Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard pulmonary function testing device that uses sensors and software to measure respiratory parameters based on established standards and direct patient effort. There is no mention of AI, ML, or any learning or adaptive algorithms.

Therapeutic

No.
The device is a diagnostic tool used to measure respiratory parameters and assess lung function, not to provide therapy or treatment.

Diagnostic

Yes

The device is described as a "pulmonary function testing device" intended for "assessment of respiratory function" by measuring various "respiratory parameters" and "lung functions". This assessment of bodily function to aid in diagnosis is the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of various sensors and valves with associated low-level firmware, indicating hardware components beyond just software. While the software processes the data, the device itself is a physical system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. The description clearly states that the Model 9100 PFT/DICO measures respiratory parameters directly from the patient's breath ("measured directly from patient effort"). It's a device that the patient interacts with directly to provide physiological data.
The device measures physical parameters of respiration. It measures flow, volume, and gas concentrations in the inhaled and exhaled air. While these measurements are used to assess lung function, they are not analyzing biological samples like blood, urine, or tissue.
The intended use is for assessing respiratory function. This is a physiological assessment, not a diagnostic test performed on a biological sample.

In summary, the Model 9100 PFT/DICO is a pulmonary function testing device that measures physiological parameters of breathing. It does not perform analysis on biological samples, which is the defining characteristic of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Model 9100 PFT/DICO is a pulmonary function testing device which uses Morgan Scientific's ComPAS2 software to measure subject respiratory parameters including FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2 and SBN2.

The device is PC-based and designed for lung function testing on adults and pediatrics, 6 years and older, in a variety of professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians' offices.

The Model 9100 PFT/DICO is intended for the assessment of respiratory function through the measurement of dynamic lung volumes i.e., spirometry and other lung functions i.e., diffusing capacity.

Product codes

BTY

Device Description

The Model 9100 PFT/DICO is composed of various sensors and valves with associated low level firmware. The firmware interfaces with the Morgan Scientific's ComPAS2 software (K213872) that resides on an on-board computer. The Model 9100 also provides for user input and present resulting data on an integral display.

The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100then determines respiratory parameters including FVC, SVC, MVV, CPF, RMS (MIP and MEP), SNIP, DLCO, MBN2 and SBN2. The Model 9100 PFT/DICO firmware does not determine any respiratory parameters.

The ComPAS2 software uses flow and volume from the Vitalograph pneumotachograph spirometer to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Model 9100 patient test benchmark to display dilution lung volume data and single / multi breath diffusion data measured directly from patient effort. This information is then provided in a report format.

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, 6 years and older

Intended User / Care Setting

Professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians' offices.

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)

Bench studies:

ATS / ERS (2019) Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement: This testing compared the pre-set parameters and waveforms provided by ATS.
ISO 23747:2007 - Anaesthetic and Respiratory Equipment - Peak Expiratory Flow Meters For The Assessment of Pulmonary Function in Spontaneously Breathing Humans
ISO 26782:2009 Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans
Mechanical Drop Test: Demonstrated that the device continues to perform within predefined specifications after being dropped.
Cleaning - High-level disinfection: Demonstrated that the reusable components can be cleaned and disinfected.

Software:

Verification and Validation: Demonstrated that the software performed according to specifications.

Electrical / EMC:

ANSI/AAMI ES60601-1:2005 (R2012) with amendments - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD) (Consolidated Text) (Includes ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012)
IEC 60601-1-2:2010 Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests
AIM 7351731 - Medical Electrical Equipment & System Electromagnetic Immunity Test for RFID Readers

Biocompatibility:

ISO 18562-2: 2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 2: Tests for Emissions of Particulate Matter
ISO 18562-3: 2017 - Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 3: Tests for Emissions of Volatile Organic Compounds (VOCs)
ISO 18562-4: 2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 4: Tests for Leachables in Condensate
ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

Transportation and Conditioning Test:

ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

Key Results: All tested supported the safety and performance of the subject device and to be considered substantially equivalent to the predicate.

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.

