(268 days)
The Virtus Metabolic Monitor is indicated for the measurement of Resting Energy Expenditure (REE) for mechanically ventilated patients, who are non-spontaneous breathing, and who are at least 18 years of age.
The Virtus Metabolic Monitor is intended to be used in Intensive Care Units (ICUs) in professional healthcare facilities only.
The Virtus Metabolic Monitor is for prescription use only.
Virtus Metabolic Monitor is a metabolic monitors designed for the measurement of resting energy expenditure (REE) for mechanically ventilated adult patients in the Intensive Care Unit (ICU).
The device is enclosed in a metal casing with a color touch screen on front for user interaction and measurement results. On the left-hand side pneumatic connections to the flow and gas sensor (Flow Sensor) and on the rear the mains power inlet, on-switch, charging indicator and USB-connector for export of results.
The Virtus Metabolic Monitor is portable and is supplied from the built-in battery or from mains, where it is automatically charged.
Here's a breakdown of the acceptance criteria and study information for the Virtus Metabolic Monitor, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| REE Accuracy | ±3% | Met acceptance criteria, measuring up to 7200 kcal/day with acceptable agreement to predicate. |
| RQ Accuracy | ±5% | Met acceptance criteria, with acceptable agreement to predicate. |
| V'O2 Accuracy | ±3% | Met acceptance criteria, measuring 75-1000 mL/min with acceptable agreement to predicate. |
| V'CO2 Accuracy | ±3% | Met acceptance criteria, measuring 75-1000 mL/min with acceptable agreement to predicate. |
| Electrical Safety | Compliance with IEC 60601-1:2005+AMD1:2012 | Met acceptance criteria. |
| EMC | Compliance with IEC 60601-1-2:2014+A1:2020 | Met acceptance criteria. |
| Risk Management | Compliance with ISO 14971:2019, acceptable residual risks | Met acceptance criteria. |
| Software | Compliance with IEC 62304:2006+A1:2015, verified to requirements and validated for intended use | Met acceptance criteria. |
| Biocompatibility | Met acceptance criteria (for disposable flow sensor) | Met acceptance criteria. |
| Shelf-life | 1 year shelf-life | Met acceptance criteria. |
| Expected Lifetime | 5 years expected lifetime | Met acceptance criteria. |
| Usability | Met acceptance criteria | Met acceptance criteria. |
| Measurement Range | REE: 500 - 7200 kcal/day; RQ: 0.05 - 2; V'O2: 75-1000mL/min; V'CO2: 75-1000mL/min | Subject device capable of measuring V'O2 and V'CO2 up to 1000 ml/min and calculating corresponding 7200kcal/day for REE. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes a "side-by-side" test against the predicate device. However, the specific sample size for this test set (number of measurements, number of patients) is not provided. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated. It's implied to be a testing scenario rather than a clinical study on patients, given the wording.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for this non-clinical, side-by-side comparison test. The comparison was made against the measurements of a cleared predicate device (Cosmed Q-NRG+).
4. Adjudication Method for the Test Set
Since the ground truth was established by comparison to a predicate device's measurements in a laboratory setting, there was no expert adjudication method described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The described testing is a non-clinical side-by-side comparison of device measurements, not a study involving human readers or their improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, the described testing is a standalone performance evaluation of the Virtus Metabolic Monitor. It directly compares the device's measurements (V'O2, V'CO2, REE) against those of a predicate device in a controlled setting, without a human-in-the-loop context.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical side-by-side test was the measurements provided by the predicate device (Cosmed Q-NRG+). The study aimed to show "acceptable agreement of measurements between the subject device and the predicate device."
8. The Sample Size for the Training Set
The document does not mention any training set or related sample size. The device calculates metabolic parameters using the standard Weir formula and relies on measured V'O2 and V'CO2. There's no indication of a machine learning-based algorithm requiring a training set in this summary.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, the method for establishing its ground truth is not applicable.
