(214 days)
Morgan Scientific's ComPAS2 is a software application intended to be used to compatible Morgan Scientific or thirdparty devices to acquire, analyze, view, store, export, and print the device outputs including measurements of flow, volume, pressure, and gas concentrations. The product is designed for use on adults and pediatrics 4 years and older, in a variety of healthcare environments such as, but not limited to, primary care, hospitals, and research health centers under the supervision of a healthcare provider.
ComPAS2 is a software application designed to provide a secure PC based medical device for creating, adding/recalling subjects, and performing cardio-pulmonary function testing on those subjects. ComPAS2 will interface and link to compatible Morgan Scientific and third-party devices to read, analyze, and display their output to allow the information to be retained with the subject. Current compatible approved devices: TransAir (K953990), SpiroAir (K042595), Body Plethysmograph (K022636), WristOx2 (K102350), tremoFlo (K170185), Pneumotrac (K142812), Micro (K160253), Model 9100 PFT/D1CO (K221030). Data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SQL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).
ComPAS2 is designed to operate with compatible cardio-pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including, but not limited to: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions (such as but not limited to helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include: a task manager to manage patient data for reporting; manual entry to input additional information; and historical data review to analyze data for trending and reporting.
The ComPAS2 device, a software application for diagnostic spirometry, was found to be substantially equivalent to its predicate device, ComPAS2 v2019.1.0 (K190568). The primary "study" proving this substantial equivalence was non-clinical performance testing of the software.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a typical quantitative pass/fail format for each performance metric, but rather highlights that performance testing demonstrated that the subject device met its acceptance criteria. The "reported device performance" is implied to be equivalent to the predicate device's performance, as the core functionality and technical characteristics remain largely the same, and the software was validated against the predicate's results.
However, based on the comparison table and the general description, we can infer some performance aspects:
| Feature/Characteristic | Acceptance Criteria (Inferred from predicate/standards) | Reported Device Performance (ComPAS2 v2022.1.0) |
|---|---|---|
| Clinical Performance | Acquire, analyze, view, store, export, and print measurements of flow, volume, pressure, and gas concentrations from compatible devices for pulmonary function testing; suitable for adults and pediatrics 4 years and older in healthcare environments. Conforms to ATS/ERS guidelines for spirometry, bronchial challenge, diffusion, lung volumes, respiratory pressures, plethysmography, oscillometry, oximetry measurements. | Functions identically to the predicate (ComPAS2 v2019.1.0) in acquiring, analyzing, viewing, storing, exporting, and printing device outputs including measurements of flow, volume, pressure, and gas concentrations. Supports the same range of pulmonary function tests (static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions, single breath diffusion, airway resistance, distribution with lung clearance index closing volume, airwave oscillometry). Conforms to ATS guidelines and specific standards (e.g., ERS/ATS 2017 for methacholine challenge, single-breath carbon monoxide uptake; ERS/ATS 2019 for spirometry). Meets ATS/ERS Review of Acceptability and Repeatability. |
| System Compatibility | Interface and link to compatible Morgan Scientific and third-party devices. Supports Windows 10. Uses MS SQL Server database. | Interfaces and links to compatible Morgan Scientific and third-party devices (e.g., TransAir, SpiroAir, Body Plethysmograph, WristOx2, tremoFlo, Pneumotrac, Micro, Model 9100 PFT/D1CO, VitaloROV/VitaloLab, VitaloQUB). Supports Windows 10 (Windows 8.1 support removed, but this is a technical update not affecting core functionality). Uses MS SQL Server for data preservation. Updated communications code base for generalized device compatibility. |
| Measurement Accuracy | Volume Accuracy: +/- 1%Flow Accuracy: +/- 2.5%Flow Range: -18 L/s to +18 L/sSampling Rate: 100-300 samples per second | Same as predicate: Volume Accuracy +/- 1%; Flow Accuracy +/- 2.5%; Flow Range -18 L/s to +18 L/s; Sampling Rate 100-300 samples per second. These are inherent to the integrated flow measurement devices, which the software processes data from. |
| Functional Equivalence | Identical functionality to predicate. | The overall functionality of ComPAS2 software remains the same as the predicate and provides the end user with the same experience. Key sub-systems interact with the database through an API. Includes features like task manager, manual entry, historical data review, subject management, report printing, trending graphs, PFT predicted value equations, population group management, data import/export, database management, color display, configurable login rules, localization support, HTML Help. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing involved "developing test cases and test runs for the performance of end-to-end testing with both biological and mechanical controls." This suggests a series of functional tests and expected outcomes rather than a traditional patient-based clinical study with a specific sample size.
