Who is the manufacturer of Model 9100 PFT/DICO?

Vitalograph Ireland, Ltd. filed the 510(k) submission for Model 9100 PFT/DICO (K221030).

What is the FDA product code for Model 9100 PFT/DICO?

BTY. It is classified under 21 CFR 868.1890 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Model 9100 PFT/DICO?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Model 9100 PFT/DICO?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Model 9100 PFT/DICO

K221030 · Vitalograph Ireland, Ltd. · BTY · Jul 15, 2022 · Anesthesiology

Device Facts

Record ID	K221030
Device Name	Model 9100 PFT/DICO
Applicant	Vitalograph Ireland, Ltd.
Product Code	BTY · Anesthesiology
Decision Date	Jul 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1890
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Model 9100 PFT/DICO is a PC-based pulmonary function testing system; utilizes heated Lilly-type pneumotachograph for airflow measurement; incorporates NDIR gas sensors for CO/CH4/CO2 and laser diode/infrared sensors for O2/CO2 during DLCO and Nitrogen washout tests. Device integrates with Morgan Scientific ComPAS2 software (K213872) on an on-board computer to process raw sensor data; outputs respiratory parameters (FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2, SBN2) in report format. Operated by healthcare professionals in clinical environments; provides objective respiratory data to assist physicians in assessing lung function and diagnosing related conditions. Benefits include non-invasive, standardized assessment of dynamic lung volumes and diffusing capacity.

Clinical Evidence

Bench testing only. Device performance validated against ATS/ERS (2019) spirometry standards, ISO 23747:2007 (peak flow), and ISO 26782:2009 (spirometers). Additional testing included mechanical drop tests, high-level disinfection validation, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1, ISO 18562 series).

Technological Characteristics

Heated Lilly-type pneumotachograph for flow; NDIR sensors for CO/CH4/CO2; laser diode/infrared sensors for O2/CO2. PC-based system running Windows 10; color LCD touchscreen interface. Connectivity via USB. Power: 24V DC medical grade supply. Biocompatibility: externally communicating, limited duration skin/mucosa contact.

Indications for Use

Indicated for lung function testing in adults and pediatrics, 6 years and older, in professional healthcare settings (primary care, hospitals, research centers, physicians' offices) to assess respiratory function via spirometry and diffusing capacity measurements.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

NDD EasyOne Pro Lab (K161534)

Reference Devices

Vyaire Vyntus ONE (K181524)
Morgan Scientific Medisoft SpiroAir (K042595)
Collins Medical nSpire Eagle (K030917)

Related Devices

K223818 — Model 9160 VitaloQUB · Vitalograph Ireland, Ltd. · May 25, 2023
K161534 — EasyOne Pro Respiratory Analysis System · Ndd Medizintechnik AG · Feb 22, 2017
K240706 — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) · Ganshorn Medizin Electronic GmbH · Dec 9, 2024
K161295 — MiniBox + · Pulmone Advanced Medical Devices, Ltd. · Oct 21, 2016
K190853 — Vyntus BODY · Vyaire Medical, Inc. · Aug 16, 2019

Submission Summary (Full Text)

{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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number." 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…