(288 days)
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.
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.
The provided text describes the regulatory clearance of the Resmon PRO FULL device. However, it does not include detailed information regarding specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy) or a study that rigorously proves the device meets these criteria in the typical sense of a clinical performance study for an AI/ML powered device.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Carefusion MasterScreen IOS K101873) through technological comparison and non-clinical performance testing. The "performance testing" described is primarily about reproducibility, repeatability, and a comparative analysis of measured parameters against the predicate, rather than a clinical effectiveness study.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not state explicit acceptance criteria in the form of thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device. The performance is assessed through reproducibility, repeatability, and comparison of measured parameters.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Pneumotach Flow Range | Resmon PRO FULL: 0-2 LPS (tidal breathing) Predicate: 0-20 LPS (tidal breathing/spirometry) |
| Flow Resolution | Resmon PRO FULL: ± 4.6 mL/s Predicate: ±10 mL/s |
| Flow Accuracy | Resmon PRO FULL: Up to 1.5 L/s ± 2% Predicate: Up to 12 L/s ± 2% or ± .2 L/s (whichever is greater) |
| CMRR | Resmon PRO FULL: > 60dB over the entire range of forcing frequencies Predicate: 60 dB at 50 Hz |
| Flow Resistance | Resmon PRO FULL: < 1 cmH2O at 1L/s Predicate: 0.5 cmH2O at 10 L/s |
| Volume Range | Resmon PRO FULL: ±2 liters Predicate: ±20 liters tidal breathing/spirometry |
| Volume Accuracy | Resmon PRO FULL: <3.5% or 0.050 L (whichever is greater) Predicate: 0.5 to 8 L: ± 3% or ± 0.05 L (whichever is greater) |
| Mouth Pressure Accuracy | Resmon PRO FULL: ±0.05% of full scale Predicate: ±2% |
| Mouth Pressure Resolution | Resmon PRO FULL: .011 mmHg Predicate: .023 (mmHg) |
| Frequency Range | Resmon PRO FULL: 5-37 Hz Predicate: 0 – 100Hz |
| Reproducibility & Repeatability | Variations < 4% (within performance specifications) |
| Equivalence of Measured Impedance Parameters | Resmon PRO FULL measures: Rinsp, Rexp, Rtot, Xinsp, Xexp, Xtot, △Xrs, R5-19. Predicate measures: Total Resistance (Rtot), Inspiratory Resistance (Rinsp), Expiratory Resistance (Rexp), Total Reactance (Xtot), Inspiratory Reactance (Xinsp), Expiratory Reactance (Xexp), deltaXrs, R5-R20. "The only difference is which frequencies are subtracted." |
| Equivalence of Measured Breathing Pattern Parameters | Both devices measure: Tidal Volume (Vt), Inspiratory Time (Ti), Expiratory Time (Te), Respiratory Duty Cycle (Ti/Ttot), Respiratory Rate (RR), Mean Inspiratory Flow (Vt/Ti), Mean Expiratory Flow (Vt/Te), Ventilation (Ve). |
| Compliance with Standards | Conforms to: ANSI AAMI ES 60601-1:2005, IEC 60601-1-2:2007. Complies with ERS Forced Oscillation Technique Guidelines. |
| New Safety/Efficacy Concerns (vs. Predicate) (Implicit) | "There are no differences between the subject device and the predicate device that raise any new safety and efficacy concerns." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Comparative testing was done with the subject device and the predicate across the range of parameters and performance specifications."
- Sample Size: Not specified. It only mentions "Multiple units were tested" for reproducibility/repeatability. There is no information on the number of subjects or types of data used for the comparative testing with the predicate.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a measurement device for physiological parameters (respiratory impedance). Its performance is evaluated against physical standards and comparison with another device, not against expert-labeled ground truth for diagnosis/interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no expert adjudication mentioned or required for this type of device evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a diagnostic spirometer using the Forced Oscillation Technique (FOT) to measure respiratory impedance. It is not an AI-assisted diagnostic imaging device or an AI application with a "human-in-the-loop" for interpretation that would typically undergo an MRMC study. It is stated that "The device is not intended to be used as a stand-alone diagnostic device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The performance tests ("Hardware Verification," "Software and System Verification and Validation," "Reproducibility and Repeatability," "Comparative testing") evaluate the device's ability to accurately measure and report physiological parameters according to its specifications and in comparison to a predicate device. This is the "standalone" performance of the measurement system itself. There are no algorithms described beyond the calculation of respiratory impedance from pressure and airflow.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation would be:
- Physical calibration standards/simulators: Used to verify accuracy, resolution, and range of flow, pressure, and volume measurements.
- Predicate device measurements: For comparative testing, the predicate's measurements serve as a reference point for demonstrating statistical equivalence in measured parameters.
