The LCI Option for Innocor is intended to measure the Lung Clearance Index (LCI), which is the cumulative expired volume required to clear an inert gas from the lungs during normal breathing in a multiple-breath washout (MBW) test divided by the Functional Residual Capacity (FRC).

Device Description

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method, c) spirometry parameters by means of forced respiratory maneuvers, and d) peripheral airway function by means of multiple-breath inert gas washout.

The basic Innocor provides cardiac output (CO) as the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations. The disappearance curve for the blood soluble gas is used to calculate pulmonary blood flow (PBF), which in the absence of a significant intrapulmonary shunt is equal to cardiac output. The functional residual capacity (FRC) is determined from the dilution of the relatively insoluble gas during the same maneuver.

The LCI Option for Innocor, used alone or in conjunction with the entire Innocor system, provides information on lung volume and peripheral airway function.

The LCI is calculated as the cumulative expired volume (VcE) required to clear the inert tracer gas from the lungs during normal breathing, minus the product of the number of wash-out breaths and the external dead space outside the lips. divided by the subject's Functional Residual Capacity (FRC). FRC is the amount of air that stays in the lungs (up to the lips) after a normal expiration. In other words, LCI represents the number of lung volume turnovers (i.e. FRCs) that the subject must breathe to clear the inert tracer gas from the lungs (by convention, to an end-tidal concentration of 1/40th of the starting concentration over three subsequent breaths).

Innocor uses a combination of two techniques to determine the LCI, using SF6 as the inert tracer gas:

Inert gas rebreathing (IGR) is used for rapid wash-in of a very small amount of SF% until an even concentration is obtained in the lungs before the wash-out can start. This allows accurate determination of the functional residual capacity (FRC) by gas analysis alone.

This is followed by multiple-breath wash-out (MBW) for determination of the cumulative expired volume (VCF) required to clear the SF6 from the lungs. The Innocor device is a compact and portable point-of-care device. The hardware in the LCI Option for Innocor is identical to that used in the Innocor Diagnostic Programmable Computer (K051907) and the Cardiopulmonary Exercise Testing Option to Innocor (K071911). The combined rebreathing/multiple breath wash-out test performed with the LCI Option for Innocor requires accurate measurements of the respiratory flow and the concentration of SF6 at the mouth during inspiration (inhalation) and expiration (exhalation). The Innocor device measures the flow and SF6 concentration by means of of a pneumotachometer and a photoacoustic infrared gas analyzer, respectively, while the patient takes multiple breaths over a period of time through a pneumatically activated respiratory valve unit (RVU). The rebreathing gas mixture for wash-in of SF6 is filled into a rubber bag prior to testing.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the LCI Option for Innocor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for LCI or FRC measurements, nor does it present a direct comparison of the device's performance against such criteria. Instead, the performance evaluation is framed as demonstrating "substantial equivalence" to predicate devices and adherence to relevant guidelines.

The performance data described focuses on:

FRC determination: Evaluated against a calibration syringe.
LCI determination: Evaluated using data from a simulation model.

The summary states: "Performance data demonstrates that the hardware and software of the LCI Option for Innocor is as safe, as effective, and performs as well as or better than the predicate devices and thus that the device is substantially equivalent to the predicate devices."

Since specific numerical acceptance criteria and a detailed breakdown of the device's measured performance against them are not provided, I cannot create a table with specific numbers. The document relies on a qualitative statement of substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify a sample size for the test set. It mentions evaluation against a "calibration syringe" for FRC and "data from simulation" for LCI. This implies bench testing rather than human subject testing for primary performance evaluation for equivalence.
Data Provenance: The data provenance is from "bench testing" using a "calibration syringe" and "simulation." This suggests laboratory-based data, not human patient data, and therefore no country of origin or retrospective/prospective designation in the conventional sense for clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

There is no mention of experts being used to establish ground truth for the test set. The ground truth for FRC assessment appears to be the known volume of the calibration syringe, and for LCI, it's derived from a simulation model. This is typical for bench testing where the 'ground truth' is a controlled, known quantity.

4. Adjudication Method for the Test Set

No adjudication method is mentioned or relevant, as the testing described is bench testing against known physical or simulated values, not human expert interpretation.

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

No MRMC comparative effectiveness study was done.
This device is a measurement instrument for physiological parameters (LCI, FRC), not an AI-assisted diagnostic tool that would involve human readers or AI assistance for interpretation. Therefore, human reader improvement with/without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The device, which functions as a "Pulmonary function data calculator," directly measures and calculates LCI and FRC. Its performance was evaluated on its own ("against a calibration syringe for FRC determination and data from simulation for LCI determination") without human operators interpreting results to determine its accuracy. The "software is different from previous models," indicating that the algorithm's performance is primary.

