(99 days)
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.
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.
The provided text describes the regulatory clearance of the Vitalograph Model 9100 PFT/DICO, a pulmonary function testing device, and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria related to a machine learning or AI model's performance.
The document outlines performance testing conducted for the device's electrical, mechanical, and biocompatibility aspects, as well as software verification and validation. It explicitly states that the device uses "Morgan Scientific's ComPAS2 software to measure subject respiratory parameters," but there's no indication that this software includes an AI or machine learning component that would require a study with human-in-the-loop performance, expert ground truthing, or MRMC studies typically associated with AI/ML medical devices.
Therefore, many of the requested details about acceptance criteria for an AI model's performance and associated study specifics (sample size for test/training, number of experts, adjudication, MRMC, standalone performance, ground truth type) cannot be extracted from this document.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and principles of operation, supported by standard bench testing and software validation.
Here's an attempt to answer the request based only on the provided text, highlighting the absence of AI/ML-specific details:
Device: Vitalograph Model 9100 PFT/DICO
Study Type: This document describes a 510(k) premarket notification for substantial equivalence, supported by bench testing, software verification/validation, and compliance with various standards. It is not an AI/ML performance study. The "study that proves the device meets the acceptance criteria" refers to the entire body of evidence submitted for 510(k) clearance, rather than a specific AI model's performance study.
1. A table of acceptance criteria and the reported device performance
The document defines performance specifications and states that testing supported the safety and performance, implying these specifications were met. The specific "acceptance criteria" for the overall device's performance are embedded in the compliance with standards and the "similar" comparisons to predicate/reference devices.
| Metric (as described in comparison table) | Subject Device (Model 9100 PFT/DICO) Performance | Predicate/Reference Device Performance (if explicitly stated as acceptance criteria) | Conclusion (based on comparison) |
|---|---|---|---|
| Flow sensor Flow range | ± 14 L/s | Predicate: ± 16 L/s | Similar (implicitly within acceptable range) |
| Flow sensor Accuracy | ± 2.5% or 0.050 L (for flow) | Predicate: Greater of ± 2% or 0.050 L | Similar in accuracy |
| Volume accuracy | ± 2 % over range of -14 to + 14 L/s | Predicate: Greater of ± 2% or 0.020 L/s | Similar in accuracy |
| Flow resistance | <1.5 cm H2O/L/s (at 14 L/s) | Predicate: <1.5 cm H2O/L/s (at 12 L/s) | Similar |
| CO Sensor Accuracy | ± 1 % of full scale | Predicate: ± 0.001 % (accuracy while different, conforms to ATS/ERS guidelines) | "Similar Accuracy range" |
| O2 Sensor Accuracy | ±0.2% of Full Scale | Reference (Oxigraph Inc K971084): ±0.2% of Full Scale | Similar |
| CO2 Sensor Accuracy | ±0.1% of Full Scale | Reference (Oxigraph Inc K971084): ±0.1% of Full Scale | Similar |
| Software Performance | "Demonstrated that the software performed according to specifications" | N/A (General software V&V) | Met specifications |
| Mechanical Performance | "Demonstrated that the device continues to perform within pre-defined specifications after being dropped" | N/A (Mechanical Drop Test) | Met specifications |
| Cleaning/Disinfection | "Demonstrated that the reusable components can be cleaned and disinfected." | N/A | Met specifications |
| Electrical / EMC | Compliant with ANSI/AAMI ES60601-1:2005 (R2012) and IEC 60601-1-2:2010 | N/A | Compliant |
| Biocompatibility | Compliant with ISO 18562-2, -3, -4: 2017 and ISO 10993-1:2003 | N/A | Compliant |
| Transportation and Conditioning | Compliant with ASTM D4169-16 and ASTM D4332-14 | N/A | Compliant |
Note on "Acceptance Criteria" for AI: The document does not describe acceptance criteria for an AI or machine learning model. The stated accuracies (e.g., flow, volume, gas sensors) are for the physical measurement components of the device, not a predictive algorithm based on complex data interpretation.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for any performance testing, other than the implication that tests were sufficient to meet specific standards (e.g., ATS/ERS waveforms, drop tests, cleaning validations). There is no test set in the context of an AI/ML model's performance.
- Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective clinical data). The performance tests are largely bench-based or simulated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of human experts establishing ground truth for a test set, as would be done for an AI/ML interpretation task. Ground truth for the device's measurements would be established by reference standards or highly accurate laboratory equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. The device measures physiological parameters; it does not "assist" human readers in interpreting complex medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an AI/ML algorithm. The device itself is the "standalone" entity that performs measurements. The software (ComPAS2) controls the device and processes the raw sensor data, but there's no indication of it being a standalone AI/ML interpreter.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The ground truth for the device's performance relies on calibration standards, reference instruments, and established engineering/medical device testing protocols (e.g., ATS/ERS guidelines for spirometry, ISO standards for gas analysis accuracy, and various electrical/mechanical standards). There is no "expert consensus," "pathology," or "outcomes data" used for performance validation in the AI/ML sense.
8. The sample size for the training set
- Not applicable. There is no mention of an AI/ML model that would require a training set. The ComPAS2 software and device firmware are likely developed using traditional software engineering and embedded system development methods, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no AI/ML training set.
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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
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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
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Indications for Use
510(k) Number (if known)
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)
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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'HanlonRegulatory Affairs / Quality Assurance Manager | |
|---|---|---|
| Submission Correspondent: | Paul Dryden ProMedic, LLC | |
| IIDeviceProprietary or Trade Name:Common/Usual Name:Classification CFR:Product Code: | Model 9100 PFT/DICOPredictive Pulmonary Function Value Calculator21 CFR 868.1890BTY | |
| IIIPredicate Device:Common/Usual Name:Classification CFR:Product Code: | NDD - K161534 - EasyOne Pro LabPredictive Pulmonary Function Value Calculator21 CFR 868.1890BTY | |
| Reference Device 1:Common/Usual Name:Classification CFR:Product Code: | Vyaire – K181524 – Vyntus ONEPulmonary-Function Data Calculator21 CFR 868.1880BZC | |
| Reference Device 2:Common/Usual Name:Classification CFR:Product Code: | Morgan Scientific - K042595 - Medisoft SpiroAirSpirometer, Diagnostic21 CFR 868.1840BZG | |
| Reference Device 3:Common/Usual Name:Classification CFR:Product Code: | Collins Medical - K030917 - nSpire EagleSpirometer, Diagnostic21 CFR 868.1840BZG |
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
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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.
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510(k) Summary Page 3 of 12
Table 1: Comparison of the Model 9100 PFT/DICO vs. the Predicate and References
| SubjectModel 9100 PFT/DICO(K221030) | PredicateNDD Easyone Pro Lab Respiratory AnalysisSystem | Reference devicesnSpire Eagle (Collins Medical Inc)(K030917) | Comparison | |
|---|---|---|---|---|
| (K161534) | Medisoft SpiroAir (Morgan Scientific)(K042595)Vyntus ONE (Vyaire)(K181524) | |||
| ProductCode | BTY | BTY | BZG, BZC / DPS | Same |
| CFR | 868.1890 | 868.1890 | 868.1840868.1880 | Same |
| Classification | Predictive pulmonary-function valuecalculator | Predictive pulmonary-function value calculator | Diagnostic SpirometerPulmonary-Function Data Calculator | Same |