NDD - K161534 - EasyOne Pro Lab

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.

Vyaire – K181524 – Vyntus ONE, Morgan Scientific - K042595 - Medisoft SpiroAir, Collins Medical - K030917 - nSpire Eagle

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 15, 2022

Vitalograph Ireland Ltd. % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704

Re: K221030

Trade/Device Name: Model 9100 PFT/DICO Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: BTY Dated: June 15, 2022 Received: June 16, 2022

Dear Paul Dryden:

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,

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 Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K221030

Device Name

Model 9100 PFT/DlCO

Indications for Use (Describe)

The Model 9100 PFT/DICO is a pulmonary function testing device which uses Morgan Scientific's ComPAS2 software to measure subject respiratory parameters including FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2 and SBN2.

The device is PC-based and designed for lung function testing on adults and pediatrics, 6 years and older, in a variety of professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians' offices.

The Model 9100 PFT/DICO is intended for the assessment of respiratory function through the measurement of dynamic lung volumes i.e., spirometry and other lung functions i.e., diffusing capacity.

Type of Use (Select one or both, as applicable)

그 XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (6/20)

3

Date Prepared:

15-Jul-22

I Submitter

Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare V95 HFT4 Ireland Tel - +353-65-6864100

| Submitter Contact: | Tony O'Hanlon
Regulatory Affairs / Quality Assurance Manager | |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--|
| Submission Correspondent: | Paul Dryden ProMedic, LLC | |
| II
Device
Proprietary or Trade Name:
Common/Usual Name:
Classification CFR:
Product Code: | Model 9100 PFT/DICO
Predictive Pulmonary Function Value Calculator
21 CFR 868.1890
BTY | |
| III
Predicate Device:
Common/Usual Name:
Classification CFR:
Product Code: | NDD - K161534 - EasyOne Pro Lab
Predictive Pulmonary Function Value Calculator
21 CFR 868.1890
BTY | |
| Reference Device 1:
Common/Usual Name:
Classification CFR:
Product Code: | Vyaire – K181524 – Vyntus ONE
Pulmonary-Function Data Calculator
21 CFR 868.1880
BZC | |
| Reference Device 2:
Common/Usual Name:
Classification CFR:
Product Code: | Morgan Scientific - K042595 - Medisoft SpiroAir
Spirometer, Diagnostic
21 CFR 868.1840
BZG | |
| Reference Device 3:
Common/Usual Name:
Classification CFR:
Product Code: | Collins Medical - K030917 - nSpire Eagle
Spirometer, Diagnostic
21 CFR 868.1840
BZG | |

IV Device Description:

The Model 9100 PFT/DICO is composed of various sensors and valves with associated low level firmware. The firmware interfaces with the Morgan Scientific's ComPAS2 software (K213872) that resides on an on-board computer. The Model 9100 also provides for user input and present resulting data on an integral display.

The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100then determines respiratory parameters including FVC, SVC, MVV, CPF, RMS (MIP and MEP), SNIP, DLCO, MBN2 and SBN2. The Model 9100 PFT/DICO firmware does not determine any

4

respiratory parameters.

The ComPAS2 software uses flow and volume from the Vitalograph pneumotachograph spirometer to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Model 9100 patient test benchmark to display dilution lung volume data and single / multi breath diffusion data measured directly from patient effort. This information is then provided in a report format.

V Indications for Use:

The Model 9100 PFT/DICO is a pulmonary function testing device which uses Morgan Scientific's ComPAS2 software to measure subject respiratory parameters including FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2 and SBN2.

The device is PC-based and designed for lung function testing on adults and pediatrics, 6 years and older, in a variety of professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians' offices.

The Model 9100 PFT/DICO is intended for the assessment of respiratory function through the measurement of dynamic lung volumes i.e., spirometry and other lung functions i.e., diffusing capacity.

VI Comparison of Technological Characteristics and Performance with the Predicate

Table 1 is a comparison - Subject Device vs. the Predicate, K161534 and References, K181524/K042595/K030917, including technological characteristics and performance.