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June 23, 2023
Virtus Technology ApS Leif Olesen CTO Svalevei 4 Roennede, DK-4683 Denmark
Re: K222982
Trade/Device Name: Virtus Metabolic Monitor Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: BTY, BZL Dated: May 15, 2023 Received: May 18, 2023
Dear Leif Olesen:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
Rachana Visaria -S
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) K222982
Device Name Virtus Metabolic Monitor
Indications for Use (Describe)
The Virtus Metabolic Monitor is indicated for the measurement of Resting Energy Expenditure (REE) for mechanically ventilated patients, who are non-spontaneous breathing, and who are at least 18 years of age.
The Virtus Metabolic Monitor is intended to be used in Intensive Care Units (ICUs) in professional healthcare facilities only.
The Virtus Metabolic Monitor is for prescription use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
510(k) Summary in accordance with 21 CFR 807.92
| Submitted by: | Virtus Technology ApsSvalevej 4DK-4683 RoennedeDenmarkTel.: +45 52 30 38 33lo@virtusmonitor.com | ||
|---|---|---|---|
| Contact Person: | Mr. Leif Olesen | ||
| Position/Title: | CTO | ||
| Date of Preparation: | June 22, 2023 | ||
| Trade Name: | Virtus Metabolic Monitor | ||
| Common/ClassificationName: | Calculator, Predicted Values, Pulmonary Function and Computer,Oxygen-Uptake | ||
| Product Code(s): | 21 CFR 868.1890, BTY and21 CFR 868.1730, BZL | ||
| Class: | Class II | ||
| Predicate Device | Substantial Equivalence to: | ||
| 510(K) Number | Model | Manufacturer | |
| K190800 | Cosmed Q-NRG+Portable MetabolicMonitor | Cosmed SrlVi dei Piani di Monte Savello 37Albano Laziale, 00041 Rome, Italy | |
| Reference Devices: | |||
| Reference 1 K051092 | GE Compact AirwayModule, E-CAiOVXfamily | GE Healthcare86 Pilgrim Road Needham, MA 02492 USA | |
| Reference 2 K093080 | TreyMed MetaphorMetabolic Monitor | TreyMed inc.N56 W24790 N. Corporate Cir., Unit C,Sussex, WI 53089, USA |
Description of Device:
Virtus Metabolic Monitor is a metabolic monitors designed for the measurement of resting energy expenditure (REE) for mechanically ventilated adult patients in the Intensive Care Unit (ICU).
The device is enclosed in a metal casing with a color touch screen on front for user interaction and measurement results. On the left-hand side pneumatic connections to the flow and gas sensor (Flow Sensor) and on the rear the mains power inlet, on-switch, charging indicator and USB-connector for export of results.
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The Virtus Metabolic Monitor is portable and is supplied from the built-in battery or from mains, where it is automatically charged.
Indications for Use:
The Virtus Metabolic Monitor is indicated for the measurement of Resting Energy Expenditure (REE) for mechanically ventilated patients, who are non-spontaneous breathing, and who are at least 18 years of age.
The Virtus Metabolic Monitor is intended to be used in Intensive Care Units (ICUs) in professional healthcare facilities only.
The Virtus Metabolic Monitor is for prescription use only.
Technological Characteristics:
The Virtus Metabolic Monitor utilizes the same technological principles as the predicate Cosmed Q-NRG+ device to continuously measure the oxygen uptake V'O2, carbon dioxide production V'CO2, and calculating the Resting Energy Expenditure REE and Respiratory Quotient RQ - both devices utilize the same control and gas sampling methods: microcontroller-driven control of gas analyzers using the side-stream method, calculation of parameters and presentation on a 10.1" color touch screen. The Virtus Metabolic Monitor uses a side-steam flow sensor and a gas sampling line for gas and flow sampling similar to the predicate device.