- Data Provenance: The document does not specify the country of origin for any data used in this non-clinical testing. The nature of the testing (bench testing, software validation) suggests it's primarily synthetic or controlled data generated internally, or data from mechanical/biological controls (e.g., spirometer calibration syringes, simulated lung models). The testing was against "existing results from ComPAS2 v2019.1.0," indicating a retrospective comparison to previously established performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this software validation was established by comparing the results of the ComPAS2 v2022.1.0 software to the "existing results from ComPAS2 v2019.1.0," the predicate device, and ensuring compliance with recognized standards (ATS/ERS guidelines). Expertise would have been in the form of engineers, quality assurance personnel, and potentially pulmonologists for clinical interpretation of the standards and expected outputs, but the document does not specify a panel of experts for "ground truth" establishment in the sense of a diagnostic interpretation study.
4. Adjudication Method for the Test Set
Not applicable. This was a software verification and validation study, not a clinical study requiring adjudication of diagnostic outcomes. Validation involved ensuring consistency and accuracy of the new software's outputs against the predicate and established standards.
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 comparative effectiveness study was done or described. The device is a software application intended to acquire, analyze, view, store, export, and print device outputs, not to provide AI-assisted diagnoses that impact human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance testing described is a standalone evaluation of the ComPAS2 software application. The "Bench" section explicitly states "software testing activities" and "system level testing to ensure that the product is capable of meeting the intended use." This indicates the algorithm's performance (i.e., the software's ability to process and display data) was tested independently. The software interfaces with hardware devices that generate the raw data, but its own function of processing and presenting that data was evaluated as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the validation of ComPAS2 v2022.1.0 was primarily:
- Existing results from the predicate device (ComPAS2 v2019.1.0): The new software's outputs were compared against the established, cleared performance of the previous version.
- Current standards for Lung Function Testing: Compliance with standards issued by the American Thoracic Society (ATS) and European Respiratory Society (ERS) (e.g., Laszlo, 2006; Macintyre et al., 2005; Miller, Crapo, Hankinson, et al., 2005; Pellegrino, et al., 2005; Wanger et al., 2005; ERS/ATS 2017 & 2019 standards).
8. The Sample Size for the Training Set
Not applicable. This is a software update to an existing device, and the testing described is primarily verification and validation against established standards and the predicate's performance. There is no mention of a machine learning or AI component requiring a "training set" in the context of this submission. The software performs calculations and displays data based on established algorithms in pulmonary function testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for machine learning or AI.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 15, 2022
Morgan Scientific, Inc. Deborah Cornish Quality & RA Manager 151 Essex Street STE 8 Haverhill, Massachusetts 01832
Re: K213872
Trade/Device Name: ComPAS2 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: June 13, 2022 Received: June 14, 2022
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
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 (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 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-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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K213872
Device Name ComPAS2
Indications for Use (Describe)
Morgan Scientific's ComPAS2 is a software application intended to be used to compatible Morgan Scientific or thirdparty devices to acquire, analyze, view, store, export, and print the device outputs including measurements of flow, volume, pressure, and gas concentrations. The product is designed for use on adults and pediatrics 4 years and older, in a variety of healthcare environments such as, but not limited to, primary care, hospitals, and research health centers under the supervision of a healthcare provider.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Date Prepared: July 15, 2022
I. Submitter:
II.
| 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 |
| Subject 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:
ComPAS2 K190568
IV. Device Description:
ComPAS2 is a software application designed to provide a secure PC based medical device for creating, adding/recalling subjects, and performing cardio-pulmonary function testing on those subjects. ComPAS2 will interface and link to compatible Morgan Scientific and third-party devices to read, analyze, and display their output to allow the information to be retained with the subject. Current compatible approved devices: TransAir (K953990), SpiroAir (K042595), Body Plethysmograph (K022636), WristOx2 (K102350), tremoFlo (K170185), Pneumotrac (K142812), Micro (K160253), Model 9100 PFT/D1CO (K221030). Data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SQL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).
ComPAS2 is designed to operate with compatible cardio-pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including, but not limited to: static
{4}------------------------------------------------
and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions (such as but not limited to helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include: a task manager to manage patient data for reporting; manual entry to input additional information; and historical data review to analyze data for trending and reporting.
The overall functionality of ComPAS2 software remains the same as the predicate and provides the end user with the same experience.
V. Indications for Use:
Morgan Scientific's ComPAS2 is a software application intended to connect to compatible Morgan Scientific or third-party devices to acquire, analyze, view, store, export, and print the device outputs including measurements of flow, volume, pressure, and gas concentrations. The product is designed for use on adults and pediatrics 4 years and older, in a variety of healthcare environments such as, but not limited to, primary care, hospitals, occupational health, and research health centers under the supervision of a healthcare provider.
