Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, and cardiopulmonary testing (CPET) parameters, aiding in the diagnosis of related conditions.

All the measurements are performed via a mouthpiece or a mask.

The results of the test can be viewed on-line with the help of a computer screen and can be printed after the test. 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

Ascent™ Cardiorespiratory Diagnostic Software ("Ascent") is a stand-alone software application which can be used with several hardware devices in the Medical Graphics Corporation product line.

The core purpose of the software for measurement, data collection and analysis of testing in patients who may be suffering from pulmonary illnesses like chronic obstructive pulmonary disease (COPD), asthma, exercise intolerance, heart failure and/or cardiorespiratory concerns where diagnosis and prognosis needs to be determined.

In conjunction with diagnostic hardware, Ascent 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, often a pulmonologist or cardiologist.

All the measurements are performed via a mouthpiece or a face mask.

AI/ML Overview

The provided text is a 510(k) summary from the FDA, which outlines the substantial equivalence determination for a medical device. This type of document focuses on comparing a new device to existing legally marketed predicate devices rather than providing detailed acceptance criteria and the results of a specific clinical study with granular performance metrics. As such, the document does not contain the specific information needed to fulfill all aspects of your request, particularly regarding detailed performance metrics, sample sizes for test sets (beyond general validation statements), expert qualifications, ground truth establishment methods for test sets, MRMC studies, or training set details.

However, I can extract the information that is present and highlight what is missing based on your request.

Missing Information:

Detailed Acceptance Criteria Table with Specific Performance Metrics: The document states that the software was "extensively validated per medical device software standards and guidance" and that "Testing results support that Ascent fulfills its intended use/indications for use." It also mentions "Performance tests included FEV1, MVV, FRC, SVC, DLCO, VA, TGV, VO2, VCO2, and VE." However, it does not provide specific quantitative acceptance criteria (e.g., "FEV1 must be within X% of ground truth") or the reported performance for these metrics.
Sample Size for Test Set and Data Provenance: The document does not specify the sample size for the test data used for performance validation, nor does it detail the provenance (country, retrospective/prospective) of this data.
Number of Experts and Qualifications for Ground Truth: The document does not describe how ground truth for the test set was established, including the number or specific qualifications of experts involved.
Adjudication Method for Test Set: No information is provided regarding adjudication methods (e.g., 2+1, 3+1).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not indicate that an MRMC study was performed or provide any effect size for human reader improvement with AI assistance.
Standalone Performance (Algorithm Only): While the document states "Ascent Cardiorespiratory Diagnostic Software is a stand-alone software application," it describes validation as "Performance validation testing was done with the subject software device and recommended hardware devices working together." It does not provide specific performance metrics for the algorithm only without human interaction in a diagnostic capacity beyond its intended function of measuring, collecting, and analyzing parameters. The software aids diagnosis, implying human interpretation.
Type of Ground Truth Used (for Test Set): The document implicitly refers to "performance tests" for various physiological parameters (FEV1, DLCO, etc.), suggesting comparison to a reference standard for these measurements. However, it does not explicitly state the nature of this "ground truth" (e.g., expert consensus, pathology, outcome data) beyond reference to ATS/ERS guidelines for standardization.
Sample Size for Training Set: No information on training data or its size is provided. This is typical for a 510(k) for software that calculates and analyzes data from hardware, rather than an AI/ML model that learns from large datasets.
How Ground Truth for Training Set was Established: Not applicable as training data details are not provided.

Information that can be extracted from the document:

The provided document is a 510(k) summary for the "Ascent Cardiorespiratory Diagnostic Software" (K242809). It details the device's substantial equivalence to predicate devices, focusing on its intended use, technological characteristics, and conformity to relevant standards and guidelines.

1. A table of acceptance criteria and the reported device performance:

As noted above, specific quantitative acceptance criteria and reported performance metrics are NOT provided in this document. The document generally states that "Ascent Cardiorespiratory Diagnostic Software was extensively validated per medical device software standards and guidance. Testing results support that Ascent fulfills its intended use/indications for use..."

