(92 days)
The ComPAS2 software is intended to operate with the Screenstar pneumotachograph spirometer, Morgan Transflow test PFT system and the Morgan transfer test benchmark PFT system. ComPAS2 uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Transfer test benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is for use in pulmonary function testing and reports.
ComPAS2 is designed to interface with various pieces of hardware (previously cleared pulmonary function testing devices, K142812, K042595, K022636, K953990, K013752) to capture clinical data in the performance of clinical testing. Those data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SOL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).
ComPAS2 is designed to operate with pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation (MVV), respiratory muscle strength, cough peak flow, lung volume sub-divisions (by helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include a task manager in order to manage patient data for reporting, manual entry in order to input additional information and historical data in order to analyze data for trending and reporting.
The user performs daily quality checks/calibrations prior to performing any tests. Once the test subject enters the Pulmonary Function Testing lab, foundation biographical information (Unique ID, Name, DOB) are either entered by the user, recalled or received in and order via Health Level 7(HL7) message from the information system. The functionality of ComPAS2 software remains the same as the predicate and provides the end user with the same experience.
Encounter information is added at the time of testing such as height, weight, diagnosis and physician. Test capability depends upon the Pulmonary Function Testing device being employed. Completed test information can be printed and handed to the physician for interpretation or data can be routed to the EMR (Electronic Medical Record).
ComPAS2 software connects using USB-powered desktop pulmonary function testing devices for the purpose of creating, adding and recalling subjects and performing pulmonary function testing on those subjects to aid in the measuring of the effect of lung disease on pulmonary function.
The ComPAS2 software is intended to interface with existing pulmonary function testing hardware to capture and display clinical data related to static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions, single breath diffusion, airway resistance, and distribution with lung clearance index closing volume, for use in pulmonary function testing and reports.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" in a typical quantitative format for device performance. Instead, it details that the ComPAS2 device has identical functionality and indications for use as its predicate device, ComPAS (K021200). The comparison table highlights that key functional performance parameters are the same between ComPAS and ComPAS2. Since ComPAS was already cleared by the FDA, the demonstration of identical functionality and adherence to the same established standards (ATS/ERS) serves as the basis for substantial equivalence.
| Performance Metric | Acceptance Criteria (Predicate ComPAS) | Reported Device Performance (ComPAS2) |
|---|---|---|
| Flow Measurement | Pneumotachograph | Pneumotachograph |
| Flow Range | -18 L/s to +18 L/s | -18 L/s to +18 L/s |
| Volume Accuracy | +/- 1% | +/- 1% |
| Flow Accuracy | +/- 2.5% | +/- 2.5% |
| Sampling Rate | 100 - 300 samples per second | 100 - 300 samples per second |
| Number of Tests per Session | 8 – Pre bronchodilator, 8 – Post Bronchodilator, Multiple Challenge Levels | 8 – Pre bronchodilator, 8 – Post Bronchodilator, Multiple Challenge Levels |
| Flow Calibration | 3L calibration syringe | 3L calibration syringe |
| Units | Metric or Traditional | Metric or Traditional |
| ATS/ERS Review of Acceptability | Yes | Yes |
| ATS/ERS Review of Repeatability | Yes | Yes |
| Standards Compliance | ATS, ERS, SSD & OSHA | ATS, ERS, SSD & OSHA |
| Quality Control | Data stored for reporting and tracking purposes | Data stored for reporting and tracking purposes |
| Hardware Communication | USB | USB |
| Database | Microsoft SQL | Microsoft SQL |
Note: The key "acceptance criterion" implicitly demonstrated is that ComPAS2 functions identically and adheres to the same established performance standards as the predicate device (ComPAS K021200), which was already cleared. The minor changes (updated operating system compatibility and localization support) are considered not to introduce new risks or alter the fundamental performance.
2. Sample Size Used for the Test Set and Data Provenance
The document states that ComPAS2 software testing involved "developing test cases and test runs for the performance of end to end testing with both biological and mechanical controls." It specifically mentions "results from ComPAS2 testing of the American Thoracic Society's 26 waveform loops for flow/volume validation (Hankinson & Crapo, 1995)".
Sample Size:
- For flow/volume validation, 26 waveform loops from the American Thoracic Society were used.
- The document does not specify a distinct 'test set' sample size in terms of patient data but rather focuses on testing the software's ability to process and display data in congruence with existing hardware and standards.
