Search Results
Found 1 results
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.
Ask a specific question about this device
Page 1 of 1