LCI OPTION FOR INNOCOR

K102047 · Innovision A/S · BZC · Nov 1, 2011 · Anesthesiology

Device Facts

• Record ID: K102047
• Device Name: LCI OPTION FOR INNOCOR
• Applicant: Innovision A/S
• Product Code: BZC · Anesthesiology
• Decision Date: Nov 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1880
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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). The specific parameters measured by the Innocor LCI Option include: LCI (Lung Clearance Index) and FRC (Functional Residual Capacity).

Device Story

LCI Option for Innocor is a software-based enhancement for the existing Innocor point-of-care pulmonary function system. It utilizes inert gas rebreathing (IGR) for initial wash-in of SF6 gas to determine Functional Residual Capacity (FRC), followed by multiple-breath washout (MBW) to measure cumulative expired volume required to clear the tracer gas. The device uses a pneumotachometer for flow measurement and a photoacoustic infrared gas analyzer for SF6 concentration. Operated by clinicians in point-of-care settings, the system processes respiratory data to calculate LCI, representing lung volume turnovers required for gas clearance. Output is used by healthcare providers to assess peripheral airway function and lung volume. The device benefits patients by providing non-invasive pulmonary diagnostics.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated using a calibration syringe to simulate lungs for FRC measurement and simulation models for LCI wash-out testing. Results demonstrate the device is as safe and effective as predicate devices.

Technological Characteristics

Compact, portable point-of-care device. Hardware identical to Innocor (K051907). Sensing: pneumotachometer for flow, photoacoustic infrared gas analyzer for SF6 concentration. Connectivity: standalone. Software: LCI calculation algorithm. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for use in children and adults for pulmonary function testing to measure Lung Clearance Index (LCI) and Functional Residual Capacity (FRC) via multiple-breath inert gas washout (MBW).

Regulatory Classification

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.

Predicate Devices

• Innocor (K051907)
• Cardiopulmonary Exercise Testing Option (K071911)
• Spirometry Option (K083879)
• COSMED QUARK (K001174)
• SensorMedics Vmax Series Pulmonary/Metabolic System (K942211)

Submission Summary (Full Text)

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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/Contact<br>Person | H. Carl Jenkins<br>The Wood Burditt Group<br>10 E. Scranton Ave., Suite 201<br>Lake Bluff, IL 60044<br>(ph) [phone] x 205<br>(fax) [phone]<br>(email) [e-mail] |
| Applicant | Innovision A/S<br>Lindvedvej 75<br>DK-5260 Odense S<br>Denmark |
| | Phone: [phone]<br>Fax: [phone]<br>[e-mail]<br>www.innovision.dk |
| Device Name | LCI Option for Innocor |
| Common Name | Pulmonary function test equipment |
| Classification | <b>LCI Option for Innocor - K102047</b><br>Calculator, pulmonary function data<br>Regulation Number: 21 CFR §868.1880<br>Product Code: BZC<br>Panel Code: Anesthesiology<br>Device Class: II |
| Legally Marketed<br>Predicate Devices | The LCI Option for Innocor is substantially equivalent in respect<br>to the intended use, design and method of operation to the<br>following legally marketed devices:<br><br>Predicate Device No. 1<br>Name: 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 for<br>non-invasive measurement of a) cardiac output (CO) and other<br>hemodynamic parameters utilizing inert gas rebreathing (IGR)<br>technology, b) metabolic parameters including oxygen uptake by<br>means of a breath-by-breath gas exchange method, c) spirometry<br>parameters by means of forced respiratory maneuvers, and<br>d) peripheral airway function by means of multiple-breath inert<br>gas washout. |

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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

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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 technological<br>characteristics<br>compared to predicate<br>devices | Comparison with predicate device Innocor with options<br>[K051907, K071911, and K083879]:<br><br>The hardware in the LCI Option for Innocor is identical to that<br>used in the predicate devices. The connection of the patient and<br>the operation of the device are similar in that the wash-in is<br>performed by rebreathing as in the basic Innocor (K051907), and<br>the wash-out is performed by breathing room air in an open-circuit<br>breath-by-breath measurement as in the Cardiopulmonary Exercise<br>Testing Option (K071911). The gas mixture is the same as that<br>used with Innocor and approved by the FDA as an integral part of<br>the device (K051907). Thus, only the software is different from<br>previous models.<br><br>Comparison with predicate device COSMED QUARK<br>[K001174]:<br><br>Both the LCI Option for Innocor and the COSMED QUARK<br>predicate device are indicated for use in pulmonary function<br>testing to measure the wash-out of a gas from the lungs during a<br>multiple-breath procedure in open-circuit mode. The LCI Option<br>for Innocor performs the same LCI functions as the COSMED<br>QUARK, by providing lung function measurements of FRC and<br>LCI from analysis of a wash-out curve. Although there are some<br>minor 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 LCI<br>are defined in the Becklake article as: Litres ventilation required to<br>wash 90% F.R.A. free of N2 / 90% F.R.A.<br>The LCI Option for Innocor employs a substantially equivalent<br>method of measuring LCI, using essentially the same indexes and<br>providing 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 simulate<br>the lungs has been compared with data from a simulation model of<br>an LCI wash-out test. Performance data demonstrates that the<br>hardware and software of the LCI Option for Innocor is as safe, as<br>effective, and performs as well as or better than the predicate<br>devices and thus that the device is substantially equivalent to the<br>predicate devices. |
| Compliance with | Except for the way the indicator gas is washed in and the way<br>FRC is determined, the LCI Option for Innocor has been<br>developed in accordance with the Official American Thoracic<br>Society/European Respiratory Society Statement: Pulmonary<br>Function Testing in Preschool Children, Am J Respir Crit Care<br>Med Vol 175. pp 1304-1345, 2007, Section 7: The Multiple-<br>Breath Inert Gas Washout Technique. |
| | The Statement includes the following remarks: |
| | MBW is performed routinely in preschool children in only<br>- a limited number of laboratories, presumably because<br>suitable equipment is not commercially available.<br>Several different inert marker gases with low solubility in |
| | blood and tissues can be used for MBW. The most well<br>known is nitrogen (N2), which can be washed out from the<br>lungs by letting the patient breathe pure oxygen (100%<br>O2). Other gases, such as argon (Ar), helium (He), or sulfur<br>hexafluoride (SF6), may also be used, but measuring these<br>gases may require expensive equipment, such as a mass<br>spectrometer. |

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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 [phone] or [phone] 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 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).

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

4. Indications for Use Statement

:

510(k) Number: Kn 10204

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