(186 days)
Not Found
No
The summary describes a system that uses impedance cardiography and arterial pressure signals to calculate 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 monitor intended for measuring cardiac output and other vital signs, which falls under diagnostic or monitoring functions, not therapeutic treatment.
Yes
The device monitors and displays various physiological parameters like Cardiac Output, Stroke Volume, Heart Rate, and blood pressures, which are used to evaluate or diagnose a patient's health status.
No
The device description explicitly states that the system consists of a monitor, an endotracheal tube, and various accessories, 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 System monitors cardiac output by impedance cardiography and provides airway management. It uses electrical signals applied to an endotracheal tube and an arterial pressure signal.
- No Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The measurements are taken directly from the patient's body using the endotracheal tube and an arterial pressure line.
Therefore, the ECOM Endotracheal Cardiac Output Monitor System is a medical device used for monitoring physiological parameters in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ECOM 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DSB
Device Description
The ECOM Endotracheal Cardiac Output Monitor System consists of a monitor, an endotracheal tube and various accessories. The system applies a high frequency, low amplitude electrical current to a series of electrodes applied to the endotracheal 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing demonstrated the ConMed ECOM Endotracheal Cardiac Output Monitor System is substantially equivalent to the predicate with regard to intended use, materials, technology, and performance. Design verification testing, including software validation, demonstrates the system complies with the applicable sections of IEC 60601-1:1988/A1:1991/A2:1995, IEC 60601-1-1:2000, IEC 60601-1-2:2001/A1:2004 and IEC 60601-1-4:2000. Material analysis demonstrates the patient contacting materials comply with the requirements of ISO 10993-1:2009.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) Summary of Safety and Effectiveness
ECOM™ Endotracheal Cardiac Output Monitoring System
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number ______________________________________________________________________________________________________________________________________________
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Establishment Registration: 1320894
B. Company Contact
Lisa Anderson Manager, Regulatory Affairs T: (315) 624-3371 F: (315) 624-3225
C. Device Name
Proprietary Name: Common Name: Classification Name: Regulation Number: Product Code: Regulatory Class: Panel:
ECOM™ Endotracheal Cardiac Output Monitor System Plethysmograph, impedance Impedance plethysmograph 870.2770 DSB = Cardiovascular
D. Predicate Device
| Device Name: | ECOM CV4 Endotracheal Cardiac Output Monitor |
|---|---|
| Company Name: | ConMed Corporation via acquisition of Imagyn Medical |
| Technologies | |
| 510(k): | K032491 |
E. Device Description
The ECOM Endotracheal Cardiac Output Monitor System consists of a monitor, an endotracheal tube and various accessories. The system applies a high frequency, low amplitude electrical current to a series of electrodes applied to the endotracheal 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
6-1
1
- Resistance (SVR), Systemic Vascular Resistance Index (SVRI), and systolic, diastolic and mean blood pressures.
F. Intended Use / Indications for Use
The ECOM 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 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.
G. Non-clinical Performance Testing
Non-clinical bench testing demonstrated the ConMed ECOM Endotracheal Cardiac Output Monitor System is substantially equivalent to the predicate with regard to intended use, materials, technology, and performance. Design verification testing, including software validation, demonstrates the system complies with the applicable sections of IEC 60601-1:1988/A1:1991/A2:1995, IEC 60601-1-1:2000, IEC 60601-1-2:2001/A1:2004 and IEC 60601-1-4:2000. Material analysis demonstrates the patient contacting materials comply with the requirements of ISO 10993-1:2009.
H. Substantial Equivalence
The differences between the predicate and the modified design do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the ConMed ECOM Endotracheal Cardiac Output Monitor System is safe and effective for the intended use and is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
ConMed Corporation Ms. Lisa Anderson Manager, Regulatory Affairs 525 French Road Utica, NY 13502
Re: K131765
:
Trade/Device Name: ECOM® Endotracheal Cardiac Output Monitor System Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: November 19, 2013 Received: November 20, 2013
Dear Ms. Anderson:
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.
3
Page 2 - Ms. Lisa Anderson
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); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Owen P. Faris -S
Bram D. Zuckerman for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K131765
510(k) Number (if known):
Device Name: ECOM® Endotracheal Cardiac Output Monitor System
Indications for Use:
The ECOM 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 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.
× Prescription Use (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 OF NEEDED) . . .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by
Owen P. Faris -S
Date: 2013.12.20
14:01:42 -05'00'
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