K Number

Device Name

ComPAS2

Manufacturer

Morgan Scientific, Inc.

Date Cleared

2022-07-15

(214 days)

Product Code

BZG

Regulation Number

868.1840

Intended 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 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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K190568

Reference Devices

K953990, K042595, K022636, K102350, K170185, K142812, K160253, K221030

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software application for acquiring, analyzing, viewing, storing, exporting, and printing data from pulmonary function testing devices. It focuses on standard data processing and management functionalities, with no mention of AI or ML techniques for analysis or interpretation.

Therapeutic

No
The device is a software application for acquiring, analyzing, viewing, storing, exporting, and printing outputs from cardio-pulmonary function testing devices, which is a diagnostic function, not therapeutic.

Diagnostic

Yes.
The device is a software application that acquires, analyzes, views, stores, exports, and prints device outputs including measurements of flow, volume, pressure, and gas concentrations from cardio-pulmonary function testing hardware, which directly contributes to diagnostic assessment by a healthcare provider.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "software application" and a "secure PC based medical device" that interfaces with separate hardware devices for data acquisition. It does not include any hardware components itself.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
ComPAS2's Function: ComPAS2 is a software application that interfaces with devices that measure physiological parameters directly from the patient. It acquires, analyzes, views, stores, exports, and prints data related to flow, volume, pressure, and gas concentrations obtained from devices like spirometers, plethysmographs, and pulse oximeters. These measurements are taken in vivo (within the living body).
Lack of Specimen Analysis: The description of ComPAS2 and its compatible devices does not mention the analysis of any biological specimens.

Therefore, ComPAS2 falls under the category of a medical device used for physiological monitoring and analysis, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

BZG

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults and pediatrics 4 years and older

Intended User / Care Setting

healthcare provider, primary care, hospitals, and research health centers

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing demonstrated that the subject device met its acceptance criteria. Testing included Software. 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.

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.

K190568

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.

K953990, K042595, K022636, K102350, K170185, K142812, K160253, K221030

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

Regulation Number and Section

§ 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).

Summary

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

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

Indications for Use

510(k) Number (if known) K213872

Device Name ComPAS2

Indications for Use (Describe)

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
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
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:

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:

Classification	Spirometer Diagnostic	Spirometer Diagnostic	Same
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.	Morgan Scientific's
ComPAS2 is a software
application intended to be
used 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.	The indications for use have
been updated from the
predicate to allow for the
additional capability of
linking ComPAS2 to
compatible Morgan Scientific
or third-party devices.
Otherwise, the indications for
use are the same.
Fundamental
Scientific
Technology	Digital Data Communication	Digital Data Communications	Same
Spirometry and
Bronchial
Challenge
acquire, analyze, view,
store and print
measures and
waveforms of
pulmonary function	Yes, from compatible device	Yes, from compatible device	Same
Diffusion acquire,
analyze, view, store
and	Yes, from compatible device	Yes, from compatible device	Same
print measures of
spirometry and gas
waveforms of
pulmonary function

Lung Volumes and
Gas Distribution_
acquire, analyze,
view, store and
print measures of
spirometry and gas
waveforms of
pulmonary function	Yes, from compatible device	Yes, from compatible device	Same
Respiratory
Pressures - acquire,
analyze, view, store
and print measures
of spirometry and
pressure waveforms
of pulmonary
function	Yes, from compatible device	Yes, from compatible device	Same
Plethysmography -
acquire, analyze,
view, store and
print measures of
spirometry, flow
pressure waveforms
of pulmonary
function	Yes, from compatible device	Yes, from compatible device	Same
Oscillometry
download, view	Yes, from compatible device	Yes, from compatible device	Same
Oximetry
download, view	Yes, from compatible device	Yes, from compatible device	Same
Microsoft Windows
Operating systems
supported	Yes, Windows 10	Yes, Windows 10	Windows 8.1 was removed
from this submission as it will
no longer be supported by
Windows after 2023
Database	MS SQL Server	MS SQL Server	Same
Where used	Hospitals, Health centers,
Primary care practices, and
clinics	Hospitals, Health centers,
Primary care practices, and
clinics	Same
Networked
operations	Yes	Yes	Same
Subject
Management:
Demographic Entry,	Yes	Yes	Same
Maintenance,
Deletion
Report printing	Yes	Yes	Same
PFT testing	Yes	Yes	Same
Trending graphs for
spirometry results	Yes	Yes	Same
PFT predicted value
equations	Yes	Yes	Same
Population group
management	Yes	Yes	Same
Data import/export	Yes	Yes	Same
Subject and
spirometry data
export	Yes	Yes	Same
Manual data entry
of results	Yes	Yes	Same
Database
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
testing	Yes	Yes	Same
Manual entry for
blood gases	Yes	Yes	Same
Reporting	Yes	Yes	Same
Data integration to
EMRs via HL7
interfacing or API	Yes	Yes	Same
Flow measurement	Pneumotachograph	Pneumotachograph	Same
Volume
measurement	Integrated flow and Rolling
seal spirometer	Integrated flow and Rolling
seal 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 Tests
per 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 Review
of Acceptability	Yes	Yes	Same
ATS/ERS Review
of Repeatability	Yes	Yes	Same
Standards
Compliance	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 editable
through script.	Predicted formulas editable
through script
Report Formats	Multiple with Report Editing
available	Multiple with Report Editing
available	Same
Quality Control	Data stored for reporting and
tracking purposes	Data stored for reporting and
tracking purposes	Same
Hardware
Communication	USB; device specific communication	USB; device general communication	Updated communications
code base to work with
compatible Morgan Scientific
and third-party devices.
Database	Microsoft SQL	Microsoft SQL	Same
Test capability			Same
	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, airwave
oscillometry. 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, airwave
oscillometry. 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.

	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	Supports Localization	Supports Localization
	HTML Help	Yes	Yes

VIII. PERFORMANCE DATA

Non-Clinical Testing

Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:

Software

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.