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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the ECOM™ Endotracheal Cardiac Output Monitoring System. It outlines the device's description, intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical study reports.

The document primarily focuses on non-clinical performance testing and regulatory compliance for substantial equivalence. Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be extracted and an indication of what is not present:

Acceptance Criteria and Device Performance

The document does not explicitly state specific acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, precision) for cardiac output measurements. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "reported device performance" is described broadly in terms of functionality and safety.

Criterion Type (Anticipated)	Acceptance Criteria (As per document)	Reported Device Performance (As per document)
Cardiac Output Accuracy	Not specified numerically	"substantially equivalent to the predicate"
Cardiac Output Precision	Not specified numerically	"substantially equivalent to the predicate"
Safety	Not specified numerically	"safe and effective for the intended use"
Functionality	Not specified numerically	"calculates and displays 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."
Electr. Safety/Comp.	Compliance with standards	"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."
Biocompatibility	Compliance with standards	"patient contacting materials comply with the requirements of ISO 10993-1:2009."
Software Validation	Not specified numerically	Demonstrated by "Design verification testing, including software validation."

Study Details (Based on the provided text)

Sample size used for the test set and the data provenance:
- Not provided. The document mentions "Non-clinical bench testing" and "Design verification testing" but does not detail sample sizes for any specific test set, nor does it specify data provenance (country of origin, retrospective/prospective). This is a 510(k) summary, which often summarizes clinical evidence rather than providing raw study details.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document does not describe any study that involved human experts establishing ground truth for performance evaluation of the device's measurements. The focus is on technical compliance and equivalence.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Since no expert review or human-involved test set for clinical performance is detailed, no adjudication method is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The ECOM system is a monitoring device that provides physiological parameters (e.g., Cardiac Output). It does not appear to be an AI-driven image interpretation or diagnostic aid that would involve "human readers" or "AI assistance" in the typical sense of an MRMC study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, indirectly. The "Non-clinical bench testing" and "Design verification testing," including software validation, would represent standalone performance assessments of the device's algorithms and hardware without a human "in the loop" of the measurement calculation. However, the specific results in terms of accuracy or precision are only generally stated as "substantially equivalent."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for clinical performance. For the non-clinical tests, the "ground truth" would be established by reference standards or validated testing equipment for electrical safety, biocompatibility, and functional performance. For cardiac output, if a clinical study were performed (which is not detailed here), the ground truth would typically be a gold standard cardiac output measurement technique (e.g., thermodilution, Fick principle, or another validated invasive method). The document only states "substantial equivalence" to a predicate, implying that the predicate's performance is the benchmark.
The sample size for the training set:
- Not applicable/Not provided. The ECOM system is described as a monitoring device with specific algorithms for calculating physiological parameters. It is not presented as a machine learning or AI device that undergoes "training" in the conventional sense of deep learning models. Its algorithms are likely based on established physiological models and impedance cardiography principles.
How the ground truth for the training set was established:
- Not applicable/Not provided. As above, the concept of a "training set" and its "ground truth" is not relevant to the type of device and testing described in this 510(k) summary.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing and regulatory compliance, rather than detailing a specific clinical performance study with predefined acceptance criteria and robust statistical analysis often associated with direct performance claims for new technologies.

Summary

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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 MedicalTechnologies
510(k):	K032491

E. Device Description

6-1

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Resistance (SVR), Systemic Vascular Resistance Index (SVRI), and systolic, diastolic and mean blood pressures.

F. Intended Use / Indications for Use

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.

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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.

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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

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K131765

510(k) Number (if known):

Device Name: ECOM® Endotracheal Cardiac Output Monitor System

Indications for Use:

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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Regulation Number and Section

§ 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.