Ascent Cardiorespiratory Diagnostic Software

K181912 · Medical Graphics Corporation · BTY · Apr 12, 2019 · Anesthesiology

Device Facts

• Record ID: K181912
• Device Name: Ascent Cardiorespiratory Diagnostic Software
• Applicant: Medical Graphics Corporation
• Product Code: BTY · Anesthesiology
• Decision Date: Apr 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece or a mask. The test can be viewed on-line with the help of a computer screen and can be printed after the test results can be saved for further referral or report generation purposes. For use of the Bronchial Challenge option, the medical director of the laboratory, physician, or person appropriately trained to treat acute bronchoconstriction, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency. The product can be utilized for patients from 4 years old and older as long as they can cooperate in the performance -- no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.

Device Story

Ascent software is a Windows desktop application that interfaces with MGC Diagnostics hardware (spirometers, plethysmographs) via USB to collect, analyze, and display lung function data. Operated by respiratory therapists or pulmonary function technologists in clinical settings, it supports tests including FVC, SVC, MVV, plethysmography, FRC (nitrogen washout), DLCO (gas chromatography), MIP/MEP, 6MWT, and bronchial provocation. The software processes raw signals from connected hardware to derive pulmonary parameters, which are then reviewed by a physician (typically a pulmonologist) for diagnostic interpretation. By facilitating standardized data collection and reporting, the device assists in the diagnosis and management of pulmonary illnesses. It does not control nebulizers for bronchial challenges; these are administered separately by clinical staff.

Clinical Evidence

No clinical data. Bench testing only. Validation included system-level performance testing and physiologic validation across 38 sessions with subjects aged 7 to 63, confirming accuracy of parameters including FVC, MVV, FRC, SVC, DLCO, VA, and TGV.

Technological Characteristics

Windows desktop application (.NET Framework). Interfaces with USB-connected pulmonary hardware (spirometers, plethysmographs). Uses gas chromatography for DLCO analysis and nitrogen washout for FRC. Complies with ISO 14971 (risk management) and IEC 62304 (software lifecycle).

Indications for Use

Indicated for patients 4 years and older capable of cooperating with pulmonary function testing (PFT) to aid in the diagnosis of pulmonary conditions like COPD and asthma. No contraindications specified beyond the requirement for trained supervision during bronchial challenge testing.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• SentrySuite Product Line (K122699)

Submission Summary (Full Text)

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April 12, 2019

Medical Graphics Corporation % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K181912

Trade/Device Name: Ascent Cardiorespiratory Diagnostic Software Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: BTY Dated: July 15, 2018 Received: July 17, 2018

Dear Mark Job:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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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Image /page/2/Picture/0 description: The image shows the logo for MGC Diagnostics. The logo consists of a gray circle with three vertical lines inside, resembling a pause symbol. Below the symbol, the text "MGC DIAGNOSTICS" is displayed, with "MGC" in yellow and "DIAGNOSTICS" in gray, followed by the registered trademark symbol.

MGC Diagnostics Corporation through its subsidiary Medical Graphics Corporation 350 Oak Grove Parkway St. Paul, Minnesota USA, 55127 -8599

## 510(k) Summary

April 11, 2019

## Submitted by:

MGC Diagnostics Corporation Through its subsidiary Medical Graphics Corporation 350 Oak Grove Parkway St. Paul, MN 55127-8599 USA 651-484-4874

## Contact Person:

Amy Fowler Regulatory Counsel for MGC Diagnostics Pathmaker FDA Law, P.L.L.C. 528 Hennepin Avenue, Suite 503 Minneapolis, MN 55403 Phone: [phone] Email: [e-mail]

Proprietary or Trade Name: Ascent™ Cardiorespiratory Diagnostic Software

Common Name: Pulmonary Function Software

## Classification Names:

Calculator, Predicted Values, Pulmonary Function, 21 CFR 868.1890, BTY Pulmonary Function Data Calculator, 21 CFR 868.1880, BZC

Predicate Device: K122699, SentrySuite Product Line

## Intended Use:

Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece or a mask. The test can be viewed on-line

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with the help of a computer screen and can be printed after the test results can be saved for further referral or report generation purposes.

For use of the Bronchial Challenge option, the medical director of the laboratory, physician, or person appropriately trained to treat acute bronchoconstriction, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency.

