(155 days)
No
The summary explicitly states that the ComPAS2 software is unchanged from a previous clearance (K213872) and that the device firmware does not determine any respiratory parameters. There is no mention of AI or ML in the description of the device's functionality or the software's operation.
No
The device is described as a "pulmonary function testing device" and its intended use is for "lung function testing" to "measure subject respiratory parameters." This indicates a diagnostic purpose rather than a therapeutic one.
Yes
The device is designed for lung function testing and measures subject respiratory parameters (e.g., FVC, SVC, MVV, DLCO, Thoracic Gas Volume, Airway Resistance) which are used by trained medical healthcare professionals to assess physiological parameters and diagnose or monitor health conditions.
No
The device description explicitly states that the Model 9160 VitaloQUB incorporates the cleared Model 9100, which is a hardware device (whole-body plethysmograph) with integrated LCD display and sensors. While the software controls the hardware and processes data, the device itself is a combination of hardware and software.
Based on the provided information, the Model 9160 VitaloQUB is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "lung function testing" and measures "subject respiratory parameters." This involves measuring physiological responses from a living subject, not analyzing samples taken from the body (in vitro).
- Device Description: The device measures parameters from the subject's breathing and uses software to calculate respiratory values. It doesn't involve the analysis of biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description doesn't mention any components or processes typically associated with IVDs, such as reagents, sample preparation, or analysis of biological specimens.
Therefore, the Model 9160 VitaloQUB falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers.
The Model 9160 VitaloQUB 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, SBN2, Thoracic Gas Volume (TGV) and Airway Resistance (Raw)
Product codes (comma separated list FDA assigned to the subject device)
JEH, BTY
Device Description
The proposed Model 9160 VitaloQUB incorporates the cleared Model 9100 (K221030) with integrated LCD display and ComPAS2 software (K213872).
The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters including the 2 new parameters.
The ComPAS2 software is unchanged from K213872. The Model 9160 and Model 9100 firmware does not determine any respiratory parameters.
The Model 9160 is adding 2 additional parameters:
- . TVG – Thoracic Gas Volume
- The volume of gas contained within the chest during body plethysmography when the O mouth shutter is closed.
- Raw Airway resistance ●
- Airway resistance (Raw) is calculated as the change in alveolar pressure (Pay) divided by O flow, which is derived by multiplying the slope of the closed shutter maneuver and the inverse slope of the open shutter maneuver, with the lung volume terms cancelling out.
The cleared Model 9100 PFT/DICO (K221030) has been cleared to measure respiratory parameters including FVC, SVC, MVV, CPF, RMS (MIP and MEP), SNIP, DLCO, MBN2 and SBN2.
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 and Model 9160 patient test and transfer test benchmark to display the data 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
lung
Indicated Patient Age Range
6 years and older
Intended User / Care Setting
trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research 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:
Bench testing that is new or leveraged from the secondary predicate Model 9100, K221030 and primary predicate K022636 - Morgan Scientific - Medisoft Body Box 5500
- . ATS / ERS (2002. 2005. 2013. 2017 and 2019) Static condition
- o MEP. MIP, SNIP, DLCO, N2 washout, VTG, Raw
- ISO 23747
- ISO 26782 ●
- Cleaning High-level disinfection (Model 9100, K221030) ●
- Comparative Performance vs. Predicate ●
Software
-
Verification and Validation ●
Electrical / EMC -
ES 60601-1 Electrical Safety ●
- IEC 60601-1-2 EMC
Biocompatibility (Model 9100, K221030)
Transportation
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.
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
§ 868.1760 Volume plethysmograph.
(a)
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2023
Vitalograph Ireland Ltd. % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K223818
Trade/Device Name: Model 9160 VitaloOUB Regulation Number: 21 CFR 868.1760 Regulation Name: Volume Plethysmograph Regulatory Class: Class II Product Code: JEH, BTY Dated: April 25, 2023 Received: April 25, 2023
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.
