ComPAS2

K213872 · Morgan Scientific, Inc. · BZG · Jul 15, 2022 · Anesthesiology

Device Facts

• Record ID: K213872
• Device Name: ComPAS2
• Applicant: Morgan Scientific, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Jul 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

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.

Device Story

ComPAS2 is a PC-based software application for cardio-pulmonary function testing. It interfaces with compatible hardware (e.g., spirometers, plethysmographs, oximeters) to acquire, analyze, and store physiological data including flow, volume, pressure, and gas concentrations. The software manages patient data, performs calculations based on standard pulmonary function equations, and generates reports. It is used in hospitals, clinics, and research centers by healthcare providers. The system supports data export to EMRs via HL7 or API and stores information in an SQL database. By centralizing data acquisition and analysis, it assists clinicians in diagnosing and monitoring respiratory conditions. The software provides trending graphs and historical data review to support clinical decision-making.

Clinical Evidence

Bench testing only. Performance validated through end-to-end testing using biological and mechanical controls. Results compared against the predicate device (v2019.1.0) to ensure consistency. Compliance with ATS/ERS standards for lung function testing (e.g., 2017/2019 ERS/ATS standards) verified through system-level testing.

Technological Characteristics

PC-based software application; SQL database backend; interfaces via USB/Bluetooth with compatible hardware. Supports Windows 10. Implements digital data communication for pulmonary function measurements. Complies with ATS/ERS/OSHA standards. No patient-contact materials.

Indications for Use

Indicated for adults and pediatrics 4 years and older undergoing cardio-pulmonary function testing in healthcare settings (primary care, hospitals, research centers) under clinician supervision.

Regulatory Classification

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.

Predicate Devices

• ComPAS2 (K190568)

Reference Devices

• TransAir (K953990)
• SpiroAir (K042595)
• Body Plethysmograph (K022636)
• WristOx2 (K102350)
• tremoFlo (K170185)
• Pneumotrac (K142812)
• Micro (K160253)
• Model 9100 PFT/D1CO (K221030)

Submission Summary (Full Text)

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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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 ([e-mail]) or phone [phone] 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

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# 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)

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Date Prepared: July 15, 2022

#### I. Submitter:

II.

| Submitter's Name: | Morgan Scientific, Inc. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 151 Essex Street STE 8<br>Haverhill, MA 01832<br>USA |
| Submitter's Phone: | [phone] |
| Official Correspondent: | Deborah Cornish<br>Quality & RA Manager, CQT<br>Morgan Scientific, Inc.<br>151 Essex Street STE 8<br>Haverhill, MA 01832<br>Phone: [phone] 978.521.4440, xt203<br>Email: [e-mail] |
| 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

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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:

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| Classification | Spirometer Diagnostic | Spirometer Diagnostic | Same |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The ComPAS software is<br>intended to operate with the<br>Screenstar pneumotachograph<br>spirometer, Morgan<br>Transflow test pulmonary<br>function testing system and<br>the Morgan transfer test<br>benchmark pulmonary<br>function testing system.<br>ComPAS uses flow and<br>volume from each of the<br>devices to display the flow<br>and volume information<br>measured directly from<br>patient effort. ComPAS also<br>utilizes gas analyzer readings<br>from the Transflow test and<br>transfer test benchmark to<br>display helium dilution lung<br>volume data and single breath<br>diffusion data measured<br>directly from patient effort.<br>This information is formatted<br>for use in pulmonary function<br>testing and reports. | Morgan Scientific's<br>ComPAS2 is a software<br>application intended to be<br>used to connect to compatible<br>Morgan Scientific or third-<br>party devices to acquire,<br>analyze, view, store, export,<br>and print the device outputs<br>including measurements of<br>flow, volume, pressure, and<br>gas concentrations. The<br>product is designed for use<br>on adults and pediatrics 4<br>years and older, in a variety<br>of healthcare environments<br>such as, but not limited to,<br>primary care, hospitals,<br>occupational health, and<br>research health centers under<br>the supervision of a<br>healthcare provider. | The indications for use have<br>been updated from the<br>predicate to allow for the<br>additional capability of<br>linking ComPAS2 to<br>compatible Morgan Scientific<br>or third-party devices.<br>Otherwise, the indications for<br>use are the same. |
| Fundamental<br>Scientific<br>Technology | Digital Data Communication | Digital Data Communications | Same |
| Spirometry and<br>Bronchial<br>Challenge<br>acquire, analyze, view,<br>store and print<br>measures and<br>waveforms of<br>pulmonary function | Yes, from compatible device | Yes, from compatible device | Same |
| Diffusion acquire,<br>analyze, view, store<br>and | Yes, from compatible device | Yes, from compatible device | Same |
| print measures of<br>spirometry and gas<br>waveforms of<br>pulmonary function | | | |
| | | | |
| Lung Volumes and<br>Gas Distribution_<br>acquire, analyze,<br>view, store and<br>print measures of<br>spirometry and gas<br>waveforms of<br>pulmonary function | Yes, from compatible device | Yes, from compatible device | Same |
| Respiratory<br>Pressures - acquire,<br>analyze, view, store<br>and print measures<br>of spirometry and<br>pressure waveforms<br>of pulmonary<br>function | Yes, from compatible device | Yes, from compatible device | Same |
| Plethysmography -<br>acquire, analyze,<br>view, store and<br>print measures of<br>spirometry, flow<br>pressure waveforms<br>of pulmonary<br>function | Yes, from compatible device | Yes, from compatible device | Same |
| Oscillometry<br>download, view | Yes, from compatible device | Yes, from compatible device | Same |
| Oximetry<br>download, view | Yes, from compatible device | Yes, from compatible device | Same |
| Microsoft Windows<br>Operating systems<br>supported | Yes, Windows 10 | Yes, Windows 10 | Windows 8.1 was removed<br>from this submission as it will<br>no longer be supported by<br>Windows after 2023 |
| Database | MS SQL Server | MS SQL Server | Same |
| Where used | Hospitals, Health centers,<br>Primary care practices, and<br>clinics | Hospitals, Health centers,<br>Primary care practices, and<br>clinics | Same |
| Networked<br>operations | Yes | Yes | Same |
| Subject<br>Management:<br>Demographic Entry, | Yes | Yes | Same |
| Maintenance,<br>Deletion | | | |
| Report printing | Yes | Yes | Same |
| PFT testing | Yes | Yes | Same |
| Trending graphs for<br>spirometry results | Yes | Yes | Same |
| PFT predicted value<br>equations | Yes | Yes | Same |
| Population group<br>management | Yes | Yes | Same |
| Data import/export | Yes | Yes | Same |
| Subject and<br>spirometry data<br>export | Yes | Yes | Same |
| Manual data entry<br>of results | Yes | Yes | Same |
| Database<br>management | 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 pulmonary<br>testing | Yes | Yes | Same |
| Manual entry for<br>blood gases | Yes | Yes | Same |
| Reporting | Yes | Yes | Same |
| Data integration to<br>EMRs via HL7<br>interfacing or API | Yes | Yes | Same |
| Flow measurement | Pneumotachograph | Pneumotachograph | Same…