The product can be utilized for patients from 4 years old and older as long as they can cooperate in the performance -- no special limit to patient's sex or height.

Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.

#### Device Description:

In conjunction with pulmonary diagnostic hardware, Ascent software, a Windows desktop application developed using Microsoft's NET Framework, is used to collect data pertaining to the patient's degree of obstruction, lung volumes, and diffusing capacity. It is also used to present the collected lung diagnostic information so that it can be checked for quality and interpreted by a qualified physician, usually a pulmonologist.

The core purpose of the software is to facilitate pulmonary function testing in patients who may be suffering from pulmonary illnesses like Chronic Obstructive Pulmonary Disease and asthma. The software will interact with connected Medical Graphics Corporation diagnostic devices to perform the desired pulmonary function tests on the patient by a professional pulmonary function technologist. The application will display both actual and derived test variables to the user after a test is performed for purposes of data review.

#### Pulmonary Function Tests

Several pulmonary function tests are supported, including the following:

- 1) Forced Vital Capacity (FVC)
- 2) Slow Vital Capacity (SVC)
- 3) Maximum Voluntary Ventilation (MVV)
- 4) Plethysmography (Pleth)
- 5) Functional Residual Capacity (FRC) Nitrogen Washout
- ୧) Diffusing Capacity (DLCO), Single breath Real Time Diffusion and Single Breath Gas Chromatography
- 7) Maximum Inspiratory/Expiratory Pressure (MIP/MEP)
- Six Minute Walk (6MWT) 8)
- 9) Challenge Testing (Bronchial Provocation (BRP))

#### Supported Devices

The software is compatible with the following hardware devices, which have been independently cleared:

| Device | FDA 510(k) Number |
|------------------------------------------------------------|-------------------|
| Platinum Elite™ Series Body Plethysmograph<br>(RTD and GC) | K943259 |
| CPFS/D USB™ Spirometer | K861486 |

#### User Information

The software is intended to be used by trained professionals within the intended environments. The typical user of the software will be respiratory therapists and/or pulmonary function technologists to collect pulmonary diagnostic information from patients and to present the collected lung diagnostic information to a qualified physician, usually a pulmonologist, for diagnostic interpretation. Users of

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the software are expected to receive training on how to work with the software prior to using the software for diagnostic purposes.

## Hardware Interaction

Ascent software is designed to interact with the Platinum Elite™ Series Body Plethysmograph (RTD and GC), and the CPFS/D USB™ Spirometer. These devices can be connected to the computer running the software via a USB port. Communication with the hardware can be managed by the application. The software can start or stop a patient test that is administered by the hardware device. The hardware device will input test results into the software where they can be managed and displayed to the user

#### Intended Operational Environment

The software is intended to be used in hospitals, clinics and other pulmonary function diagnostic environments. The software is intended to be installed as a desktop application on a Windows based personal computer.

#### Summary of General Information Compared to Predicate Device:

#### General Information Table

| | Subject Device | Predicate Device | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Ascent Cardiorespiratory<br>Diagnostic Software | SentrySuite Product Line | N/A |
| 510(k)<br>Number | TBD | K122699 | N/A |
| Decision Date | TBD | Nov. 19. 2012 | N/A |
| Manufacturer | Medical Graphics<br>Corporation | CareFusion | N/A |
| Classification | Class II | Class II | Same |
| Classification<br>Name | 1) Calculator, Predicted Values, Pulmonary Function; BTY<br><br>2) Pulmonary function data calculator; BZC | 1) Calculator, Predicted Values,<br>Pulmonary Function; BTY<br><br>2) Pulmonary function data Calculator; BZC<br><br>3) Diagnostic Spirometer; BZG<br><br>4) Volume plethysmograph; JEH | The subject device chooses a subset of the classifications used by the predicate device.<br><br>Because two classifications are the same, and there are no classifications that are used by the subject device that are not used by the predicate device, this is not an issue for substantial equivalence. |
| Regulation | 868.1890<br>868.1880 | 868.1840<br>868.1890<br>868.1880<br>868.1760 | See above. |
| Product Codes | BTY, BZG | BTY, BZG, BZC, JEH | See above. |
| Prescription<br>Use? | Yes | Yes | Same |
| Proposed Intended Use/<br>Indications for Use Statement for<br>Subject Device | Predicate Device Cleared<br>Intended Use/ Indications for<br>Use Statement (K122699) | Comparison | |
| Ascent Cardiorespiratory<br>Diagnostic Software is intended to<br>be used for measurements, data<br>collection and analysis of lung<br>function (PFT) parameters, aiding<br>in the diagnosis of related<br>conditions. | The SentrySuite Product line is<br>intended to be used for<br>measurements, data collection<br>and<br>analysis of lung function (PFT)<br>parameters, aiding in the diagnosis<br>of related conditions. | Identical, except for predicate<br>device's use of nasal adapters and<br>subject device's more specific<br>supervision requirement. | |
| All the measurements are<br>performed via a mouthpiece or a<br>mask. The results of the test can<br>be viewed on-line with the help of<br>a computer screen and can be<br>printed after the test. The test<br>results can be saved for further<br>referral or report generation<br>purposes. | All the measurements are<br>performed via a mouthpiece, a<br>mask or nasal adapters. The results<br>of the test can be viewed on-line<br>with the help of a computer screen<br>and can be printed after the test.<br>The test results can be saved for<br>further referral or report<br>generation purposes. | | |
| For use of the Bronchial Challenge<br>option, the medical director of the<br>laboratory, physician, or person<br>appropriately trained to treat<br>acute bronchoconstriction,<br>including appropriate use of<br>resuscitation equipment, must be<br>close enough to respond quickly to<br>an emergency. | Use of the Option Bronchial<br>Challenge requires the supervision<br>of a physician familiar with<br>emergency medicine. | | |
| The product can be utilized for<br>patients from 4 years on and older<br>as long as they can cooperate in<br>the performance -- no special limit<br>to patient's sex or height. | The products can be utilized for<br>patients from 4 years on and older<br>as long as they can cooperate in<br>the performance – no special limit<br>to patient's sex or height. | | |
| Measurements will be performed<br>under the direction of a physician<br>in a hospital environment,<br>physician's office or similar<br>settings. | Measurements will be performed<br>under the direction of a physician<br>in a hospital environment,<br>physician's office or similar<br>settings. | | |
| | Ascent<br>Cardiorespiratory<br>Diagnostic Software | Predicate Device Cleared<br>Technological Characteristics<br>(K122699) | Comparison |
| Hardware | • Desktop or Notebook<br>Computer<br>• Trolley or Desk | • Desktop or Notebook<br>Computer<br>• Trolley or Stand with<br>Power Supply<br>• Pneumotach Handle<br>• Analyzer box (gas)<br>• APS Pro<br>• Nebulizer head<br>• Compressor | Similar (see<br>discussion) |
| | • Measurement Devices<br>• CPFS/D USB™ Spirometer<br>• Platinum Elite™ Series Body<br>Plethysmograph (RTD and GC) | • Measurement Device<br>• MasterScreen Pneumo<br>• MasterScreen IOS<br>• MasterScreen PFT/ PFT Body | |
| Performance<br>Specifications<br>(Measurement<br>Programs) | • Bronchial Test (Challenge Option) | • Bronchial Test<br>o Bronchospasmolysis<br>o Bronchoprovocation<br>o Pulsed Nebulization<br>o Continuous<br>Nebulization | Similar (see<br>discussion) |
| | • Spirometry<br>• Incentive Spirometry<br>• Flow/ Volume<br>• MVV | • Spirometry<br>• Incentive Spirometry<br>• Flow/ Volume<br>• MVV<br>• R-Occlusion (Airway<br>Resistance)<br>• Impulse Oscillometry | |
| | • FRC Nitrogen Washout<br>• Real Time Single Breath Diffusion<br>(0.3%CO, 0.3% CH4, 21% O2, Bal N2) | • FRC Helium Rebreathing<br>• Real Time Single Breath Diffusion<br>0.3%CO, 0.3% CH4, 21% O2, Bal N2)<br>• Intra Breath Diffusion | |
| | • Diffusion Single Breath Gas<br>Chromatography (GC) (0.3% CO,<br>0.5% Ne, 21% O2, Bal N2) | • Diffusion Single Breath (0.3% CO,<br>9.5% He, Bal Ambient Air) | |
| | • Body<br>Plethysmography | • Body<br>Plethysmography<br>• Respiratory Drive P0.1 | |
| | • PI/PE Max (MIP/MEP) | • PI/ME Max (MIP/MEP) | |

