Who is the manufacturer of Virtus Metabolic Monitor?

Virtus Technology Aps filed the 510(k) submission for Virtus Metabolic Monitor (K222982).

What is the FDA product code for Virtus Metabolic Monitor?

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

What is the regulatory pathway for Virtus Metabolic Monitor?

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

What are the predicate devices for Virtus Metabolic Monitor?

Cosmed Q-NRG+ Portable Metabolic Monitor (K190800).

Who can help prepare an FDA 510(k) submission like Virtus Metabolic Monitor?

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

Virtus Metabolic Monitor

K222982 · Virtus Technology Aps · BTY · Jun 23, 2023 · Anesthesiology

Device Facts

Record ID	K222982
Device Name	Virtus Metabolic Monitor
Applicant	Virtus Technology Aps
Product Code	BTY · Anesthesiology
Decision Date	Jun 23, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1890
Device Class	Class 2

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 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.

Device Story

Virtus Metabolic Monitor measures Resting Energy Expenditure (REE) in mechanically ventilated adult patients. Device inputs include gas and flow data via a side-stream flow sensor placed in the breathing circuit between the endotracheal tube and ventilator Y-piece. It utilizes an embedded microcontroller to process differential pressure signals (flow) and infrared/paramagnetic gas analysis (CO2/O2) to calculate REE, Respiratory Quotient (RQ), O2 uptake (V'O2), and CO2 production (V'CO2). Results are displayed on a 10.1-inch color touch screen and exportable via USB. Used in ICUs by professional healthcare staff; provides real-time metabolic data to assist clinicians in nutritional management and patient monitoring. Portable design with internal battery or mains power. Benefits include accurate metabolic assessment for ventilated patients to guide clinical decision-making.

Clinical Evidence

Bench testing only. Side-by-side comparison with the predicate device demonstrated acceptable agreement for V'O2, V'CO2, and REE measurements across the range of 100–1000 mL/min. Device met all acceptance criteria for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 62366-1), and biocompatibility. Software verified and validated per IEC 62304.

Technological Characteristics

Side-stream metabolic monitor; metal casing with 10.1" color TFT touchscreen. Sensing: fixed orifice pneumotach (flow), infrared (CO2), paramagnetic (O2). Microcontroller-based control. Power: 100-240VAC or internal Li-ion battery (RRC2450). Connectivity: USB for data export. Software: moderate level of concern, lifecycle per IEC 62304. Dimensions: 26 x 19.5 x 15 cm; Weight: 2.5 kg. IPX0 protection.

Indications for Use

Indicated for measurement of Resting Energy Expenditure (REE) in mechanically ventilated, non-spontaneous breathing patients aged 18 years and older in Intensive Care Units.

Regulatory Classification

Identification

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

Predicate Devices

Cosmed Q-NRG+ Portable Metabolic Monitor (K190800)

Reference Devices

GE Compact Airway Module, E-CAiOVX family (K051092)
TreyMed Metaphor Metabolic Monitor (K093080)

Related Devices

K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors · Cosmed Srl · Feb 6, 2020
K190561 — NICU V'02 · Cosmed Nordic Aps · Sep 4, 2020
K200076 — Breezing Med · Tf Health Co. · Sep 25, 2020
K021605 — MEDGEM · Healthetech, Inc. · Jun 14, 2002
K021490 — REEVUE INDIRECT CALORIMETER, MODEL#8100 · Korr Medical Technologies, Inc. · Jan 2, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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 {2}------------------------------------------------ # 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ 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.