 1 L/s (C100: 1.0 ± 5% cmH2O.s/L at 1 L/s). Discussion: Small difference, within potential variation of bacterial/viral filters, does not raise different questions of safety and effectiveness.
Volume Range	Identical to C100 (+3 Liters)
Volume Accuracy	Identical to C100 (<3.0% or 0.050 L (whichever is greater))
Mouth Pressure (PM) Sensor Type	Identical to C100 (Piezo Resistive)
Mouth Pressure Linearity	Identical to C100 (2% of full Scale up to 5 cm H2O)
Mouth Pressure Resolution	Modified: 0.00265 cmH2O (0.00195 mmHg) (C100: 0.0053 cmH2O (0.0039 mmHg)). Discussion: Improved resolution, does not raise different questions of safety and effectiveness.
Mouth Pressure Range	Modified: ± 5 cmH2O (C100: ± 10 cmH2O). Discussion: Sufficient for human measurements as FOT measurements never exceed +/- 5 cm H2O, does not change performance specifications, and does not raise different questions of safety and effectiveness.
Effective Device Dead Space	Identical to C100 (35 ml)
Test Signal / Frequency range	Identical to C100 (Sinusoidal signal at specific frequencies, between 5-41Hz)
Pseudo-Random Noise (PSRN) Stimulus	Identical to C100 (5-37 Hz, 7-41 Hz)
Single Frequency Stimuli for within-breath analysis of respiratory impedance	Identical to C100 (Can offer 5 to 41 Hz)
Multi-Frequency Stimulus for with-in breath analysis of respiratory impedance	Identical to C100 (5-11-19, 5 to 37 and 7 to 41 Hz)
Calculated Impedance Parameters	Identical to C100 (Rtot, Rinsp, Rexp, Xtot, Xinsp, Xexp, R5-R19, R5-R20, AX, Fres)
Calculated Breathing Pattern Parameters	Identical to C100 (Vt, Ti, Te, Ti/Ttot, RR, Vt/Ti, Vt/Te, Ve)
Breathing Circuit Design	Modified (C2 has static mesh with separate piston; C100 has vibrating mesh). Discussion: Flow path and component designs are sufficiently close to provide the same input oscillatory excitation profiles and respiratory response measurements, does not raise different questions of safety and effectiveness.
Test duration	Identical to C100 (minimum 3 measurements, 20 seconds each, 2 valid breaths min per measurement, total 60 seconds and 6 breaths min per test)
Energy Type	Modified: Integrated rechargeable battery pack (3.7 volts 5000mAh 18.5Wh), charged via AC/DC Power adaptor 110-240 V to 5 V DC. (C100: AC/DC Power adapter 110-240 V / 47-63Hz to 24 V DC). Discussion: No effect to functional performance and does not raise different questions of safety and effectiveness.
Compatible Bacterial/Viral Filter and nose clip	Identical to C100 (Single use, 510(k) cleared PFT Filter (K111587) and nose clip)
Patient Contact/Biocompatibility	Identical to C100 (Externally communicating (Indirect), Tissue, limited duration Surface, Skin, limited duration)
Biocompatibility Assessment	C2 tested identically as C100, ensuring acceptable emissions of VOCs, CO, CO2, Ozone, particulates. Compliant with ISO 10993-1, -5, -10, -12; ISO-18562-1/2/3; 21 CFR 801.415, and National Air Quality and OSHA limits.
Electrical Safety / Electromagnetic Compatibility	Compliant with IEC60601-1, Ed. 3.1; IEC 60601-1-2, Ed 4. Additionally tested for immunity to EM energy (AIM 7351731 Rev 2.0), wireless communication standards (FCC Part 15, Subpart B, IEEE/ANSI C63.27-2017), and lithium battery standard (IEC/UL 62133 2012, IEC 62133-2 :2017).
Cleaning/Disinfection	Identical to C100 (Validated per FDA guidance ("Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", 2015) and AAMI TIR30:2011).
Impedance Accuracy	Demonstrated compliance with ERS FOT recommendations for impedance accuracy.
Resistance Accuracy	Not explicitly quantified but implied as equivalent and compliant.
Reactance Accuracy	Not explicitly quantified but implied as equivalent and compliant.
Intra-Device Total Resistance Repeatability	Measurement variations < 3.0% (across all intra-device repeatability tests).
Intra-Device Total Reactance Repeatability	Measurement variations < 3.0% (across all intra-device repeatability tests).
Intra-Device Total Impedance Repeatability	Measurement variations < 3.0% (across all intra-device repeatability tests).
Tidal Volume Accuracy	Not explicitly quantified but implied as equivalent and compliant.
Intra-Device Tidal Volume Repeatability	Measurement variations < 3.0% (across all intra-device repeatability tests).
Reproducibility and Repeatability	Demonstrated consistency between predicate and proposed C2 device with measurement variations < 3.0%.
Hardware Performance	Bench tests conducted to validate that hardware requirements were met.
Software Verification and Validation	Per IEC 62304:2006+A1:2015 and relevant FDA Guidances (Content of Premarket Submissions for Software, Off-The-Shelf Software, Cybersecurity).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for any comparative testing or validation performed (e.g., for impedance accuracy, repeatability). It refers to "comparative testing and results as noted above demonstrating equivalent oscillometry performance."