1
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 (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 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.
Ethan L. Nyberg -S
for James Lee Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K223818
Device Name
Model 9160 VitaloQUB
Indications for Use (Describe)
The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers.
The Model 9160 VitaloQUB 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, SBN2, Thoracic Gas Volume (TGV) and Airway Resistance (Raw)
Type of Use (Select one or both, as applicable)
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: | 24-May-23 |
|---|---|
| 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: | Model 9160 VitaloQUB |
| Common/Usual Name: | Plethysmograph, Volume |
| Classification CFR: | 21 CFR 868.1760 |
| Product Code: | JEH |
| III | |
| Primary Predicate Device: | K022636 - Morgan Scientific – Medisoft Body Box 550 |
| Common/Usual Name: | Plethysmograph, Volume |
| Classification CFR: | 21 CFR 868.1760 |
| Product Code: | JEH |
| Secondary Predicate Device: | K221030 - Vitalograph Model 9100 PFT/DICO |
| Common/Usual Name: | Predictive Pulmonary Function Value Calculator |
| Classification CFR: | 21 CFR 868.1890 |
| Product Code: | BTY |
| Reference Device: | K213872 - Morgan ComPAS2 |
| Common/Usual Name: | Diagnostic Spirometer |
| Classification CFR: | 21 CFR 868.1840 |
| Product Code: | BZG |
IV Device Description:
The proposed Model 9160 VitaloQUB incorporates the cleared Model 9100 (K221030) with integrated LCD display and ComPAS2 software (K213872).
The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters including the 2 new parameters.
The ComPAS2 software is unchanged from K213872. The Model 9160 and Model 9100 firmware does not determine any respiratory parameters.
The Model 9160 is adding 2 additional parameters:
- . TVG – Thoracic Gas Volume
4
510(k) Summary Page 2 of 11
- The volume of gas contained within the chest during body plethysmography when the O mouth shutter is closed.
- Raw Airway resistance ●
- Airway resistance (Raw) is calculated as the change in alveolar pressure (Pay) divided by O flow, which is derived by multiplying the slope of the closed shutter maneuver and the inverse slope of the open shutter maneuver, with the lung volume terms cancelling out.
The cleared Model 9100 PFT/DICO (K221030) has been cleared to measure respiratory parameters including FVC, SVC, MVV, CPF, RMS (MIP and MEP), SNIP, DLCO, MBN2 and SBN2.
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 and Model 9160 patient test and transfer test benchmark to display the data directly from patient effort. This information is then provided in a report format.
V Indications for Use:
The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers.
The Model 9160 VitaloOUB 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, SBN2, Thoracic Gas Volume (TGV) and Airway Resistance (Raw)
VI Comparison of Technological Characteristics and Performance with the Predicate
Table 1 is a comparison - Subject Device vs. the Predicates, K022636 - Morgan Scientific - Medisoft Body Box 5500 and K221030 – Vitalograph Model 9100 PFT/DICO including technological characteristics and performance.
5
510(k) Summary Page 3 of 11
Table 1 - Comparison of Subject vs. Predicate
| | Subject
Model 9160 | Primary Predicate
Morgan Scientific – Medisoft Body Box 5500 | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K223818 | K022636 | - |
| Product Code | JEH – 868-1760 - Volume Plethysmograph
Secondary BTY – 868.1890 - Predictive
pulmonary-function value calculator | JEH – 868-1760 - Volume Plethysmograph | Similar |
| Indications for
Use | The Model 9160 VitaloQUB is a whole-body
plethysmograph device, when used with the
Vitalograph Model 9100, is designed for lung
function testing on adults and pediatrics, 6 years
and older, by trained medical healthcare
professionals in a variety of professional healthcare
environments e.g., primary care, hospitals, and
pharmaceutical research centers.
