ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR

K032491 · Imagyn Medical Technologies, Inc. · DSB · Sep 4, 2003 · Cardiovascular

Device Facts

• Record ID: K032491
• Device Name: ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
• Applicant: Imagyn Medical Technologies, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Sep 4, 2003
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The ECOM CV4 (Endotracheal Cardiac Output Monitor) System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM Endotracheal Tube. The ECOM CV4 System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used. The ECOM CV4 System will display the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressures.

Device Story

System comprises ECOM CV4 endotracheal tube and monitor; inputs include high-frequency, low-amplitude electrical current applied via tube to tracheal mucosa; device measures resulting voltage/impedance; monitor also processes ECG and arterial pressure signals via external cables. System displays R-Wave, impedance waveforms, cardiac output (CO), stroke volume (SV), heart rate (HR), and blood pressures. Used in clinical settings for intubated patients; operated by clinicians. Output provides real-time hemodynamic monitoring to assist clinical decision-making during short-term airway management. Benefits include integrated airway and hemodynamic monitoring.

Clinical Evidence

Clinical performance tested with clinical data; results met acceptance criteria. Specific metrics not provided in summary.

Technological Characteristics

Impedance plethysmograph; utilizes high-frequency, low-amplitude electrical current. Components include endotracheal tube, monitor, tube cable, arterial pressure cable, ECG cable, and lead wire. Tested for electrical safety, ASTM standards, and biocompatibility.

Indications for Use

Indicated for patients requiring oral intubation for 24 hours or less who also require an arterial pressure line for monitoring.

Regulatory Classification

Identification

An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• ECOM Endotracheal Cardiac Output Monitor (K021174)

Submission Summary (Full Text)

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## 510(k) Summary - ECOM CV4 System

| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Imagyn Medical Technologies, Inc.<br>1 Park Plaza, Suite 1100<br>Irvine, CA 92614 |
| Contact Person | Julie Powell<br>Vice President Quality Assurance / Regulatory Affairs<br>Imagyn Medical Technologies, Inc.<br>1 Park Plaza, Suite 1100<br>Irvine, CA 92614<br>Phone: [phone]<br>Fax: [phone]<br>E Mail: [e-mail] |
| Date Prepared | August 8, 2003 |
| Name | ECOM™ CV4 Endotracheal Cardiac Output Monitor |
| Classification<br>Names | Impedance plethysmograph |
| Device<br>Classification | Regulatory Class: II<br>Product Code: DSB<br>Classification Panels: Cardiovascular Device Panel<br>Regulation Number: 21 CFR 870.2770 |
| Predicate<br>Device(s) | Imagyn Medical Technologies, Inc.<br>ECOM Endotracheal Cardiac Output Monitor<br>510(k) number K021174<br>Clearance date April 29, 2003 |

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| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Federal, Food, Drug and Cosmetic Act |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The ECOM CV4 System consists of an ECOM CV4 Endotracheal Tube and<br>an integrated ECOM CV4 Monitor. The ECOM CV4 Monitor includes a Tube<br>Cable, Arterial Pressure Cable, ECG Cable, ECG Lead Wire, and power<br>cordset. |
| | The ECOM CV4 System applies a high frequency, low amplitude electrical<br>current and measures the resulting voltage directly from the tracheal mucosa<br>by way of an ECOM CV4 Endotracheal Tube. The ECOM CV4 Monitor will<br>display the tube and surface R-Wave and the Impedance Waveforms as well<br>as the patient's Caridac Output (CO), Heart Rate (HR), Stroke Volume (SV),<br>Systolic and Diastolic Pressures. |
| Indications for<br>Use | The ECOM CV4 (Endotracheal Cardiac Output Monitor) System is intended<br>for the monitoring of cardiac output by impedance cardiography while<br>providing airway management by oral intubation with an ECOM Endotracheal<br>Tube. The ECOM CV4 System is indicated for use in patients who are<br>expected to be intubated for 24 hours or less and in whom an arterial pressure<br>line is used. |
| | The ECOM CV4 System will display the R-Wave Detection and the<br>Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke<br>Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressures. |
| Nonclinical<br>Performance | The ECOM CV4 System was tested and passed all required electrical safety,<br>ASTM, and biocompatibility testing. |
| Clinical<br>Performance | The ECOM CV4 System performance was tested with clinical data and the results<br>met the acceptance criteria. |
| Conclusion | The ECOM CV4 System is substantially equivalent to the 510(k) cleared<br>(K021174) ECOM System. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three lines representing its wings or feathers, and below that, three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Imagyn Medical Technologies, Inc. c/o Ms. Julie Powell Vice President, Quality Assurance Regulatory Affairs 1 Park Plaza, Suite 1100 Irvine, CA 92614

Re: K032491

> Trade Name: ECOM CV4 Endotracheal Cardiac Output Monitor Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II (two) Product Code: DSB Dated: August 8, 2003 Received: August 12, 2003

Dear Ms. Powell:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

Warning: The irregular tracheal cuff surface of the ECOM tracheal tube presents a potential for local pressure injury to the trachea. The safety of the ECOM tracheal tube for more than 24 hours use has not been established. The ECOM tracheal tube should not be inserted when a duration of intubation longer than 24 hours can be anticipated.

SEP - 4 2003

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Page 2 - Ms. Julie Powell

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If vour 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 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsma/dsmamain.html.

Sincerely yours,

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

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## 510(k) Number (if known): K0 3249 /

Device Name: ECOM CV4 Endotracheal Cardiac Output Monitor

Indications for Use:

The ECOM CV4 (Endotracheal Cardiac Output Monitor) System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM Endotracheal Tube. The ECOM System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used.

The ECOM CV4 System will display the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K032491

(Optional Format 3-10-98)
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