The data provenance is also not explicitly stated as retrospective or prospective, nor does it mention the country of origin. The testing described appears to be primarily bench/laboratory validation rather than clinical studies on human subjects, except for the implied context of "patient" measurements.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The validation focuses on engineering and performance specifications, not necessarily clinical interpretation by experts for ground truth establishment. The reference to ERS FOT recommendations implies adherence to established physiological measurement standards rather than expert consensus on diagnostic outcomes.

4. Adjudication Method for the Test Set

Since the ground truth establishment by experts is not described, an adjudication method is not applicable/not mentioned. The testing appears to be objective measurements against defined technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or described in this document. The submission focuses on demonstrating substantial equivalence of the device's technical performance and safety to a predicate device, not on comparing its diagnostic effectiveness with or without AI assistance for human readers. This device is a diagnostic measurement tool, not an AI-assisted interpretation tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document states, "The tremoflo C2 is not intended to be used as a stand-alone diagnostic device." This suggests that while there are algorithms within the device (e.g., for calculating impedance parameters), its clinical use requires human interpretation in conjunction with other diagnostic information. The performance data focuses on the accuracy and repeatability of the measurements themselves, which can be seen as "standalone" performance of the measurement technology, but not as a standalone diagnostic decision.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

Technical Specifications: Adherence to defined physical parameters (flow range, volume accuracy, pressure resolution, etc.).
Standards Compliance: Demonstrated compliance with international standards (e.g., ERS FOT recommendations [1], IEC 60601-1, IEC 60601-1-2, ISO 10993 series, ISO-18562 series, FCC Part 15, IEEE/ANSI C63.27-2017, IEC/UL 62133, IEC 62304).
Predicate Device Equivalence: Direct comparison and demonstration of similar or improved technical performance to the legally marketed predicate device (tremoFlo C100), with justification for any differences not raising new questions of safety or effectiveness.
Bench Testing: Validation through controlled laboratory experiments for accuracy and repeatability (e.g., impedance, resistance, reactance, tidal volume).

It does not involve expert consensus, pathology, or outcomes data in the clinical diagnostic sense, as the device provides measurements, not a diagnosis.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a measurement system based on physical principles (Forced Oscillation Technique). While it uses software and firmware, it is not described as utilizing a machine learning or AI model that requires a distinct "training set" of data in the typical sense for image interpretation or diagnosis. The "software updates were implemented and tested" refers to general software engineering validation, not AI model training.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI/ML model, this question is not applicable. The ground truth for the device's technical specifications and performance is established through adherence to engineering principles, regulatory standards, and comparative testing against the predicate device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

June 20, 2023

Thorasys Thoracic Medical Systems, Inc. Christopher McLean RA/QA Representative 6560 Avenue de l'Esplanade Suite #103 Montreal, Quebec H2V 4L5 Canada

