(268 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware and standard metabolic measurement principles.
No
Explanation: The device is indicated for measurement of Resting Energy Expenditure (REE), which is a diagnostic function, not a therapeutic intervention.
Yes
The device measures Resting Energy Expenditure (REE), which is a physiological parameter. While REE measurement itself isn't a diagnosis, it provides critical information for patient management. The "Intended Use / Indications for Use" states that the device "is indicated for the measurement of Resting Energy Expenditure (REE) for mechanically ventilated patients" and is used in ICUs, implying its role in assessing patient metabolic status to inform clinical decisions, such as nutritional support, which is a key part of patient diagnosis and management. The "Summary of Performance Studies" also mentions measuring gas exchange (V'O2, V'CO2) which are indicators of metabolic health and can be used to diagnose various conditions. Therefore, by providing objective measurements of physiological parameters used to assess a patient's condition and guide treatment strategies, it functions as a diagnostic device.
No
The device description explicitly states it is enclosed in a metal casing with a touch screen, pneumatic connections, power inlet, and USB connector, indicating it is a physical hardware device, not software-only.
Based on the provided text, the Virtus Metabolic Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Virtus Metabolic Monitor Function: The Virtus Metabolic Monitor measures Resting Energy Expenditure (REE) by analyzing the gases exchanged during respiration (oxygen uptake and carbon dioxide production) in mechanically ventilated patients. This is a measurement taken directly from the patient's breath, not from a specimen collected from the body.
- Lack of Specimen Handling: The description does not mention any collection, preparation, or analysis of biological specimens.
Therefore, the Virtus Metabolic Monitor falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
BTY, BZL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
at least 18 years of age.
Intended User / Care Setting
Intensive Care Units (ICUs) in professional healthcare facilities only.
for prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary output parameters:
REE: 500 - 7200 kcal/day ±3%
RQ: 0.05 - 2 ±5%
V'O2: 75-1000mL/min ±3%
V'CO2: 75-1000mL/min ±3%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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 Aps
Svalevej 4
DK-4683 Roennede
Denmark
Tel.: +45 52 30 38 33
lo@virtusmonitor.com | | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--|
| Contact Person: | Mr. Leif Olesen | | |
| Position/Title: | CTO | | |
| Date of Preparation: | June 22, 2023 | | |
| Trade Name: | Virtus Metabolic Monitor | | |
| Common/Classification
Name: | Calculator, Predicted Values, Pulmonary Function and Computer,
Oxygen-Uptake | | |
| Product Code(s): | 21 CFR 868.1890, BTY and
21 CFR 868.1730, BZL | | |
| Class: | Class II | | |
| | | | |
| Predicate Device | Substantial Equivalence to: | | |
| 510(K) Number | Model | Manufacturer | |
| K190800 | Cosmed Q-NRG+
Portable Metabolic
Monitor | Cosmed Srl
Vi dei Piani di Monte Savello 37
Albano Laziale, 00041 Rome, Italy | |
| Reference Devices: | | | |
| Reference 1 K051092 | GE Compact Airway
Module, E-CAiOVX
family | GE Healthcare
86 Pilgrim Road Needham, MA 02492 USA | |
| Reference 2 K093080 | TreyMed Metaphor
Metabolic 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.
4
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 Metabolic
Monitor (predicate
device(PD)) | Remark |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Virtus Technology Aps | Cosmed Srl. | |
| Model Number | Virtus Metabolic Monitor
VM-1 | Cosmed Q-NRG+
Portable Metabolic
Monitor | |
| 510(k) Number | K222982 | K190800 | |
| Application/Intended 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 Q-NRG+ Portable
Metabolic Monitor is
indicated for the
measurement of Resting
Energy Expenditure
(REE) for spontaneously
breathing and (Q-NRG+
only) ventilated patients: | Similar
The SD is intended for
patients, who are at least
18 years of age only,
therefore the weight
limitations are not
applicable for the SD. |
| | | | |
| Product/Feature | Virtus Metabolic Monitor
(Subject Device (SD)) | Cosmed Q-NRG+
Portable Metabolic
Monitor (predicate
device(PD)) | Remark |
| Patient Population | The SD is only intended
for mechanically
ventilated patients, who
are non-spontaneous
breathing. | - Spontaneously
breathing subjects >15
kg (33 lb) when using a
canopy;
Spontaneously
breathing subjects age
6 and >10 kg (22 lb)
when using a face
mask;
Ventilated subjects age
10 and >10 kg (22 lb). | Similar
Subject device claims for
mechanically ventilated
patients, who are non-
spontaneous breathing,
and who are at least 18
years of age is within the
claims of the PD |
| Environment of Use | The Virtus Metabolic
Monitor is intended to be
used in Intensive Care
Units (ICUs) in
professional healthcare
facilities only. | The device is intended to
be used in professional
healthcare facilities only
(limited to ICUs for
ventilated patients). | Same |
| Operation and Operating Principles | | | |
| Flow sensor | Fixed orifice pneumotach,
which does not require
calibration. | Variable orifice flow
Pneumotach Flowmeter,
which requires calibration
before use. | Similar function to
predicate device
Same (identical) as used
in RD2 |
| CO2 Analyzer technology | Side stream infra-red | Side stream infra-red | Same |
| 02 Analyzer technology | Paramagnetic | Galvanic fuel cell | Similar / Substantially
equivalent technology.
