(440 days)
Not Found
No
The summary describes a device that uses the Forced Oscillation Technique (FOT) to measure respiratory system impedance. The description focuses on the physical principles of FOT, the hardware components (sensors, actuator), and standard software for data management and analysis. There is no mention of AI, ML, or related concepts in the intended use, device description, performance studies, or any other section. The analysis is based on deriving mechanical properties from pressure and airflow responses, which is a standard signal processing technique, not necessarily AI/ML.
No
The device is intended to measure respiratory system impedance to assess lung function, which is a diagnostic purpose, not a therapeutic one.
No
The "Device Description" explicitly states, "The tremoflo C2 is not intended to be used as a stand-alone diagnostic device."
No
The device description explicitly states "The main tremoflo C2 Unit is a lightweight handheld device. It contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the tremoflo C2 Airwave Oscillometry System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- tremoflo C2 Function: The tremoflo C2 measures respiratory system impedance by applying external pressure waves and analyzing the patient's breathing response. This is a non-invasive test performed directly on the patient's respiratory system, not on a specimen taken from the body.
- Lack of Specimen Analysis: The device description and intended use do not mention the collection or analysis of any biological specimens.
Therefore, the tremoflo C2 falls under the category of a medical device used for physiological measurement, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PNV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
pediativ and adult patients 4 years of age or older.
Intended User / Care Setting
pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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).
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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
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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
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Indications for Use
510(k) Number (if known) K221024
Device Name tremoflo C2 Airwave Oscillometry System
Indications for Use (Describe)
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.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the word "THORASYS" in a bold, sans-serif font. The letters are a 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 #103 |
| Quebec, 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 Airwave | |
| Oscillometry System | K170185 |
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.
4
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.
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. |
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Predicate Product Comparison
| Technical Feature/
| Specification | C100 (Predicate) | C2 (Subject) |
|---|---|---|
| Fundamental Scientific | ||
| Technology | Forced Oscillation Technique and Pneumotach per ERS | |
| FOT 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 Rejection | ||
| Ratio (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/s |
| Discussion: The difference in resistance to flow is small and within | ||
| the potential variation of resistance for bacterial/viral filters that | ||
| may be used with the tremoflo C100 system and does not raise | ||
| different questions of safety and effectiveness. | ||
| Volume Range | +3 Liters | Identical |
| Volume Accuracy |