K Number
K190561
Device Name
NICU V'02
Manufacturer
Date Cleared
2020-09-04

(549 days)

Product Code
Regulation Number
868.1730
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use in mechanically ventilated neonate, infant and pediatic patients where the precise and direct measurement of oxygen uptake (VO2), carbon dioxide excretion (VCO2), resting energy expenditure (REE) and respiratory quotient (RQ) will allow the attending physician to plan and monitor an optimal nutrition regime for the patient in terms of substrate composition and utilization.
Device Description
The NICU V'O2 device is an indirect calorimeter that allows accurate and precise quantification of oxygen consumption (V'O2), carbon dioxide excretion (V'CO2), resting energy expenditure (REE, the number of calories consumed per day) and respiratory quotient (RQ, the ratio of V'CO2 to V'O2) in mechanically ventilated patients. Patients include neonate, infant and pediatric patients with a body weight from 0.5 kg, low minute ventilation, high respiratory rate, and receiving fluctuating and/or elevated inspiratory oxygen concentrations. The device functions by measuring oxygen concentration (using laser diode sensor technology) and carbon dioxide concentration (using NDIR infrared sensor technology) in inspired and expired gas as well as inspiratory flow. The inspiratory flowmeter (differential pressure type pneumotach) is attached at the patient inspiratory outlet of the ventilator. An inspiratory gas sample line is connected to the inspiratory limb of the patient breathing circuit, and an expiratory gas sample line is connected to the ventilator exhaust. The device automatically alternates between these two sample points. Oxygen consumption is determined by comparing the amounts of oxygen in inspired and expired gas, and carbon dioxide excretion is determined by comparing the amounts of carbon dioxide in expired and inspired gas, respectively, per unit of time. These amounts are calculated from the primary measurements of oxygen and carbon dioxide concentrations and gas flow. The resting energy expenditure (or resting metabolic rate), which is defined as the number of calories the body expends daily during resting conditions, is calculated from the values of oxygen consumption and carbon dioxide excretion using the modified Weir equation: REE = (V'O2 x 3.941 + V'CO2 x 1.106) x 1440 kcal min / day L Respiratory Quotient is calculated as the ratio of carbon dioxide produced by the patient to oxygen consumed by the patient. The duration of measurement can be from tens of minutes to 24 hours, partly because the inspiratory flowmeter only sees dry gas and therefore does not significantly change calibration over time. The device consists of two main components. An analyzer unit to which the patient is connected via gas sample and flowmeter pressure lines, and a computer running the dedicated software application under the Windows operating system. The software application works in conjunction with the hardware, and the computer presents in real time measured signals and computed physiological parameters, both as numeric and graphical data. The computer is the main control interface for the ICU staff using the device and offers options for offline data management. The device is powered through an external medical AC/DC power supply.
More Information

Not Found

No
The device description details standard sensor technology and calculations based on established physiological equations (modified Weir equation). There is no mention of AI, ML, or any learning algorithms used for data processing or parameter determination. Performance studies focus on accuracy against reference methods, not on training or validation of AI/ML models.

No.
The device measures metabolic parameters to help physicians plan optimal nutrition regimes, but it does not directly treat or mitigate a disease or condition.

Yes

The device is indicated for the "precise and direct measurement of oxygen uptake (VO2), carbon dioxide excretion (VCO2), resting energy expenditure (REE) and respiratory quotient (RQ)" to allow the physician to "plan and monitor an optimal nutrition regime." This fits the definition of a diagnostic device as it measures physiological parameters to aid in patient management and treatment planning.

No

The device description explicitly states that the device consists of two main components: an analyzer unit (hardware with sensors and flowmeter) and a computer running software. The software works in conjunction with the hardware to process data from the sensors. Therefore, it is not a software-only medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
  • Device Function: The NICU V'O2 device measures physiological parameters (oxygen uptake, carbon dioxide excretion, energy expenditure, respiratory quotient) directly from the patient's inspired and expired breath. It does not analyze specimens derived from the human body in vitro.
  • Measurement Method: The device uses sensors to analyze the composition and flow of gases in the patient's breathing circuit. This is a direct measurement from the patient, not an in vitro analysis of a biological sample.