7. The Type of Ground Truth Used

FRC: Calibration syringe (known, controlled volume).
LCI: Data from a simulation model.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is consistent with a device that is essentially a physiological measurement calculator, where the calculations are based on established scientific principles rather than a machine learning model that requires a "training set" in the typical sense. The "software is different from previous models" but this likely refers to implemented algorithms for calculation, not machine learning.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of machine learning, there is no discussion of how ground truth for a training set was established.

Summary

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5. 510(k) Summary

Image /page/0/Picture/1 description: The image shows the word "innovision" in a stylized font. The letters are black and bold, and the word is slightly slanted upwards from left to right. There is a curved line above the "i" in "innovision", with a small circle at the end of the line.

NOV

1 2011

LCI Option

Date of Summary	April 5, 2011
Submitter/ContactPerson	H. Carl JenkinsThe Wood Burditt Group10 E. Scranton Ave., Suite 201Lake Bluff, IL 60044(ph) (847) 234-7500 x 205(fax) (847) 574-0728(email) hcjenkins@woodburditt.com
Applicant	Innovision A/SLindvedvej 75DK-5260 Odense SDenmark
	Phone: +45 65 95 91 00Fax: +45 65 95 78 00info@innovision.dk www.innovision.dk
Device Name	LCI Option for Innocor
Common Name	Pulmonary function test equipment
Classification	LCI Option for Innocor - K102047Calculator, pulmonary function dataRegulation Number: 21 CFR §868.1880Product Code: BZCPanel Code: AnesthesiologyDevice Class: II
Legally MarketedPredicate Devices	The LCI Option for Innocor is substantially equivalent in respectto the intended use, design and method of operation to thefollowing legally marketed devices:Predicate Device No. 1Name: Innocor
	510(k) number: K051907
	Manufacturer: Innovision A/S, Denmark
	Predicate Device No. 2
	Name: Cardiopulmonary Exercise Testing Option
	510(k) number: K071911
	Manufacturer: Innovision A/S, Denmark
	Predicate Device No. 3
	Name: Spirometry Option
	510(k) number: K083879
	Manufacturer: Innovision A/S, Denmark
	Predicate Device No. 4
	Name: COSMED QUARK
	510(k) number: K001174
	Manufacturer: COSMED S.r.l., Italy
	Predicate Device No. 5
	Name: SensorMedics Vmax Series Pulmonary/Metabolic System
	510(k) number: K942211
	Manufacturer: SensorMedics
Device Description	Innocor is a compact point-of-care device intended to be used fornon-invasive measurement of a) cardiac output (CO) and otherhemodynamic parameters utilizing inert gas rebreathing (IGR)technology, b) metabolic parameters including oxygen uptake bymeans of a breath-by-breath gas exchange method, c) spirometryparameters by means of forced respiratory maneuvers, andd) peripheral airway function by means of multiple-breath inertgas washout.

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The LCI Option for Innocor, used alone or in conjunction with the entire Innocor system, provides information on lung volume and peripheral airway function.

Innocor uses a combination of two techniques to determine the LCI, using SF6 as the inert tracer gas:

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analysis alone.

This is followed by multiple-breath wash-out (MBW) for determination of the cumulative expired volume (VCF) required to clear the SF6 from the lungs. The Innocor device is a compact and portable point-of-care device. The hardware in the LCI Option for Innocor is identical to that used in the Innocor Diagnostic Programmable Computer (K051907) and the Cardiopulmonary Exercise Testing Option to Innocor (K071911). combined rebreathing/multiple breath wash-out test The performed with the LCI Option for Innocor requires accurate measurements of the respiratory flow and the concentration of SF6 at the mouth during inspiration (inhalation) and expiration (exhalation). The Innocor device measures the flow and SF6 concentration by means of of a pneumotachometer and a photoacoustic infrared gas analyzer, respectively, while the patient takes multiple breaths over a period of time through a pneumatically activated respiratory valve unit (RVU). The rebreathing gas mixture for wash-in of SF6 is filled into a rubber bag prior to testing. Intended Use and The LCI Option for Innocor is intended to measure the Lung Clearance Index (LCI), which is the cumulative expired volume Indications required to clear an inert gas from the lungs during normal breathing in a multiple-breath washout (MBW) test divided by the Functional Residual Capacity (FRC). The specific parameters measured by the Innocor LCI Option include:

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Abbreviation	Name	Unit
LCI	Lung Clearance Index	(none)
FRC	Functional Residual capacity	L [BTPS]
Summary of technologicalcharacteristicscompared to predicatedevices	Comparison with predicate device Innocor with options[K051907, K071911, and K083879]:The hardware in the LCI Option for Innocor is identical to thatused in the predicate devices. The connection of the patient andthe operation of the device are similar in that the wash-in isperformed by rebreathing as in the basic Innocor (K051907), andthe wash-out is performed by breathing room air in an open-circuitbreath-by-breath measurement as in the Cardiopulmonary ExerciseTesting Option (K071911). The gas mixture is the same as thatused with Innocor and approved by the FDA as an integral part ofthe device (K051907). Thus, only the software is different fromprevious models.Comparison with predicate device COSMED QUARK[K001174]:Both the LCI Option for Innocor and the COSMED QUARKpredicate device are indicated for use in pulmonary functiontesting to measure the wash-out of a gas from the lungs during amultiple-breath procedure in open-circuit mode. The LCI Optionfor Innocor performs the same LCI functions as the COSMEDQUARK, by providing lung function measurements of FRC andLCI from analysis of a wash-out curve. Although there are someminor descriptive characteristics differences between the LCI