5

510(k) Summary Page 3 of 12

Table 1: Comparison of the Model 9100 PFT/DICO vs. the Predicate and References

| | Subject
Model 9100 PFT/DICO
(K221030) | Predicate
NDD Easyone Pro Lab Respiratory Analysis
System | Reference devices
nSpire Eagle (Collins Medical Inc)
(K030917) | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | (K161534) | Medisoft SpiroAir (Morgan Scientific)
(K042595)
Vyntus ONE (Vyaire)
(K181524) | |
| Product
Code | BTY | BTY | BZG, BZC / DPS | Same |
| CFR | 868.1890 | 868.1890 | 868.1840
868.1880 | Same |
| Classification | Predictive pulmonary-function value
calculator | Predictive pulmonary-function value calculator | Diagnostic Spirometer
Pulmonary-Function Data Calculator | Same |
| Indications
for Use | The Vitalograph Model 9100 PFT/DICO
is a pulmonary function testing device
which uses Morgan Scientific's
ComPAS2 software to measure subject
respiratory parameters including FVC,
SVC, MVV, CPF, RMS, SNIP, DLCO,
MBN2 and SBN2.
The device is PC-based and designed for
lung function testing on adults and
pediatrics, 6 years and older, in a variety
of professional healthcare environments
e.g., primary care, hospitals,
pharmaceutical research centers and
physicians' offices.
The Model 9100 PFT/DICO is intended
for the assessment of respiratory function
through the measurement of dynamic
lung volumes i.e., spirometry and other
lung functions i.e., diffusing capacity. | EasyOne Pro/LAB is designed for conducting
lung function measurements in general or
specialist practices or in hospitals.
EasyOne Pro/LAB can also be used in clinical
settings in occupational medicine for
performing lung function screenings or
measurements.
EasyOne Pro/LAB is used to conduct lung
function measurements on adults and children
starting at age 4, except measurements of
diffusing capacity of the lung based on CO
(DLCO), which can be performed on adults and
children starting at age 6. | K030917
The Collins EAGLE (Diffusion Spirometer) is a
Pulmonary Function Test System. is intended as
a configurable, non-invasive pulmonary
function tester (PFT) testing system. These tests
are suitable for both pediatric and adult patient
testing.
K042595
The SpiroAir PFT System is intended to operate
with the ComPAS pulmonary function software.
ComPAS uses flow and volume from the
SpiroAir to display the flow and volume
information measured directly from patient
effort. ComPAS utilizes gas analyzer readings
from the SpiroAir to display single breath
diffusion data measured directly from patient
effort. This information is formatted for use in
pulmonary function testing and reports. | Similar
K181524 includes
the CPF /
MIP/MEP and
SNIP
Vyntus includes
many other
indications which
are not pertinent to
the subject device. |

6

| 510(k) Summary
Page 4 of 12 | K181524
The Vyntus ONE / SentrySuite product line is
intended to be used for measurements, data
collection and analysis of lung function (PFT)
and cardio-pulmonary (CPET) parameters,
aiding in the diagnosis of related conditions.
The results of the test can be viewed online with
the help of a computer screen and can be printed
after the test. The test results can be saved for
future reference or report generation purposes.
The products can be utilized with patients aged
4 years and older as long as they can cooperate
in the performance - no special limit to patient's
sex or height exists. Measurements will be
performed under the direction of a physician in
a hospital environment, physician's office or
similar setting (professional healthcare
facilities). A qualified physician has to reassess
all Vyntus / SentrySuite measurements. An
interpretation by Vyntus ONE / SentrySuite is
only significant if it is considered in connection
with other clinical findings. Additional for
Vyntus ECG: The Vyntus ECG is intended for
measuring the surface electrocardiogram (ECG)
of a patient. The acquired ECG can be recorded
and displayed on the screen or printed on paper.
12-lead ECGs are analyzed automatically and
suggestions for the interpretation of the resting
ECG can be made by the software. ECG
interpretation statements made by the Vyntus /
SentrySuite represent partial qualitative and
quantitative information on the patient's
cardiovascular condition and no therapy or
drugs can be administered based solely on the
interpretation statements. The Vyntus ECG can | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Summary
Page 5 of 12 | K221030 |
| | | be used for non-interpretive applications in
patients age 4 years and older and a weight of
20 kg or higher. The Vyntus ECG is intended to |
| | | be used for routine ECG collection, recording
both under resting and stress conditions. The |
| | | measurement is performed by trained healthcare
professionals under the direction of a physician |
| | | in healthcare facilities (e.g. the doctor's office
or hospital). The Vyntus ECG is not intended
for intracranial use. The Vyntus ECG is not |
| | | intended for use in an EMS environment
(Emergency Medical Services Environment). |
| | | The Vyntus ECG is not intended for use in
home healthcare environments. Automatic
interpretation of the ECG is not possible for |
| | | pediatric and adolescent patients below 16 years
of age and for patients with pacemakers |