Therefore, while this device is a medical device used for patient monitoring and management, it does not fit the definition of an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The device is indicated for use in mechanically ventilated neonate, infant and pediatic patients where the precise and direct measurement of oxygen uptake (VO2), carbon dioxide excretion (VCO2), resting energy expenditure (REE) and respiratory quotient (RQ) will allow the attending physician to plan and monitor an optimal nutrition regime for the patient in terms of substrate composition and utilization.
Applications
The NICU V'O2 device is a non-invasive indirect calorimeter for use in clinical and/or research applications for determination of metabolic parameters by measuring expired gas composition (oxygen and carbon dioxide) and volume.
The device is intended for use by qualified medical staff in professional healthcare facilities.

Product codes (comma separated list FDA assigned to the subject device)

BZL

Device Description

The NICU V'O2 device is an indirect calorimeter that allows accurate and precise quantification of oxygen consumption (V'O2), carbon dioxide excretion (V'CO2), resting energy expenditure (REE, the number of calories consumed per day) and respiratory quotient (RQ, the ratio of V'CO2 to V'O2) in mechanically ventilated patients. Patients include neonate, infant and pediatric patients with a body weight from 0.5 kg, low minute ventilation, high respiratory rate, and receiving fluctuating and/or elevated inspiratory oxygen concentrations.

The device functions by measuring oxygen concentration (using laser diode sensor technology) and carbon dioxide concentration (using NDIR infrared sensor technology) in inspired and expired gas as well as inspiratory flow. The inspiratory flowmeter (differential pressure type pneumotach) is attached at the patient inspiratory outlet of the ventilator. An inspiratory gas sample line is connected to the inspiratory limb of the patient breathing circuit, and an expiratory gas sample line is connected to the ventilator exhaust. The device automatically alternates between these two sample points.

Oxygen consumption is determined by comparing the amounts of oxygen in inspired and expired gas, and carbon dioxide excretion is determined by comparing the amounts of carbon dioxide in expired and inspired gas, respectively, per unit of time. These amounts are calculated from the primary measurements of oxygen and carbon dioxide concentrations and gas flow.

The resting energy expenditure (or resting metabolic rate), which is defined as the number of calories the body expends daily during resting conditions, is calculated from the values of oxygen consumption and carbon dioxide excretion using the modified Weir equation:

REE = (V'O2 x 3.941 + V'CO2 x 1.106) x 1440 kcal x min / (day x L)

Respiratory Quotient is calculated as the ratio of carbon dioxide produced by the patient to oxygen consumed by the patient.

The duration of measurement can be from tens of minutes to 24 hours, partly because the inspiratory flowmeter only sees dry gas and therefore does not significantly change calibration over time.

The device consists of two main components. An analyzer unit to which the patient is connected via gas sample and flowmeter pressure lines, and a computer running the dedicated software application under the Windows operating system. The software application works in conjunction with the hardware, and the computer presents in real time measured signals and computed physiological parameters, both as numeric and graphical data. The computer is the main control interface for the ICU staff using the device and offers options for offline data management.

The device is powered through an external medical AC/DC power supply.

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

neonate, infant and pediatric patients

Intended User / Care Setting

qualified medical staff in professional healthcare facilities.

