Model 9160 VitaloQUB

K223818 · Vitalograph Ireland, Ltd. · JEH · May 25, 2023 · Anesthesiology

Device Facts

• Record ID: K223818
• Device Name: Model 9160 VitaloQUB
• Applicant: Vitalograph Ireland, Ltd.
• Product Code: JEH · Anesthesiology
• Decision Date: May 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1760
• Device Class: Class 2
• Attributes: Pediatric

Intended 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)

Device Story

Model 9160 VitaloQUB is a whole-body plethysmograph used with Vitalograph Model 9100; functions as an add-on to enable measurement of Thoracic Gas Volume (TGV) and Airway Resistance (Raw). Device utilizes a heated Lilly-type pneumotachograph for airflow measurement; integrates with Morgan Scientific ComPAS2 software (K213872) for data processing and reporting. Operates in professional healthcare settings; managed by trained clinicians. Input data includes patient airflow, gas concentrations (CO, CH4, O2, CO2) via NDIR and laser diode sensors. Software calculates respiratory parameters (FVC, SVC, MVV, DLCO, MBN2, SBN2, TGV, Raw) based on patient effort. Output provided as clinical reports to assist healthcare providers in assessing respiratory function. Benefits include comprehensive pulmonary function assessment in a controlled plethysmographic environment.

Clinical Evidence

Bench testing only. Performance validated against ATS/ERS (2002, 2005, 2013, 2017, 2019) standards for MEP, MIP, SNIP, DLCO, N2 washout, VTG, and Raw. Testing included ISO 23747 and ISO 26782 compliance, comparative performance against predicates, software verification/validation, electrical safety (ES 60601-1), EMC (IEC 60601-1-2), and biocompatibility.

Technological Characteristics

Whole-body plethysmograph; heated Lilly-type pneumotachograph flow sensor; NDIR CO/CO2 sensors; laser diode O2 sensor; molar mass sensor for CH4. Connectivity via USB to PC running Windows 10. Power: 24V DC via medical-grade supply (80-240 VAC). Biocompatibility: Externally communicating, tissue/surface contact, limited duration. Standards: ES 60601-1, IEC 60601-1-2, ISO 23747, ISO 26782, ATS/ERS.

Indications for Use

Indicated for lung function testing in adults and pediatric patients 6 years and older. Used by trained healthcare professionals in primary care, hospitals, and research centers.

Regulatory Classification

Identification

A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.

Predicate Devices

• Morgan Scientific – Medisoft Body Box 5500 (K022636)
• Vitalograph Model 9100 PFT/DICO (K221030)

Reference Devices

• Morgan ComPAS2 (K213872)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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)

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| Date Prepared: | 24-May-23 |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| I<br>Submitter | |
| Vitalograph Ireland Ltd.<br>Gort Road Business Park<br>Ennis Co Clare V95 HFT4 Ireland<br>Tel - [phone] | |
| Submitter Contact: | Tony O'Hanlon<br>Regulatory Affairs / Quality Assurance Manager |
| Submission Correspondent: | Paul Dryden ProMedic, LLC |
| II<br>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

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### 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.

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## 510(k) Summary Page 3 of 11