Same technology as RD2 |
| Flow Analyzer technology | Differential pressure
signal | Differential pressure
signal | Same |
| Placement of sensor | In breathing circuit
between the endotracheal
tube and filter and the
ventilator circuit Y piece | In breathing circuit
between the endotracheal
tube and filter and the
ventilator circuit Y piece | Same |
| Control Mechanism | Embedded
microcontroller | Embedded
microcontroller | Same |
| Modes of Operation | Ventilator mode | Ventilator, canopy, and
mask modes | Similar
The functionality of the
ventilator mode is the
same for the SD and the
PD. |
| Product/Feature | Virtus Metabolic Monitor
(Subject Device (SD)) | Cosmed Q-NRG+
Portable Metabolic
Monitor (predicate
device(PD)) | Remark |
| Operating
Modes/Sequences | • Start device - power on
• Select New
Measurement
• Enter Patient
demographic
• Attach Flow Sensor
tubes
• Connect Flow Sensor
to patient airway tube
• Start measurement
• Review Result
• Disconnect Flow
Sensor from patient
airway tube
• Clean after use | • Start device - power on
• Select New
Measurement
• Enter Patient
demographic
• Select Ventilator mode
• Calibrate flow sensor
• Attach Flow Sensor
tubes
• Connect Flow Sensor
to patient airway tube
• Start measurement
• Review Result
• Disconnect Flow
Sensor from patient
airway tube
• Clean after use | Similar
Calibration shall not be
performed for the subject
device and the simpler
sequence and logic
operation enhances the
use of the subject device
and therefore the
sequence and logic
operation are the same. |
| Measurement range and
accuracy | Primary output
parameters:
REE: 500 - 7200
kcal/day ±3%
RQ: 0.05 - 2 ±5%
V'O2: 75-1000mL/min
±3%
V'CO2: 75-1000mL/min
±3% | Primary output
parameters:
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 is
greater)
V'CO2: 0.01-1L/min ±3%
or 5mL/min (whichever is
greater) | Primary output
parameters are the same
for SD and PD |
| Algorithms | Weir formula to calculate
the Resting Energy
Expenditure (REE) | Weir formula to calculate
the Resting Energy
Expenditure (REE) | Same |
| User Interface | | | |
| Display Type | Color TFT with integrated
touchscreen | Color TFT with integrated
touchscreen | Same |
| Navigation | Soft keys with symbols
and clear text | Soft keys with symbols
and clear text | Same |
| Product/Feature | Virtus Metabolic Monitor
(Subject Device (SD)) | Cosmed Q-NRG+
Portable Metabolic
Monitor (predicate
device(PD)) | Remark |
| Output values | Measurements are shown
in graphs and values for:
Resting Energy
Expenditure REE,
Respiratory Quotient RQ,
Oxygen uptake V'O2 &
Carbon Dioxide
production V'CO2 | Measurements are shown
in graphs and values for:
Resting Energy
Expenditure REE,
Respiratory Quotient RQ,
Oxygen uptake V'O2 &
Carbon Dioxide
production V'CO2 | Same |
| Reports | Reports in .pdf and .csv
formats exported to USB
flash drive | Reports in .pdf and .csv
formats exported to USB
flash drive | Same |
| Power | | | |
| Power source: Mains | 100-240VAC, 50/60Hz
50VA
Class II double insulated | 100-240VAC, 50/60Hz,
100-130VA
Class I with protective
earth | Similar
Differences have no
effect on safety or
effectiveness |
| Internal Battery | Li-lon "smart" battery,
RRC2450, 3450mAh,
14.4V 49.7Wh
Up to 3 hours operation | Li-lon "smart" battery,
RRC2450, 3450mAh,
14.4V 49.7Wh
Up 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.
8
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.