(232 days)
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.
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.
The provided text describes the Tremoflo C-100 Airwave Oscillometry System, a medical device used to measure respiratory system impedance. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a table format with corresponding "reported device performance." However, it presents a Predicate Product Comparison table that lists various technical features and specifications of the Tremoflo C-100 and compares them to its predicate device, the Resmon PRO FULL. The "Comparison" column in this table effectively acts as an assessment against benchmarked performance (the predicate device) or relevant standards (ERS FOT recommendations).
Below is a summary derived from the provided comparison, highlighting what could be interpreted as acceptance criteria based on equivalence or standards, and the TremoFlo's reported performance against these.
Table: Derived Acceptance Criteria and Reported Device Performance
| Feature/Specification | Acceptance Criteria (Derived or Standard) | TremoFlo C-100 Reported Performance |
|---|---|---|
| Indications for Use | Equivalent to Predicate: Measure respiratory system impedance using FOT for pediatric and adult patients (4+ years), used by trained personnel. | Identical to predicate. |
| Fundamental Scientific Technology | Equivalent to Predicate: Forced Oscillation Technique and Pneumotach per ERS FOT recommendations. | Identical to predicate. |
| Pneumotach Flow Range | Sufficient for FOT measurements (Predicate: ± 2 L/s). | ± 2.5 L/s (Increased flow range compared to predicate). |
| Flow Resolution | Sufficient for FOT measurements (Predicate: ± 4.6 mL/s). | ± 1.4 ml/s (Slightly better than predicate). |
| Flow Linearity | Within ranges to provide equivalent performance per bench testing (Predicate: ± 2% up to 1.5 L/s). | ± 2% up to 1.0 L/s (Differences are small and still within ranges to provide equivalent performances in both devices per bench testing). |
| Common Mode Rejection Ratio (CMRR) | Provide accurate and reproducible results equivalent to predicate (>60dB over entire range of forcing frequencies). | Alternate dynamic software compensation (Provided accurate and reproducible results equivalent to those provided by the predicate based on performance testing). |
| Device Load to Patient | <1 cmH2O at 1L/s (Predicate). | 1.0 ± 5% cmH2O.s/L at 1 L/s (Difference in resistance to flow is small and within potential variation of resistance for bacterial/viral filters). |
| Volume Range | Sufficient for FOT measurements (Predicate: ± 2 Liters). | ±3 Liters (Increased volume range). |
| Volume Accuracy | Equal to or better than predicate (<3.5% or 0.050 L). | <3.0% or 0.050 L (whichever is greater) (Slightly greater volume accuracy). |
| Mouth Pressure Linearity | Within ERS FOT Recommendation of 2% up to 5 cmH2O (Predicate: ±0.050% of full scale up to 2.5 cm H2O). | 2% of full Scale up to 5 cm H2O (Differences are small and still within ranges to provide equivalent performances per bench testing and meeting ERS FOT Recommendation). |
| Mouth Pressure Resolution | Equal to or better than predicate (0.015 cmH2O). | 0.0053 cmH2O (0.0039 mmHg) (Better resolution). |
| Mouth Pressure Range | Sufficient for FOT measurements (Predicate: ± 2.5 cmH2O). | ± 10 cmH2O (Increased Mouth Pressure Range). |
| Effective Device Dead Space | Equivalent to predicate (35 ml). | 35 ml (Equivalent). |
| Test Signal/Frequency Range | Sinusoidal signal at specific frequencies, within medium frequency range per ERS FOT Recommendation (Predicate: 5-37Hz). | Sinusoidal signal at specific frequencies, between 5-41Hz (Slightly increased user selectable frequency range; still within medium frequency range per ERS FOT). |
| Pseudo-Random Noise Stimulus | Frequency range sufficient for FOT (Predicate: 5-37 Hz). | 5-37 Hz, 7-41 Hz (Offers a slightly increased frequency range). |
| Multi-Frequency Stimulus Accuracy | Accuracy equivalent to predicate as per performance bench testing; frequencies within medium range per ERS FOT Recommendation. | Accuracy equivalent to predicate as per performance bench testing (Offers a slightly increased frequency range, 5-11-19, 5 to 37 and 7 to 41 Hz). Frequencies still within medium frequency range per ERS FOT Recommendation. |
| Calculated Impedance Parameters | Identical parameters to predicate; substantially equivalent performance per bench testing. | Identical parameters to predicate, with additional AX and R5-R20 (Performances were substantially equivalent as per bench testing). |
| Calculated Breathing Pattern Parameters | Identical parameters to predicate; substantially equivalent performance per bench testing. | Identical parameters to predicate (Substantially equivalent performances as per bench testing). |
| Electrical Safety & EMC | Compliant with ES60601-1:2005 +A2012 (IEC60601-1, Edition 3.1) and IEC 60601-1-2:2007. | Compliant as per standards (Equivalent). |
| Biocompatibility | Acceptable VOC, Carbon Monoxide, Carbon Dioxide, Ozone and particulate matter levels from breathing pathways per ISO 10993-1 and FDA Guidance. | Testing performed to verify acceptable levels consistent with indirect patient contact (Equivalent). |
| Cleaning/Disinfection | Validated with labelled cleaning and low-level disinfection method per FDA guidance. | Validated as per FDA guidance (Equivalent). |
Study Proving Device Meets Acceptance Criteria:
The document states that no clinical study was conducted. Instead, the device met the acceptance criteria through a series of non-clinical performance data and bench testing. The primary method for demonstrating performance against criteria was by showing substantial equivalence to a legally marketed predicate device (Resmon PRO FULL), supported by adherence to relevant international standards and guidelines (e.g., ERS FOT recommendations, ISO, IEC).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- The document mentions "Reproducibility and Repeatability 3 units were tested with repeated measurements," indicating a sample size of 3 physical device units for this specific test.
- For other bench tests, the sample size is not explicitly stated in terms of number of devices or number of test cases/simulations, but it generally refers to laboratory testing.
- Data Provenance:
- All data presented is from non-clinical bench testing and internal validation.
- The testing was conducted by Thorasys Thoracic Medical Systems, Inc. (The company developing the device) and was reviewed for the 510(k) submission.
- It is retrospective in the sense that it's laboratory validation performed prior to submission, rather than prospective clinical trials.
- The country of origin of the data is implicitly Canada, where Thorasys Thoracic Medical Systems, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for the non-clinical bench testing involved physical measurements against known standards or comparison with a predicate device. It did not involve human experts establishing ground truth for diagnostic interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since no human expert-based ground truth was established, there was no need for an adjudication method. The testing involved objective measurements and comparisons to engineering specifications, established standards, or the predicate device's performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study explicitly states: "No clinical study was conducted."
6. Standalone Performance Study (Algorithm Only)
- Standalone Study: Yes, a "standalone" or "algorithm-only" performance was conducted in the sense that the device's inherent measurement capabilities and "impedance and breathing pattern parameters" were assessed through bench testing. This refers to the device's technical specifications and how accurately it measures physical properties, irrespective of human interpretation in a clinical context. The performance data section lists:
- "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%."
- The comparisons in the "Predicate Product Comparison" table also reflect standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the non-clinical testing was based on:
- Engineering specifications and known physical standards: For measurements like flow range, resolution, linearity, pressure, volume, etc.
- Performance of a legally marketed predicate device (Resmon PRO FULL): The Tremoflo C-100's features and performance were directly compared to the predicate to demonstrate substantial equivalence.
- International standards and guidelines: Such as the European Respiratory Society (ERS) FOT recommendations (Oostveen et al., Eur Respir J 2003), AAMI ES60601-1, IEC 60601-1-2, ISO 10993-1, and FDA guidance documents for biocompatibility, cleaning/disinfection, and software validation.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a measurement system and not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. Its function is based on physical principles (Forced Oscillation Technique) rather than learning from data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set was used for an AI/ML model.
{0}------------------------------------------------
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
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 #103Quebec, 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.