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)

Bench Testing: A comprehensive in vitro performance test was conducted to determine the accuracy of the V'O2 and V'CO2 measurements and derived parameters at varying VO2 and ventilator settings. A lung simulator was used as a reliable reference technique (gold standard) to quantitatively establish accuracy and reliability of the device. Simulated V'O2 and V'CO2 were varied by infusion of a certified gas mixture (50% O2/50% CO2) into an artificial lung circuit (silicone bellows) at a constant rate, comparing measured with simulated V'O2 and V'CO2 within a matrix of varying metabolic rate, tidal volume (peak pressure above PEEP), respiratory rate, and fraction of inspired oxygen (FiO2, normoxic and hyperoxic mixtures). Respiratory parameters were changed via settings on an infant ventilator driving the lung simulator. Conclusion: Bench testing has shown that this device Can measure V'O2, V'CO2 and derived RQ and REE with

§ 868.1730 Oxygen uptake computer.

(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 4, 2020

Innovision ApS % H. Jenkins Regulatory Affairs Consultant Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, Illinois 60044

Re: K190561

Trade/Device Name: Nicu V'02 Regulation Number: 21 CFR 868.1730 Regulation Name: Oxygen Uptake Computer Regulatory Class: Class II Product Code: BZL Dated: July 31, 2020 Received: August 3, 2020

Dear H. Jenkins:

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,

Todd Courtney 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

2

Indications for Use

510(k) Number (if known) K190561

Device Name NICU V'O2

Indications for Use (Describe)

The device is indicated for use in mechanically ventilated neonate, infant and pediatic patients where the precise and direct measurement of oxygen uptake (VO2), carbon dioxide excretion (VCO2), resting energy expenditure (REE) and respiratory quotient (RQ) will allow the attending physician to plan and monitor an optimal nutrition regime for the patient in terms of substrate composition and utilization.

Applications

The NICU V'O2 device is a non-invasive indirect calorimeter for use in clinical and/or research applications for determination of metabolic parameters by measuring expired gas composition (oxygen and carbon dioxide) and volume.

The device is intended for use by qualified medical staff in professional healthcare facilities.

Population studied

Clinical testing has been performed in intubated, mechanically ventilated neonates and infants with ability to tolerate brief interruptions in the ventilatory circuit when connecting and disconnecting the device.

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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3

510(k) Summary

1. Applicant Information

Name:COSMED Nordic ApS
Address:Lucernemarken 23, DK-5260 Odense S, DENMARK
Phone number:(+45) 65 95 91 00
Contact person(s):Peter Clemensen (CEO - Nordic) - pc@cosmed.com
Karen Hvid Ipsen (Director QA/RA - Nordic) - ki@cosmed.com
Type of Submission:Traditional 510(k)
Submission Number:K190561
Date of preparation:February 22, 2019
Date of revision:August 27, 2020
Submitter (US Agent):The Wood Burditt Group
10 E. Scranton Ave., Suite 201
Lake Bluff, IL 60044
(847) 234-7500
Contact person: H. Carl Jenkins - hcienkins@woodburditt.com

2. Device Name and Classification

Trade Name:NICU V'O2
Common or Usual Name:Indirect calorimeter
Regulatory Class:Class II
Classification Name:Oxygen uptake computer
(21 CFR 868.1730, Product Code BZL. Panel: Anesthesiology)

3. Identification of Legally Marketed Predicate Devices

Primary Predicate
Device:MedGraphics Express Series
Manufacturer:Medical Graphics Corporation (Now MGC Diagnostics)
510(k) number:K070858
Secondary Predicate No. 1
Device:Innocor (incl. Cardiopulmonary Exercise Testing Option)
Manufacturer:Innovision ApS (same as applicant)
510(k) number(s)K051907, K071911 and K083879
Secondary Predicate No. 2
Device:REEVUE Indirect Calorimeter (Model: 8100)
Manufacturer:KORR Medical Technologies, Inc.