7

8

| 510(k) Summary

Page 6 of 12
	Subject
Model 9100 PFT/DICO
(K221030)	Predicate
NDD Easyone Pro Lab Respiratory Analysis
System
(K161534)	Reference devices
nSpire Eagle (Collins Medical Inc)
(K030917)
Medisoft SpiroAir (Morgan Scientific)
(K042595)
Vyntus ONE (Vyaire)
(K181524)	Comparison
Fundamental
scientific
technology	Measurement of patient air flow via
Heated Lilly type pneumotachograph.
The DLCO Gas Analyzer utilizes non-
dispersive infrared (NDIR) technology to
measure the concentrations of Carbon
Monoxide (CO), Methane (CH4) and
Carbon Dioxide (CO2) during the DLCO
test. The N2 Washout Gas Analyzer uses
laser diode absorption to measure the
concentration of Oxygen (O2) and uses an
infrared sensor to measure the
concentration of Carbon Dioxide (CO2)
during the Nitrogen (N2) Washout test.	Measurement of patient air flow via ultrasonic
transit time flow sensor.
DLCO test - determination of inhaled and
exhaled gas concentrations: CO gas
concentration measured by infrared absorption
with CO sensor.
Helium tracer gas concentration measured by
molar mass sensor	'nSpire Eagle' (Collins Medical Inc)
K030917
Uses a pneumotach for patient air flow
including pressure sensors and multiple gas
analyzers which are electrochemical and
infrared.
'Medisoft SpiroAir' (Morgan Scientific)
K042595
Software which calculates various PFT
measurements which connected to a PFT
device.
'Vyntus ONE' (Vyaire)
K181524
Ultrasonic flow sensor for patient air flow and
software to calculate various PFT
measurements.	Similar
The difference in
gases used have
been cleared in
the reference
devices.
Parameters
measured	FVC
SVC
MVV
DLCO
CPF, RMS (MIP/MEP), SNIP
Single and Multiple Breath Nitrogen
washout (MBN2 and SBN2)	FVC
FVL
SVC
MVV
Pre-post Bronchodilator
Single Breath CO Diffusion (DLCO) including
Lung Volume
Multiple Breathing Nitrogen washout (MWB)	'nSpire Eagle' (Collins Medical Inc)
K030917 for SBN2
'Medisoft SpiroAir' (applicant was Morgan
Scientific)
K042595 for RMS
K181524 includes the CPF / MIP/MEP and
SNIP
Also	Similar
The references
show hardware
that does measure
the specific
parameters
Page / of 12
	Subject
Model 9100 PFT/DICO
(K221030)	Predicate
NDD Easyone Pro Lab Respiratory Analysis
System
(K161534)	Reference devices
nSpire Eagle (Collins Medical Inc)
(K030917)
Medisoft SpiroAir (Morgan Scientific)
(K042595)
Vyntus ONE (Vyaire)
(K181524)	Comparison
Patient use	Multi-patient, multi-use	Multi-patient, multi-use	Multi-patient, multi-use	Similar
User
Interface	Color LCD Touchscreen	Resistive touch screen for data entry and display	Various display types	Similar
Operating
System	Microsoft Windows 10	Microsoft Windows 8
Embedded SQLite/Microsoft SQL server
database	Not disclosed	Similar
Patient
Interface	Disposable Bacteria / Viral Filter
Disposable Mouthpieces	Disposable breathing tube Spirette
Disposable barrier shield DLCO Barriette
Disposable barrier shield FRC Barriette	Disposable mouthpiece
Head gear
