(92 days)
No
The document describes a software system for capturing, displaying, and reporting pulmonary function data from existing hardware. There is no mention of AI or ML being used for analysis, interpretation, or any other function. The testing described focuses on validating against existing standards and a predicate device, not on training or evaluating an AI/ML model.
No
The device is described as software for pulmonary function testing and reporting, measuring and displaying flow and volume information, and lung volume data. It aids in measuring the effect of lung disease on pulmonary function but does not directly treat or diagnose.
Yes
The device aids in the measuring of the effect of lung disease on pulmonary function, indicating its role in diagnosing and monitoring health conditions.
No
The device description explicitly states that ComPAS2 is designed to interface with various pieces of hardware (previously cleared pulmonary function testing devices) to capture clinical data. It also mentions connecting using USB-powered desktop pulmonary function testing devices. This indicates a reliance on and interaction with physical hardware components for its primary function of data acquisition.
Based on the provided text, the ComPAS2 software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ComPAS2's function: The text clearly states that ComPAS2 operates with pulmonary function testing devices to measure physiological parameters directly from the patient's effort (flow, volume, gas analyzer readings from patient effort). It processes and displays this data for use in pulmonary function testing and reports.
- No mention of samples: There is no mention of ComPAS2 analyzing samples taken from the patient's body.
Therefore, ComPAS2 is a software component of a pulmonary function testing system that measures physiological responses directly from the patient, not an in vitro diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BZG
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pulmonary Function Testing lab, physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ComPAS2 was found to be substantially equivalent to the predicate device ComPAS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K142812, K042595, K022636, K953990, K013752
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
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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3
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 8 |
| Haverhill, MA 01832 | |
| USA | |
| Submitter's Phone: | (978) 521-4440 |
| Official Correspondent: | Deborah Cornish |
| Quality & RA Manager, CQT | |
| Morgan Scientific, Inc. | |
| 151 Essex Street STE 8 | |
| Haverhill, MA 01832 | |
| Phone: 800.525.5002 978.521.4440, xt203 | |
| Email: 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
4
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.
5
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.
6
| 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 for | |||
| use | The ComPAS 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. ComPAS uses flow and | |||
| volume from each of the devices to | |||
| display the flow and volume information | |||
| measured directly from patient effort. | |||
| ComPAS 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. | 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. | - | ||
| Description | ComPAS is designed to operate with | ||
| pulmonary function testing hardware by | |||
| manufacturers offering the capability to | |||
| measure key pulmonary functions | |||
| including: static and dynamic | |||
| spirometry, maximum voluntary | |||
| ventilation, 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. | 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, maximum voluntary | |||
| ventilation, 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. | - | ||
| Standards and | |||
| References | ATS/ERS 2005 {ATS/ERS Task Force: | ||
| Standardization of Lung Function | |||
| Testing} | |||
| EN ISO 14971 | |||
| EN 60601-1 | |||
| EN 60601-1-2 | |||
| IEC 62366 | |||
| IEC 62304 | |||
| 21 CFR 820 | |||
| 13485:2016 | |||
| SOR 98-282 | ATS/ERS 2005 {ATS/ERS Task Force: | ||
| Standardization of Lung Function | |||
| Testing} | |||
| EN ISO 14971 | |||
| EN 60601-1 | |||
| EN 60601-1-2 | |||
| IEC 62366 | |||
| IEC 62304 | |||
| 21 CFR 820 | |||
| 13485:2016 | |||
| SOR 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 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 | - |
| Predicted Values | Standard Sets include: GLI, NHANES | ||
| III, Knudson, Rosenthal and others. | |||
| Predicted formulas editable through | |||
| script. | Standard Sets include: GLI, | ||
| NHANES III, Knudson, Rosenthal | |||
| and others. | |||
| Predicted formulas editable | |||
| through script | - | ||
| Report Formats | Multiple with Report Editing available | Multiple with Report Editing available | - |
| 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 | - |
| Operating System | Windows 7 & 10 | Windows 8.1 & 10 (64 bit) | Updated |
| from | |||
| Windows 7 | |||
| & 10 to | |||
| Windows | |||
| 8.1 & 10 (64 | |||
| bit) | |||
| Test capability | Static and dynamic spirometry, | ||
| bronchial challenge, maximum | |||
| voluntary ventilation, 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. | Static and dynamic spirometry, | ||
| bronchial challenge, maximum | |||
| voluntary ventilation, 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. | - | ||
| Function | ComPAS (K021200) | ComPAS2 (K190568) | Difference |
| Patient Height | |||
| Recording | Standing height, arm span, demi arm | ||
| span, forearm and knee | Standing height, arm span, demi | ||
| arm span, forearm and knee | - | ||
| Data backup | Automated through user-configurable | ||
| scheduler | Automated through user- | ||
| configurable scheduler | - | ||
| Test History/ Data | |||
| Trending | Available during testing and reporting | Available during testing and | |
| reporting | - | ||
| System Security | Through configurable login rules | Through configurable login rules | - |
| Language Capability | English Only | Supports Localization | Updated to |
| include | |||
| localization | |||
| HTML Help | Yes | Yes | - |
ComPAS (K021200) and ComPAS2 (K190568) Substantial Comparison:
7
Software Function Substantial Comparison:
8
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.