- Established scientific principles: The device's operation based on the Forced Oscillation Technique (FOT) adheres to these principles.
8. The sample size for the training set
Not applicable. This document does not describe the development of an AI/ML algorithm that requires a training set. The device appears to be a hardware-based measurement system with embedded software for calculations, not a learnable model.
9. How the ground truth for the training set was established
Not applicable (as above).
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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
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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 Purdie350 Oak Grove ParkwaySt Paul MN 55127 USAPhone: 651.766.3358Fax: 651.484.8941 |
| Proprietary or Trade Name: | Resmon PRO FULL |
| Common/Usual Name: | Device for measuring respiratory impedance |
| Classification Name: | PNV Diagnostic Spirometer21 CFR 868.1840, Class IIBZC Calculator, Pulmonary Function Data21 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.
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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
| Technicalfeature/specification | MasterScreen IOSK101873 | Resmon PRO FULL |
|---|---|---|
| Fundamental ScientificTechnology | Forced Oscillation Technique / pressureto flow conversion technique(pneumotach handle) | Forced Oscillation Technique andPneumotach |
| 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 (whicheveris greater) | Up to 1.5 L/s ± 2% |
| CMRR | 60 dB at 50 Hz | > 60dB over the entire range of forcingfrequencies |
| Flow Resistance | 0.5 cmH2O at 10 L/s | < 1 cmH2O at 1L/s |
| Volume Range | ±20 liters tidal breathing/spirometry | ±2 liters |
| Volume Accuracy | 0.5 to 8 L: ± 3% or ± 0.05 L (whicheveris greater) | <3.5% or 0.050 L (whichever is greater) |
| Mouth Pressure (PM) | Piezo Resistive | Piezo Resistive |
| Mouth Pressure Accuracy | ±2% | ±0.05% of full scale |
| Mouth Pressure Resolution | .023 (mmHg) | .011 mmHg |
| Test Signal | Impulse of alternating direction of allfrequencies between 0-100Hz. | Sinusoidal signal at specific frequencies,between 5-37Hz |
| Pulse Interval | .1 to 6 seconds | Not Available |
| Impulse length | 45 ms | Not Available |
| Frequency Range | 0 – 100Hz | 5-37 Hz |
| Single Impulse PowerSpectrum | -20dB at 40 Hz | Not Applicable |
| Pseudo-Random Noise(PSRN) Stimulus | Not available | 5-37 Hz |
| Single Frequency Stimulifor a within-breath analysisof respiratory impedance | Not available | 5, 6, 8, 10 Hz |
| Multi-Frequency Stimulusfor a within-breath analysisof respiratory impedanceand an estimation of thefrequency-dependence ofrespiratory impedance | 5-20 Hz | 5-11-19 Hz |
| Technicalfeature/specification | MasterScreen IOSK101873 | Resmon PRO FULL |
| Reference Resistance | 2 cmH2O/L/s (accuracy <±2%) | The resistance of the calibration object has anapproximate value of R = 2.6 cmH2O/L/s.Actual values are identified on the calibrationobject label. |
| Reference Reactance | Not available | The reactance of the calibration objectincreases with frequency. The slope of X is~0.2 cmH2O/L/s² |
| Patient Population | MasterScreen IOS can be used for adult,geriatric and pediatric population | Resmon PRO FULL can be used in pediatricand adult patients 4 years of age or older |
| Energy Type | 100-240 V / 50-60Hz | 100-240 V / 50-60Hz |
| Accessories | Single use,Filter, nose clip and optionalMouthpieceProvided by the user | Single use,Filter, nose clip and optionalMouthpieceProvided by the user |
| Patient contact | Externally communicating (Indirect),Tissue, limited durationSurface, Skin, limited duration for noseclip and inlet of filter | Externally communicating (Indirect), Tissue,limited durationSurface, Skin, limited duration for nose clipand inlet of filter |
| Calculated ImpedanceParameters | Total Resistance (Rtot)Inspiratory Resistance (Rinsp)Expiratory Resistance (Rexp)Total Reactance (Xtot)Inspiratory Reactance (Xinsp)Expiratory Reactance (Xexp)deltaXrsR5-R20 | Total Resistance (Rtot)Inspiratory Resistance (Rinsp)Expiratory Resistance (Rexp)Total Reactance (Xtot)Inspiratory Reactance (Xinsp)Expiratory Reactance (Xexp)deltaXrsR5-R19 |
| Calculated BreathingPattern Parameters | Tidal Volume (Vt)Inspiratory Time (Ti)Expiratory Time (Te)Respiratory Duty Cycle (Ti/Ttot)Respiratory Rate (RR)Mean Inspiratory Flow (Vt/Ti)Mean Expiratory Flow (Vt/Te)Ventilation (Ve) | Tidal Volume (Vt)Inspiratory Time (Ti)Expiratory Time (Te)Respiratory Duty Cycle (Ti/Ttot)Respiratory Rate (RR)Mean Inspiratory Flow (Vt/Ti)Mean Expiratory Flow (Vt/Te)Ventilation (Ve) |
| Breathing Circuit | Includes a pneumotach for the flowmeasurement in series with an elbowconnector and a screen resistance at theopposite end. A woofer loudspeaker,protected by a screen, is used to generatethe stimulus during the test | Includes a pneumotach for the flowmeasurement in series with a low-resistanceand high-inertance tube. A wooferloudspeaker, protected by a siliconemembrane, is used to generate the stimulusduring the test. An air blower flushes fresh airinside the circuit to avoid rebreathing. |
| Hardware | IOS HeadTrolley or StandAccessories | Resmon PRO FULL HeadStandAccessories |
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510(k) Summary November 1, 2016
Page 3 of 5
Comparison to Predicate Device:
The Resmon PRO FULL is viewed as substantially equivalent to the predicate device because: The Resmon PRO FULL uses the same technology and has similar indications for use. There are no differences between the Resmon PRO FULL and the predicate with questions about safety or efficacy.