Comparison of Technological Features to Predicate and Reference Devices:
| Product/Feature | Virtus Metabolic Monitor(Subject Device (SD)) | Cosmed Q-NRG+Portable MetabolicMonitor (predicatedevice(PD)) | Remark |
|---|---|---|---|
| Manufacturer | Virtus Technology Aps | Cosmed Srl. | |
| Model Number | Virtus Metabolic MonitorVM-1 | Cosmed Q-NRG+Portable MetabolicMonitor | |
| 510(k) Number | K222982 | K190800 | |
| Application/Intended use: | The Virtus MetabolicMonitor is indicated forthe measurement ofResting EnergyExpenditure (REE) formechanically ventilatedpatients, who are non-spontaneous breathing,and who are at least 18years of age. | The Q-NRG+ PortableMetabolic Monitor isindicated for themeasurement of RestingEnergy Expenditure(REE) for spontaneouslybreathing and (Q-NRG+only) ventilated patients: | SimilarThe SD is intended forpatients, who are at least18 years of age only,therefore the weightlimitations are notapplicable for the SD. |
| Product/Feature | Virtus Metabolic Monitor(Subject Device (SD)) | Cosmed Q-NRG+Portable MetabolicMonitor (predicatedevice(PD)) | Remark |
| Patient Population | The SD is only intendedfor mechanicallyventilated patients, whoare non-spontaneousbreathing. | - Spontaneouslybreathing subjects >15kg (33 lb) when using acanopy;Spontaneously-breathing subjects age>6 and >10 kg (22 lb)when using a facemask;Ventilated subjects age>10 and >10 kg (22 lb). | SimilarSubject device claims formechanically ventilatedpatients, who are non-spontaneous breathing,and who are at least 18years of age is within theclaims of the PD |
| Environment of Use | The Virtus MetabolicMonitor is intended to beused in Intensive CareUnits (ICUs) inprofessional healthcarefacilities only. | The device is intended tobe used in professionalhealthcare facilities only(limited to ICUs forventilated patients). | Same |
| Operation and Operating Principles | |||
| Flow sensor | Fixed orifice pneumotach,which does not requirecalibration. | Variable orifice flowPneumotach Flowmeter,which requires calibrationbefore use. | Similar function topredicate deviceSame (identical) as usedin RD2 |
| CO2 Analyzer technology | Side stream infra-red | Side stream infra-red | Same |
| 02 Analyzer technology | Paramagnetic | Galvanic fuel cell | Similar / Substantiallyequivalent technology.Same technology as RD2 |
| Flow Analyzer technology | Differential pressuresignal | Differential pressuresignal | Same |
| Placement of sensor | In breathing circuitbetween the endotrachealtube and filter and theventilator circuit Y piece | In breathing circuitbetween the endotrachealtube and filter and theventilator circuit Y piece | Same |
| Control Mechanism | Embeddedmicrocontroller | Embeddedmicrocontroller | Same |
| Modes of Operation | Ventilator mode | Ventilator, canopy, andmask modes | SimilarThe functionality of theventilator mode is thesame for the SD and thePD. |
| Product/Feature | Virtus Metabolic Monitor(Subject Device (SD)) | Cosmed Q-NRG+Portable MetabolicMonitor (predicatedevice(PD)) | Remark |
| OperatingModes/Sequences | • Start device - power on• Select NewMeasurement• Enter Patientdemographic• Attach Flow Sensortubes• Connect Flow Sensorto patient airway tube• Start measurement• Review Result• Disconnect FlowSensor from patientairway tube• Clean after use | • Start device - power on• Select NewMeasurement• Enter Patientdemographic• Select Ventilator mode• Calibrate flow sensor• Attach Flow Sensortubes• Connect Flow Sensorto patient airway tube• Start measurement• Review Result• Disconnect FlowSensor from patientairway tube• Clean after use | SimilarCalibration shall not beperformed for the subjectdevice and the simplersequence and logicoperation enhances theuse of the subject deviceand therefore thesequence and logicoperation are the same. |
| Measurement range andaccuracy | Primary outputparameters:REE: 500 - 7200kcal/day ±3%RQ: 0.05 - 2 ±5%V'O2: 75-1000mL/min±3%V'CO2: 75-1000mL/min±3% | Primary outputparameters:REE: 0-7200 kcal/day±3% or 36kcal/day(whichever is greater)RQ: 0-2.00 ±5% or 0.04(whichever is greater)V'O2: 0.01-1 L/min ±3%or 5mL/min (whichever isgreater)V'CO2: 0.01-1L/min ±3%or 5mL/min (whichever isgreater) | Primary outputparameters are the samefor SD and PD |
| Algorithms | Weir formula to calculatethe Resting EnergyExpenditure (REE) | Weir formula to calculatethe Resting EnergyExpenditure (REE) | Same |