The Model 9160 VitaloQUB 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, SBN2, Thoracic
Gas Volume (TGV) and Airway Resistance (Raw) | The Body Box 5500 when used in conjunction with a
computer and the ComPAS pulmonary function
software is intended to perform plethysmography,
diffusion and spirometry to provide pulmonary function
testing in adult and pediatric patients. | Similar
Subject device has similar
indications to the predicate. |
| Patient
population | 6 years and older | Pediatric (not defined) and adults | Similar |
| Fundamental
scientific
technology | Measurement of patient air flow via Heated Lilly
type pneumotachograph.
Test gases – Methane (CH4), Carbon Monoxide
(CO), Carbon Dioxide (CO2), Oxygen (O2) and
Nitrogen (N2) | Not specified | Similar
The subject device uses the
same technology of the
secondary predicate Model
9100 K221030 |
| | Subject
Model 9160 | Predicate
Morgan Scientific – Medisoft Body Box 5500 | Comparison |
| Parameters
measured | FVC
SVC
MVV
DLCO
CPF, RMS (MIP/MEP), SNIP
Single and Multiple Breath Nitrogen washout (MBN2 and SBN2)
VTG
Raw | Plethysmography, diffusion and spirometry
This uses the ComPAS software and thus is able to calculate and display the same parameters | Similar
Subject device is adding
Thoracic Gas Volume
(VTG) and
Airway Resistance (Raw) |
| Patient use | Multi-patient, multi-use | Multi-patient, multi-use | Similar |
| User Interface | Color LCD Touchscreen | Not specified | Similar |
| Operating
System | Microsoft Windows 10 | Not specified | Similar |
| Patient Interface | Disposable Bacteria / Viral Filter
Disposable Mouthpieces
Whole body enclosure | Whole body enclosure | Similar |
| Components | • Main Unit (embedded computer, touch screen monitor)
• Handheld Flow sensor
• Internal Breathing valve assembly (for DLCO and FRC tests)
• DLCO gas mix supply
• 24V DC via medical grade power supply
• 100% Oxygen gas supply
• Whole body enclosure | Not specified | Similar |
| 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. | All test types -measurement of patient air flow via pneumotachograph flow sensor. | Similar |
| 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).
Measurement of VTG and Raw use the same
sensors as the Model 9100 | | | |
| | Subject
Model 9160 | Predicate
Morgan Scientific - Medisoft Body Box 5500 | Comparison |
| Accuracy | Flow range: $\pm$ 14 L/s
Flow accuracy:
$\pm$ 2 % over range of -14 to + 14 L/s
Volume accuracy
$\pm$ 2.5 % or 0.050 L | Not specified | Similar |
| Operating
temperature
range | +15 -32°C | Not specified | Similar |
| Performance
standards | ISO 23747:2015, ISO 26782:2009,
ATS/ERS: 2002, 2005, 2013, 2017 and 2019 | Not specified | Similar |
| Electrical Safety
and EMC | ES 60601-1
IEC 60601-1-2 | Not specified | Similar |
| Communications | USB
Morgan Scientific ComPAS2 | Morgan Scientific ComPAS | Similar |
| | Subject
Model 9160 | Secondary Predicate
Model 9100 PFT/DICO | Comparison |
| K# | K223818 | K221030 | |
| Product Code | New - JEH - 868.1760 - Volume Plethysmograph
Secondary - BTY – 868.1890
Predictive pulmonary-function value
calculator | BTY - 868.1890
Predictive pulmonary-function value
calculator | Same, but the addition of the
full body enclosure adds
JEH |
| Classification | Predictive pulmonary-function value calculator | Predictive pulmonary-function value
calculator | Same |
| Indications for
Use | The Model 9160 VitaloQUB is a whole-body
plethysmograph device, when used with the
Vitalograph Model 9100, is designed for lung
function testing on adults and pediatrics, 6 years
and older, by trained medical healthcare
professionals in a variety of professional healthcare
environments e.g., primary care, hospitals, and
pharmaceutical research centers.