It mentions that "Performance tests included FEV1, MVV, FRC, SVC, DLCO, VA, TGV, VO2, VCO2, and VE." However, no numerical results or thresholds are given. The validation was done referencing the following guidelines/standards for "acceptability and repeatability":

ATS/ ERS Standardisation of Spirometry (2019)
ERS/ ATS Standardisation of the Measurements of Lung Volumes (2023)
2017 ERS/ ATS Standards for Single-Breath Carbon Monoxide Uptake in the Lung
ERS Technical Standard on Bronchial Challenge Testing (2017)
2017 ATS Guidelines for a Standardized PF Report
ATS/ ACCP Statement on Cardiopulmonary Exercise Testing (2003)

Summary of available information for a table format (conceptual, as specific numerical data is missing):

Performance Measure	Acceptance Criteria (Stated as conforming to standards)	Reported Device Performance (General Statement)
FEV1	Conforms to ATS/ERS Standardisation of Spirometry (2019) requirements for acceptability and repeatability.	Testing results support intended use.
MVV	Conforms to ATS/ERS Standardisation of Spirometry (2019) requirements for acceptability and repeatability.	Testing results support intended use.
FRC	Conforms to ERS/ATS Standardisation of the Measurements of Lung Volumes (2023) requirements for acceptability and repeatability.	Testing results support intended use.
SVC	Conforms to ATS/ERS Standardisation of Spirometry (2019) requirements for acceptability and repeatability.	Testing results support intended use.
DLCO	Conforms to 2017 ERS/ATS Standards for Single-Breath Carbon Monoxide Uptake in the Lung for acceptability and repeatability.	Testing results support intended use.
VA	Conforms to 2017 ERS/ATS Standards for Single-Breath Carbon Monoxide Uptake in the Lung for acceptability and repeatability.	Testing results support intended use.
TGV	Conforms to ERS/ATS Standardisation of the Measurements of Lung Volumes (2023) requirements for acceptability and repeatability.	Testing results support intended use.
VO2	Conforms to ATS/ACCP Statement on Cardiopulmonary Exercise Testing (2003) guidelines.	Testing results support intended use.
VCO2	Conforms to ATS/ACCP Statement on Cardiopulmonary Exercise Testing (2003) guidelines.	Testing results support intended use.
VE	Conforms to ATS/ACCP Statement on Cardiopulmonary Exercise Testing (2003) guidelines.	Testing results support intended use.
Cybersecurity	Addressed as per FDA Guidance - Cybersecurity in Medical Devices.	Not specified explicitly beyond "addressed."
Risk Management	Conforms to ISO 14971.	Not specified explicitly.
Software Life Cycle	Conforms to IEC 62304.	Not specified explicitly.

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified. The document only states "Software validation testing involved system level tests, performance tests and safety testing based on hazard analysis. Performance validation testing was done with the subject software device and recommended hardware devices working together."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

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 MRMC study is mentioned or implied. The software is described as
"aiding in the diagnosis of related conditions" and presenting "diagnostic information so that it can be checked for quality and interpreted by a qualified physician." This device is a "Predictive Pulmonary-Function Value Calculator" and performs measurements and analysis, but it is not described as an AI system assisting human readers in image interpretation or diagnosis in a comparative effectiveness study context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is indeed described as a "stand-alone software application." However, the performance validation was done "with the subject software device and recommended hardware devices working together." Its output (measurements and analysis) is intended to be "displayed to the user" and "interpreted by a qualified physician."
The document does not provide performance metrics for the algorithm only in a way that suggests a diagnostic output without human interpretation or hardware interaction. It's a software that processes data from hardware to provide measurements and analysis, not, for example, a diagnostic image analysis AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document implies that the ground truth for the performance tests (FEV1, DLCO, etc.) would be established by the standardized measurement techniques defined by governing bodies like ATS/ERS/ACCP. These typically involve comparing the device's calculated values against accepted reference methods for deriving those physiological parameters, often involving highly calibrated equipment and expert technicians following strict protocols. However, the exact nature of this "ground truth" (e.g., what gold standard was used for comparison) is not explicitly detailed beyond referencing the standards themselves.

8. The sample size for the training set:

This information is not provided in the document. This type of device (a calculator/analyzer) is typically engineered based on established physiological formulas and algorithms, rather than being "trained" on large datasets in the way a deep learning AI model would be.

9. How the ground truth for the training set was established:

Not applicable, as training set details are not provided and the device functions as a calculator based on established science, not a machine learning model that learns from a labeled training set.

