INNOCOR

K051907 · Innovision A/S · DQK · Mar 2, 2006 · Cardiovascular

Device Facts

• Record ID: K051907
• Device Name: INNOCOR
• Applicant: Innovision A/S
• Product Code: DQK · Cardiovascular
• Decision Date: Mar 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

Innocor is indicated for the determination of a number of hemodynamic parameters. Cardiac Output (CO) is 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 and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation ≤ 95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to CO. As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures. With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters: Cardiac Output Arterial Oxygen Saturation Heart Rate Stroke Volume Lung Volume Cardiac Index Stroke Index Blood Pressures (Systolic, Diastolic, Mean Arterial) Systemic Vascular Resistance

Device Story

Innocor is a compact point-of-care device for hemodynamic monitoring. Input: inhaled inert gas concentrations measured over 3-4 respirations; pulse oximetry; optional NIBP cuff. Operation: utilizes inert gas rebreathing (IGR) technology to measure gas solubility differences, calculating pulmonary blood flow (PBF) as a proxy for cardiac output (CO). Device integrates pulse oximetry and NIBP modules to derive additional parameters like stroke volume, cardiac index, and systemic vascular resistance. Used in clinical settings by healthcare providers. Output: digital display of hemodynamic values. Clinical utility: provides non-invasive assessment of cardiac function and hemodynamic status, aiding clinical decision-making without invasive catheterization.

Clinical Evidence

Clinical testing demonstrated substantial equivalence to thermodilution cardiac output computers and the Direct Fick method. No specific sample sizes or p-values provided in the summary. Bench testing and clinical comparison data support the accuracy of the inert gas rebreathing technology for cardiac output and the integrated pulse oximetry/NIBP modules.

Technological Characteristics

Compact point-of-care device. Sensing: inert gas rebreathing (IGR) for CO, pulse oximetry for SpO2, NIBP cuff for blood pressure. Connectivity: standalone. Software: programmable diagnostic computer. Parameters calculated: CO, PBF, Stroke Volume, Cardiac Index, Stroke Index, Systemic Vascular Resistance.

Indications for Use

Indicated for determination of hemodynamic parameters including Cardiac Output, Arterial Oxygen Saturation, Heart Rate, Stroke Volume, Lung Volume, Cardiac Index, Stroke Index, Blood Pressures, and Systemic Vascular Resistance in patients. Contraindicated for patients with significant intrapulmonary shunt (arterial oxygen saturation > 95% required for PBF to equal CO).

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

• Thermodilution Cardiac Output Computers (American Edwards Laboratories) (K872529, K830892)
• Direct Fick Method (preamendment)
• MTS Option for the ESCORT II Monitor (K970763)
• Model 9303 Neonatal/Adult Vital Signs Monitor (K982776)
• SleepScreen and ApnoeScreen Cardio (K021138)
• Zoll M-Series (NIBP Option) (K032363)
• Clever TD-3018ATM Blood Pressure Monitor (K051703)

Submission Summary (Full Text)

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K051907 1/2

## 510(k) Summary

| Applicant | Innovision A/S<br>Lindvedvej 75<br>DK-5260 Odense S<br>Denmark |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Same |
| Device Name | Innocor™ |
| Common Name | Computer, diagnostic, programmable |
| Classification | Relevant Device Information: Class II<br>Panel Code: Cardiovascular<br>Product Code(s): DQK<br>Regulation: §870.1425 |
| | Innocor has been shown by clinical testing to be substantially<br>equivalent in respect to its intended use to measure cardiac<br>output to two predicate technologies: 1) Thermodilution Cardiac<br>Output Computers (American Edwards Laboratories) K872529<br>and K830892 and 2) the Direct Fick Method preamendment<br>calculation method. |
| Summary of Substantial<br>Equivalence | The pulse oximeter component in the Innocor has been shown to<br>be substantially equivalent to the<br>K970763 MTS Option for the ESCORT II Monitor<br>(Attachment 10A) K982776 Model 9303 Neonatal/Adult Vital Signs<br>Monitor (See Attachment 2D) K021138 SleepScreen and ApnoeScreen Cardio<br>(Attachment 10B) |
| | The NIBP component option in the Innocor has been shown to<br>be substantially equivalent to the K032363 Zoll M-Series (NIBP Option) K051703 Clever TD-3018ATM Blood Pressure Monitor |
| | Innocor is a compact point-of-care device intended to be used<br>for measurement of a) cardiac output (CO) utilizing inert gas<br>rebreathing (IGR) technology and b) other hemodynamic<br>parameters. |
| Device Description | Two Models will be made available initially in the U.S:<br>Innocor Innocor with NIBP option With the NIBP module option, the device will provide values for<br>the hemodynamic parameters included in the Indications for Use<br>below. |
| Intended Use and Indications | Innocor is indicated for the determination of a number of<br>hemodynamic parameters.<br>Cardiac Output (CO) is the principal measured parameter.<br>Utilizing inert gas rebreathing, Innocor measures the relative<br>levels of two inhaled gases of differing blood solubility over<br>approximately 3-4 respirations and calculates pulmonary blood<br>flow (PBF). In the absence of a significant intrapulmonary shunt<br>(arterial oxygen saturation ≤ 95% as measured by a pulse<br>oximeter incorporated in the Innocor), PBF is equal to CO.<br>As an optional accessory, Innocor includes a noninvasive Blood<br>Pressure (NIBP) monitoring system. This option provides<br>systolic, diastolic and mean arterial pressures.<br>With the NIBP option, Innocor provides values for the following<br>measured and calculated hemodynamic parameters:<br>Cardiac Output Arterial Oxygen Saturation Heart Rate Stroke Volume Lung Volume Cardiac Index Stroke Index Blood Pressures (Systolic, Diastolic, Mean Arterial) Systemic Vascular Resistance |

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Food and Drug Administration

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design with three stylized wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem.

9200 Corporate Boulevard Rockville MD 20850

MAR 2 2006

Innovision A/S c/o Mr. Richard O. Wood The Wood Burditt Group 1025 W. Everett Rd, Suite 100 Lake Forest, IL 60045

Re: K051907

Trade Name: Innocor Regulation Number: 21 CFR 870.1425 Regulation Name: Diagnostic Programmable Computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 13, 2005 Received: July 14, 2005

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 I least be advised that i Dri biboadse or our device complies with other requirements of the Act that I DA has made a decormination and Jointinistered by other Federal agencies. You must or any it catal statutes and regulations and limited to: registration and listing (21 Comply with an the Not 81equirements)(1); good manufacturing practice requirements as set CFN Fart 607), labeling (21 CFR Part 800); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (Declients on a sectibed in your Section 510(k) I mis icter will anow you to organ manxoning of substantial equivalence of your device to a legally prematication. The PDA mining of casification 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 If you desire specific advice 10. 900 [phone]. Also, please note the regulation entitled, Contact the Office of Oomphaller as (21 (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Bhimma 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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## Indications for Use

## 510(k) Number (if known): K051907

## Device Name: Innocor

Indications For Use: Innocor is indicated for the determination of a number of hemodynamic parameters.

> Cardiac Output (CO) is 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 and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation ≤ 95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to CC.

> As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures.

With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters:

- Cardiac Output
- Arterial Oxygen Saturation
- Heart Rate
- Stroke Volume
- Lung Volume
- Cardiac Index
- troke Index
- Blood Pressures (Systolic, Diastolic, Mean Arterial)
- ystemic Vascular Resistance
- Systemic Vascular Resistance Index

Prescription Use ਮ (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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K051907

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