Disposable Mask
Disposable nose clip	Similar
Components	Main Unit (embedded computer, touch screen and monitor) Handheld flow sensor Breathing valve assembly (for DLCO and FRC tests) DLCO gas mix supply 24V DC medical grade power supply from 80-240 VAC, 50/60 Hz power 100% Oxygen gas supply	Main Unit (embedded computer, touch screen and monitor) Handheld Flow sensor Internal Breathing valve assembly (for DLCO and FRC tests) DLCO gas mix supply 24V DC power supply 100% Oxygen gas supply	Components include Main unit Software Flow sensor Internal gas flow mechanism	Similar
Size	410 mm x 380 mm x 342 mm	270 mm x 335 mm x 270 mm	Not disclosed	Similar
	Subject
Model 9100 PFT/DICO
(K221030)	Predicate
NDD Easyone Pro Lab Respiratory
Analysis System
(K161534)	Reference devices
nSpire Eagle (Collins Medical Inc)
(K030917)
Medisoft SpiroAir (Morgan Scientific)
(K042595)
Vyntus ONE (Vyaire)
(K181524)	Comparison
Principle of
Operation	All test types -measurement of patient
air flow via heated Lilly type
pneumotachograph flow sensor.
DLCO test - determination of in- and
exhaled gas concentrations: CO gas
concentration measured by infrared
absorption with CO sensor.
Methane tracer gas concentration
measured by molar mass sensor.
MBW test - determination of in- and
exhaled gas concentrations:
Nitrogen tracer gas concentration
determined by a combination of molar
mass measurement (molar mass sensor)
and CO2 measurement (CO/CO2 sensor).	All test types -measurement of patient air flow
via ultrasonic transit time flow sensor.
DLCO test - determination of in- and exhaled
gas concentrations: CO gas concentration
measured by infrared absorption with CO
sensor.
Helium tracer gas concentration measured by
molar mass sensor.
MBW test - determination of in- and exhaled
gas concentrations:
Nitrogen tracer gas concentration determined
by a combination of molar mass measurement
(molar mass sensor) and CO2 measurement
(CO/CO2 sensor).	All test types -measurement of patient air flow
via a flow sensor.
Gas analyzers for measurement of various
gases.
K042595 - Medisoft SpiroAir (Morgan
Scientific) uses a Lilly Screen.	Similar
Test Gases for
DLCO	Medical grade gas mix
CO: 0.3 %
CH4: 0.3 %
Balance air	Medical grade gas mix
CO: 0.3 %
Helium: 10 %
Oxygen: 18 % - 25 %
Nitrogen: balance	K030917
CO
CO2
CH4
K181524
Nitrogen	Similar
The difference
in gases used are
used in cleared
reference
devices.
Test gas
requirements for
Nitrogen
washout test	Oxygen: 100 %
Nitrogen: balance	Oxygen: 100 %
Nitrogen: balance	K181524
Oxygen: 100 %
Nitrogen: balance	Same
	Subject
Model 9100 PFT/DICO
(K221030)	Predicate
NDD Easyone Pro Lab Respiratory
Analysis System
(K161534)	Reference devices
nSpire Eagle (Collins Medical Inc)
(K030917)
Medisoft SpiroAir (Morgan Scientific)
(K042595)
Vyntus ONE (Vyaire)
(K181524)	Comparison
Flow sensor
Flow range	$\pm$ 14 L/s
$\pm$ 2.5% or 0.050 L	$\pm$ 16 L/s
Greater of $\pm$ 2% or 0.050 L	K030917
Resistance is