Summary

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October 17, 2024

Medical Graphics Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K242809

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, BZC Dated: September 17, 2024 Received: September 17, 2024

Dear Prithul Bom:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

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Page

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Binoy J.
Mathews -S
Digitally signed by Binoy J.
Mathews -S
Date: 2024.10.17 16:18:59
-04'00'

For

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) K242809

Device Name Ascent Cardiorespiratory Diagnostic Software

Indications for Use (Describe)

All the measurements are performed via a mouthpiece or a mask.

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

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.

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/4/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

October 17, 2024

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. 1415 Lilac Drive N Minneapolis, MN 55422 Phone: (612) 356-9653 Email: fowler@pathmakerlaw.com

Proprietary or Trade Name: Ascent™ Cardiorespiratory Diagnostic Software

Available Model Number: v2.1

Common Name: Cardiorespiratory Diagnostic Software

Classification Names:

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

Predicate Devices: K181912, Ascent™ Cardiorespiratory Diagnostic Software K133925, Vyntus SentrySuite Product Line

Intended Use/Indications for Use:

All the measurements are performed via a mouthpiece or a mask.

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

The product can be utilized for patients from 4 vears 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:

Ascent™ Cardiorespiratory Diagnostic Software ("Ascent") is a stand-alone software application which can be used with several hardware devices in the Medical Graphics Corporation product line.

All the measurements are performed via a mouthpiece or a face mask.

Pulmonary Function Tests

The following pulmonary function tests will be supported:

1. Forced Vital Capacity (FVC)
Slow Vital Capacity (SVC) 2)
1. Maximum Voluntary Ventilation (MVV)
1. Plethysmography (Pleth)
1. Functional Residual Capacity (FRC)
FRC Nitrogen Washout vs FRC Helium Rebreathing a)
Diffusing Capacity (DLCO), Single breath Real Time Diffusion and single-breath gas ୧) chromatography
1. Maximum Inspiratory/Expiratory Pressure (MIP/MEP)
1. Six Minute Walk (6MWT) – software supports recording of results only, does not conduct test
1. Challenge Testing (Bronchial Provocation (BRP))

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Cardiopulmonary Exercise Tests (CPET)

For CPET testing, the software will be testing the patient's metabolic response while exercising or resting by collecting breath data. The gas samples are dried by Nafion tubes and analyzed for O2 and CO2 content. From the breathing volume and the differences between inspiratory and expiratory O2 and CO2 concentrations, the oxygen uptake and the CO2 production (VO2 and VCO2) are calculated by the software.

The following cardiopulmonary exercise tests will be supported by the Ascent software:

1. Breath by breath Cardiopulmonary Exercise Test (CPET
- a. Test can utilize Bike, Ergometer or other exercise device (i.e., Rowing Machine)
- b. Measuring high/low FiO2, end tidal, respiratory drive
1. Indirect Calorimetry
- a. Resting Test
- b. Face Tent Test
1. High/Low FiO2 (HAST)
1. Exercise Flow Volume Loops
1. Cardiac Output
1. Six Minute Walk (6MWT)
- a. The software supports a 6MWT by accepting test result data via Bluetooth functionality from a Nonin WristOx 3150 Pulse Oximeter.

Hardware interaction

An MGCD hardware device can be connected to the computer running Ascent™ Cardiorespiratory Diagnostic Software via a USB port. Communication with 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 output test results into the software where they can be managed and displayed to the user.

Ascent™ Cardiorespiratory Diagnostic Software will display a "device dashboard" on the home screen that will allow the user to view the status of any connected MGC device. The dashboard indicates the status of the selected device, the calibration status of the device, and the current device warm-up time. The Dashboard also allows the user to start/stop the vacuum pump if the device is so-equipped.

User Information

The software is intended to be used by trained professionals within the intended environments. And to present the collected lung diagnostic information to a qualified physician, (usually a pulmonologist or cardiologist), fordiagnostic interpretation. Users of the software are expected to receive training on how to work with the software prior to using the software for diagnostic purposes.

Intended Operational Environment

The software is intended to be used in hospitals, clinics and other pulmonary function and cardiorespiratory diagnostic environments. The software can also be used in any environment that has qualified physician oversight.

The software is intended to be installed as a desktop application on a Microsoft Windows based personal computer.