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510(k) number:K021490
Reference method
Device:Douglas Bag (Gold Standard)
Manufacturer:N/A
510(k) number:N/A

4. Device Description

The NICU V'O2 device is an indirect calorimeter that allows accurate and precise quantification of oxygen consumption (V'O2), carbon dioxide excretion (V'CO2), resting energy expenditure (REE, the number of calories consumed per day) and respiratory quotient (RQ, the ratio of V'CO2 to V'O2) in mechanically ventilated patients. Patients include neonate, infant and pediatric patients with a body weight from 0.5 kg, low minute ventilation, high respiratory rate, and receiving fluctuating and/or elevated inspiratory oxygen concentrations.

The device functions by measuring oxygen concentration (using laser diode sensor technology) and carbon dioxide concentration (using NDIR infrared sensor technology) in inspired and expired gas as well as inspiratory flow. The inspiratory flowmeter (differential pressure type pneumotach) is attached at the patient inspiratory outlet of the ventilator. An inspiratory gas sample line is connected to the inspiratory limb of the patient breathing circuit, and an expiratory gas sample line is connected to the ventilator exhaust. The device automatically alternates between these two sample points.

Oxygen consumption is determined by comparing the amounts of oxygen in inspired and expired gas, and carbon dioxide excretion is determined by comparing the amounts of carbon dioxide in expired and inspired gas, respectively, per unit of time. These amounts are calculated from the primary measurements of oxygen and carbon dioxide concentrations and gas flow.

The resting energy expenditure (or resting metabolic rate), which is defined as the number of calories the body expends daily during resting conditions, is calculated from the values of oxygen consumption and carbon dioxide excretion using the modified Weir equation:

$$REE = \left(V'O_2 \times 3.941 + V'CO_2 \times 1.106\right) \times 1440 ,\frac{kcal \cdot min}{day \cdot L}$$

Respiratory Quotient is calculated as the ratio of carbon dioxide produced by the patient to oxygen consumed by the patient.

1 Initially described by Gordon Douglas in Proceedings Of The Physiological Society, March 18, 1911 "A method for determining the total respiratory exchange in man".

Reviewed e.g. by Shephard, Eur J Appl Physiol (2017) 117:381–387: "Open-circuit respirometry: a brief historical review of the use of Douglas bags and chemical analyzers''.

5

The duration of measurement can be from tens of minutes to 24 hours, partly because the inspiratory flowmeter only sees dry gas and therefore does not significantly change calibration over time.

The device consists of two main components. An analyzer unit to which the patient is connected via gas sample and flowmeter pressure lines, and a computer running the dedicated software application under the Windows operating system. The software application works in conjunction with the hardware, and the computer presents in real time measured signals and computed physiological parameters, both as numeric and graphical data. The computer is the main control interface for the ICU staff using the device and offers options for offline data management.

The device is powered through an external medical AC/DC power supply.

ട്. Indications for Use Statement

The device is indicated for use in mechanically ventilated neonate, infant and pediatric patients where the precise and direct measurement of oxygen uptake (V'O2), carbon dioxide excretion (V'CO2), resting energy expenditure (REE) and respiratory quotient (RQ) will allow the attending physician to plan and monitor an optimal nutrition regime for the patient in terms of substrate composition and utilization.

Applications

The NICU V'O2 device is a non-invasive indirect calorimeter for use in clinical and/or research applications for determination of metabolic parameters by measuring expired gas composition (oxygen and carbon dioxide) and volume.

The device is intended for use by qualified medical staff in professional healthcare facilities.

Population studied

Clinical testing has been performed in intubated, mechanically ventilated neonates and infants with ability to tolerate brief interruptions in the ventilatory circuit when connecting and disconnecting the device.

6. Comparison of Technological Characteristics

MedGraphics Express Series Equivalence

The MedGraphics Express Series (MedGraphics device) has been chosen as primary predicate because of similarities to the new NICU V'O2 device in its intended use/indications for use. They are both intended for indirect calorimetry and determination of metabolic parameters for nutritional assessment of ventilated patients. They both measure oxygen consumption (VO2) and carbon dioxide excretion (VCO2) and compute the respiratory quotient (RQ) and the resting energy expenditure (REE) using the Weir equation. The MedGraphics device may also be used for spontaneously breathing patients contrary to the NICU V'O2. There are also minor technological dissimilarities in the oxygen sensor type used to determine O2 concentrations and in gas collection principles in the two devices. These differences are covered by the secondary predicates.

