(155 days)
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 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
- Raw Airway resistance
The provided text describes the regulatory clearance for the VitaloQUB Model 9160, a whole-body plethysmograph device. However, it does not contain specific details on the acceptance criteria or a dedicated study report that demonstrates the device explicitly meets numerical acceptance criteria. The text focuses on establishing substantial equivalence to predicate devices.
Here's an analysis based on the information available and what is missing:
The submission states that "Performance testing demonstrated that the subject device met its acceptance criteria," and then lists the types of testing performed. However, it does not provide the specific numerical acceptance criteria or the reported device performance for these criteria.
1. Table of acceptance criteria and the reported device performance:
| Parameter/Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Thoracic Gas Volume (VTG) | Not explicitly stated in the provided text | Not explicitly stated in the provided text |
| Airway Resistance (Raw) | Not explicitly stated in the provided text | Not explicitly stated in the provided text |
| FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2, SBN2 | Not explicitly stated as specific acceptance criteria for the new device, but implied to meet predicate performance | Not explicitly stated as specific performance for the new device, but implied to meet predicate performance |
| Flow accuracy | ± 2 % over range of -14 to + 14 L/s | Subject Device: ± 2 % over range of - 14 to + 14 L/s (Stated in comparison table, implying performance matches requirement) |
| Volume accuracy | ± 2.5 % or 0.050 L | Subject Device: ± 2.5 % or 0.050 L (Stated in comparison table, implying performance matches requirement) |
| CO Sensor Accuracy | ±1 % of full scale | Subject Device: ±1 % of full scale (Stated in comparison table, implying performance matches requirement) |
| CO2 (NDIR) Sensor Accuracy | ±2.5 % of full scale | Subject Device: ±2.5 % of full scale (Stated in comparison table, implying performance matches requirement) |
| CH4 Sensor Accuracy | ±2.5% of full scale | Subject Device: ±2.5% of full scale (Stated in comparison table, implying performance matches requirement) |
| O2 Sensor Accuracy | ±0.2% of Full Scale | Subject Device: ±0.2% of Full Scale (Stated in comparison table, implying performance matches requirement) |
| CO2 (N2 washout) Sensor Accuracy | ±0.1% of Full Scale | Subject Device: ±0.1% of Full Scale (Stated in comparison table, implying performance matches requirement) |
| Compliance with Performance Standards | ISO 23747:2015, ISO 26782:2009, ATS/ERS: 2002, 2005, 2013, 2017 and 2019 | Subject Device: Complies with these standards (Implied by inclusion in comparison table and statement of updated performance testing) |
| Electrical Safety | ES 60601-1 | Subject Device: Complies with ES 60601-1 (Implied by inclusion in comparison table and statement of updated performance testing) |
| EMC | IEC 60601-1-2 | Subject Device: Complies with IEC 60601-1-2 (Implied by inclusion in comparison table and statement of updated performance testing) |
| Cleaning High-level disinfection | Not explicitly stated | Performance testing for cleaning/disinfection was completed (leveraged from predicate) |
| Software | Verification and Validation | Verification and Validation completed |
| Biocompatibility | Not explicitly stated | Biocompatibility testing completed (leveraged from predicate) |
| Transportation | Not explicitly stated | Transportation testing completed |
Missing Information: For VTG and Raw, while the document states performance testing was done, the specific acceptance criteria and the results demonstrating compliance are not provided. The accuracy values listed in the table are copied directly from the "Subject Model 9160" column, indicating that these are the device's inherent specifications, and the comparison section implies they are similar to or meet expectations based on the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text mentions "Bench testing" but does not detail the sample sizes for any of the performance tests, nor does it specify if any clinical data with human subjects (and thus data provenance) was used for direct performance evaluation of VTG and Raw measurements. The comparison tables focus on technological characteristics and principle of operation similarities to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The device outputs objective physiological measurements, rather than interpretations requiring expert consensus as ground truth. If clinical studies were performed for the new parameters (VTG, Raw), the method of establishing ground truth would depend on the study design. However, the document provided does not detail such clinical studies or the involvement of experts in establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. Given the nature of the device (measuring physiological parameters rather than rendering diagnoses or classifications), an adjudication method for a test set as described is unlikely to be directly applicable in the same way as for image-based diagnostic AI. If human subject studies were conducted to compare measurements, adjudication of patient conditions might be relevant, but this is not detailed.
