ECOM™ Cardiac Output Monitoring System

K172196 · Ecom Medical, Inc. · DSB · Sep 19, 2017 · Cardiovascular

Device Facts

• Record ID: K172196
• Device Name: ECOM™ Cardiac Output Monitoring System
• Applicant: Ecom Medical, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Sep 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The ECOM Cardiac Output Monitoring System is intended for the monitoring of cardiac output by impedance cardiography. The ECOM System displays 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. 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 with the 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 Double Lumen Endobronchial Tube is used to isolate the left lung of a patient for surgery, one lung ventilation or one lung anesthesia. The ECOM Endobronchial Tube is indicated for use in thoracic surgery, bronchspirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. The tube allows isolation and selective insufflation or deflation of either lung.

Device Story

System monitors cardiac output via impedance cardiography; utilizes high-frequency, low-amplitude electrical current applied to electrodes on endotracheal/endobronchial tubes. Inputs include impedance signals from tube electrodes and arterial pressure signals. System calculates and displays CO, CI, SV, SVV, HR, SVR, SVRI, and blood pressures. Used in clinical settings (e.g., surgery) by clinicians; provides real-time hemodynamic data to assist in patient management and airway control. Double-lumen tube design allows selective lung isolation/ventilation. Benefits include integrated airway management and hemodynamic monitoring.

Clinical Evidence

Bench testing only. Design verification confirmed system monitors and displays R-Wave detection, impedance waveforms, and hemodynamic parameters (CO, SV, HR, BP). Material analysis confirmed compliance with ISO 10993-1:2009.

Technological Characteristics

Impedance plethysmograph; high-frequency, low-amplitude electrical current sensing. Patient-contacting materials compliant with ISO 10993-1:2009. System includes monitor and double-lumen endobronchial tubes. Connectivity via arterial pressure line integration.

Indications for Use

Indicated for patients expected to be intubated for 24 hours or less requiring arterial pressure monitoring; also indicated for thoracic surgery, one-lung ventilation/anesthesia, and bronchspirometry requiring lung isolation.

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 Cardial Output Monitor System (K131765)
• Well Lead Endobronchial Tubes (K092886)

Submission Summary (Full Text)

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Public Health Service

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

September 19, 2017

ECOM Medical, Inc., % Cheryl Blake Regulatory Affairs 27392 Capricho Mission Viejo, California 92692

Re: K172196

Trade/Device Name: ECOM™ Cardiac Output Monitoring System Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Additional Product Codes: CBI Dated: July 22, 2017 Received: July 25, 2017

Dear Cheryl Blake:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hillebrenner

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) K172196

Device Name ECOM Cardiac Output Monitoring System

#### Indications for Use (Describe)

The ECOM Cardiac Output Monitoring System is intended for the monitoring of cardiac output by impedance cardiography.

The ECOM System displays 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.

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 with the 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 Double Lumen Endobronchial Tube is used to isolate the left lung of a patient for surgery, one lung ventilation or one lung anesthesia. The ECOM Endobronchial Tube is indicated for use in thoracic surgery, bronchspirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. The tube allows isolation and selective insufflation or deflation of either lung.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) Summary of Safety and Effectiveness

# ECOM™ Cardiac Output Monitoring System

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ECOM Medical, Inc. is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K172196 as of September 14, 2017.

#### A. Submitter

ECOM Medical, Inc 27127 Calle Arroyo, Suite 1905 San Juan Capistrano, CA 92576 USA

Establishment Registration: 13010770019

#### B. Applicant Correspondent

Cheryl Blake Regulatory Consultant 27392 Capricho Mission Viejo, CA 92692 [e-mail] 949-285-3517

#### C. Device Name

| Proprietary Name: | ECOM™ Cardiac Output Monitoring System |
|----------------------|----------------------------------------|
| Common Name: | Plethysmograph, impedance |
| Classification Name: | Impedance plethysmograph |
| Regulation Number: | 870.2770 |
| Product Code: | DSB |
| Regulatory Class: | II |
| Panel: | Cardiovascular |

#### D. Predicate Device

| Primary Device Name: | ECOM Endotracheal Cardial Output Monitor System |
|------------------------|---------------------------------------------------------|
| Company Name: | ECOM Medical via acquisition of ECOM division of Conmed |
| 510(k): | K131765 |
| Secondary Device Name: | Well Lead Endobronchial Tubes |
| Company Name: | Well Lead Medical Device Instruments Ltd. |
| 510(k): | K092886 |

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## E. Device Description

The ECOM Cardiac Output Monitor System consists of a monitor, and various accessories. The line extension of the ECOM Double Lumen Endobronchial Tube to the systems line of Endotrachel tubes continues to apply a high frequency. low amplitude electrical current to a series of electrodes applied to the endobronchial tube. The resulting signals, when used in conjunction with an arterial pressure signal, allow for the calculation and display of Cardiac Output (CO), Cardiac Input (CI), Stroke Volume (SV), Stroke Volume Variation (SVV), Heart Rate (HR), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), and systolic, diastolic and mean blood pressures. No changes have been made to the monitor system in K131765 or the endobronchial tube design in K092886.

## F. Intended Use / Indications for Use

The ECOM Cardiac Output Monitoring System is intended for the monitoring of cardiac output by impedance cardiography.

The ECOM System displays 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.

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 with the 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 Double Lumen Endobronchial Tube is used to isolate the left lung of a patient for surgery, one lung ventilation or one lung anesthesia. The ECOM Endobronchial Tube is indicated for use in thoracic surgery, bronchspirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. The tube allows isolation and selective insufflation or deflation of either lung.

### G. Non-clinical Performance Testing

Non-clinical bench testing demonstrated the ECOM Endobronchial Cardiac Output Monitor System is substantially equivalent to the predicate with regard to intended use, materials, technology, and performance of the monitoring. Design verification testing, demonstrates the system, using the previously cleared monitor and software, monitors and displays 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. Material analysis demonstrates the patient contacting materials comply with the requirements of ISO 10993-1:2009.

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## H. Substantial Equivalence

The differences between the predicate and the new tube design do not raise any new risks of safety or efficacy. No changes have been made to the devices represented in K131765 and K092886. No changes have been made to the endobronchial tube design and only IFU has been updated to include the endobronchial tube supporting information. Additional supporting information per this premarket submission confirms that the ECOM Endobronchial Cardiac Output Monitor System is safe and effective for the intended use and is substantially equivalent to the predicate devices.