Re: K221024

Trade/Device Name: tremoflo C2 Airwave Oscillometry System Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: PNV Dated: May 18, 2023 Received: May 18, 2023

Dear Christopher McLean:

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 (OS) 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 mediation-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,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221024

Device Name tremoflo C2 Airwave Oscillometry System

Indications for Use (Describe)

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)
----------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

510(k) Summary

Submitter Information:

Company Name:	THORASYS Thoracic Medical Systems, Inc.
Company Address:	6560 Avenue de l'Esplanade Suite #103Quebec, Canada H2V 4L5
Contact Person:	Christopher McLean
Date Summary Prepared:	June 14, 2023
Trade Name:	tremoflo C2 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
THORASYS Thoracic Medical Systems, Inc.	tremoFlo C100 AirwaveOscillometry System	K170185

Device Description:

{4}------------------------------------------------

As compared to the tremoFlo C100 Airwave Oscillometry System predicate (tremoflo C100), the modifications are summarized as follows:

. Changes to the enclosures and the internal hardware and related firmware components such to integrate the two main units of the prior tremoflo C100 version (i.e., the Handheld Unit and the Cradle Unit in the C100) into a single main handheld unit with a new display screen to show the breathing traces and help the user connect their computer to the tremoflo.
Changes to include Wi-Fi and Bluetooth wireless interfaces and also a USB interface on the main unit for communication to the user's computer instead of the ethernet cable connection in the tremoflo C100
. Changes to the software to accommodate the new communication modes and the hardware/firmware changes.
Changes to include a rechargeable battery module to allow operation without connections to the mains supply as was required in the C100.

Predicate Product Comparisons:

Indications for Use - No Change

Predicate:	Subject:
tremoFlo C-100 Airwave Oscillometry System	tremoflo C2 Airwave Oscillometry System
The tremoFlo C-100 Airwave Oscillometry System is	The tremoflo C2 Airwave Oscillometry System is
intended to measure respiratory system impedance	intended to measure respiratory system impedance
using the Forced Oscillation Technique (FOT). tremoFlo	using the Forced Oscillation Technique (FOT). The
C-100 Airwave Oscillometry System is intended for use	tremoflo C2 Airwave Oscillometry System is intended
with pediatric and adult patients 4 years of age or older.	for use with pediatric and adult patients 4 years of age
The device is designed to be used by pulmonologists,	or older. The device is designed to be used by
general practitioners, nurses, respiratory therapists,	pulmonologists, general practitioners, nurses,
laboratory technologists, medical researchers and	respiratory therapists, laboratory technologists, medical
similarly trained personnel in hospitals, clinics, and	researchers and similarly trained personnel in hospitals,
private physician offices.	clinics, and private physician offices.

{5}------------------------------------------------

Predicate Product Comparison

Technical Feature/Specification	C100 (Predicate)	C2 (Subject)
Fundamental ScientificTechnology	Forced Oscillation Technique and Pneumotach per ERSFOT recommendations [1].	Identical
Pneumotach Flow Range	± 2.5 L/s	Identical
Flow Resolution	±1.4 ml/s	Identical
Flow Linearity	± 2% up to 1.0 L/s	Identical
Common Mode RejectionRatio (CMRR)	Dynamic software compensation signal processing	Identical
Device Load to Patient	1.0 ± 5% cmH2O.s/L at 1 L/s	Modified: 1.1 ± 5% cmH2O.s/L at 1 L/sDiscussion: The difference in resistance to flow is small and withinthe potential variation of resistance for bacterial/viral filters thatmay be used with the tremoflo C100 system and does not raisedifferent questions of safety and effectiveness.
Volume Range	+3 Liters	Identical
Volume Accuracy	<3.0% or 0.050 L (whichever is greater)	Identical
Mouth Pressure (PM)	Piezo Resistive	Identical
Mouth Pressure Linearity	2% of full Scale up to 5 cm H2O	Identical
Mouth Pressure Resolution	0.0053 cmH2O (0.0039 mmHg)	0.00265 cmH2O (0.00195 mmHg)Discussion: improved resolution does not raise different questionsof safety and effectiveness.
Mouth Pressure Range	± 10 cmH2O	Modified: ± 5 cmH20Discussion: By design the pressure range in FOT measurementsnever exceeds +/- 5 cm H2O. This is sufficient for humanmeasurements, does not change the performance specifications,and does not raise different questions of safety and effectiveness.
Effective Device DeadSpace	35 ml	Identical
Technical Feature/Specification	C100 (Predicate)	C2 (Subject)
Test Signal / Frequencyrange	Sinusoidal signal at specific frequencies, between 5-41Hz	Identical
Pseudo-Random Noise(PSRN) Stimulus	5-37 Hz, 7-41 Hz	Identical
Single Frequency Stimulifor a within-breath analysisof respiratory impedance	Can offer 5 to 41 Hz	Identical
Multi-Frequency Stimulusfor a with-in breathanalysis of respiratoryimpedance and anestimation of thefrequency-dependence ofrespiratory impedance	5-11-19, 5 to 37 and 7 to 41 Hz	Identical
Energy Type	AC/DC Power adapter 110-240 V / 47-63Hz to 24 V DC	Modified: Integrated rechargeable battery pack, 3.7 volts5000mAh 18.5Wh, charged via AC/DC Power adaptor 110-240 V to5 V DCDiscussion: In addition to the option of being powered through amedical grade power supply as in the C100, the C2 can also beused in battery operation without the need to connect the deviceto the mains via a power supply. No effect to functionalperformance and does not raise different questions of safety andeffectiveness.
Compatible Bacterial/ViralFilter and nose clip	Single use,510(k) cleared PFT Filter (K111587) and nose clip	Identical
Patient Contact/Biocompatibility	Externally communicating (Indirect), Tissue, limiteddurationSurface, Skin, limited duration for nose clip and inlet offilter.	Identical.The C2 was tested identically as in the C100 to ensure that theindirect gas contact from their breathing flow pathways presentacceptable emissions of VOCs, CO, CO2, Ozone and particulate
Technical Feature/Specification	C100 (Predicate)	C2 (Subject)
Calculated ImpedanceParameters	Total Resistance (Rtot)Inspiratory Resistance (Rinsp)Expiratory Resistance (Rexp)Total Reactance (Xtot)Inspiratory Reactance (Xinsp)Expiratory Reactance (Xexp)R5-R19, R5-R20AXFres	Identical
Calculated BreathingPattern Parameters	Tidal Volume (Vt)Inspiratory Time (Ti)Expiratory Time (Te)Respiratory Duty Cycle (Ti/Ttot)Respiratory Rate (RR)Mean Inspiratory Flow (Vt/Ti)Mean Expiratory Flow (Vt/Te)Ventilation (Ve)	Identical
Breathing Circuit	Includes a pneumotach with a mesh for the flowmeasurement. A breath-through low resistanceVibrating Mesh (patented) is placed in series with thepneumotach and used to generate the oscillationstimulus during the test.	Modified: includes a pneumotach with a mesh for the flowmeasurement. A breath-through low resistance mesh (static) isplaced in series with the pneumotach at the exhaust. This circuitconnects in parallel to a space with a piston which provides theoscillation stimulus during the test.Discussion: Both include a pneumotach and mesh in the breathingcircuit, except that the mesh in the C2 is static with the pistonbeing separate in a closed line connected and providing theoscillations to the breathing circuit as opposed to being combinedwith the mesh in the C100 (vibrating mesh). The flow path andcomponent designs are sufficiently close to that in the predicatedevice to provide the same input oscillatory excitation profiles andthe same respiratory response measurements in both two devices.This does not raise different questions of safety and effectiveness.
Technical Feature/Specification	C100 (Predicate)	C2 (Subject)
Test duration	A minimum of 3 measurements with a minimumduration of 20 seconds each and 2 valid breathsminimum per measurements for a total of 60 secondsand 6 breaths minimum per test.	Identical
Electrical SafetyElectromagneticCompatibility	Compliant with• IEC60601-1, Ed. 3.1• IEC 60601-1-2, Ed 4	Identical for:• IEC60601-1, Ed. 3.1• IEC 60601-1-2, Ed 4Additionally tested for immunity to EM energy in RF range per:• AIM 7351731 Rev 2.0Added compliance to wireless communication standards:• FCC Part 15, Subpart B• coexistence test (EEE/ANSI C63.27-2017)Added compliance to lithium battery standard:• IEC/UL 62133 2012 and IEC 62133-2 :2017Discussion: these are to ensure compliance to the standards forthe added wireless communication and rechargeable batteryfunctions.
Cleaning/Disinfection	Non-sterile and Non-Critical device with validated andlabelled cleaning and low-level disinfection method perFDA Guidance ("Reprocessing Medical Devices in HealthCare Settings: Validation Methods and Labeling", 2015)	Identical - Validated per FDA guidance as done for the C100

