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.

AI/ML Overview

The information provided describes the NICU V'O2 device, an indirect calorimeter for neonate, infant, and pediatric patients.

1. Table of acceptance criteria and the reported device performance:

Parameter Measured	Acceptance Criteria (Error)	Reported Device Performance (Mean Percentage Error)
V'O2	< 15% (Bench Testing)	~3% (Clinical Study)
V'CO2	< 15% (Bench Testing)	~3% (Clinical Study)
RQ	< 15% (Bench Testing)	Not explicitly stated for overall RQ, but derived from V'O2 and V'CO2 performance.
REE	< 15% (Bench Testing)	Not explicitly stated for overall REE, but derived from V'O2 and V'CO2 performance.

2. Sample size used for the test set and the data provenance:

Clinical Study (Test Set): The document states "An in vivo performance test was conducted in newborn patients". The exact number of patients (sample size) is not explicitly stated in the provided text.
Data Provenance: The patients were "newborn patients" in a clinical setting. The country of origin is not specified. The study was prospective as it was an "in vivo performance test conducted in newborn patients".
Animal Testing (Test Set): The document states "An in vivo performance test was conducted in animals to determine the accuracy of the V'O2 and V'CO2 measurements...". The exact number of animals is not explicitly stated, but it refers to "Sprague-Dawley rats". The study was prospective.
Bench Testing (Test Set): Performed using a "lung simulator". This is an
in vitro test, not involving human or animal subjects, hence no specific sample size for "test set" in the traditional sense, but rather a range of simulated conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The ground truth for the clinical and animal studies was established using the Douglas Bag method, which is described as the "gold standard" for respiratory gas exchange.
The document does not specify the number of experts or their qualifications involved in performing the Douglas Bag measurements or interpreting the results to establish the ground truth for the test set.

4. Adjudication method for the test set:

The document describes comparing the NICU V'O2 device measurements directly against the "Douglas Bag gas collection as reference technique." This indicates a direct comparison to a gold standard, not a consensus-based adjudication among multiple reviewers. Therefore, no specific adjudication method like "2+1" or "3+1" was employed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The NICU V'O2 device is an indirect calorimeter that directly measures physiological parameters. It is not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, this was a standalone performance study. The device's measurements (V'O2, V'CO2, RQ, REE) were directly compared to the gold standard (Douglas Bag method) in both animal and clinical settings. The performance metrics (bias and precision) are reported for the device itself, indicating a standalone evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for both animal and clinical studies was the Douglas Bag gas collection method, which is considered the "gold standard" for respiratory gas exchange. This is a direct physiological measurement.

8. The sample size for the training set:

The document does not mention a "training set" in the context of device development. This suggests the device's algorithms and parameters were likely validated through engineering and laboratory testing rather than machine learning on a distinct training dataset. The studies described are performance validation studies.

9. How the ground truth for the training set was established:

As no "training set" for a machine learning algorithm is mentioned, this question is not applicable based on the provided information.

Summary

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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

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

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

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

Sincerely,

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

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Indications for Use

510(k) Number (if known) K190561

Device Name NICU V'O2

Indications for Use (Describe)

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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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.comKaren 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 Group10 E. Scranton Ave., Suite 201Lake Bluff, IL 60044(847) 234-7500Contact 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

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

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''.

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

Population studied

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.

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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.