Data Provenance:
- The 26 waveform loops are derived from a standard set (American Thoracic Society). The original provenance (country of origin, retrospective/prospective) of these standardized waveforms is not detailed in this document, but they represent a recognized benchmark for spirometry validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish "ground truth" for the test set in the context of this software clearance. The validation relies on standardized waveforms and comparison with the predicate device's existing results. The "ground truth" for the performance metrics (e.g., flow accuracy, volume accuracy) is inherently established by the widely accepted ATS/ERS standards and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. There was no mention of an adjudication process by multiple experts for establishing ground truth for the software's performance, as the validation relied on standardized waveforms and comparison to predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study typically assesses how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The ComPAS2 software is a data acquisition and display system for pulmonary function tests, not an AI-driven interpretive aid for human readers. Its validation focuses on accurate data processing and display, matching the predicate device.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly conducted, focused on the software's ability to accurately process and display data. The "ComPAS2 software testing activities consisted of developing test cases and test runs for the performance of end to end testing with both biological and mechanical controls." The results were "validated against existing results from ComPAS, the aforenamed predicate device." This indicates the software was tested independently to ensure its calculations and outputs matched expected results based on the predicate and established standards.
7. Type of Ground Truth Used
The ground truth used for validating ComPAS2's performance appears to be a combination of:
- Established industry standards: Specifically, the American Thoracic Society and European Respiratory Society's Standardization for Lung Function Testing (ATS/ERS 2005, and later updates from 2017). These standards define acceptable accuracy and performance for spirometry.
- Standardized mechanical and biological controls/waveforms: The mention of "26 waveform loops for flow/volume validation (Hankinson & Crapo, 1995)" points to using standardized, known input data against which the software's outputs are compared.
- Predicate device results: The software's output was validated against "existing results from ComPAS," implying that the previously cleared and validated performance of the predicate serves as a benchmark for equivalence.
8. Sample Size for the Training Set
The document does not mention a "training set" because ComPAS2 is not described as a machine learning or AI algorithm in the context of typical AI device development that requires a training set. It is a software redesign of an existing pulmonary function testing application. Its development involves standard software engineering practices rather than algorithmic training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no mention of a training set or machine learning algorithm.
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June 6, 2019
Morgan Scientific, Inc. Deborah Cornish Manager Quality & RC 151 Essex Street STE 8 Haverhill, Massachusetts 01832
Re: K190568
Trade/Device Name: ComPAS2 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: May 6, 2019 Received: May 7, 2019
Dear Deborah Cornish:
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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-regulatoryassistance/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,
for Michael Ryan Director DHT1C: Division of ENT, 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) K190568
Device Name ComPAS2
Indications for Use (Describe)
The ComPAS2 software is intended to operate with the Screenstar pneumotachograph spirometer, Morgan Transflow test PFT system and the Morgan transfer test benchmark PFT system. ComPAS2 uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Transfer test benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is for use in pulmonary function testing and reports.
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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This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR 807.92
Date 510(k) summary prepared: May 06, 2019
I. SUBMITTER
| Submitter's Name: | Morgan Scientific, Inc. |
|---|---|
| Submitter's Address: | 151 Essex Street STE 8Haverhill, MA 01832USA |
| Submitter's Phone: | (978) 521-4440 |
| Official Correspondent: | Deborah CornishQuality & RA Manager, CQTMorgan Scientific, Inc.151 Essex Street STE 8Haverhill, MA 01832Phone: 800.525.5002 978.521.4440, xt203Email: deborah@morgansci.com |
| II. DEVICE | |
| Trade/proprietary name: | ComPAS2 |
| Common or Usual Name: | ComPAS2 |
| Regulation name: | Diagnostic spirometer |
| Classification: | 21 CFR 868.1840 (product Code: BZG) |
| Classification name: | Diagnostic Devices |
| Regulatory Class: | II |
| III. PREDICATE DEVICE | |
| Substantial Equivalence is claimed with:ComPAS - K021200 (Class 2 - Computerized Pulmonary Analysis |
System-product code BZG)
IV. DEVICE DESCRIPTION
ComPAS2 is designed to interface with various pieces of hardware (previously cleared pulmonary function testing devices, K142812, K042595, K022636, K953990, K013752) to capture clinical data in the performance of clinical testing. Those data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in
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an SOL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).
ComPAS2 is designed to operate with pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation (MVV), respiratory muscle strength, cough peak flow, lung volume sub-divisions (by helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include a task manager in order to manage patient data for reporting, manual entry in order to input additional information and historical data in order to analyze data for trending and reporting.
The user performs daily quality checks/calibrations prior to performing any tests. Once the test subject enters the Pulmonary Function Testing lab, foundation biographical information (Unique ID, Name, DOB) are either entered by the user, recalled or received in and order via Health Level 7(HL7) message from the information system. The functionality of ComPAS2 software remains the same as the predicate and provides the end user with the same experience.
Encounter information is added at the time of testing such as height, weight, diagnosis and physician. Test capability depends upon the Pulmonary Function Testing device being employed. Completed test information can be printed and handed to the physician for interpretation or data can be routed to the EMR (Electronic Medical Record).
ComPAS2 software connects using USB-powered desktop pulmonary function testing devices for the purpose of creating, adding and recalling subjects and performing pulmonary function testing on those subjects to aid in the measuring of the effect of lung disease on pulmonary function.
V. INDICATIONS FOR USE
The ComPAS2 software is intended to operate with the Screenstar pneumotachograph spirometer, Morgan Transflow test pulmonary function testing system and the Morgan transfer test benchmark pulmonary function testing system. ComPAS2 uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Transflow test and transfer test benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is formatted for use in pulmonary function testing and reports.
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VI. TECHNICAL AND SUBSTANTIALLY EQUIVALENT CHARACTERISTICS COMPARISON WITH PREDICATE DEVICE
Technical Characteristics
The characteristics of the ComPAS2 Software are similar and substantially equivalent to those of the predicate device ComPAS listed in the comparison table. The similarities are as follows:
- Identical functionality ●
- Conforms to ATS guidelines ●
The differences between the predicate ComPAS and subject ComPAS2 software application are as follows:
- . Windows 8.1 or 10 (64 bit)
- Language capability supports localization
- .NET, C#, WPF ●
The primary difference between the modified device and the predicate device is the conversion of ComPAS software from Visual Basic version 6 into .Net, C#, and WPF. The functionality and intended use of the product remain the same. The difference is not visible to the end user as a result of the coding update.
No new risks have been identified since the previously cleared predicate (ComPAS K021200). The risks have been evaluated for ComPAS2 software. No new risks have been identified for ComPAS2. The functionality of ComPAS2 is identical to its predicate ComPAS. The indications for use are the same. The diagnostic software device is to be used with previously cleared predicate hardware devices: , K142812, K042595, K022636, K953990, K013752. The software application functionality and indications for use remain unchanged.
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| Predicate ComPAS software | ComPAS2 software | Difference | |
|---|---|---|---|
| Model Name | ComPAS (K021200) | ComPAS2 (K190568) | - |
| 510(k)Number | K021200 | K190568 | - |
| Classification | Class II Device 21 CFR 868.1840 | Class II Device 21 CFR 868.1840 | - |
| Indications foruse | The ComPAS software is intended tooperate with the Screenstarpneumotachograph spirometer, MorganTransflow test pulmonary functiontesting system and the Morgan transfertest benchmark pulmonary functiontesting system. ComPAS uses flow andvolume from each of the devices todisplay the flow and volume informationmeasured directly from patient effort.ComPAS also utilizes gas analyzerreadings from the Transflow test andtransfer test benchmark to displayhelium dilution lung volume data andsingle breath diffusion data measureddirectly from patient effort. Thisinformation is formatted for use inpulmonary function testing and reports. | The ComPAS2 software is intended tooperate with the Screenstarpneumotachograph spirometer, MorganTransflow test pulmonary functiontesting system and the Morgan transfertest benchmark pulmonary functiontesting system. ComPAS2 uses flow andvolume from each of the devices todisplay the flow and volume informationmeasured directly from patient effort.ComPAS2 also utilizes gas analyzerreadings from the Transflow test andtransfer test benchmark to displayhelium dilution lung volume data andsingle breath diffusion data measureddirectly from patient effort. Thisinformation is formatted for use inpulmonary function testing and reports. | - |
| Description | ComPAS is designed to operate withpulmonary function testing hardware bymanufacturers offering the capability tomeasure key pulmonary functionsincluding: static and dynamicspirometry, maximum voluntaryventilation, respiratory muscle strength,cough peak flow, lung volume sub-divisions (by helium dilution, nitrogenwashout and plethysmography), singlebreath diffusion, airway resistance,distribution with lung clearance indexclosing volume. Other features include atask manager in order to manage patientdata for reporting, manual entry in orderto input additional information andhistorical data in order to analyze datafor trending and reporting. | ComPAS2 is designed to operate withpulmonary function testing hardware bymanufacturers offering the capability tomeasure key pulmonary functionsincluding: static and dynamicspirometry, maximum voluntaryventilation, respiratory muscle strength,cough peak flow, lung volume sub-divisions (by helium dilution, nitrogenwashout and plethysmography), singlebreath diffusion, airway resistance,distribution with lung clearance indexclosing volume. Other features include atask manager in order to manage patientdata for reporting, manual entry in orderto input additional information andhistorical data in order to analyze datafor trending and reporting. | - |