6

Innocor Model INN00010 Predecessor Device Equivalence

The Innocor Model INN00010 (Innocor device) actively marketed in the US by applicant as a CPX system has been included as a secondary predicate both for the indications for use which include measurements of VO2, V'CO2 and RO and because the oxygen sensor technology and flow measurement principle in this legally marketed device are identical to those of the new NICU V'O2 device. Like the primary predicate, Innocor uses the breath-by-breath gas exchange method. Innocor has not been selected as the primary predicate since it is not intended for ventilated patients or neonates/infants and does not compute REE from the metabolic parameters.

REEVUE Indirect Calorimeter Equivalence

The REEVUE Indirect Calorimeter (REEVUE device) has been selected as an additional secondary predicate because of similarities in intended use/indications for use and technologies, and to demonstrate that the mixing box principle has been applied instead of the breath-bybreath principle for an indirect calorimeter that is legally marketed. This device, however, does not measure CO2 as do the other predicates but instead assumes a constant RO (ratio of V'CO2 to VO2). Besides, the REEVUE device is only indicated for spontaneously breathing patients where supplementary oxygen is not being given.

Reference method

The Douglas Bag, where expired gas from the patient is collected in a non-diffusing gas bag over time and subsequently analyzed for volume and composition, is considered the gold standard for respiratory gas exchange and hence estimation of energy expenditure (indirect calorimetry). It has been included as a reference method because, in addition to bench testing, it has been used to validate the NICU VO2 in an animal model and in a clinical performance test in patients.

Substantial Equivalence Comparison Matrix / Summary of Technological Characteristics

The technological characteristics of the new NICU V'O2 device are compared to those of the predicate devices below. Intended use/indications for use are based on the 510(k) summaries for the devices, whereas data on technological characteristics is obtained partly from product information from product data sheets and websites etc.