The Model 9160 VitaloQUB 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, SBN2, Thoracic
Gas Volume (TGV) and Airway Resistance (Raw) | 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. | Similar
Subject device is adding
VTG and Raw parameters |
| Patient
population | 6 years and older | 6 years and older | Similar |
| 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) | 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 | Similar
The subject device uses the
same technology of the
secondary predicate Model
9100 |
| | | | |
| | Methane (CH4) and Carbon Dioxide (CO2) during | (CH4) and Carbon Dioxide (CO2) during the DLCO | |
| | the DLCO test. The N2 Washout Gas Analyzer | test. The N2 Washout Gas Analyzer uses laser diode | |
| | uses laser diode absorption to measure the | absorption to measure the concentration of Oxygen (O2) | |
| | concentration of Oxygen (O2) and uses an infrared | and uses an infrared sensor to measure the | |
| | sensor to measure the concentration of Carbon | concentration of Carbon Dioxide (CO2) during the | |
| | Dioxide (CO2) during the Nitrogen (N2) Washout | Nitrogen (N2) Washout test. | |
| | test. | | |
| | Subject | Secondary Predicate | Comparison |
| | Model 9160 | Model 9100 PFT/DICO | |
| Parameters | FVC | FVC | Similar |
| measured | SVC | SVC | Subject device is adding |
| | MVV | MVV | Thoracic Gas Volume |
| | DLCO | DLCO | (VTG) and |
| | CPF, RMS (MIP/MEP), SNIP | CPF, RMS (MIP/MEP), SNIP | Airway Resistance (Raw) |
| | Single and Multiple Breath Nitrogen washout | Single and Multiple Breath Nitrogen washout | which the predicate has |
| | (MBN2 and SBN2) | (MBN2 and SBN2) | |
| | MIP/MEP | MIP//MEP | |
| | Adding | | |
| | TVG | | |
| | Raw | | |
| Patient use | Multi-patient, multi-use | Multi-patient, multi-use | Similar |
| | | | |
| User Interface | Color LCD Touchscreen | Color LCD Touchscreen | Similar |
| Operating | Microsoft Windows 10 | Microsoft Windows 10 | Similar |
| System | | | |
| Patient Interface | Disposable Bacteria / Viral Filter | Disposable Bacteria / Viral Filter | Similar |
| | Disposable Mouthpieces | Disposable Mouthpieces | Subject device places the |
| | Whole body enclosure | | Model 9100 patient interface |
| | | | inside a whole body |
| | | | enclosure |
| Components | Main Unit (embedded computer, touch screen and monitor) Handheld Flow sensor Internal Breathing valve assembly (for DLCO and FRC tests) DLCO gas mix 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 | Similar
The subject device includes
a whole body enclosure
similar to the predicate |
| | 24V DC via medical grade power supply 100% Oxygen gas supply Whole body enclosure | 24V DC via medical grade power supply 100% Oxygen gas supply | |
| | Subject
Model 9160 | Secondary Predicate
Model 9100 PFT/DICO | 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).
Measurement of VTG and Raw use the same
sensors as the Model 9100 | 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). | Similar
Subject device with the
whole body enclosure can
now provide data to the
ComPAS2 software to
calculate VTG and Raw like
the predicates and reference
device. |
| Test Gases for
DLCO | Medical grade gas mix
CO: 0.3 %
CH4: 0.3 %
Balance air | Medical grade gas mix
CO: 0.3 %
CH4: 0.3 %
Balance air | Similar |
| Test gas
requirements for
Nitrogen
washout test | Oxygen: 100 %
Nitrogen: balance | Oxygen: 100 %
Nitrogen: balance | Similar |
| Flow sensor
Flow range
Volume accuracy
Flow accuracy
Flow resistance | $ \pm $ 14 L/s
$ \pm $ 2.5 % or 0.050 L
$ \pm $ 2 % over range of -14 to + 14 L/s