Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.

Therapeutic

No.
The device measures Resting Energy Expenditure (REE) but does not provide treatment or alter the patient's condition.

Diagnostic

No

The device measures Resting Energy Expenditure (REE), which is a physiological parameter. While this information can be used by healthcare professionals to assist in diagnosis (e.g., of metabolic disorders), the device itself doesn't provide a diagnosis. It provides data that a clinician might use as part of a diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states "Portable Metabolic Monitors," which are hardware devices designed for measurement. The performance studies also include testing for electrical safety, EMC, and biocompatibility, which are relevant to hardware components, not software alone.

IVD (In Vitro Diagnostic)

Based on the provided information, the Q-NRG & Q-NRG+ Portable Metabolic Monitors are not In Vitro Diagnostic (IVD) devices.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
Device Function: The Q-NRG & Q-NRG+ devices measure Resting Energy Expenditure (REE) by analyzing the gases exchanged during breathing (oxygen consumption and carbon dioxide production). This is a direct measurement of a physiological process happening within the patient's body, not an analysis of a sample taken from the body.
Intended Use: The intended use describes the measurement of REE in spontaneously breathing and ventilated patients. This involves direct interaction with the patient's airways, not the analysis of a biological specimen.

Therefore, while these devices are medical devices used in a healthcare setting, they fall under a different regulatory category than IVDs. They are devices that directly interact with the patient to measure physiological parameters.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations:

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).

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (Iimited to ICUs for ventilated patients).

Product codes

BTY

Device Description

The Q-NRG and Q-NRG+ devices are Portable Metabolic Monitors, designed for the measurement of resting energy expenditure (REE) in both spontaneously breathing and mechanically ventilated patients.

The two versions of the product are detailed in Table 1.

Table 1: Device versions
Measurement Modes	Q-NRG	Q-NRG+
Ventilator assisted	Not available	Standard
Canopy	Standard	Option
Face mask	Option	Option

The Q-NRG and Q-NRG+ devices comprise the parts identified in Table 2.

Table 2: Device components
Item	Q-NRG	Q-NRG+
Main device	Standard	Standard
Canopy mode accessories	Standard	Option
Ventilation mode accessories	Not available	Option
Face mask mode accessories	Option	Option
PC Software (OMNIA)	Option	Option
Clamp for pole/rail with VESA mounting plate	Option	Option
Calibration syringe	Option	Option
Calibration Cylinder and Regulator	Option	Option

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Indirect contact with patient's airways

Indicated Patient Age Range

Spontaneously breathing subjects age >6
Ventilated subjects age >10

Intended User / Care Setting

The Q-NRG and Q-NRG+ are to be used by physicians or by trained personnel under the responsibility of a physician.
professional healthcare facilities only (limited to ICUs for ventilated patients).

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)

Non-clinical testing of the Q-NRG and Q-NRG+ includes:

Electrical safety
Electromagnetic Compatibility (EMC)
Accuracy validation
Coexistence testing
Biocompatibility
Reprocessing validation
Human factors

More detail of the non-clinical testing is provided in Table 3.

Table 3: Non-clinical testing
Test type	Reference
Electrical safety	ANSI/AAMI ES 60601-1:2005/®2012 + A1:2012 + C1:2009/®2012 + A2:2010/®2012, FDA recognition #19-4 IEC 60601-1-2:2014, FDA recognition #19-8
EMC	ETSI EN 301 489-17 v3.2.0 draft ETSI EN 301 489-1 v2.2.0 draft FCC Part 15 par. 107, 109 ICES-003 Issue 6: January 19, 2016, updated April 2017
Accuracy validation	Mask Measurement Accuracy, according to internal validation protocol Canopy Measurement Accuracy, according to internal validation protocol Ventilator Measurement Accuracy, according to internal validation protocol
Coexistence testing	Coexistence testing between Q-NRG/Q-NRG+ Bluetooth and other environmental wireless disturbances (i.e. Network Wi-Fi), according to the indications reported in S. Seidman, N. LaSorte, "An Experimental Method for Evaluating Wireless Coexistence of a Bluetooth Medical Device," IEEE EMC Magazine, October 2014
Biocompatibility	ISO 10993-1:2009, FDA recognition #2-220 ISO 10993-5:2009, FDA recognition #2-245 ISO 10993-10:2010, FDA recognition #2-174 ISO 18562-2:2017, FDA recognition #1-135 ISO 18562-3:2017, FDA recognition #1-136 ISO 18562-4:2017, FDA recognition #1-137 FDA Guidance Use of International Standard ISO 10993-1, June 16, 2016
Reprocessing validation	According to internal validation protocol
Human Factors	According to internal verification protocol

The results of the above testing assist in demonstration of substantial equivalence of the subject device with the predicate device, as many of the same standards have been used.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Measurement Accuracy:
Ventilation:

Regulation Number and Section

§ 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).

