(232 days)
No
The summary describes a device using the Forced Oscillation Technique (FOT) to measure respiratory impedance. It details hardware components, software for data management and analysis, and standard performance and safety testing. There is no mention of AI, ML, or related concepts like training/test sets, image processing, or specific AI/ML metrics.
No.
The device is intended to measure respiratory system impedance and assess lung function, not to treat a medical condition.
Yes
The device is described as a "portable lung function testing device" that assesses lung function and provides a "full report of lung mechanics," which are used to derive "mechanical properties" from pressure and airflow response. This information is used to evaluate the state of the respiratory system, indicating a diagnostic purpose.
No
The device description explicitly states that the tremoFlo C-100 Airwave Oscillometry System includes a "lightweight handheld device connected to a cradle unit" which contains "electronics, pressure and flow sensors, and the actuator providing the forced oscillations." This indicates the presence of physical hardware components beyond just software. The summary also mentions "Hardware performance validation tests" and "Electrical safety and Electromagnetic Compatibility" testing, further confirming it is not a software-only device.
Based on the provided information, the tremoFlo C-100 Airwave Oscillometry System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "measure respiratory system impedance using the Forced Oscillation Technique (FOT)." This is a measurement of a physiological function within the body, not an analysis of a sample taken from the body.
- Device Description: The device works by applying pressure waves to the patient's breathing and measuring the response. This is a direct interaction with the patient's respiratory system, not the testing of a biological sample.
- Lack of Sample Analysis: The description does not mention the collection or analysis of any biological samples (like blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The tremoFlo C-100 measures a physical property of the respiratory system in vivo.
N/A
Intended Use / Indications for Use
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.
Product codes
PNV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratory system / Lung function
Indicated Patient Age Range
pediatric 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 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
§ 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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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
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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
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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.
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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 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 #103 | |
| Quebec, 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.
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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 Oscillometry
| System | Resmon PRO FULL K152585 |
|---|---|
| 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 Resmon PRO FULL is intended to measure |
| respiratory system impedance using the Forced | |
| Oscillation Technique (FOT). Resmon PRO FULL 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. |
Predicate Product Comparison
| Technical
Feature/
Specification | Tremoflo C-100
Airwave Oscillometry
System | Predicate:
Resmon PRO FULL | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental
Scientific
Technology | Forced Oscillation
Technique and
Pneumotach per ERS
FOT recommendations
[1]. | Forced Oscillation
Technique and
Pneumotach per ERS
FOT recommendations
[1]. | Identical |
| Pneumotach Flow
Range | ± 2.5 L/s | ± 2 L/s | tremoFlo has a 0.5 L/s increased
flow range. |
| Flow Resolution | ±1.4 ml/s | ±4.6 mL/s | tremoFlo flow resolution is
slightly
better). |
| Flow Linearity | ± 2% up to 1.0 L/s | ± 2% up to 1.5 L/s | the differences are small and
still within ranges to provide
equivalent performances in both
devices per the bench testing. |
| Common Mode
Rejection Ratio | Alternate dynamic
software compensation | >60dB over the entire
range of forcing | Based on the performance
testing the tremoFlo |
| Technical
Feature/
Specification | Tremoflo C-100
Airwave Oscillometry
System | Predicate:
Resmon PRO FULL | Comparison |
| (CMRR) | signal processing
(derived from Farré et
al.[3]) | frequencies | compensation provided accurate
and reproducible results that are
equivalent to those provided by
the predicate. |
| Device Load to
Patient | 1.0 ± 5% cmH2O.s/L at
1 L/s |