(288 days)
Not Found
No
The description focuses on the physical measurement technique (FOT) and the device's hardware and software for real-time calculation of impedance. There is no mention of AI or ML algorithms for data analysis, interpretation, or prediction.
No
The device is intended to measure respiratory system impedance, assess mechanical properties, and track lung mechanics, but there is no indication that it provides any form of therapy or treatment.
No
The device description explicitly states: "The device is not intended to be used as a stand-alone diagnostic device." While it measures parameters related to the respiratory system, it is designed for assessment and not for making a definitive diagnosis on its own.
No
The device description explicitly states it consists of a "main unit" and an "adjustable holder with a clamp," indicating physical hardware components beyond just software. The performance studies also include "Hardware Verification" and "Biocompatibility" testing for hardware.
Based on the provided information, the Resmon PRO FULL is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Resmon PRO FULL measures respiratory system impedance by applying pressure oscillations at the patient's mouth and measuring pressure and airflow. This is a direct measurement on the patient, not an analysis of a biological sample taken from the patient.
- The description focuses on a non-invasive lung function test. The Forced Oscillation Technique (FOT) is described as a non-invasive method for measuring the mechanical properties of the respiratory system.
- There is no mention of analyzing biological samples. The device description and intended use do not involve the collection or analysis of blood, urine, tissue, or any other biological specimen.
Therefore, the Resmon PRO FULL falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 in hospitals, clinics, and private physician offices.
Product codes
PNV, BZC
Device Description
Resmon PRO FULL is a device for the assessment of the mechanical impedance based on the Forced Oscillation Technique (FOT).
FOT is a non-invasive lung function test for measuring the mechanical properties of the respiratory system. It consists in applying very small pressure oscillations (1-3 cmH2O peak-to-peak) of a given frequency/frequencies (usually below 40Hz) at the patient's mouth while she/he is breathing normally. During the test, the device measures pressure at the mouth and airflow to calculate respiratory impedance in real-time. Impedance is the complex ratio between pressure and airflow estimated at the frequency of the stimulating waveform. Common stimulating waveforms range from a simple sinusoid wave to a composite of different frequencies or impulses. The first approach is utilized for tracking swift changes in respiratory impedance. Examples of this include breath changes in lung mechanics or outcome measurements of specific interventions. The latter is used to assess the frequency dependency of impedance (related to the degree of lung heterogeneity) and identify the parameters of mathematical models of the respiratory system.
FOT allows for measurement during a patient's normal breathing pattern, with no forced effort required, making it suitable for monitoring non-cooperative patients, such as elderly patients, children or very severely ill patients with limited forced capacity. The test is usually performed with the subject seated, wearing a nose-clip (to prevent airflow leaks from the nose during normal breathing) and with hands on cheeks (to prevent the shunt of the pressure stimulus in the upper airways). The device is not intended to be used as a stand-alone diagnostic device.
Resmon PRO FULL consists of a main unit which has been designed to be used stand-alone, without the need of any personal computer, and an adjustable holder with a clamp to fix such unit to a table/desk and to regulate its height and orientation to the patient during an FOT test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratory system / lung
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)
Non-clinical hardware and software verification and validation, and compliance with standards. Biocompatibility testing based on ISO 10993-1 and G95-1 for VOCs, Carbon Monoxide, Carbon Dioxide, Ozone and particulate matter detection (PM2
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, ribbon-like element beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Medical Graphics Corporation % Amv Fowler Consultant for Medical Graphics 350 Oak Grove Parkway St. Paul, Minnesota 55127
Re: K152585
Trade/Device Name: Resmon PRO FULL Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: PNV, BZC Dated: May 19, 2016 Received: May 23, 2016
Dear Ms. Fowler:
This letter corrects our substantially equivalent letter of June 24, 2016.
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 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
1
the quality systems (OS) 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 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 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. 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) K152585
Device Name
Resmon PRO FULL
Indications for Use (Describe)
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.
| 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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510(k) Summary November 1, 2016 Page 1 of 5
| Date Prepared | November 1, 2016 |
|---|---|
| Official Contact: | Jim Purdie |
| 350 Oak Grove Parkway | |
| St Paul MN 55127 USA | |
| Phone: 651.766.3358 | |
| Fax: 651.484.8941 | |
| Proprietary or Trade Name: | Resmon PRO FULL |
| Common/Usual Name: | Device for measuring respiratory impedance |
| Classification Name: | PNV Diagnostic Spirometer |
| 21 CFR 868.1840, Class II | |
| BZC Calculator, Pulmonary Function Data | |
| 21 CFR 868.1880, Class II | |
| Predicate Device: | Carefusion MasterScreen IOS 510(k) K101873 |
Device Description:
Resmon PRO FULL is a device for the assessment of the mechanical impedance based on the Forced Oscillation Technique (FOT).
FOT is a non-invasive lung function test for measuring the mechanical properties of the respiratory system. It consists in applying very small pressure oscillations (1-3 cmH2O peak-to-peak) of a given frequency/frequencies (usually below 40Hz) at the patient's mouth while she/he is breathing normally. During the test, the device measures pressure at the mouth and airflow to calculate respiratory impedance in real-time. Impedance is the complex ratio between pressure and airflow estimated at the frequency of the stimulating waveform. Common stimulating waveforms range from a simple sinusoid wave to a composite of different frequencies or impulses. The first approach is utilized for tracking swift changes in respiratory impedance. Examples of this include breath changes in lung mechanics or outcome measurements of specific interventions. The latter is used to assess the frequency dependency of impedance (related to the degree of lung heterogeneity) and identify the parameters of mathematical models of the respiratory system.
FOT allows for measurement during a patient's normal breathing pattern, with no forced effort required, making it suitable for monitoring non-cooperative patients, such as elderly patients, children or very severely ill patients with limited forced capacity. The test is usually performed with the subject seated, wearing a nose-clip (to prevent airflow leaks from the nose during normal breathing) and with hands on cheeks (to prevent the shunt of the pressure stimulus in the upper airways). The device is not intended to be used as a stand-alone diagnostic device.
Resmon PRO FULL consists of a main unit which has been designed to be used stand-alone, without the need of any personal computer, and an adjustable holder with a clamp to fix such unit to a table/desk and to regulate its height and orientation to the patient during an FOT test.
Specifications for the device can be found in the table of comparison below.
4
Intended Users:
Clinicians
Indications for Use:
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 in hospitals, clinics, and private physician offices.
Device Comparison
Table 1 - Comparison with the MasterScreen IOS K101873
| Technical
feature/specification | MasterScreen IOS
K101873 | Resmon PRO FULL |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental Scientific
Technology | Forced Oscillation Technique / pressure
to flow conversion technique
(pneumotach handle) | Forced Oscillation Technique and
Pneumotach |
| Pneumotach Flow Range | 0-20 LPS (tidal breathing/spirometry) | 0-2 LPS (tidal breathing) |
| Flow Resolution | ±10 mL/s | ± 4.6 mL/s |
| Flow Accuracy | Up to 12 L/s ± 2% or ± .2 L/s (whichever
is greater) | Up to 1.5 L/s ± 2% |
| CMRR | 60 dB at 50 Hz | > 60dB over the entire range of forcing
frequencies |
| Flow Resistance | 0.5 cmH2O at 10 L/s |