VI. Modifications:
ComPAS2 v2022.1.0 is a modification to the software predicate ComPAS2 v2019.1.0, cleared under K190568. Use of interfacing with latest Windows technology, etc., this software application was updated to accommodate the connection to compatible Morgan Scientific and third-party devices (including, but not limited to: VitaloROV/VitaloLab and VitaloQUB) to acquire, analyze, view, store, export, and print the device output.
Software: Use of interfacing with the latest Windows technology, SQL, HL7
VII. Comparison of Technological Characteristics and Performance with the Predicate:
Technical Characteristics
The characteristics of the ComPAS2 v2022.1.0 software are substantially equivalent to those of the predicate device ComPAS2 v2019.1.0 listed in the comparison table. The similarities are as follows:
- Identical functionality ●
- Conforms to ATS guidelines
The differences between the predicate ComPAS2 v2019.1.0 and subject ComPAS2 v2022.1.0 software application are as follows: The addition of generalized device communications applicable to compatible Morgan Scientific and third-party devices.
| Predicate | Subject | Comparison | |
|---|---|---|---|
| ComPAS2 2019.1.0 software | ComPAS2 2022.1.0 software | ||
| 510(k) Number | K190568 | K213872 | - |
| Product Code | BZG | BZG | Same |
ComPAS2 (K190568) and ComPAS2 Substantial Comparison:
{5}------------------------------------------------
| Classification | Spirometer Diagnostic | Spirometer Diagnostic | Same |
|---|---|---|---|
| Indications for use | The ComPAS software isintended to operate with theScreenstar pneumotachographspirometer, MorganTransflow test pulmonaryfunction testing system andthe Morgan transfer testbenchmark pulmonaryfunction testing system.ComPAS uses flow andvolume from each of thedevices to display the flowand volume informationmeasured directly frompatient effort. ComPAS alsoutilizes gas analyzer readingsfrom the Transflow test andtransfer test benchmark todisplay helium dilution lungvolume data and single breathdiffusion data measureddirectly from patient effort.This information is formattedfor use in pulmonary functiontesting and reports. | Morgan Scientific'sComPAS2 is a softwareapplication intended to beused to connect to compatibleMorgan Scientific or third-party devices to acquire,analyze, view, store, export,and print the device outputsincluding measurements offlow, volume, pressure, andgas concentrations. Theproduct is designed for useon adults and pediatrics 4years and older, in a varietyof healthcare environmentssuch as, but not limited to,primary care, hospitals,occupational health, andresearch health centers underthe supervision of ahealthcare provider. | The indications for use havebeen updated from thepredicate to allow for theadditional capability oflinking ComPAS2 tocompatible Morgan Scientificor third-party devices.Otherwise, the indications foruse are the same. |
| FundamentalScientificTechnology | Digital Data Communication | Digital Data Communications | Same |
| Spirometry andBronchialChallengeacquire, analyze, view,store and printmeasures andwaveforms ofpulmonary function | Yes, from compatible device | Yes, from compatible device | Same |
| Diffusion acquire,analyze, view, storeand | Yes, from compatible device | Yes, from compatible device | Same |
| print measures ofspirometry and gaswaveforms ofpulmonary function | |||
| Lung Volumes andGas Distribution_acquire, analyze,view, store andprint measures ofspirometry and gaswaveforms ofpulmonary function | Yes, from compatible device | Yes, from compatible device | Same |
| RespiratoryPressures - acquire,analyze, view, storeand print measuresof spirometry andpressure waveformsof pulmonaryfunction | Yes, from compatible device | Yes, from compatible device | Same |
| Plethysmography -acquire, analyze,view, store andprint measures ofspirometry, flowpressure waveformsof pulmonaryfunction | Yes, from compatible device | Yes, from compatible device | Same |
| Oscillometrydownload, view | Yes, from compatible device | Yes, from compatible device | Same |
| Oximetrydownload, view | Yes, from compatible device | Yes, from compatible device | Same |
| Microsoft WindowsOperating systemssupported | Yes, Windows 10 | Yes, Windows 10 | Windows 8.1 was removedfrom this submission as it willno longer be supported byWindows after 2023 |
| Database | MS SQL Server | MS SQL Server | Same |
| Where used | Hospitals, Health centers,Primary care practices, andclinics | Hospitals, Health centers,Primary care practices, andclinics | Same |
| Networkedoperations | Yes | Yes | Same |
| SubjectManagement:Demographic Entry, | Yes | Yes | Same |
| Maintenance,Deletion | |||
| Report printing | Yes | Yes | Same |
| PFT testing | Yes | Yes | Same |
| Trending graphs forspirometry results | Yes | Yes | Same |
| PFT predicted valueequations | Yes | Yes | Same |
| Population groupmanagement | Yes | Yes | Same |
| Data import/export | Yes | Yes | Same |
| Subject andspirometry dataexport | Yes | Yes | Same |