| Indicationsfor Use | The Vitalograph Model 9100 PFT/DICOis a pulmonary function testing devicewhich uses Morgan Scientific'sComPAS2 software to measure subjectrespiratory parameters including FVC,SVC, MVV, CPF, RMS, SNIP, DLCO,MBN2 and SBN2.The device is PC-based and designed forlung function testing on adults andpediatrics, 6 years and older, in a varietyof professional healthcare environmentse.g., primary care, hospitals,pharmaceutical research centers andphysicians' offices.The Model 9100 PFT/DICO is intendedfor the assessment of respiratory functionthrough the measurement of dynamiclung volumes i.e., spirometry and otherlung functions i.e., diffusing capacity. | EasyOne Pro/LAB is designed for conductinglung function measurements in general orspecialist practices or in hospitals.EasyOne Pro/LAB can also be used in clinicalsettings in occupational medicine forperforming lung function screenings ormeasurements.EasyOne Pro/LAB is used to conduct lungfunction measurements on adults and childrenstarting at age 4, except measurements ofdiffusing capacity of the lung based on CO(DLCO), which can be performed on adults andchildren starting at age 6. | K030917The Collins EAGLE (Diffusion Spirometer) is aPulmonary Function Test System. is intended asa configurable, non-invasive pulmonaryfunction tester (PFT) testing system. These testsare suitable for both pediatric and adult patienttesting.K042595The SpiroAir PFT System is intended to operatewith the ComPAS pulmonary function software.ComPAS uses flow and volume from theSpiroAir to display the flow and volumeinformation measured directly from patienteffort. ComPAS utilizes gas analyzer readingsfrom the SpiroAir to display single breathdiffusion data measured directly from patienteffort. This information is formatted for use inpulmonary function testing and reports. | SimilarK181524 includesthe CPF /MIP/MEP andSNIPVyntus includesmany otherindications whichare not pertinent tothe subject device. |
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| 510(k) SummaryPage 4 of 12 | K181524The Vyntus ONE / SentrySuite product line isintended to be used for measurements, datacollection 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 withthe help of a computer screen and can be printedafter the test. The test results can be saved forfuture reference or report generation purposes.The products can be utilized with patients aged4 years and older as long as they can cooperatein the performance - no special limit to patient'ssex or height exists. Measurements will beperformed under the direction of a physician ina hospital environment, physician's office orsimilar setting (professional healthcarefacilities). A qualified physician has to reassessall Vyntus / SentrySuite measurements. Aninterpretation by Vyntus ONE / SentrySuite isonly significant if it is considered in connectionwith other clinical findings. Additional forVyntus ECG: The Vyntus ECG is intended formeasuring the surface electrocardiogram (ECG)of a patient. The acquired ECG can be recordedand displayed on the screen or printed on paper.12-lead ECGs are analyzed automatically andsuggestions for the interpretation of the restingECG can be made by the software. ECGinterpretation statements made by the Vyntus /SentrySuite represent partial qualitative andquantitative information on the patient'scardiovascular condition and no therapy ordrugs can be administered based solely on theinterpretation statements. The Vyntus ECG can | |
|---|---|---|
| 510(k) SummaryPage 5 of 12 | K221030 | |
| be used for non-interpretive applications inpatients age 4 years and older and a weight of20 kg or higher. The Vyntus ECG is intended to | ||
| be used for routine ECG collection, recordingboth under resting and stress conditions. The | ||
| measurement is performed by trained healthcareprofessionals under the direction of a physician | ||
| in healthcare facilities (e.g. the doctor's officeor hospital). The Vyntus ECG is not intendedfor 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 inhome healthcare environments. Automaticinterpretation of the ECG is not possible for | ||
| pediatric and adolescent patients below 16 yearsof age and for patients with pacemakers |
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| 510(k) SummaryPage 6 of 12 | ||||
|---|---|---|---|---|
| SubjectModel 9100 PFT/DICO(K221030) | PredicateNDD Easyone Pro Lab Respiratory AnalysisSystem(K161534) | Reference devicesnSpire Eagle (Collins Medical Inc)(K030917)Medisoft SpiroAir (Morgan Scientific)(K042595)Vyntus ONE (Vyaire)(K181524) | Comparison | |
| Fundamentalscientifictechnology | Measurement of patient air flow viaHeated Lilly type pneumotachograph.The DLCO Gas Analyzer utilizes non-dispersive infrared (NDIR) technology tomeasure the concentrations of CarbonMonoxide (CO), Methane (CH4) andCarbon Dioxide (CO2) during the DLCOtest. The N2 Washout Gas Analyzer useslaser diode absorption to measure theconcentration of Oxygen (O2) and uses aninfrared sensor to measure theconcentration of Carbon Dioxide (CO2)during the Nitrogen (N2) Washout test. | Measurement of patient air flow via ultrasonictransit time flow sensor.DLCO test - determination of inhaled andexhaled gas concentrations: CO gasconcentration measured by infrared absorptionwith CO sensor.Helium tracer gas concentration measured bymolar mass sensor | 'nSpire Eagle' (Collins Medical Inc)K030917Uses a pneumotach for patient air flowincluding pressure sensors and multiple gasanalyzers which are electrochemical andinfrared.'Medisoft SpiroAir' (Morgan Scientific)K042595Software which calculates various PFTmeasurements which connected to a PFTdevice.'Vyntus ONE' (Vyaire)K181524Ultrasonic flow sensor for patient air flow andsoftware to calculate various PFTmeasurements. | SimilarThe difference ingases used havebeen cleared inthe referencedevices. |