| Standards andReferences | ATS/ERS 2005 {ATS/ERS Task Force:Standardization of Lung FunctionTesting}EN ISO 14971EN 60601-1EN 60601-1-2IEC 62366IEC 6230421 CFR 82013485:2016SOR 98-282 | ATS/ERS 2005 {ATS/ERS Task Force:Standardization of Lung FunctionTesting}EN ISO 14971EN 60601-1EN 60601-1-2IEC 62366IEC 6230421 CFR 82013485:2016SOR 98-282 | - |
| Function | ComPAS (K021200) | ComPAS2 (K190568) | Difference |
| Flow measurement | Pneumotachograph | Pneumotachograph | - |
| Flow Range | -18 L/s to + 18 L/s | -18 L/s to + 18 L/s | - |
| Volume Accuracy | +/- 1% | +/- 1% | - |
| Flow Accuracy | +/- 2.5% | +/- 2.5% | - |
| Sampling Rate | 100 - 300 samples per second | 100 - 300 samples per second | - |
| Number of Tests perSession | 8 – Pre bronchodilator8 - Post BronchodilatorMultiple Challenge Levels | 8 – Pre bronchodilator8 - Post BronchodilatorMultiple Challenge Levels | - |
| Flow Calibration | 3L calibration syringe | 3L calibration syringe | - |
| Units | Metric or Traditional | Metric or Traditional | - |
| ATS/ERS Review ofAcceptability | Yes | Yes | - |
| ATS/ERS Review ofRepeatability | Yes | Yes | - |
| Standards Compliance | ATS, ERS, SSD & OSHA | ATS, ERS, SSD & OSHA | - |
| Predicted Values | Standard Sets include: GLI, NHANESIII, Knudson, Rosenthal and others.Predicted formulas editable throughscript. | Standard Sets include: GLI,NHANES III, Knudson, Rosenthaland others.Predicted formulas editablethrough script | - |
| Report Formats | Multiple with Report Editing available | Multiple with Report Editing available | - |
| Quality Control | Data stored for reporting and trackingpurposes | Data stored for reporting andtracking purposes | - |
| HardwareCommunication | USB | USB | - |
| Database | Microsoft SQL | Microsoft SQL | - |
| Operating System | Windows 7 & 10 | Windows 8.1 & 10 (64 bit) | UpdatedfromWindows 7& 10 toWindows8.1 & 10 (64bit) |
| Test capability | Static and dynamic spirometry,bronchial challenge, maximumvoluntary ventilation, respiratorymuscle strength, cough peak flow,lung volume sub-divisions (by heliumdilution, nitrogen washout andplethysmography), single breathdiffusion, airway resistance,distribution with lung clearance indexclosing volume. Other featuresinclude a task manager in order tomanage patient data for reporting,manual entry in order to inputadditional information and historicaldata in order to analyze data fortrending and reporting. | Static and dynamic spirometry,bronchial challenge, maximumvoluntary ventilation, respiratorymuscle strength, cough peak flow,lung volume sub-divisions (byhelium dilution, nitrogen washoutand plethysmography), singlebreath diffusion, airway resistance,distribution with lung clearanceindex closing volume. Otherfeatures include a task manager inorder to manage patient data forreporting, manual entry in order toinput additional information andhistorical data in order to analyzedata for trending and reporting. | - |
| Function | ComPAS (K021200) | ComPAS2 (K190568) | Difference |
| Patient HeightRecording | Standing height, arm span, demi armspan, forearm and knee | Standing height, arm span, demiarm span, forearm and knee | - |
| Data backup | Automated through user-configurablescheduler | Automated through user-configurable scheduler | - |
| Test History/ DataTrending | Available during testing and reporting | Available during testing andreporting | - |
| System Security | Through configurable login rules | Through configurable login rules | - |
| Language Capability | English Only | Supports Localization | Updated toincludelocalization |
| HTML Help | Yes | Yes | - |
ComPAS (K021200) and ComPAS2 (K190568) Substantial Comparison:
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Software Function Substantial Comparison:
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VII. TESTING AND VALIDATION
Measurement activities conducted for ComPAS2 are in accordance with the set of current standards issued by the American Thoracic Society and European Respiratory Society's Standardization for Lung Function Testing (e.g., Laszlo, 2006; Macintyre et.al., 2005; Miller, Crapo, Hankinson, et.al., 2005; Pellegrino, et.al., 2005; Wanger et.al., 2005). In addition, the newly issued standards on methacholine challenge testing (ERS/ATS, 2017) and standards for single-breath carbon monoxide uptake in the lung (ERS/ATS, 2017) were also applied.
ComPAS2 software testing activities consisted of developing test cases and test runs for the performance of end to end testing with both biological and mechanical controls. Results of these tests were then validated against existing results from ComPAS, the aforenamed predicate device. Requirements and the design specification were reviewed for consistency and accuracy. Final validation was accomplished through system level testing to ensure that the product is capable of meeting the intended use. As an example of the testing and validation activities described above, results from ComPAS2 testing of the American Thoracic Society's 26 waveform loops for flow/volume validation (Hankinson & Crapo, 1995) are provided with this submission.
VIII. CONCLUSION:
Section 10 - Page | 6
ComPAS2 was found to be substantially equivalent to the predicate device ComPAS.
§ 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).