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Indications - The indications for use are similar. The subject device utilizes the impedance oscillatory technique and is to be used in combination with other approved pulmonary diagnostic methods if used for diagnostic purposes. The predicate device incorporates spirometry (used for diagnostic purposes) and the impedance oscillatory technique. The proposed indications reflect the usefulness of the subject device in the assessment and measurement of the respiratory system impedance per the published guidance. Overall, the indications for use are similar when comparing the same forced oscillation technology. The differences do not affect substantial equivalence.
Prescriptive - The Resmon PRO FULL and predicate are prescription devices.
Design and Technology - The Resmon PRO FULL and predicate have equivalent design features and technology
Performance and Specifications - The Resmon PRO FULL has equivalent specifications of performance as compared to the predicate. There are some measured parameters that are different for example R5-19 for the subject device vs. R5-20 for the predicate. The difference is which frequencies are subtracted. These are relative and reference measurements not for diagnostic use.
Compliance with Standards - The Resmon PRO FULL conforms to the following standards:
- . ANSI AAMI ES 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007 Collateral standard: Electromagnetic Compatibility Requirements and ● Tests
Resmon PRO FULL also complies with ERS Forced Oscillation Technique Guidelines.
Patient Population - The Resmon PRO FULL and MasterScreen IOS are indicated for pediatrics and adults
Environment of Use - Resmon PRO FULL and MasterScreen IOS are for clinics, hospitals and doctor's offices.
Differences -There are no differences between the subject device and the predicate device that raise any new safety and efficacy concerns.
Summary of Performance Testing
We performed the following tests.
Non-clinical:
- Hardware Verification o
- Software and System Verification and Validation O
- Compliance with ANSI AAMI ES 60601-1:2005 O
- Compliance with IEC 60601-1-2:2007 O
Biocompatibility:
Based upon ISO 10993-1 and G95-1 the testing for hardware is VOCs, Carbon Monoxide, Carbon Dioxide, Ozone and particulate matter (PM2 <) detection. The patient contact is Externally
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510(k) Summary November 1, 2016 Page 5 of 5
Communicating, Tissue, Limited Duration (<24 hours). There are no direct patient contacting parts to this device.
Comparative:
Comparative testing was done with the subject device and the predicate across the range of parameters and performance specifications. The study objectives were:
- . To establish the level of reproducibility and repeatability of the Resmon PRO FULL measured parameters
- . To test the Resmon PRO FULL measured parameters compared with those provided by the predicate device, MasterScreen IOS
The following parameters were tested:
- Impedance parameters ●
- O Rinsp: inspiratory resistance
- Rexp: expiratory resistance o
- Rtot: total resistance o
- Xinsp: inspiratory reactance O
- Xexp: inspiratory reactance O
- Xtot: total reactance O
- △Xrs: difference between Xinsp and Xexp at 5 Hz O
- O R519: difference between Rinsp at 5 Hz and Rinsp at 19 Hz
- Breathing pattern parameters ●
- Ti: inspiratory time o
- Te: expiratory time o
- Ti/Ttot: respiratory duty cycle O
- RR: respiratory rate O
- Vt: Tidal volume O
- Vt/Ti: mean inspiratory flow O
- Vt/Te: mean expiratory flow O
- Ve: minute ventilation O
Reproducibility and Repeatability: Multiple units were tested and the results demonstrated consistency between the difference devices and for multiple measurement with variations < 4%. This was within performance specifications.
Animal
None
Clinical
None
Substantial Equivalence Conclusion-
Based on the above, we conclude that the Resmon PRO FULL is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with the same international standards
§ 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).