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## Summary of Intended Use of Device Compared to Predicate Device:

## Intended Use Table

The tests run by Ascent are largely a subset of the tests run by the SentrySuite predicate device. In a few tests, the technology varies a bit. These similarities and differences are discussed below in both tabular and text form:

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## Summary of Technological Characteristics of Device Compared to Predicate Device:

## Technological Characteristics Table

The tests run by Ascent are largely a subset of the tests run by the SentrySuite predicate device. In a few tests, the technology varies a bit. These similarities and discussed below in both tabular and text form:

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#### TECHNOLOGICAL CHARACTERISTICS TABLE - DISCUSSION

There are a few tests where there are minor differences between the subject device and predicate device:

#### Bronchial Test

Both Ascent and the predicate device can conduct and record data from a bronchial challenge test. However, Ascent does not interface with or control a nebulizer or dosimeter, unlike the predicate device. The pulmonary function response of a challenge agent is measured with Ascent after the clinical user provides the agent through a non-integrated nebulizer/ dosimeter.

#### Lung Diffusion Tests

Both Ascent and the predicate device measure diffusion capacity via Real Time Single Breath technique.

Both Ascent and the predicate device also utilize a single breath diffusion measurement technique in which one average alveolar sample is collected for analysis. The subject device uses gas chromatography to measure CO and Ne while the predicate device uses separate gas analyzers for CO and He to obtain diffusing capacity.

#### R-Occlusion Airway Resistance

R-Occlusion (interrupter technique airway resistance) measures airways resistance by measuring airflow and mouth pressure at zero flow. R-Occlusion airway resistance technique is only available on the Predicate Device.

#### FRC Nitrogen Washout vs FRC Helium Rebreathing

The subject device determines FRC by using the multiple breath nitrogen washout technique where the FRC is determined by the volume of nitrogen washed out of the lungs during the test. The nitrogen is replaced as the patient breathes 100% oxygen during the test. The predicate device uses the helium rebreathing technique in which the FRC is determined by measuring the helium concentration after equilibration occurs.

#### Respiratory Drive P0.1 (P100)

Only the predicate device measures P0.1, the pressure measured at patient's mouth after a shutter or balloon has occluded the breathing pathway. This assesses the ventilatory response to an increased level of carbon dioxide (or decreased level of oxygen).

The hardware components used with Ascent software are similar to those used with the predicate device. Like the predicate device, Ascent is designed to interface with hardware devices that perform spirometry, whole-body plethysmography, and other pulmonary function tests. The technological characteristics are largely the same, and where there are differences do not raise new questions of safety or effectiveness.

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## Determination of Substantial Equivalence Based on Nonclinical Tests

Ascent Cardiorespiratory Diagnostic Software was validated per medical device software standards and guidance. Testing results support that Ascent fulfills its intended use/indications for use and is substantially equivalent to the predicate device.

## Non-clinical Performance:

Software validation testing involved system level tests, performance tests and safety testing based on hazard analysis. Physiologic performance validation testing was done with the subject software device and recommended hardware devices working together. Performance test parameters included FVC, MVV, FRC, SVC, DLCO, VA, and TGV. There were 38 test sessions, involving subjects from seven to sixtythree years old. In addition to the verification and validation testing activities executed by Medical Graphics Corporation to establish the performance and functionality of Ascent Cardiorespiratory Diagnostic Software and the predicate device, some standards were utilized:

ISO 14971 Applications of Risk Management to Medical Devices IEC 62304:2006+AMD1:2015 Medical Device Software – Software Life Cycle Processes

## Determination of Substantial Equivalence Based on Clinical Tests: Not applicable.

## Comparison to Predicate Device and Conclusion:

Ascent Cardiorespiratory Diagnostic Software is substantially equivalent to the predicate device, SentrySuite Product Line (K122699). The intended use for Ascent is substantially equivalent to the intended use/indications for use statement of SentrySuite Product Line, K122699. The technological characteristics of Ascent are almost identical to those of the predicate device. These characteristics of Ascent software have been validated through software validation procedures and the software performs as intended. MGC Diagnostics believes the predicate device confirms the subject device has the same intended use, the technological characteristics are largely the same, and where there are differences, the differences do not raise new questions of safety or effectiveness.

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