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:
This is not applicable to this device. The VitaloQUB Model 9160 is a pulmonary function measurement device. It measures physiological parameters and does not involve "readers" or "AI assistance" in the diagnostic interpretation sense for which MRMC studies are typically performed. The device itself performs the measurements and calculations (via the ComPAS2 software), it does not assist human interpretation of complex data (like images) in a way that would be quantified by an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is inherently a standalone measurement system in terms of calculating the parameters. The ComPAS2 software, which is part of the system, outputs the respiratory parameters. This is the "algorithm only" performance. The document states: "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...". The performance testing mentioned ("Bench testing", "ATS / ERS (2002, 2005, 2013, 2017 and 2019) Static condition") assesses the accuracy of these measurements directly from the device/software. Specific performance for VTG and Raw measurements would have been assessed in this standalone manner, but the numerical results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For physiological measurement devices, the "ground truth" is typically established by physical standards, calibration gases, and established reference methods or simulated physiological conditions that adhere to recognized industry standards (e.g., ATS/ERS standards). The document mentions compliance with various ISO and ATS/ERS standards, which dictate the methods and accuracy requirements for such measurements. For example, gas concentrations for DLCO are compared against medical-grade gas mixes, and flow/volume against calibrated instruments.
8. The sample size for the training set:
This information is not provided. As the device is a measurement instrument incorporating software (ComPAS2) for calculations based on physical readings, it's not described as an AI/ML device that requires a "training set" in the conventional sense (e.g., for pattern recognition or classification). The software implements algorithms for physiological calculations rather than learning from data in a machine learning paradigm.
9. How the ground truth for the training set was established:
This information is not provided, and likely not applicable as the device is not described as an AI/ML system requiring a training set with ground truth in the context of machine learning. The algorithms are based on established physiological principles and equations.
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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.
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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 (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
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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 |
|---|---|
| ISubmitter | |
| Vitalograph Ireland Ltd.Gort Road Business ParkEnnis Co Clare V95 HFT4 IrelandTel - +353-65-6864100 | |
| Submitter Contact: | Tony O'HanlonRegulatory Affairs / Quality Assurance Manager |
| Submission Correspondent: | Paul Dryden ProMedic, LLC |
| IIDevice | |
| 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
| SubjectModel 9160 | Primary PredicateMorgan Scientific – Medisoft Body Box 5500 | Comparison | |
|---|---|---|---|
| K# | K223818 | K022636 | - |
| Product Code | JEH – 868-1760 - Volume PlethysmographSecondary BTY – 868.1890 - Predictivepulmonary-function value calculator | JEH – 868-1760 - Volume Plethysmograph | Similar |