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Supported Devices

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

Device	Manufacturer	Device Class	ProductCode	FDA 510(k)Number
Platinum Elite™ Series bodyplethysmograph (RTD and GC)	Medical GraphicsCorporation	2	CCM	K943259
CPFS/D USB™ spirometer	Medical GraphicsCorporation	2	BTY	K861486
Ultima Series™ cardiorespiratorydiagnostic systems	Medical GraphicsCorporation	2	BZL	K061731
Pulse Oximeter	Nonin	2	DQA	K080255
Pulse Oximeter	Nonin	2	DQA	K040589
Pulse Oximeter	Nonin	2	DQA	K102350
NIBP	Suntech Medical	2	DXN	K122401
Treadmill	Full Vision	1	IOL	N/A1
Treadmill	Woodway	1	IOL	N/A1
Treadmill	Medisoft RAMItalia	1	IOL	N/A1
Treadmill	Lode	1	IOL	N/A1
Treadmill	H/P/Cosmos	1	IOL	N/A1
Treadmill	Ergoline	1	IOL	N/A1
Ergometer	Lode	2	ISD	K851097
Ergometer	Lode	2	DXN	K060820
Ergometer	Lode	2	MUD	K060820
Ergometer	Ergoline	2	ISD	510(k) Exempt
ECG	Philips Healthcare	2	DQK	K121638
ECG	Baxter Healthcare	2	DPS	K152944
Heart Rate	Medtronic(formally Zephyr)	2	MHX, DRX	K113045

² – Noted Class 1 devices are exempted from premarket notification requirements.

Summary of Intended Use/Indications for Use of Device Compared to Predicate Device:

The intended use/indications for use statement for the subject device combines the intended use statements of both predicates. The addition of cardiopulmonary (CPET) testing is supported by the second predicate device. The intended patient population and intended user is the subject and predicate devices.

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Summary of Technological Characteristics of Device Compared to Predicate Device:

Technological Characteristics Table

	Subject DeviceAscent Cardiorespiratory DiagnosticSoftware	Predicate DeviceAscent CardiorespiratoryDiagnostic Software	Predicate DeviceVyntus/SentrySuite Product Line	Comparison
510(k) Number	K242809	K181912	K133925
Decision Date	TBD	April 12, 2019	August 22, 2014
Manufacturer	Medical Graphics Corporation	Medical Graphics Corporation	CareFusion Germany
Classification	Class II	Class II	Class II	Identical
Classification Name	1) Calculator, Predicted Values,Pulmonary Function; BTY2) Pulmonary function data calculator,BZC	1) Calculator, Predicted Values,Pulmonary Function; BTY2) Pulmonary function data calculator,BZC	Pulmonary function datacalculator, BZC	All use Pulmonary functiondata calculator, BZC
Regulations	868.1880868.1890	868.1880868.1890	868.1880	Similar
Product Codes	BTY, BZC	BTY, BZC	BZC	Similar
Prescription Use?	Yes	Yes	Yes	Same
Intended UseStatement	Ascent Cardiorespiratory DiagnosticSoftware is intended to be used formeasurements, data collection and analysisof lung function (PFT) parameters andcardiopulmonary testing (CPET)parameters, aiding in the diagnosis ofrelated conditions.All the measurements are performed via amouthpiece or a mask.The results of the test can be viewed on-line with the help of a computer screenand can be printed after the test. The testresults can be saved for further referral orreport generation purposes.	Ascent Cardiorespiratory DiagnosticSoftware is intended to be used formeasurements, data collection andanalysis of lung function (PFT)parameters, aiding in the diagnosis ofrelated conditions.All the measurements are performed via amouthpiece or a mask. The results of thetest can be viewed on-line with the help ofa computer screen and can be printedafter the test. The test results can be savedfor further referral or report generationpurposes.For use of the Bronchial Challenge option,	The Vyntus/SentrySuiteproduct line is intended to beused for measurements, datacollection and analysis of lungfunction (PFT) parameters andcardio-pulmonary (CPET)parameters, aiding in thediagnosis of related conditions.The results of the test can beviewed online with the help ofa computer screen and can beprinted after the test. The testresults can be saved for futurereference or report generation	Same
	For use of the Bronchial Challenge option,the medical director of the laboratory,physician, or person appropriately trainedto treat acute bronchoconstriction,including appropriate use of resuscitationequipment, must be close enough torespond quickly to an emergency.The product can be utilized for patientsfrom 4 years old and older as long as theycan cooperate in the performance -- nospecial limit to patient's sex or height.Measurements will be performedunder the direction of a physician in ahospital environment, physician'soffice or similar settings.	physician, or person appropriately trainedto treat acute bronchoconstriction,including appropriate use of resuscitationequipment, must be close enough torespond quickly to an emergency.The product can be utilized for patientsfrom 4 years old and older as long as theycan cooperate in the performance-- no special limit to patient's sex orheight.Measurements will be performedunder the direction of a physician in ahospital environment, physician'soffice or similar settings.	purposes.The products can be utilizedwith patients age 4 years andolder as long as they cancooperate in the performance– no special limit to patient'ssex or height exists.Measurements will beperformed under the directionof a physician in a hospitalenvironment, physician's officeor similar setting (professionalhealthcare facilities).
AssociatedHardware	• Desktop or Notebook Computer• Trolley or Desk• Measurement Devices- CPFS/D USB Spirometer- Platinum Elite Series Body- Plethysmograph- Ultima Series- Other optional items	• Desktop or Notebook Computer• Trolley or Desk• Measurement Devices- CPFS/D USB Spirometer- Platinum Elite Series Body- Plethysmograph	• Desktop or NotebookComputer• Cart• Measurement Devices- Vyntus CPX unit- Vyntus table toppower module- Digital VolumeTransducer- Ambient module- USB cable- Other optional items	Similar
Calibration Method	• Flow 3L Syringe• O2/CO2 – integrated gas calibration• Real Time DLCO - integrated gascalibration•Plethysmography – integratedDeadweight and 50cc Cal Pump•MIP/MEP – Integrated Deadweightor water manometer	• Flow 3L Syringe• O2/CO2 – integrated gas calibration• Real Time DLCO – integrated gascalibration•Plethysmography - integratedDeadweight and 50cc Cal Pump•MIP/MEP – Integrated Deadweight	N/A	Similar
Bronchial Test	• Bronchial TestO BronchospasmolysisO Bronchoprovocation	• Bronchial TestO BronchospasmolysisO Bronchoprovocation	N/A	Identical to K181912
Spirometry	• Spirometry (Slow and Forced)	• Spirometry (Slow and Forced)	• Spirometry (Slow and Forced)	Identical to K181912