| User Interface | |||
| Display Type | Color TFT with integratedtouchscreen | Color TFT with integratedtouchscreen | Same |
| Navigation | Soft keys with symbolsand clear text | Soft keys with symbolsand clear text | Same |
| Product/Feature | Virtus Metabolic Monitor(Subject Device (SD)) | Cosmed Q-NRG+Portable MetabolicMonitor (predicatedevice(PD)) | Remark |
| Output values | Measurements are shownin graphs and values for:Resting EnergyExpenditure REE,Respiratory Quotient RQ,Oxygen uptake V'O2 &Carbon Dioxideproduction V'CO2 | Measurements are shownin graphs and values for:Resting EnergyExpenditure REE,Respiratory Quotient RQ,Oxygen uptake V'O2 &Carbon Dioxideproduction V'CO2 | Same |
| Reports | Reports in .pdf and .csvformats exported to USBflash drive | Reports in .pdf and .csvformats exported to USBflash drive | Same |
| Power | |||
| Power source: Mains | 100-240VAC, 50/60Hz50VAClass II double insulated | 100-240VAC, 50/60Hz,100-130VAClass I with protectiveearth | SimilarDifferences have noeffect on safety oreffectiveness |
| Internal Battery | Li-lon "smart" battery,RRC2450, 3450mAh,14.4V 49.7WhUp to 3 hours operation | Li-lon "smart" battery,RRC2450, 3450mAh,14.4V 49.7WhUp to 3 hours operation | Same |
| Rate of Protection | IPX0 | IPX0 | Same |
| Mechanical | |||
| Dimensions | 26 x 19.5 x 15 cm | 31 x 21 x 27 cm | Similar size |
| Weight | 2.5 kg | 4.65 | Similar weight |
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As summarized above, the Virtus Metabolic Monitor utilizes equivalent technological characteristics and specifications as the cleared predicate device.
Non-Clinical Tests:
The Virtus Metabolic Monitor was laboratory tested to current applicable standards for medical device electrical safety and electromagnetic compatibility. The following standards were utilized in compliance testing:
- Electrical safety testing per IEC 60601-1:2005+AMD1:2012 ●
- . Electromagnetic compatibility testing per IEC 60601-1-2:2014+A1:2020
The device met acceptance criteria for compliance to the standards.
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Risk management, risk and hazard analysis was performed to the following standard:
- Application of risk management to medical devices per ISO 14971:2019 ●
- Usability evaluation per IEC 62366-1:2015+A1:2020 for professional use .
The device met risk management criteria for acceptability of residual risks.
The Virtus Metabolic Monitor embedded software was developed in accordance with FDA quidelines for moderate level of concern devices. The software lifecycle process was evaluated to meet:
- Medical device software lifecycle process per IEC 62304:2006+A1:2015 as per . internal SW development QMS-procedure under ISO13485:2016
- Device software was verified to requirements and validated to meet the specified . intended use.
The disposable Virtus Flow Sensor in its final finished form is identical to the EZ-Flow Sensor cleared in K093080. A materials certification was provided by TreyMed Inc to support this.
The disposable Virtus Flow Sensor met acceptance criteria for biocompatibility.
The Virtus Metabolic Monitor was evaluated for one year shelf-life and five years expected lifetime and met acceptance criteria for performance after testing.
The Virtus Metabolic Monitor was evaluated for usability and met acceptance criteria for performance after testing.
The Virtus Metabolic Monitor was tested side-by-side against the predicate device with respect to measure the oxygen uptake V'O2, carbon dioxide production V'CO2 and Resting Energy Expenditure REE. The test showed acceptable agreement of measurements between the subject device and the predicate device over the entire range from 100 – 1000 ml/min for both V'O2 and V'CO2 and hence the REE are equally close. It further showed that the subject device is capable of measuring V'O2 and V'CO2 up to 1000 ml/min and calculating the corresponding value of 7200kcal/day for REE. The side-by-side test met acceptance criteria for measurement comparison and accuracy.
In summary, the Virtus Metabolic Monitor met acceptance criteria for conformance to applicable standards, performance, biocompatibility and lifetime. Residual risks met criteria for acceptability for the intended use.
Conclusions: The Virtus Metabolic Monitor is substantially equivalent to the predicate device.
§ 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).