Summary

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February 6, 2020

Cosmed Srl % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 Rome, 00153 Italy

Re: K190800

Trade/Device Name: Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: BTY Dated: January 6, 2020 Received: January 9, 2020

Dear Roger Gray:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James J. Lee, Ph.D. Assistant Director DHT1C: Division of ENT, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K 190800

Device Name

Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors

Indications for Use (Describe)

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations:

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 1b).

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (Iimited to ICUs for ventilated patients).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for COSMED, a metabolic company. The logo features a blue griffin inside of a blue circle on the left. To the right of the griffin is the company name, "COSMED" in large, blue letters. Below the company name is the tagline "The Metabolic Company" in smaller, gray letters.

510(k) Reference:	K190800
Device Name:	Cosmed Q-NRG & Q-NRG+ Portable Metabolic Monitors
Type of 510(k) submission:	Traditional
Date of submission:	5 February 2020
Manufacturer:	Cosmed Srl
Vi dei Piani di Monte Savello 37
Albano Laziale
00041 Rome, Italy
Phone:
Fax:	+39 06 931 5492
+39 06 931 4580
FDA Establishment Reg. Number:	8021084
510(k) Owner and Submitter:	Cosmed Srl
Vi dei Piani di Monte Savello 37
Albano Laziale
00041 Rome, Italy
Owner/Operator Reg. Number:	8021084
510(k) Application Correspondent:	Mr Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Piazza Albania 10
00153 Rome, Italy
Phone:
Fax:
Email:	+39 06 578 2665
+39 06 574 3786
rgray@donawa.com
FDA Product Code:	BTY
FDA Regulation Number:	21 CFR 868.1890
FDA Classification Name:	Calculator, Pulmonary Function Data
Classification Panel:	Anesthesiology
Common Name:	Calculator, predicted values, pulmonary function; Ventilator,
continuous, facility use
FDA Classification:	Class II
Submission Type:	510(k)

510(k) Summary

Indications for Use:

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations:

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).

The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (limited to ICUs for ventilated patients).

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Image /page/4/Picture/0 description: The image shows the logo for COSMED, The Metabolic Company. On the left is a blue circle with a griffin inside. To the right of the circle is the word "COSMED" in large, blue letters. Below the word "COSMED" is the phrase "The Metabolic Company" in smaller, gray letters.

Device Description:

The Q-NRG and Q-NRG+ devices are Portable Metabolic Monitors, designed for the measurement of resting energy expenditure (REE) in both spontaneously breathing and mechanically ventilated patients.

The two versions of the product are detailed in Table 1.

Table 1: Device versions
Measurement Modes	Q-NRG	Q-NRG+
Ventilator assisted	Not available	Standard
Canopy	Standard	Option
Face mask	Option	Option

The Q-NRG and Q-NRG+ devices comprise the parts identified in Table 2.

Table 2: Device components
Item	Q-NRG	Q-NRG+
Main device	Standard	Standard
Canopy mode accessories	Standard	Option
Ventilation mode accessories	Not available	Option
Face mask mode accessories	Option	Option
PC Software (OMNIA)	Option	Option
Clamp for pole/rail with VESA mounting plate	Option	Option
Calibration syringe	Option	Option
Calibration Cylinder and Regulator	Option	Option

Performance data:

The essential performance of the Q-NRG and Q-NRG+ devices is to measure or calculate:

. REE (kcal/day) Resting Enerqy Expenditure
VO2 (ml/min) Oxygen Uptake * ●
. VCO2 (ml/min) Carbon Dioxide production
RQ (---) Respiratory Quotient

Average resting oxygen uptake for a healthy individual is 3.5 ml/Kg/min (1 MET - Metabolic Equivalent).

The Q-NRG and Q-NRG+ are to be used by physicians or by trained personnel under the responsibility of a physician.

The Q-NRG and Q-NRG+ are not intended for long term use or as continuous monitoring devices for surveillance of vital physiological processes.

Non-clinical testing:

Non-clinical testing of the Q-NRG and Q-NRG+ includes:

Electrical safety
Electromagnetic Compatibility (EMC)
Accuracy validation ●
Coexistence testing ●
Biocompatibility
Reprocessing validation ●
Human factors ●

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Image /page/5/Picture/0 description: The image shows the logo for COSMED, The Metabolic Company. On the left is a blue circle containing a blue griffin. To the right of the griffin is the word "COSMED" in large blue letters. Below the word "COSMED" is the phrase "The Metabolic Company" in smaller letters.

More detail of the non-clinical testing is provided in Table 3.