	• Incentive Spirometry• Flow/ Volume• MVV	• Incentive Spirometry• Flow/ Volume• MVV	• MVV
FRC NitrogenWashout	• FRC Nitrogen Washout	• FRC Nitrogen Washout	N/A	Identical to K181912
Real Time SingleBreath Diffusion	• Real Time Single Breath Diffusion	• Real Time Single Breath Diffusion	N/A	Identical to K181912
Diffusion SingleBreath CO/He	• Diffusion Single Breath CO/He	• Diffusion Single Breath CO/He	N/A	Identical to K181912
BodyPlethysmography	• Body Plethysmography	• Body Plethysmography	N/A	Identical to K181912
Respiratory Drive	• PI/PE Max (MIP/MEP)	• PI/PE Max (MIP/MEP)	N/A	Identical to K181912
Breath-by-Breath	Breath-by-Breath	N/A	Breath-by-Breath	Identical to K133925
Indirect Calorimetry	Indirect Calorimetry	N/A	Indirect Calorimetry	Identical to K133925
Six Minute Walk(6MWT)	Six Minute Walk (6MWT)	Six Minute Walk (6MWT)	N/A	Similar to K181912
High AltitudeSimulation Test	High/Low FiO2 (HAST)	N/A	Breath-by-Breath	Similar to K133925
Exercise FlowVolume Loops	Exercise Flow Volume Loops	Spirometry	Breath-by-Breath	Similar to K133925 andK181912
Cardiac Output	Calculated value, derived from VO2 andblood gases	N/A	Calculated value, derivedfrom VO2 and blood gases	Similar to K133925
Software
Software deviceonly	Yes	Yes	No, this device hassoftware and hardware	Identical to K181912
Software NetworkOptions	• Use as Workstation• Data integration• Database handling• Networked database• Offline mode• Network printing	• Use as Workstation• Data integration• Database handling• Networked database• Offline mode• Network printing	• Use as Workstation• Use as Server• Online Connection• Vlink connection• GTD connection• Data integration• Database handling• JINET server	Identical to K181912

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The subject device and the predicate devices are all software programs that are used with a variety of hardware systems to collect, display, manage and store patient data from pulmonary function tests and cardiorespiratory tests. Most of the test functionality is the same. There are just a few tests where there are minor differences between the subject device and one of the predicate devices:

Six Minute Walk Test (6MWT) 1.

The subject device performs an additional test which is not performed by the K133925 predicate but is similar to K181912. The 6MWT is typically performed to assess response to a medical or surgical intervention but may also be used to assess functional capacity of the subject and to help titrate oxygen as the patient walks. The object of the test is to have the subject walk as far as possible in 6 minutes. K181912 implements the 6MWT as simple lap counter allowing the medical professional to determine the total distance traveled. The subject device support input of pulse oximetry and heart rate data from an independent medical device into the test for real-time observation and subsequent reporting.

2. High Altitude Simulation Test (HAST)

HAST is a method of assessing a patient's ability to be exposed to conditions with a reduced partial pressure of oxygen, such as air travel or a high-altitude environment. A medical professional varies the inspired O2 concentration for subjects either at rest or during exercise. The mechanism which delivers this altered gas concentration to the patient is independent of the subject device. Measurement is accomplished via a breath-by-breath method, similar to K133925 in which both inspiratory and expiratory concentrations of oxygen (O2) and CO2 are measured.

3. Exercise Flow Volume Loops (ExFVL)

ExFVL integrates a flow volume loop during an exercise gas exchange test. Both predicate devices support spirometry and K133925 supports breath-by-breath exercise testing. Subject device allows for a single maximal inhalation maneuver to be executed during the breath-by-breath exercise test. The resulting exercise flow volume loop can be overlayed over a flow volume loop collected during spirometry or the resting phase of the CPET test.

4. Breath by Breath

Breath by breath is a comprehensive evaluation of the cardiovascular, pulmonary, and muscular systems during physical activity. The test typically involves exercising on a treadmill or stationary bike while breathing through a mouthpiece connected to a metabolic cart. Key measurements involve oxygen uptake (VO2), carbon dioxide production (VCO2), and ventilation. Subject device is similar to K133925 in the measurements of VO2, VCO2 ,and VE, however subject device includes additional derived values which are calculated values from literature.

5. Indirect calorimetry

An indirect calorimetry test measures the amount of oxygen consumed and carbon dioxide produced by the body to estimate resting energy expenditure (REE). Subject device is equivalent in performance to predicate K133925.

6. Cardiac output

Cardiac output is a calculated parameter using the VO2 measurement by the subject device and blood gases which are manually entered by the clinician. Subject device measures VO2 in a substantially equivalent manner as K133925. This is a calculated parameter and well-established calculation from literature via FICK method.

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Determination of Substantial Equivalence Based on Nonclinical Tests

Ascent Cardiorespiratory Diagnostic Software was extensively validated per medical device software standards and guidance. Testing results support that Ascent fulfills its intended use/indications for use and 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. Performance validation testing was done with the subject software device and recommended hardware devices working together. Performance tests included FEV1, MVV, FRC, SVC, DLCO, VA, TGV, VO2, VCO2, and VE. Cybersecurity issues have been addressed. 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
FDA Guidance Content of Premarket Submissions for Device Software Functions ●
FDA Guidance - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Ascent Cardiorespiratory Diagnostic Software was evaluated per American Thoracic Society (ATS), European Respiratory Society (ERS), and American College of Chest Physicians (ACCP) guidelines. The following statements/ standards were referenced for acceptability and repeatability guidelines and production of a standardized report:

ATS/ ERS Standardisation of Spirometry (2019) ●
ERS/ ATS Standardisation of the Measurements of Lung Volumes (2023)
2017 ERS/ ATS Standards for Single-Breath Carbon Monoxide Uptake in the Lung
ERS Technical Standard on Bronchial Challenge Testing (2017)
2017 ATS Guidelines for a Standardized PF Report
ATS/ ACCP Statement on Cardiopulmonary Exercise Testing (2003)

Comparison to Predicate Devices and Conclusion:

The subject device, Ascent, is identical in many ways to its predecessor, Ascent predicate. The addition of the CPET tests are supported by the Vyntus/SentrySuite predicate device and are consistent with the intended use of measurements, data collections and analysis of lung function parameters.

Ascent Cardiorespiratory Diagnostic Software is substantially equivalent to the predicate devices, Ascent Cardiorespiratory Diagnostic Software (K181912) and Vyntus/SentrySuite Product line (K133925). MGC Diagnostics comparisons to the predicate demonstrate the subject device has the same intended use and similar technological characteristics any differences do not raise new questions of safety or effectiveness.

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).