Specification	Subject device	Predicate Devices
	NICU V'O2	PrimaryMedGraphics Express	Secondary No. 1Innocor INN00010	Secondary No. 2REEVUE IC
510(k) Number	Proposed device	K070858	K071911	K021490
Product code	BZL	BZL	BZLDQK	BZL
Class	Class II	Identical	Identical	Identical
Intended Use	Indirect calorimetry	Indirect calorimetry& cardiopulmonaryfunction testing	Cardiopulmonaryfunction testing	Indirect calorimetry
Specification	Subject device	Predicate Devices
	NICU V'O2	PrimaryMedGraphics Express	Secondary No. 1Innocor INN00010	Secondary No. 2REEVUE IC
	The NICU V'O2 device isa non-invasive indirectcalorimeter intended foruse in clinical and/orresearch applications fordetermination of metabolicparameters by measuringexpired gas composition(oxygen and carbondioxide) and volume.	MedGraphics ExpressSeries is intended formedical applicationsrequiring a non-invasiveassessment of thecardiopulmonaryresponse to exercise ormeasurement of energyexpenditure usingindirect calorimetry.	Innocor'scardiopulmonaryexercise testing option isintended to measureoxygen uptake(metabolic rate) andrelated parameters toobjectively and non-invasively assess cardiacand pulmonary functionat rest and duringexercise.	The device is intended foruse in clinical andresearch applications tomeasure oxygen uptake.
Target patientpopulation	Neonate to pediatric.Mechanicallyventilated.	No documentationcontained in 510(k)summary. Inferredfrom datasheet:Pediatric to adult.Mechanically venti-lated and spontane-ously breathing.	Pediatric to adult.Spontaneouslybreathing.	Pediatric to adultDevice not compatiblewith mechanicalventilation or patientson supplementaloxygen.
Target users	Prescription use only.	Identical	Identical	Identical
Patient interface	No patient contact.Distal sensors insertedin breathing circuit.	No patient contact(in mechanicalventilation mode).Proximal sensors.	Mouthpiece or mask.Proximal sensors.	Mouthpiece or mask.Proximalunidirectionalbreathing valves anddistal sensors.
Parameters	V'O2	Identical	V'O2	V'O2
	V'CO2		V'CO2	V'CO2 not determined
	RQ		RQ	RQ not determined
	REE		REE not calculated	REE
Operating principle	Mixing box /	Breath-by-breath /	Breath-by-breath /	Mixing box /
	Inspiratory flowmeasurement	Proximal flowmeasurement	Proximal flowmeasurement	Expiratory flowmeasurement
	Inspiratory andexpiratory O2 and CO2measurement (Side-stream)	Proximal O2 and CO2measurement (Side-stream)	Proximal O2 and CO2measurement (Side-stream)	Expiratory O2measurement (Side-stream inside ofequipment).Ambient (inspired) O2concentration assumed20.93%.
	REE: Modified WeirEquation usingmeasured O2 and CO2.	No documentationcontained in 510(k)summary.	REE not calculated.	Similar - However,CO2 not measured.REE calculation basedon assumed RQ of0.83.
Oxygen sensorspecification:	Laser diode absorptionspectroscopy	Galvanic cell	Laser diode absorp-tion spectroscopy	Galvanic fuel cell
Specification	Subject device	Predicate Devices
	NICU V'O2	PrimaryMedGraphics Express	Secondary No. 1Innocor INN00010	Secondary No. 2REEVUE IC
Carbon dioxidesensor specification:	Non-dispersive IRspectroscopy	Non-dispersive IRspectroscopy	Photoacoustic IRspectroscopy	None
Flow sensorspecification:	Type: Differentialpressure pneumotach(Mesh screen type)	Type: Differentialpressure pneumotach(Bidirectional pitottube)	Type: Differentialpressure pneumotach(Mesh screen type)	Type: Differentialpressure pneumotach(Fixed orifice)
Clinical	Validated by benchtesting, in an animalmodel and in patients.Reference method:Douglas bag.	No data submitted.	Validated by benchtesting.	Validated by benchtesting 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 <15% error within the neonatal size range, and functions well up to respiratory rates of 60-80 BPM and FrO2 of 0.7.

The in vitro validation has been published in the peer-reviewed article:

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Nachman et al. A device for the quantification of oxygen consumption and caloric expenditure in the neonatal range. Anesth Analg 2018;127:95-104.

Animal Testing

An in vivo performance test was conducted in animals to determine the accuracy of the V'O2 and V'CO2 measurements and derived parameters at respiratory variables reflective of those present in Sprague-Dawley rats on mechanical ventilation using a clinical ventilator. Douglas bag gas collection was used as reference technique.

In conclusion, the device has been demonstrated to exhibit clinically acceptable bias and precision in V'O2, V'CO2, RQ and REE in vivo in animals under low minute ventilations.

There were no procedure related complications in the animal study.

The animal validation has been published in the peer-reviewed article:

Nachman et al. A device for the quantification of oxygen consumption and caloric expenditure in the neonatal range. Anesth Analg 2018;127:95-104.

8. Clinical Performance Data to Establish Equivalence

An in vivo performance test was conducted in newborn patients on an infant ventilator to determine the accuracy of the V'O2 and V'CO2 measurements and derived parameters. Douglas bag gas collection was used as reference technique.

In conclusion, the device has been demonstrated to exhibit clinically acceptable bias and precision in V'O2, V'CO2, RQ and REE in patients under low minute ventilations and high respiratory rates. The bias in V'O2 and V'CO2 were +0.22 mL/kg/min and +0.033 mL/kg/min, respectively, corresponding to a mean percentage error (i.e. discrepancy between device and reference) of approximately 3%.

No procedure related adverse effects or complications were observed in the clinical study.

The clinical validation has been published in the peer-reviewed article:

Nachman et al. A device for the quantification of oxygen consumption and caloric expenditure in the neonatal range. Anesth Analg 2018;127:95-104.

9. Substantial Equivalence Conclusion

The NICU V'O2 device meets the functional claims, product specifications and intended use as described in the product labeling.

The performance of the NICU V'O2 device was evaluated by a combination of bench testing, animal testing and a clinical study in order to make the validation as comprehensive as possible and at the same time limit the number of tests on patients required to support substantial equivalence.

An accuracy of 20% (determined as the difference between device and reference measurements or simulator) was considered clinically acceptable. The results indicated that the device meets or exceeds the pass criteria for each test. The device can measure V'O2, V'CO2, RQ and REE

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with sufficient accuracy for clinical decision-making within the neonatal to pediatric size range, including in the setting of tachypnea or hyperoxia.

Based on its underlying technology and on performance as documented in the bench tests, animal tests and clinical trial, Innovision concludes that the NICU V'O2 device is substantially equivalent to the predicate devices described in the submission that are currently legally marketed for the same intended use.

Regulation Number and Section

§ 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).