SpecificationSubject devicePredicate Devices
NICU V'O2Primary
MedGraphics ExpressSecondary No. 1
Innocor INN00010Secondary No. 2
REEVUE IC
510(k) NumberProposed deviceK070858K071911K021490
Product codeBZLBZLBZL
DQKBZL
ClassClass IIIdenticalIdenticalIdentical
Intended UseIndirect calorimetryIndirect calorimetry
& cardiopulmonary
function testingCardiopulmonary
function testingIndirect calorimetry
SpecificationSubject devicePredicate Devices
NICU V'O2Primary
MedGraphics ExpressSecondary No. 1
Innocor INN00010Secondary No. 2
REEVUE IC
The NICU V'O2 device is
a non-invasive indirect
calorimeter intended for
use in clinical and/or
research applications for
determination of metabolic
parameters by measuring
expired gas composition
(oxygen and carbon
dioxide) and volume.MedGraphics Express
Series is intended for
medical applications
requiring a non-invasive
assessment of the
cardiopulmonary
response to exercise or
measurement of energy
expenditure using
indirect calorimetry.Innocor's
cardiopulmonary
exercise testing option is
intended to measure
oxygen uptake
(metabolic rate) and
related parameters to
objectively and non-
invasively assess cardiac
and pulmonary function
at rest and during
exercise.The device is intended for
use in clinical and
research applications to
measure oxygen uptake.
Target patient
populationNeonate to pediatric.
Mechanically
ventilated.No documentation
contained in 510(k)
summary. Inferred
from datasheet:
Pediatric to adult.
Mechanically venti-
lated and spontane-
ously breathing.Pediatric to adult.
Spontaneously
breathing.Pediatric to adult
Device not compatible
with mechanical
ventilation or patients
on supplemental
oxygen.
Target usersPrescription use only.IdenticalIdenticalIdentical
Patient interfaceNo patient contact.
Distal sensors inserted
in breathing circuit.No patient contact
(in mechanical
ventilation mode).
Proximal sensors.Mouthpiece or mask.
Proximal sensors.Mouthpiece or mask.
Proximal
unidirectional
breathing valves and
distal sensors.
ParametersV'O2IdenticalV'O2V'O2
V'CO2V'CO2V'CO2 not determined
RQRQRQ not determined
REEREE not calculatedREE
Operating principleMixing box /Breath-by-breath /Breath-by-breath /Mixing box /
Inspiratory flow
measurementProximal flow
measurementProximal flow
measurementExpiratory flow
measurement
Inspiratory and
expiratory O2 and CO2
measurement (Side-
stream)Proximal O2 and CO2
measurement (Side-
stream)Proximal O2 and CO2
measurement (Side-
stream)Expiratory O2
measurement (Side-
stream inside of
equipment).
Ambient (inspired) O2
concentration assumed
20.93%.
REE: Modified Weir
Equation using
measured O2 and CO2.No documentation
contained in 510(k)
summary.REE not calculated.Similar - However,
CO2 not measured.
REE calculation based
on assumed RQ of
0.83.
Oxygen sensor
specification:Laser diode absorption
spectroscopyGalvanic cellLaser diode absorp-
tion spectroscopyGalvanic fuel cell
SpecificationSubject devicePredicate Devices
NICU V'O2Primary
MedGraphics ExpressSecondary No. 1
Innocor INN00010Secondary No. 2
REEVUE IC
Carbon dioxide
sensor specification:Non-dispersive IR
spectroscopyNon-dispersive IR
spectroscopyPhotoacoustic IR
spectroscopyNone
Flow sensor
specification:Type: Differential
pressure pneumotach
(Mesh screen type)Type: Differential
pressure pneumotach
(Bidirectional pitot
tube)Type: Differential
pressure pneumotach
(Mesh screen type)Type: Differential
pressure pneumotach
(Fixed orifice)
ClinicalValidated by bench
testing, in an animal
model and in patients.
Reference method:
Douglas bag.No data submitted.Validated by bench
testing.Validated by bench
testing and in patients.
Reference method:
Douglas bag.

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7. Non-Clinical Performance Data to Establish Equivalence

The NICU V'O2 device has been thoroughly tested through non-clinical performance testing and validation that establishes equivalence. The following validation testing was applied to the development of the system as summarized in the following: Performance verification against bench top simulator and animal comparative testing.

Bench Testing

A comprehensive in vitro performance test was conducted to determine the accuracy of the V O2 and VCO2 measurements and derived parameters at varying VO2 and ventilator settings.

A lung simulator was used as a reliable reference technique (gold standard) to quantitatively establish accuracy and reliability of the device. In this technique, simulated V'O2 and V'CO2 can be varied by infusion of a certified gas mixture (50% O2/50% CO2) into an artificial lung circuit (silicone bellows) at a constant rate, comparing measured with simulated V'O2 and V'CO2 within a matrix of varying metabolic rate, tidal volume (peak pressure above PEEP), respiratory rate, and fraction of inspired oxygen (FiO2, normoxic and hyperoxic mixtures). Respiratory parameters were changed via settings on an infant ventilator driving the lung simulator.

Infusion was provided by means of a mass flow controller.

As the volumetric flow rate of CO2 from the test gas directly represents true VCO2 at standard temperature and pressure, it can be assessed how accurately the measured VCO2 resembles the known reference flow. Similarly, a precisely-known flow of O2 (with zero N2 content) is utilized to simulate a negative V'O2 (i.e. O2 production). Since the CO2 and O2 fractions in the test gas are chosen to be equal, the reference RQ is equal to -1.

In conclusion, bench testing has shown that this device Can measure V'O2, V'CO2 and derived RQ and REE with