{4}------------------------------------------------
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 OscillometrySystem | Resmon PRO FULL K152585 |
|---|---|
| The tremoFlo C-100 Airwave Oscillometry Systemis intended to measure respiratory systemimpedance using the Forced Oscillation Technique(FOT). tremoFlo C-100 Airwave OscillometrySystem is intended for use with pediatric and adultpatients 4 years of age or older. The device isdesigned to be used by pulmonologists, generalpractitioners, nurses, respiratory therapists,laboratory technologists, medical researchers andsimilarly trained personnel in hospitals, clinics, andprivate physician offices. | The Resmon PRO FULL is intended to measurerespiratory system impedance using the ForcedOscillation Technique (FOT). Resmon PRO FULL isintended for use with pediatric and adult patients 4years of age or older. The device is designed to beused by pulmonologists, general practitioners,nurses, respiratory therapists, laboratorytechnologists, medical researchers and similarlytrained personnel in hospitals, clinics, and privatephysician offices. |
Predicate Product Comparison
| TechnicalFeature/Specification | Tremoflo C-100Airwave OscillometrySystem | Predicate:Resmon PRO FULL | Comparison |
|---|---|---|---|
| FundamentalScientificTechnology | Forced OscillationTechnique andPneumotach per ERSFOT recommendations[1]. | Forced OscillationTechnique andPneumotach per ERSFOT recommendations[1]. | Identical |
| Pneumotach FlowRange | ± 2.5 L/s | ± 2 L/s | tremoFlo has a 0.5 L/s increasedflow range. |
| Flow Resolution | ±1.4 ml/s | ±4.6 mL/s | tremoFlo flow resolution isslightlybetter). |
| Flow Linearity | ± 2% up to 1.0 L/s | ± 2% up to 1.5 L/s | the differences are small andstill within ranges to provideequivalent performances in bothdevices per the bench testing. |
| Common ModeRejection Ratio | Alternate dynamicsoftware compensation | >60dB over the entirerange of forcing | Based on the performancetesting the tremoFlo |
| TechnicalFeature/Specification | Tremoflo C-100Airwave OscillometrySystem | Predicate:Resmon PRO FULL | Comparison |
| (CMRR) | signal processing(derived from Farré etal.[3]) | frequencies | compensation provided accurateand reproducible results that areequivalent to those provided bythe predicate. |
| Device Load toPatient | 1.0 ± 5% cmH2O.s/L at1 L/s | <1 cmH2O at 1L/s | the difference in resistance toflow is small and within thepotential variation of resistancefor bacterial/viral filters. |
| Volume Range | ±3 Liters | ±2 Liters | tremoFlo has increased volumerange. |
| Volume Accuracy | <3.0% or 0.050 L(whichever is greater) | <3.5% or 0.050 L(whichever is greater) | the tremoFlo has a slightlygreater volume accuracy. |
| Mouth Pressure | Piezo Resistive | Piezo Resistive | Identical |
| Mouth PressureLinearity | 2% of full Scale up to 5cm H2O | ±0.050% of full scaleup to 2.5 cm H2O | the differences in pressurelinearity are small and stillwithin ranges to provideequivalent performances per thebench testing and meeting theERS FOT Recommendation [1]of 2 % up to 5 cmH2O. |
| Mouth PressureResolution | 0.0053 cmH2O (0.0039mmHg) | 0.015 cmH2O(0.011mmHg) | Tremoflo has better resolution. . |
| Mouth PressureRange | ± 10 cmH2O | ± 2.5 cmH2O | the tremoFlo has increased MouthPressure Range. |
| Effective DeviceDead Space | 35 ml | 35 ml | Equivalent. |
| Test Signal /Frequency range | Sinusoidal signal atspecific frequencies,between 5-41Hz | Sinusoidal signal atspecific frequencies,between 5-37Hz | tremoFlo provides a sinusoidalsignal but with a slightlyincreased user selectablefrequency range |
| Pseudo-RandomNoise Stimulus | 5-37 Hz, 7-41 Hz | 5-37 Hz | tremoFlo offers a slightlyincreased frequency range |
| Single FrequencyStimuli for awithin-breathanalysis ofrespiratoryimpedance | Can offer 5 to 41 Hz | 5,6,8 and 10 Hz | tremoFlo offers a slightlyincreased frequency range withan accuracy equivalent to thepredicate as per the performancebench testing. The frequenciesare still within the mediumfrequency range per the ERSFOT 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]. |
| TechnicalFeature/Specification | Tremoflo C-100Airwave OscillometrySystem | Predicate:Resmon PRO FULL | Comparison |
| Stimulus for awith-in breathanalysis ofrespiratoryimpedance and anestimation of thefrequency-dependence ofrespiratoryimpedance | to 41 Hz | increased frequency range withan accuracy equivalent to thepredicate as per the performancebench testing. The frequenciesare still within the mediumfrequency range per the ERSFOT Recommendation [1]. | |