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Option for Innocor and the COSMED QUARK, performance data from bench testing demonstrates substantial equivalence. The performance of the LCI Option for Innocor has been evaluated against a calibration syringe for FRC determination and data from simulation for LCI determination. Performance data a demonstrates that the hardware and software of the LCI Option for Innocor is substantially equivalent to a legally marketed predicate diagnostic device for LCI determination.

Further, except for the way the indicator gas is washed in and the way FRC is determined, the LCI Option for Innocor meets the relevant recommendations in the Official American Thoracic Society/European Respiratory Society Statement: Pulmonary Function Testing in Preschool Children, Am J Respir Crit Care Med Vol 175. pp 1304-1345, 2007, Section 7: The Multiple-Breath Inert Gas Washout Technique.

Comparison with predicate device SensorMedics Vmax Series Pulmonary/Metabolic System [K942211]:

Both the LCI Option for Innocor and the SensorMedics Vmax Series Pulmonary/Metabolic System (K942211) are intended to measure LCI, and are for use in children and adults.

The SensorMedics Vmax Series Pulmonary/Metabolic System was granted premarket clearance based, in part, on the Vmax calculating and providing LCI as one of the Distribution Parameters in the device's Normal Predicted Equation Sets.

The numerator and denominator of the fraction which defines LCI in the Vmax are defined in the Vmax 510(k) submission by reference to the cited article titled "A NEW INDEX OF THE INTRAPULMONARY MIXTURE OF INSPIRED AIR" by Margaret R. Becklake, Thorax (1952), 7, 111. More specifically,

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	the numerator and denominator of the fraction which defines LCIare defined in the Becklake article as: Litres ventilation required towash 90% F.R.A. free of N2 / 90% F.R.A.The LCI Option for Innocor employs a substantially equivalentmethod of measuring LCI, using essentially the same indexes andproviding the same information.
Performance Testing /	The LCI Option for Innocor has been evaluated against a
Summary of	calibration syringe simulating the lungs for FRC measurement (in
Substantial	the same way as for the predicate device, Innocor), and data
Equivalence (SE)	obtained from a bench test using a calibration syringe to simulatethe lungs has been compared with data from a simulation model ofan LCI wash-out test. Performance data demonstrates that thehardware and software of the LCI Option for Innocor is as safe, aseffective, and performs as well as or better than the predicatedevices and thus that the device is substantially equivalent to thepredicate devices.
Compliance with	Except for the way the indicator gas is washed in and the wayFRC is determined, the LCI Option for Innocor has beendeveloped in accordance with the Official American ThoracicSociety/European Respiratory Society Statement: PulmonaryFunction Testing in Preschool Children, Am J Respir Crit CareMed Vol 175. pp 1304-1345, 2007, Section 7: The Multiple-Breath Inert Gas Washout Technique.
	The Statement includes the following remarks:
	MBW is performed routinely in preschool children in only- a limited number of laboratories, presumably becausesuitable equipment is not commercially available.Several different inert marker gases with low solubility in
	blood and tissues can be used for MBW. The most wellknown is nitrogen (N2), which can be washed out from thelungs by letting the patient breathe pure oxygen (100%O2). Other gases, such as argon (Ar), helium (He), or sulfurhexafluoride (SF6), may also be used, but measuring thesegases may require expensive equipment, such as a massspectrometer.

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5. 510(k) Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV - 1 2011

Innovision A/V Regulatory Counsel C/O Mr. H. Carl Jenkins The Wood Burditt Group LLC 10 E. Scranton Avenue, Suite 201 Lake Bluff, Illinois 60044

Re: K102047

Trade/Device Name: LCI Option for Innocor Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-Function Data Calculator Regulatory Class: II Product Code: BZC Dated: April 5, 2011 Received: April 6, 2011

Dear Mr. 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. 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.

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Page 2 - Mr. Jenkins

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: LCI Option for Innocor

Indications for Use:

The specific parameters measured by the Innocor LCI Option include:

Abbreviation	Name	Unit
LCI	Lung Clearance Index	(none)
FRC	Functional Residual Capacity	L [BTPS]

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Indications for Use Statement

510(k) Number: Kn 10204

Page 4.1 of 4.1

Regulation Number and Section

§ 868.1880 Pulmonary-function data calculator.

(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).