(60 days)
No
The summary describes a system that uses impedance cardiography and arterial pressure signals to calculate and display physiological parameters. There is no mention of AI or ML in the intended use, device description, or performance studies. The calculations appear to be based on established physiological principles and signal processing, not AI/ML algorithms.
No.
The device is described as a monitoring system that calculates and displays various cardiac parameters; it does not mention any direct therapeutic action or treatment.
Yes
The ECOM Cardiac Output Monitoring System is intended for the monitoring of cardiac output and displays information such as R-Wave Detection, Impedance Waveforms, Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure, which are used to assess a patient's physiological status and guide medical management.
No
The device description explicitly states the system consists of a "monitor, and various accessories" and an "endobronchial tube," indicating the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ECOM Cardiac Output Monitoring System measures physiological parameters directly from the patient's body using impedance cardiography and arterial pressure signals. It involves applying electrical current and monitoring the resulting signals.
- No Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient.
The device is a monitoring system that measures physiological parameters in vivo (within the living body).
N/A
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.
Product codes
DSB, CBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
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.(b)
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.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it, and an abstract symbol in the center. The symbol resembles a stylized human figure or bird in flight, composed of three overlapping profiles facing to the right.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 cherylblake@cox.net 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.