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510(k) Data Aggregation
(440 days)
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.
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.
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.
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(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.
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