| Manual data entryof results | Yes | Yes | Same |
| Databasemanagement | Yes | Yes | Same |
| Color display | Yes | Yes | Same |
| Population groups | Adult, Pediatric | Adult, Pediatric | Same |
| Communication | Bluetooth, USB | Bluetooth, USB | Same |
| Storage | Dependent on storage media | Dependent on storage media | Same |
| Biocompatibility | No patient contact | No patient contact | Same |
| Full pulmonarytesting | Yes | Yes | Same |
| Manual entry forblood gases | Yes | Yes | Same |
| Reporting | Yes | Yes | Same |
| Data integration toEMRs via HL7interfacing or API | Yes | Yes | Same |
| Flow measurement | Pneumotachograph | Pneumotachograph | Same |
| Volumemeasurement | Integrated flow and Rollingseal spirometer | Integrated flow and Rollingseal spirometer | Same |
| Flow Range | -18 L/s to + 18 L/s | -18 L/s to + 18 L/s | Same |
| Volume Accuracy | +/- 1% | +/- 1% | Same |
| Flow Accuracy | +/- 2.5% | +/- 2.5% | Same |
| Sampling Rate | 100_300 samples per second | 100_300 samples per second | Same |
| Number of Testsper Session | 8_ Pre bronchodilator | 8_ Pre bronchodilator | Same |
| 8_ Post Bronchodilator | 8_ Post Bronchodilator | ||
| Multiple Challenge Levels | Multiple Challenge Levels | ||
| Flow Calibration | 3L calibration syringe | 3L calibration syringe | Same |
| Units | Metric or Traditional | Metric or Traditional | Same |
| ATS/ERS Reviewof Acceptability | Yes | Yes | Same |
| ATS/ERS Reviewof Repeatability | Yes | Yes | Same |
| StandardsCompliance | ATS, ERS, SSD & OSHA | ATS, ERS, SSD & OSHA | Same |
| Predicted Values | Standard Sets include: GLI,NHANES III, Knudson,Rosenthal and others. | Standard Sets include: GLI,NHANES III, Knudson,Rosenthal and others. | Same |
| Predicted formulas editablethrough script. | Predicted formulas editablethrough script | ||
| Report Formats | Multiple with Report Editingavailable | Multiple with Report Editingavailable | Same |
| Quality Control | Data stored for reporting andtracking purposes | Data stored for reporting andtracking purposes | Same |
| HardwareCommunication | USB; device specific communication | USB; device general communication | Updated communicationscode base to work withcompatible Morgan Scientificand third-party devices. |
| Database | Microsoft SQL | Microsoft SQL | Same |
| Test capability | Same | ||
| Static and dynamicspirometry, bronchialchallenge, maximumvoluntary ventilation,respiratory muscle strength,cough peak flow, lungvolume sub-divisions (byhelium dilution, nitrogenwashout andplethysmography), singlebreath diffusion, airwayresistance, distribution withlung clearance index closingvolume, airwaveoscillometry. Other featuresinclude a task manager inorder to manage patient datafor reporting, manual entry inorder to input additionalinformation and historicaldata in order to analyze datafor trending and reporting. | Static and dynamicspirometry, bronchialchallenge, maximumvoluntary ventilation,respiratory muscle strength,cough peak flow, lungvolume sub-divisions (byhelium dilution, nitrogenwashout andplethysmography), singlebreath diffusion, airwayresistance, distribution withlung clearance index closingvolume, airwaveoscillometry. Other featuresinclude a task manager inorder to manage patient datafor reporting, manual entry inorder to input additionalinformation and historicaldata in order to analyze datafor trending and reporting. | ||
| Patient HeightRecording | Standing height, arm span,demi arm span, forearm andknee | Standing height, arm span,demi arm span, forearm andknee | |
| Data backup | Automated through user-configurable scheduler | Automated through user-configurable scheduler | |
| Test History/ DataTrending | Available during testing andreporting | Available during testing andreporting | |
| System Security | Through configurable loginrules | Through configurable loginrules | |
| LanguageCapability | Supports Localization | Supports Localization | |
| HTML Help | Yes | Yes |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
VIII. PERFORMANCE DATA
Non-Clinical Testing
Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:
Software
{10}------------------------------------------------
Bench
Measurement activities conducted for ComPAS2 are in accordance with the set of current standard 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), standardization of spirometry (ERS/ATS 2019) 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 ComPAS2 v2019.1.0, 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.
IX. DIFFERENCES AND CONCLUSIONS:
Discussion of Differences:
The identified differences do not raise new or different concerns of safety or effectiveness relative to the predicate.
Substantial Equivalence Conclusion:
The differences do not present different concerns of safety or effectiveness than the predicate device, the ComPAS2 2022.1.0 was found to be substantially equivalent to the predicate device ComPAS2 2019.1.0.
§ 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).