Table 3: Non-clinical testing
Test type	Reference
Electrical safety	ANSI/AAMI ES 60601-1:2005/®2012 + A1:2012 + C1:2009/®2012 + A2:2010/®2012, FDA
recognition #19-4
IEC 60601-1-2:2014, FDA recognition #19-8
EMC	ETSI EN 301 489-17 v3.2.0 draft
	ETSI EN 301 489-1 v2.2.0 draft
	FCC Part 15 par. 107, 109
	ICES-003 Issue 6: January 19, 2016, updated April 2017
Accuracy validation	Mask Measurement Accuracy, according to internal validation protocol
	Canopy Measurement Accuracy, according to internal validation protocol
	Ventilator Measurement Accuracy, according to internal validation protocol
Coexistence
testing	Coexistence testing between Q-NRG/Q-NRG+ Bluetooth and other environmental
wireless disturbances (i.e. Network Wi-Fi), according to the indications reported in S.
Seidman, N. LaSorte, "An Experimental Method for Evaluating Wireless Coexistence of a
Bluetooth Medical Device," IEEE EMC Magazine, October 2014
Biocompatibility	ISO 10993-1:2009, FDA recognition #2-220
	ISO 10993-5:2009, FDA recognition #2-245
	ISO 10993-10:2010, FDA recognition #2-174
	ISO 18562-2:2017, FDA recognition #1-135
	ISO 18562-3:2017, FDA recognition #1-136
	ISO 18562-4:2017, FDA recognition #1-137
	FDA Guidance Use of International Standard ISO 10993-1, June 16, 2016
Reprocessing
validation	According to internal validation protocol
Human Factors	According to internal verification protocol

The results of the above testing assist in demonstration of substantial equivalence of the subject device with the predicate device, as many of the same standards have been used.

Substantial equivalence

The predicate device selected for comparison with the Q-NRG+ Portable Metabolic Monitors is:

Predicate Device:	Quark RMR Metabolic Cart
Sponsor:	Cosmed Srl, Italy
510(k) Number:	K120146
Clearance Date:	11 December 2012
FDA Product Code:	BTY
Classification Name:	Predictive Pulmonary-Function Value Calculator
Regulation No:	21 CFR 868.1890
Class:	II

Predicate device comparison table:

Table 4 provides evidence of substantial equivalence of the subject device with the selected predicate device.

Table 4: Predicate device comparison table
Feature	Subject device	Predicate device	Similarity
Device name	Q-NRG & Q-NRG+ Portable
Metabolic Monitors	Quark RMR Metabolic Cart	N/A
Table 4: Predicate device comparison table
Feature	Subject device	Predicate device	Similarity
Device
Manufacturer	Cosmed Srl, Italy	Cosmed Srl, Italy	Same
510(k) Reference	This submission	K120146	N/A
FDA Product
Code	BTY	BTY	Same
FDA
Classification
Name	Calculator, Pulmonary
Function Data	Calculator, Pulmonary
Function Data	Same
FDA Regulation
Number	21 CFR 868.1890	21 CFR 868.1890	Same
Device
description	Portable metabolic monitors,
designed for the measurement
of resting energy expenditure
(REE) in both spontaneously
breathing and mechanically
ventilated patients	Metabolic cart for gas
exchange analysis (VO2,
VCO2) either during resting or
exercise. either with
spontaneously breathing
subjects (at rest and during
exercise) or mechanically
assisted patients	Similar, subject device is not
indicated for exercising patients
Indications for
use	The Q-NRG & Q-NRG+
Portable Metabolic Monitors
are indicated for the
measurement of Resting
Energy Expenditure (REE) for
spontaneously breathing and
(Q-NRG+ only) ventilated
patients, within the following
populations:

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).
The Q-NRG & Q-NRG+
Portable Metabolic Monitors
are intended to be used in
professional healthcare
facilities only (limited to ICUs
for ventilated patients). | Measurement of resting
metabolism (face mask): age 6
to adults;
Measurement of resting
metabolism (canopy dilution):
15 kg/30 lb to adults;
Measurement of resting
metabolism (ventilated
patients): age 10 to adults. | Very similar. The subject device
adds a lower limit for the
patient's weight in order to avoid
use of the device on people
weighing less than 10 kg |
| Use environment | Indoor use (healthcare
facilities) | Indoor use (healthcare
facilities) | Same |
| Device
measurements
(output
parameters) | Resting Energy Expenditure
and related parameters (VO2,
VCO2, RQ) | Resting Energy Expenditure
and related parameters (VO2,
VCO2, RQ) (other
measurements available as
options) | Same |
| Measurement
mode(s) | Face mask, canopy,
mechanically ventilated
patients | Face mask, canopy,
mechanically ventilated
patients | Same |
| Measurement
Range | Ventilation: 1-25 l/min
VO2: 0.01-1 l/min
VCO2: 0.01-1 l/min | Ventilation: 0-50 l/min
VO2: not specified
VCO2: not specified | Substantially equivalent for the
maximum patient ventilation of
the intended patient population
and condition e.g. at rest. |
| Table 4: Predicate device comparison table | | | |
| Feature | Subject device | Predicate device | Similarity |
| Measurement
Accuracy | Ventilation: