CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR

K071911 · Innovision A/S · DQK · Sep 7, 2007 · Cardiovascular

Device Facts

• Record ID: K071911
• Device Name: CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
• Applicant: Innovision A/S
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It 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. With the cardiopulmonary exercise testing option, Innocor provides values for: Main metabolic parameters: Oxygen uptake Carbon dioxide excretion Expiratory minute ventilation Calculated/derived parameters: Oxygen uptake per kg Respiratory exchange ratio Alveolar ventilation Anatomical dead space (Fowler dead space) Tidal volume Respiratory rate End-tidal concentration of oxygen End-tidal concentration of carbon dioxide Expiratory quotient / ventilatory equivalent for oxygen Expiratory quotient / ventilatory equivalent for carbon dioxide And the following calculated parameters after an incremental exercise test: Anaerobic threshold Respiratory compensation Rest values Values at AT point Values at max exercise

Device Story

Innocor is a point-of-care system for non-invasive hemodynamic and metabolic monitoring. The Cardiopulmonary Exercise Testing (BbB) option measures respiratory flow and gas concentrations breath-by-breath using a pneumotachometer placed between a respiratory valve and the patient. Inputs include real-time respiratory flow and gas concentration data during ambient air breathing. The system processes these inputs to calculate metabolic parameters (VO2, VCO2, VE) and derived indices (e.g., anaerobic threshold, respiratory exchange ratio, dead space). Used in clinical settings by healthcare providers to assess cardiac and pulmonary function during exercise testing. Output is displayed for clinician review to evaluate patient exercise capacity and physiological response. Benefits include objective, non-invasive assessment of cardiopulmonary status.

Clinical Evidence

Bench testing only. The device demonstrated substantial equivalence to the predicate Ultima System (K061731) in its ability to measure metabolic parameters on a breath-by-breath basis.

Technological Characteristics

Point-of-care diagnostic system. Uses differential pressure pneumotachometer for respiratory flow measurement. Measures gas concentrations for metabolic analysis. Connectivity: Integrated option for Innocor platform. Software-based calculation of metabolic and respiratory parameters.

Indications for Use

Indicated for patients requiring objective, non-invasive assessment of cardiac and pulmonary function at rest and during exercise (e.g., incremental exercise testing on bicycle ergometer or treadmill). Provides metabolic and respiratory parameters including VO2, VCO2, and ventilation.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Innocor (K051907)
• Ultima System (K061731)

Submission Summary (Full Text)

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K071911

## 5. 510(k) Summary

SEP - 7 2007

| Date of Summary | 9 July 2007 | |
|-------------------|--------------------------------------------------------------|------------------------------------------------------------|
| Submitter/Contact | Richard O. Wood | |
| Person | The Wood Burditt Group | |
| | FDA Regulatory Counseling | |
| | 1025 W. Everett Rd., Suite 100 | |
| | Lake Forest, IL 60045 | |
| | (ph) [phone] x 203 | |
| | (fax) [phone] | |
| | (email) [e-mail] | |
| Applicant | Innovision A/S | Phone: [phone] |
| | Lindvedvej 75 | Fax: [phone] |
| | DK-5260 Odense S | [e-mail] |
| | Denmark | www.innovision.dk |
| Device Name | Cardiopulmonary Exercise Testing Option to | Innocor |
| | (referred to in this submission as "Cardiopulmonary Exercise | |
| | | Testing Option to Innocor," "Breath-by-Breath System," and |
| | "BbB System") | |
| Common Name | Cardiopulmonary Exercise Testing System | |
| Classification | | [Hemodynamic Measurements—Already Cleared K051907] |
| | Computer, diagnostic, programmable | |
| | Regulation Number: 21 CFR §870.1425 | |
| | Product Code: DQK | |
| | Panel Code: Cardiovascular | |
| | Device Class: IIa | |
| | | |
| | [Cardiopulmonary Exercise Testing Option] | |
| | Oxygen uptake computer | |
| | Regulation Number: 21 CFR §868.1730 | |
| | Product Code: BZL | |
| | Panel Code: Anesthesiology | |
| | Device Class: IIa | |

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| Legally Marketed | The Cardiopulmonary Exercise Testing Option to Innocor is |
|--------------------|-----------------------------------------------------------------|
| Predicate Devices | substantially equivalent in respect to the intended use, design |
| | and method of operation to: |
| | |
| | Predicate Device No. 1 |
| | Name: Innocor |
| | 510(k) number: K051907 |
| | Manufacturer: Innovision A/S, Denmark |
| | |
| | Predicate Device No. 2 |
| | Name: Ultima System |
| | 510(k) number: K061731 |
| | Manufacturer: Medical Graphics Corporation, MN |
| 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, and b) metabolic parameters |
| | including oxygen uptake by means of a breath-by-breath gas |
| | exchange method. |
| | The Breath-by-Breath option provides measurements of gas |
| | exchange parameters including oxygen uptake (VO2), carbon |
| | dioxide excretion (VCO2), ventilation (VE) and end-tidal gas |
| | concentrations plus a number of derived parameters. These |
| | parameters are determined by simultaneous measurements of |
| | the respiratory flow and gas concentrations when breathing |
| | ambient air. The respiratory flow is measured by means of a |
| | differential pressure type flowmeter (pneumotachometer) |
| | placed between the respiratory valve unit and the patient. |
| | The gas exchange calculations are carried out online for each |
| | breath between the rebreathing tests. This gives the |
| | opportunity to perform an incremental exercise test on a |
| | bicycle ergometer or treadmill and measure the progress of |
| | cardiac function, pulmonary function and gas exchange at |
| | the same time. |
| Intended Use and | A cardiopulmonary exercise testing option is available for |

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.

| Indications | Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It 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. With the cardiopulmonary exercise testing option, Innocor provides values for: |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Main metabolic parameters: |
| | Oxygen uptake |
| | Carbon dioxide excretion |
| | Expiratory minute ventilation |
| | Calculated/derived parameters: |
| | Oxygen uptake per kg |
| | Respiratory exchange ratio |
| | Alveolar ventilation |
| | Anatomical dead space (Fowler dead space) |
| | Tidal volume |
| | Respiratory rate |
| | End-tidal concentration of oxygen |
| | End-tidal concentration of carbon dioxide |
| | Expiratory quotient / ventilatory equivalent for oxygen |
| | Expiratory quotient / ventilatory equivalent for carbon dioxide |
| | And the following calculated parameters after an incremental exercise test: |
| | Anaerobic threshold |
| | Respiratory compensation |
| | Rest values |

:

.

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| Values at AT point | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Values at max exercise | |
| Performance Testing | The Cardiopulmonary Exercise Testing Option to Innocor<br>has been shown by bench testing to be substantially<br>equivalent in respect to its intended use to measure metabolic<br>parameters on a breath-by-breath basis to the legally<br>marketed predicate device Medical Graphics Ultima System,<br>K061731. |

:

:

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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2007

Innovision A/S c/o Mr. Richard O. Wood Sponsor Representative The Wood Burditt Group LLC 1025 Everett Road, Suite 100 Lake Forest, IL 60045

Re: K071911

Trade Name: Innocor, Models INN00400 and INN00500 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: August 29, 2007 Received: September 5, 2007

Dear Mr. Wood:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Richard O. Wood

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Bhimimao for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. Indications for Use

## 510(k) Number (if known): __ K ( 7/ 9/1

Device Name: Cardiopulmonary Exercise Testing Option to Innocor

Indications for Use:

A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-bybreath measurements of flow, oxygen uptake and carbon dioxide production. It 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. With the cardiopulmonary exercise testing option, Innocor provides values for:

Main metabolic parameters:

- * Oxygen uptake
- Carbon dioxide excretion
- · Expiratory minute ventilation

Calculated/derived parameters:

- Oxygen uptake per kg
- · Respiratory exchange ratio
- Alveolar ventilation
- · Anatomical dead space (Fowler dead space)
- · Tidal volume
- · Respiratory rate
- · End-tidal concentration of oxygen
- · End-tidal concentration of carbon dioxide
- · Expiratory quotient / ventilatory equivalent for oxygen
- · Expiratory quotient / ventilatory equivalent for carbon dioxide

And the following calculated parameters after an incremental exercise test:

- · Anaerobic threshold
- · Respiratory compensation
- " Rest values
- · Values at AT point
- · Values at max exercise

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)

B. Rammima

lylslon Sign-Off) Division of Cardlovascular Devices 510(k) Number

4. Indications for Use Statement

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