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

[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.

{9}------------------------------------------------

Discussion of Technological Differences

The main technology of the device is unchanged in the proposed to the C100 predicate. lt involves the same Forced Oscillation Technique (FOT) using the same methods, and the user selected multi-frequency sinusoidal excitation pressure profile specifications (i.e. the waveforms) are the same as in the C100.

The corresponding output and display of pulmonary function characteristics, the patient's respiratory system resistance and reactance at each sinusoidal frequency, the related or other derived outcome parameters (e.g., breathing rate, inspiratory/expiratory volume, etc.) are identical as in the C100 per the same corresponding unchanged Host Software functionalities and algorithms and as was described in the original C100 510(k) aside from the communication protocols and interface changes as described below.

While many of the subcomponents and the breathing circuit were redesigned or re-organized, the C2's performance specifications were re-verified and found to be the same or to be negligibly impacted as compared to the C100. The added wireless communication modes in addition to the predicate's wired communication are for the same functions as the predicate wired mode, which is solely for data and information transfer between the user's computer and the main device unit and do not involve any time critical or time sensitive transfer requirements. These were implemented and tested following telecommunications standards and the FDA guidance Radio Frequency Wireless Technology in Medical Devices. The added battery pack powers the C2 with DC power equivalently as in the C100 via its AC/DC power supply. It was also implemented and tested in compliance with safety standards. The software updates were implemented and tested similarly as in the C100 predicate.

Performance Data:

. Device performance measurement - comparative testing and results as noted above demonstrating equivalent oscillometry performance between the predicate and the proposed C2 device and compliance with the ERS FOT recommendations ([1] as noted above) for the impedance accuracy. The tested parameters included:
- -Resistance Accuracy
- -Reactance Accuracy
- ー Impedance Accuracy
- -Intra-Device Total Resistance Repeatability
- Intra-Device Total Reactance Repeatability -
- -Intra-Device Total Impedance Repeatability
- -Tidal Volume Accuracy
- -Intra-Device Tidal Volume Repeatability
Reproducibility and Repeatability testing demonstrated consistency between the predicate and proposed C2 device with measurement variations < 3.0%.
. Electrical safety and Electromagnetic Compatibility - as per current standards IEC 60601-1:2005+A1:2012 and IEC 60601-1-2:2014+A1:2020 and additionally per AIM 7351731:2017 as noted above.
. Biocompatibility assessment and gas pathway assessment of volatile organic compounds (VOCs), particulates, ozone, CO, and CO2 emission levels per ISO 10993-1:2018, 10993-5:2009, ISO 10993-10:2010, ISO 10993-12:2013, ISO-18562-1/2/3:2017, 21 CFR 801.415, and National Air Quality and

{10}------------------------------------------------

OSHA limits. Contact Type and Duration: Externally communicating (Indirect), Tissue, limited duration (<24 hours); Surface, Intact Skin and Oral Mucosa, limited duration (<24 hours)

Cleaning/Disinfection Validation Testing - validated as per the FDA guidance; Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (2015) and AAMI TIR30:2011.
. Hardware performance validation tests – bench tests conducted to validate that hardware requirements were met.
. Software verification and validation testing – per IEC 62304:2006+A1:2015 and 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).

Conclusion:

Based on the above, the tremoflo C2 Airwave Oscillometry System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
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.(b)
Classification. Class II (performance standards).