| ReferenceResistance of thecalibration object | 2 cmH2O.s/L | R 2.6 cmH2O/L/s. | The difference of 0.6cmH2O/L/s on the nominalresistance value has no impacton the calibration checkperformance. |
| ReferenceReactance | The slope of X is 0.017cmH2O/L/s² | The slope of X is ~0.2cmH2O/L/s² | Both devices have similarcharacteristics and both checkfor the reactance accuracy uponcalibration. |
| Patient Population | pediatric and adultpatients 4 years or older | pediatric and adultpatients 4 years orolder | Identical |
| Energy Type | 110-240 V / 47-63Hz | 100-240 V / 50-60Hz | Equivalent. |
| CompatibleBacterial/ViralFilter and noseclip | Single use,Given 510(k) clearedPFT Filter (K111587)and nose clip | Single use,Specification ofstandard Filter, noseclip and optionalMouthpiece asprovided by the User | Both devices use a single usefilter and nose clip. |
| Patient Contact/Biocompatibility | Externallycommunicating(Indirect), Tissue,limited durationSurface, Skin, limitedduration for nose clipand inlet of filter. | Externallycommunicating(Indirect), Tissue,limited durationSurface, Skin, limitedduration for nose clipand inlet of filter. | Only the nose clip and filtercome in contact with the patient. |
| CalculatedImpedanceParameters | Total Resistance (Rtot)Inspiratory Resistance(Rinsp)Expiratory Resistance(Rexp)Total Reactance (Xtot) | Total Resistance (Rtot)Inspiratory Resistance(Rinsp)Expiratory Resistance(Rexp)Total Reactance (Xtot) | The provided parameters areidentical with the tremoFloproviding additionally AX,which is derived from thereactance curve, and alsoproviding R5-R20 in addition toR5-R20. The performances |
| TechnicalFeature/Specification | Tremoflo C-100Airwave OscillometrySystem | Predicate:Resmon PRO FULL | Comparison |
| Inspiratory Reactance(Xinsp)Expiratory Reactance(Xexp)deltaXrsR5-R19, R5-R20 | Inspiratory Reactance(Xinsp)Expiratory Reactance(Xexp)deltaXrsR5-R19 | were substantially equivalent asper bench testing. | |
| AXfres (frequency whenXtot=0) | fres | ||
| CalculatedBreathing PatternParameters | 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) | Tidal Volume (Vt)Inspiratory Time (Ti)Expiratory Time (Te)Respiratory DutyCycle (Ti/Ttot)Respiratory Rate (RR)Mean Inspiratory Flow(Vt/Ti)Mean Expiratory Flow(Vt/Te)Ventilation (Ve) | The provided parameters areidentical with substantiallyequivalent performances as perbench testing. |
| Breathing Circuit | Includes a pneumotachfor the flow. A breathe-through low resistanceVibrating Mesh(patented) is placed inseries with thepneumotach and used togenerate the stimulusduring the test. | Includes a pneumotachfor the flowmeasurement in serieswith a low-resistanceand high-inertancetube. A wooferloudspeaker, protectedby a siliconemembrane, is used togenerate the stimulusduring the test. An airblower flushes freshair inside the circuit toavoid rebreathing. | No substantial differences. Thelow dead space offered by thecompactness of the tremoFlodoes not necessitate a blower toflush air out of the breathingpathway. |
| Test duration | A minimum of 3measurements with aminimum duration of 20seconds each and 2 validbreaths minimum permeasurements for a totalof 60 seconds and 6breaths minimum per test. | One measurement with 5valid breaths minimumwhen used for single ofmulti frequency inputwaveforms, or from 30seconds measurementperiod when used forpseudo-random noiseinput waveforms. | Similar - tremoFlo minimum of 6breaths/60 seconds, as compared toin the predicate's 5 breathsminimum (single of multifrequency input) or 30 secondsmeasurement period (pseudo-random noise input). |
| TechnicalFeature/Specification | Tremoflo C-100Airwave OscillometrySystem | Predicate:Resmon PRO FULL | Comparison |
| Hardware | tremoFlo Handheld andCradle UnitsLaptop or desktopcomputer | Resmon PRO FULLHeadStand | Both devices provide a userinterface and computer that areembedded for the Resmondevice, and for the tremoFloalternately hosted on an externalcomputer. |
| Electrical SafetyElectromagneticCompatibility | Compliant withES60601-1:2005 +A2012 (IEC60601-1,Edition 3.1)IEC 60601-1-2:2007 | Compliant withES60601-1:2005(IEC60601-1, Edition3.0)IEC 60601-1-2:2007 | Equivalent. |
| Cleaning/Disinfection | Non-Critical devicewith validated andlabelled cleaning andlow-level disinfectionmethod. | Non-Critical devicewith validated andlabelled cleaning andlow-level disinfectionmethod. | Equivalent. |
{5}------------------------------------------------
{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.
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.
{9}------------------------------------------------
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.
§ 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).