| Parametersmeasured | FVCSVCMVVDLCOCPF, RMS (MIP/MEP), SNIPSingle and Multiple Breath Nitrogenwashout (MBN2 and SBN2) | FVCFVLSVCMVVPre-post BronchodilatorSingle Breath CO Diffusion (DLCO) includingLung VolumeMultiple Breathing Nitrogen washout (MWB) | 'nSpire Eagle' (Collins Medical Inc)K030917 for SBN2'Medisoft SpiroAir' (applicant was MorganScientific)K042595 for RMSK181524 includes the CPF / MIP/MEP andSNIPAlso | SimilarThe referencesshow hardwarethat does measurethe specificparameters |
| Page / of 12 | ||||
| SubjectModel 9100 PFT/DICO(K221030) | PredicateNDD Easyone Pro Lab Respiratory AnalysisSystem(K161534) | Reference devicesnSpire 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 |
| UserInterface | Color LCD Touchscreen | Resistive touch screen for data entry and display | Various display types | Similar |
| OperatingSystem | Microsoft Windows 10 | Microsoft Windows 8Embedded SQLite/Microsoft SQL serverdatabase | Not disclosed | Similar |
| PatientInterface | Disposable Bacteria / Viral FilterDisposable Mouthpieces | Disposable breathing tube SpiretteDisposable barrier shield DLCO BarrietteDisposable barrier shield FRC Barriette | Disposable mouthpieceHead gearDisposable MaskDisposable 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 |
| SubjectModel 9100 PFT/DICO(K221030) | PredicateNDD Easyone Pro Lab RespiratoryAnalysis System(K161534) | Reference devicesnSpire Eagle (Collins Medical Inc)(K030917)Medisoft SpiroAir (Morgan Scientific)(K042595)Vyntus ONE (Vyaire)(K181524) | Comparison | |
| Principle ofOperation | All test types -measurement of patientair flow via heated Lilly typepneumotachograph flow sensor.DLCO test - determination of in- andexhaled gas concentrations: CO gasconcentration measured by infraredabsorption with CO sensor.Methane tracer gas concentrationmeasured by molar mass sensor.MBW test - determination of in- andexhaled gas concentrations:Nitrogen tracer gas concentrationdetermined by a combination of molarmass measurement (molar mass sensor)and CO2 measurement (CO/CO2 sensor). | All test types -measurement of patient air flowvia ultrasonic transit time flow sensor.DLCO test - determination of in- and exhaledgas concentrations: CO gas concentrationmeasured by infrared absorption with COsensor.Helium tracer gas concentration measured bymolar mass sensor.MBW test - determination of in- and exhaledgas concentrations:Nitrogen tracer gas concentration determinedby a combination of molar mass measurement(molar mass sensor) and CO2 measurement(CO/CO2 sensor). | All test types -measurement of patient air flowvia a flow sensor.Gas analyzers for measurement of variousgases.K042595 - Medisoft SpiroAir (MorganScientific) uses a Lilly Screen. | Similar |
| Test Gases forDLCO | Medical grade gas mixCO: 0.3 %CH4: 0.3 %Balance air | Medical grade gas mixCO: 0.3 %Helium: 10 %Oxygen: 18 % - 25 %Nitrogen: balance | K030917COCO2CH4K181524Nitrogen | SimilarThe differencein gases used areused in clearedreferencedevices. |
| Test gasrequirements forNitrogenwashout test | Oxygen: 100 %Nitrogen: balance | Oxygen: 100 %Nitrogen: balance | K181524Oxygen: 100 %Nitrogen: balance | Same |
| SubjectModel 9100 PFT/DICO(K221030) | PredicateNDD Easyone Pro Lab RespiratoryAnalysis System(K161534) | Reference devicesnSpire Eagle (Collins Medical Inc)(K030917)Medisoft SpiroAir (Morgan Scientific)(K042595)Vyntus ONE (Vyaire)(K181524) | Comparison | |
| Flow sensorFlow range | $\pm$ 14 L/s$\pm$ 2.5% or 0.050 L | $\pm$ 16 L/sGreater of $\pm$ 2% or 0.050 L | K030917Resistance is < 1.4 cmH2O/L/Sec @ 14 L/Sec. | Similar |
| Volume accuracy | $\pm$ 2 % over range of -14 to + 14 L/s | Greater of $\pm$ 2% or 0.020 L/s | Volume accuracy is +/- 3%, and it is calibratedby using a knownvolume displacement device 3-liter syringe as astandard | The subject andpredicate aresimilar inaccuracy |