## Table 1 - Comparison of Subject vs. Predicate

| | Subject<br>Model 9160 | Primary Predicate<br>Morgan Scientific – Medisoft Body Box 5500 | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K223818 | K022636 | - |
| Product Code | JEH – 868-1760 - Volume Plethysmograph<br>Secondary BTY – 868.1890 - Predictive<br>pulmonary-function value calculator | JEH – 868-1760 - Volume Plethysmograph | Similar |
| Indications for<br>Use | The Model 9160 VitaloQUB is a whole-body<br>plethysmograph device, when used with the<br>Vitalograph Model 9100, is designed for lung<br>function testing on adults and pediatrics, 6 years<br>and older, by trained medical healthcare<br>professionals in a variety of professional healthcare<br>environments e.g., primary care, hospitals, and<br>pharmaceutical research centers.<br><br>The Model 9160 VitaloQUB is a pulmonary<br>function testing device which uses Morgan<br>Scientific's ComPAS2 software to measure subject<br>respiratory parameters including FVC, SVC, MVV,<br>CPF, RMS, SNIP, DLCO, MBN2, SBN2, Thoracic<br>Gas Volume (TGV) and Airway Resistance (Raw) | The Body Box 5500 when used in conjunction with a<br>computer and the ComPAS pulmonary function<br>software is intended to perform plethysmography,<br>diffusion and spirometry to provide pulmonary function<br>testing in adult and pediatric patients. | Similar<br>Subject device has similar<br>indications to the predicate. |
| Patient<br>population | 6 years and older | Pediatric (not defined) and adults | Similar |
| Fundamental<br>scientific<br>technology | Measurement of patient air flow via Heated Lilly<br>type pneumotachograph.<br>Test gases – Methane (CH4), Carbon Monoxide<br>(CO), Carbon Dioxide (CO2), Oxygen (O2) and<br>Nitrogen (N2) | Not specified | Similar<br>The subject device uses the<br>same technology of the<br>secondary predicate Model<br>9100 K221030 |
| | Subject<br>Model 9160 | Predicate<br>Morgan Scientific – Medisoft Body Box 5500 | Comparison |
| Parameters<br>measured | FVC<br>SVC<br>MVV<br>DLCO<br>CPF, RMS (MIP/MEP), SNIP<br>Single and Multiple Breath Nitrogen washout (MBN2 and SBN2)<br>VTG<br>Raw | Plethysmography, diffusion and spirometry<br>This uses the ComPAS software and thus is able to calculate and display the same parameters | Similar<br>Subject device is adding<br>Thoracic Gas Volume<br>(VTG) and<br>Airway Resistance (Raw) |
| Patient use | Multi-patient, multi-use | Multi-patient, multi-use | Similar |
| User Interface | Color LCD Touchscreen | Not specified | Similar |
| Operating<br>System | Microsoft Windows 10 | Not specified | Similar |
| Patient Interface | Disposable Bacteria / Viral Filter<br>Disposable Mouthpieces<br>Whole body enclosure | Whole body enclosure | Similar |
| Components | • Main Unit (embedded computer, touch screen monitor)<br>• Handheld Flow sensor<br>• Internal Breathing valve assembly (for DLCO and FRC tests)<br>• DLCO gas mix supply<br>• 24V DC via medical grade power supply<br>• 100% Oxygen gas supply<br>• Whole body enclosure | Not specified | Similar |
| Principle of<br>Operation | All test types -measurement of patient air flow via heated Lilly type pneumotachograph flow sensor.<br>DLCO test - determination of in- and exhaled gas concentrations: CO gas concentration measured by infrared absorption with CO sensor.<br>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<br>concentrations:<br>Nitrogen tracer gas concentration determined<br>by a combination of molar mass measurement<br>(molar mass sensor) and CO2 measurement<br>(CO/CO2 sensor).<br>Measurement of VTG and Raw use the same<br>sensors as the Model 9100 | | | |
| | Subject<br>Model 9160 | Predicate<br>Morgan Scientific - Medisoft Body Box 5500 | Comparison |
| Accuracy | Flow range: $\pm$ 14 L/s<br>Flow accuracy:<br>$\pm$ 2 % over range of -14 to + 14 L/s<br>Volume accuracy<br>$\pm$ 2.5 % or 0.050 L | Not specified | Similar |
| Operating<br>temperature<br>range | +15 -32°C | Not specified | Similar |
| Performance<br>standards | ISO 23747:2015, ISO 26782:2009,<br>ATS/ERS: 2002, 2005, 2013, 2017 and 2019 | Not specified | Similar |
| Electrical Safety<br>and EMC | ES 60601-1<br>IEC 60601-1-2 | Not specified | Similar |
| Communications | USB<br>Morgan Scientific ComPAS2 | Morgan Scientific ComPAS | Similar |
| | Subject<br>Model 9160 | Secondary Predicate<br>Model 9100 PFT/DICO | Comparison |
| K# | K223818 | K221030 | |
| Product Code | New - JEH - 868.1760 - Volume Plethysmograph<br><br>Secondary - BTY – 868.1890<br>Predictive pulmonary-function value<br>calculator | BTY - 868.1890<br>Predictive pulmonary-function value<br>calculator | Same, but the addition of the<br>full body enclosure adds<br>JEH |
| Classification | Predictive pulmonary-function value calculator | Predictive pulmonary-function value<br>calculator | Same |
| Indications for<br>Use | The Model 9160 VitaloQUB is a whole-body<br>plethysmograph device, when used with the<br>Vitalograph Model 9100, is designed for lung<br>function testing on adults and pediatrics, 6 years<br>and older, by trained medical healthcare<br>professionals in a variety of professional healthcare<br>environments e.g., primary care, hospitals, and<br>pharmaceutical research centers.<br><br>The Model 9160 VitaloQUB is a pulmonary<br>function testing device which uses Morgan<br>Scientific's ComPAS2 software to measure subject<br>respiratory parameters including FVC, SVC, MVV,<br>CPF, RMS, SNIP, DLCO, MBN2, SBN2, Thoracic<br>Gas Volume (TGV) and Airway Resistance (Raw) | The Model 9100 PFT/DICO is a pulmonary function<br>testing device which uses Morgan Scientific's<br>ComPAS2 software to measure subject respiratory<br>parameters including FVC, SVC, MVV, CPF, RMS,<br>SNIP, DLCO, MBN2 and SBN2.<br><br>The device is PC-based and designed for lung function<br>testing on adults and pediatrics, 6 years and older, in<br>a variety of professional healthcare environments e.g.,<br>primary care, hospitals, pharmaceutical research<br>centers and physicians' offices.<br><br>The Model 9100 PFT/DICO is intended for the<br>assessment of respiratory function through the<br>measurement of dynamic lung volumes i.e., spirometry<br>and other lung functions i.e., diffusing capacity. | Similar<br>Subject device is adding<br>VTG and Raw parameters |
| Patient<br>population | 6 years and older | 6 years and older | Similar |
| Fundamental<br>scientific<br>technology | Measurement of patient air flow via Heated Lilly<br>type pneumotachograph.<br>The DLCO Gas Analyzer utilizes non-dispersive<br>infrared (NDIR) technology to measure the<br>concentrations of Carbon Monoxide (CO) | Measurement of patient air flow via Heated Lilly type<br>pneumotachograph.<br>The DLCO Gas Analyzer utilizes non-dispersive<br>infrared (NDIR) technology to measure the<br>concentrations of Carbon Monoxide (CO), Methane | Similar<br>The subject device uses the<br>same technology of the<br>secondary predicate Model<br>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…