| Indications forUse | The Model 9160 VitaloQUB is a whole-bodyplethysmograph device, when used with theVitalograph Model 9100, is designed for lungfunction testing on adults and pediatrics, 6 yearsand older, by trained medical healthcareprofessionals in a variety of professional healthcareenvironments e.g., primary care, hospitals, andpharmaceutical research centers.The Model 9160 VitaloQUB is a pulmonaryfunction testing device which uses MorganScientific's ComPAS2 software to measure subjectrespiratory parameters including FVC, SVC, MVV,CPF, RMS, SNIP, DLCO, MBN2, SBN2, ThoracicGas Volume (TGV) and Airway Resistance (Raw) | The Body Box 5500 when used in conjunction with acomputer and the ComPAS pulmonary functionsoftware is intended to perform plethysmography,diffusion and spirometry to provide pulmonary functiontesting in adult and pediatric patients. | SimilarSubject device has similarindications to the predicate. |
| Patientpopulation | 6 years and older | Pediatric (not defined) and adults | Similar |
| Fundamentalscientifictechnology | Measurement of patient air flow via Heated Lillytype pneumotachograph.Test gases – Methane (CH4), Carbon Monoxide(CO), Carbon Dioxide (CO2), Oxygen (O2) andNitrogen (N2) | Not specified | SimilarThe subject device uses thesame technology of thesecondary predicate Model9100 K221030 |
| SubjectModel 9160 | PredicateMorgan Scientific – Medisoft Body Box 5500 | Comparison | |
| Parametersmeasured | FVCSVCMVVDLCOCPF, RMS (MIP/MEP), SNIPSingle and Multiple Breath Nitrogen washout (MBN2 and SBN2)VTGRaw | Plethysmography, diffusion and spirometryThis uses the ComPAS software and thus is able to calculate and display the same parameters | SimilarSubject device is addingThoracic Gas Volume(VTG) andAirway Resistance (Raw) |
| Patient use | Multi-patient, multi-use | Multi-patient, multi-use | Similar |
| User Interface | Color LCD Touchscreen | Not specified | Similar |
| OperatingSystem | Microsoft Windows 10 | Not specified | Similar |
| Patient Interface | Disposable Bacteria / Viral FilterDisposable MouthpiecesWhole 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 ofOperation | 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 gasconcentrations:Nitrogen tracer gas concentration determinedby a combination of molar mass measurement(molar mass sensor) and CO2 measurement(CO/CO2 sensor).Measurement of VTG and Raw use the samesensors as the Model 9100 | |||
| SubjectModel 9160 | PredicateMorgan Scientific - Medisoft Body Box 5500 | Comparison | |
| Accuracy | Flow range: $\pm$ 14 L/sFlow accuracy:$\pm$ 2 % over range of -14 to + 14 L/sVolume accuracy$\pm$ 2.5 % or 0.050 L | Not specified | Similar |
| Operatingtemperaturerange | +15 -32°C | Not specified | Similar |
| Performancestandards | ISO 23747:2015, ISO 26782:2009,ATS/ERS: 2002, 2005, 2013, 2017 and 2019 | Not specified | Similar |
| Electrical Safetyand EMC | ES 60601-1IEC 60601-1-2 | Not specified | Similar |
| Communications | USBMorgan Scientific ComPAS2 | Morgan Scientific ComPAS | Similar |
| SubjectModel 9160 | Secondary PredicateModel 9100 PFT/DICO | Comparison | |
| K# | K223818 | K221030 | |
| Product Code | New - JEH - 868.1760 - Volume PlethysmographSecondary - BTY – 868.1890Predictive pulmonary-function valuecalculator | BTY - 868.1890Predictive pulmonary-function valuecalculator | Same, but the addition of thefull body enclosure addsJEH |
| Classification | Predictive pulmonary-function value calculator | Predictive pulmonary-function valuecalculator | Same |
| Indications forUse | The Model 9160 VitaloQUB is a whole-bodyplethysmograph device, when used with theVitalograph Model 9100, is designed for lungfunction testing on adults and pediatrics, 6 yearsand older, by trained medical healthcareprofessionals in a variety of professional healthcareenvironments e.g., primary care, hospitals, andpharmaceutical research centers.The Model 9160 VitaloQUB is a pulmonaryfunction testing device which uses MorganScientific's ComPAS2 software to measure subjectrespiratory parameters including FVC, SVC, MVV,CPF, RMS, SNIP, DLCO, MBN2, SBN2, ThoracicGas Volume (TGV) and Airway Resistance (Raw) | The Model 9100 PFT/DICO is a pulmonary functiontesting