| Flow accuracyFlow resistance | <1.5 cm H2O/L/s (at 14 L/s) | <1.5 cm H2O/L/s (at 12 L/s) | K042595SoftwareK181524Ultrasonic Flow Sensor • Flow Accuracy(exhalation) 0 to 14 L/S: 1,5% or 0,05 L/S(whichever is greater) • Flow Accuracy(inhalation) 0 to 14 L/S: 2,5% or 0,05 L/S(whichever is greater) • Flow Range 0 to 18 L/Sbidirectional • Flow Resolution 1ml/s • VolumeAccuracy (exhalation) 0 to 14L: 1,5% or 0,05L(whichever is greater) • Volume Accuracy(inhalation) 0 to 14L: 2,5% or 0,05L (whicheveris greater) • Volume Range +/- 30 L (softwarelimited) • Volume Resolution 1mlDigital Volume Transducer • Flow: 0 – 15 L/s(3%) • Volume: 0 – 10 L (2%) • Resolution:3ml • Resistance: | |
| CO / CO2 SensorType | Infrared absorptionCO - $\pm$ 1 % of full scale | Infrared absorptionCO - $\pm$ 0.001 % | Infrared absorption | SimilarAccuracy range |
| SubjectModel 9100 PFT/DICO(K221030) | PredicateNDD Easyone Pro Lab RespiratoryAnalysis System(K161534) | Reference devicesnSpire Eagle (Collins Medical Inc)(K030917)Medisoft SpiroAir (Morgan Scientific)(K042595)Vyntus ONE (Vyaire)(K181524) | ATS / ERSguidelines foraccuracy.Comparison | |
| O2 / CO2 SensorTypeAccuracy | Laser diode absorption for O2Infrared for CO2O2 - ±0.2% of Full ScaleCO2 - ±0.1% of Full Scale | Does not contain Oxygen / CO2 sensor fromthe IR bench mentioned above | Oxigraph Inc K971084Laser diode absorption for O2Infrared for CO2O2 - ±0.2% of Full ScaleCO2 - ±0.1% of Full Scale | Similar |
| Operatingtemperaturerange | 15-32°C | Not disclosed | K18152410-34°C | Labelingdisclosure |
| Communications | USBMorgan Scientific ComPAS2 | Not available | K042595 – Morgan ComPAS software | Similar |
| Power | 24VDC output via medical grade powersupply via input of 80-240 VAC 50-60Hz | 110-240 VAC | 110-240 VAC | Similar |
| Biocompatibility | Externally communicating, Tissue andSurface Contact, Skin / Mucosa, LimitedDuration | Externally communicating, Tissue and SurfaceContact, Skin / Mucosa, Limited Duration | Externally communicating, Tissue and SurfaceContact, Skin / Mucosa, Limited Duration | Similar |
510(k) Summary
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510(1-) C-
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VII Difference and Substantial Equivalence Discussions
Intended Use/ Indications for Use
The indications for use are similar to the predicate. That is to conduct lung function measurements including DLCO. SBN2 and MBN2. This includes using both predicate and reference devices as presented in the above table.
Technological Characteristics and Principles of Operation
The measurement of flow is the Lilly Screen technology when using trace gases for DLCO and Nitrogen washout testing and is similar to the predicate and reference devices.
The basic difference between the subject device and the predicate is the technology of measuring and calculating flow which is ultrasonic (predicate) vs. a heated Lilly pneumotachograph for the subject device. The subject device technology uses the Lilly screen assembly which is heated to take change in temperature into account, an important influence on results. The reference Medisoft SpiroAir (Morgan Scientific) (K042595) also uses a Lilly Screen.
The subject device includes gas sensors for measuring CO. The accuracy of the sensors while different than the predicate, + 1% of full scale vs. + 0.001%, conform to the requirements of ATS / ERS guidelines. The difference in accuracy based upon the ATS / ERS guidelines does not raise a different concern of safety and efficacy.
The operating principle, measuring technology, range, application and use are similar to the predicate and the noted reference devices.
VIII Performance Testing
Bench
- 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. O
- 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 pre-defined specifications O after being dropped
- . Cleaning - High-level disinfection
- O Demonstrated that the reusable components can be cleaned and disinfected.
Software
- . Verification and Validation
Demonstrated that the software performed according to specifications o
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
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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
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. ISO 18562-3: 2017 - Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 3: Tests for Emissions of Volatile Organic Compounds (VOCs)
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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
All tested supported the safety and performance of the subject device and to be considered substantially equivalent to the predicate.
IX Substantial Equivalence Conclusion
The differences do not present different questions of safety or effectiveness than the predicate device. The Model 9100 PFT/DICO is substantially equivalent to the predicate NDD EasyOne Pro Lab, K161534.
§ 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).