device which uses Morgan Scientific'sComPAS2 software to measure subject respiratoryparameters including FVC, SVC, MVV, CPF, RMS,SNIP, DLCO, MBN2 and SBN2.The device is PC-based and designed for lung functiontesting on adults and pediatrics, 6 years and older, ina variety of professional healthcare environments e.g.,primary care, hospitals, pharmaceutical researchcenters and physicians' offices.The Model 9100 PFT/DICO is intended for theassessment of respiratory function through themeasurement of dynamic lung volumes i.e., spirometryand other lung functions i.e., diffusing capacity. | SimilarSubject device is addingVTG and Raw parameters |
| Patientpopulation | 6 years and older | 6 years and older | Similar |
| Fundamentalscientifictechnology | Measurement of patient air flow via Heated Lillytype pneumotachograph.The DLCO Gas Analyzer utilizes non-dispersiveinfrared (NDIR) technology to measure theconcentrations of Carbon Monoxide (CO) | Measurement of patient air flow via Heated Lilly typepneumotachograph.The DLCO Gas Analyzer utilizes non-dispersiveinfrared (NDIR) technology to measure theconcentrations of Carbon Monoxide (CO), Methane | SimilarThe subject device uses thesame technology of thesecondary predicate Model9100 |
| 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 | SimilarThe subject device includesa whole body enclosuresimilar 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 | ||
| SubjectModel 9160 | Secondary PredicateModel 9100 PFT/DICO | Comparison | |
| Principle ofOperation | All test types -measurement of patient airflow via heated Lilly type pneumotachograph flowsensor.DLCO test - determination of in- and exhaled gasconcentrations: CO gas concentrationmeasured by infrared absorption with CO sensor.Methane tracer gas concentration measured bymolar mass sensor.MBW test - determination of in- and exhaled gasconcentrations:Nitrogen tracer gas concentration determinedby a combination of molar mass measurement(molar mass sensor) and CO2 measurement(CO/CO2 sensor).Measurement of VTG and Raw use the samesensors as the Model 9100 | All test types -measurement of patient airflow via heated Lilly type pneumotachograph flowsensor.DLCO test - determination of in- and exhaled gasconcentrations: CO gas concentrationmeasured by infrared absorption with CO sensor.Methane tracer gas concentration measured bymolar mass sensor.MBW test - determination of in- and exhaled gasconcentrations:Nitrogen tracer gas concentration determinedby a combination of molar mass measurement (molarmass sensor) and CO2 measurement (CO/CO2 sensor). | SimilarSubject device with thewhole body enclosure cannow provide data to theComPAS2 software tocalculate VTG and Raw likethe predicates and referencedevice. |
| Test Gases forDLCO | Medical grade gas mixCO: 0.3 %CH4: 0.3 %Balance air | Medical grade gas mixCO: 0.3 %CH4: 0.3 %Balance air | Similar |
| Test gasrequirements forNitrogenwashout test | Oxygen: 100 %Nitrogen: balance | Oxygen: 100 %Nitrogen: balance | Similar |
| Flow sensorFlow rangeVolume accuracyFlow accuracyFlow resistance | $ \pm $ 14 L/s$ \pm $ 2.5 % or 0.050 L$ \pm $ 2 % over range of -14 to + 14 L/s<1.5 cm H2O/L/s (at 14 L/s) | $ \pm $ 14 L/s$ \pm $ 2.5 % or 0.050 L$ \pm $ 2 % over range of -14 to + 14 L/s<1.5 cm H2O/L/s (at 14 L/s) | Similar |
| CO / CO2 Sensor | Infrared absorption | Infrared absorption | Similar |
| Type | |||
| Accuracy | CO - ±1 % of full scale | CO - ±1 % of full scale | |
| CO2 - ±2.5 % of full scale | CO2 - ±2.5 % of full scale | ||
| CH4 - ±2.5% of full scale | CH4 - ±2.5% of full scale | ||
| Subject | Secondary Predicate | Comparison | |
| Model 9160 | Model 9100 PFT/DICO | ||
| O2 / CO2 Sensor | Laser diode absorption for O2 | Laser diode absorption for O2 | Similar |
| Type | Infrared for CO2 | Infrared for CO2 | |
| Accuracy | O2 - ±0.2% of Full Scale | O2 - ±0.2% of Full Scale | |
| CO2 - ±0.1% of Full Scale | CO2 - ±0.1% of Full Scale | ||
| Operating | 15-32°C | 15-32°C | Similar |
| temperature | |||
| range | |||
| Performance | ISO 23747:2015, ISO 26782:2009, | ISO 23747:2015, ISO 26782:2009, | Similar |
| standards | ATS/ERS: 2002, 2005, 2013, 2017 and 2019 | ATS/ERS: 2002, 2005, 2013, 2017 and 2019 | |
| Electrical Safety | ES 60601-1 | ES 60601-1 | Similar |
| and EMC | IEC 60601-1-2 | IEC 60601-1-2 | |
| Communications | USB | USB | Similar |
| Morgan Scientific ComPAS2 | Morgan Scientific ComPAS2 | Uses K213872 software | |
| Power / Energy | 24VDC output via medical grade power supply via | 24VDC output via medical grade power supply via | Similar |
| Source | input of 80-240 VAC 50-60 Hz | input of 80-240 VAC 50-60 Hz | |
| Biocompatibility | Externally communicating, Tissue and Surface | Externally communicating, Tissue and Surface Contact, | Similar |
| Contact, Skin / Mucosa, Limited Duration | Skin / Mucosa, Limited Duration | Materials in patient contactare the same |
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Table 2: Comparison of the Model 9160 vs. the Secondary Predicate
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K223818
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VII Difference Between Subject and Predicates and Reference
The Model 9160 VitaloQUB is an add-on accessory to the Vitalograph Model 9100 PFT/DICO, K221030, that incorporates the Morgan Scientific ComPAS2 software, K213872.
The main difference is the addition of a whole body enclosure that allows the collection of data to be calculated by the ComPAS 2 software. Namely - Thoracic Gas Volume (VTG) and Airway resistance (Raw) which are similar to the predicate.
These differences are addressed with the use of a predicate device, K022636 - Morgan Scientific -Medisoft Body Box 5500 which has the same intended use and has a whole body enclosure and provides parameters via ComPAS software.
The technology for flow measurements is a heated Lilly Pneumotachograph type Flowhead for the measuring technology which is identical to the secondary predicate, Model 9100, K221030.
We have updated performance testing as applicable. This would include the applicable safety and performance standards such as ES 60601-1, IEC 60601-1-2, ATS/ERS performance standards, ISO 23747 and ISO 26782, as well as industry standards and guidelines similar to the predicate.
The operating principle, measuring technology, range, application and use are similar to the predicates and the noted reference devices.
Substantial Equivalence Discussion VIII
The Model 9160 is substantially equivalent to the predicates K022636 - Morgan Scientific - Medisoft Body Box 5500 and K221030 - Vitalograph Model 9100 PFT/DICO any differences have been addressed with the secondary predicate and reference devices.
Intended Use/ Indications for Use
The indications for use are similar to the predicates. That is to conduct lung function measurements.
Technological Characteristics and Principles of Operation
The measurement of flow is Lilly Screen technology and is similar to the secondary predicate device.
Non-clinical Testing
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
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IX Discussion of Differences
There are no significant differences between the subject device and the predicates.
This data is already cleared by the Morgan Scientific ComPAS 2 software, K213872.
These differences are addressed with the secondary predicate K221030 – Vitalograph Model 9100 PFT/DICO
These differences do not raise different risks compared to the predicates and reference.
X Substantial Equivalence Conclusion
A comparison of the subject device has demonstrated that the subject device is substantially equivalent to the predicate and reference devices. Any differences do not raise different questions of safety or effectiveness than the predicate and reference devices.
§ 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).