(23 days)
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.
The ECOM CV4 System consists of an ECOM CV4 Endotracheal Tube and an integrated ECOM CV4 Monitor. The ECOM CV4 Monitor includes a Tube Cable, Arterial Pressure Cable, ECG Cable, ECG Lead Wire, and power cordset.
The ECOM CV4 System applies a high frequency, low amplitude electrical current and measures the resulting voltage directly from the tracheal mucosa by way of an ECOM CV4 Endotracheal Tube. The ECOM CV4 Monitor will display the tube and surface R-Wave and the Impedance Waveforms as well as the patient's Caridac Output (CO), Heart Rate (HR), Stroke Volume (SV), Systolic and Diastolic Pressures.
The provided document describes the ECOM CV4 System, an Endotracheal Cardiac Output Monitor. However, the document (a 510(k) summary) focuses on regulatory clearance and substantial equivalence to a predicate device, rather than a detailed study proving performance against specific acceptance criteria.
The clinical performance section states: "The ECOM CV4 System performance was tested with clinical data and the results met the acceptance criteria." Unfortunately, the document does not specify what those acceptance criteria were, nor does it provide details about the clinical study itself.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT SPECIFIED | "met the acceptance criteria" |
Reasoning: The document explicitly states: "The ECOM CV4 System performance was tested with clinical data and the results met the acceptance criteria." However, it does not define what those acceptance criteria were (e.g., specific accuracy thresholds, precision values, sensitivity, specificity, etc.).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Cannot be determined from the provided text. The document only mentions "clinical data" was used but gives no details about the sample size, its origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Cannot be determined from the provided text. The document does not describe how ground truth was established, which experts were involved, or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Cannot be determined from the provided text. There is no information regarding any adjudication process for the test set.
5. 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
Not applicable/Cannot be determined. This device is an Endotracheal Cardiac Output Monitor, which outputs physiological measurements (Cardiac Output, Heart Rate, Stroke Volume, Pressures). It is not an AI-assisted diagnostic imaging system that involves human readers interpreting images. Therefore, a Multi-Reader Multi-Case (MRMC) study and "human readers improve with AI vs without AI assistance" are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The device itself performs the measurement and displays the output (CO, SV, HR, etc.). While a human monitors and uses this information, the "performance" described (measuring cardiac output) is inherent to the device's function, implying a standalone assessment of its measurement capabilities. However, specific standalone performance metrics (e.g., accuracy against a gold standard) are not provided in detail beyond "met the acceptance criteria."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Cannot be determined from the provided text. The document mentions "clinical data" but does not specify the ground truth methodology used to validate the ECOM CV4's measurements. For cardiac output monitors, ground truth typically involves a more invasive, established method (e.g., pulmonary artery catheter thermodilution) against which the new device's readings are compared. This information is absent.
8. The sample size for the training set
Not applicable/Cannot be determined from the provided text. The ECOM CV4 is described as measuring physiological parameters via impedance cardiography. It's not a machine learning/AI device in the modern sense that typically has distinct "training" and "test" sets of data for algorithm development. Its "performance" refers to the accuracy and reliability of its physiological measurements, which would be validated against a reference method rather than trained on a dataset.
9. How the ground truth for the training set was established
Not applicable/Cannot be determined from the provided text. See explanation for point 8.
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510(k) Summary - ECOM CV4 System
| 510(k)Summary | This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|---|---|
| Submitter | Imagyn Medical Technologies, Inc.1 Park Plaza, Suite 1100Irvine, CA 92614 |
| Contact Person | Julie PowellVice President Quality Assurance / Regulatory AffairsImagyn Medical Technologies, Inc.1 Park Plaza, Suite 1100Irvine, CA 92614Phone: 269 623 6836Fax: 269 623 6836E Mail: julie.powell@imagyn.com |
| Date Prepared | August 8, 2003 |
| Name | ECOM™ CV4 Endotracheal Cardiac Output Monitor |
| ClassificationNames | Impedance plethysmograph |
| DeviceClassification | Regulatory Class: IIProduct Code: DSBClassification Panels: Cardiovascular Device PanelRegulation Number: 21 CFR 870.2770 |
| PredicateDevice(s) | Imagyn Medical Technologies, Inc.ECOM Endotracheal Cardiac Output Monitor510(k) number K021174Clearance date April 29, 2003 |
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| PerformanceStandards | Performance standards have not been established by the FDA under section514 of the Federal, Food, Drug and Cosmetic Act |
|---|---|
| DeviceDescription | The ECOM CV4 System consists of an ECOM CV4 Endotracheal Tube andan integrated ECOM CV4 Monitor. The ECOM CV4 Monitor includes a TubeCable, Arterial Pressure Cable, ECG Cable, ECG Lead Wire, and powercordset. |
| The ECOM CV4 System applies a high frequency, low amplitude electricalcurrent and measures the resulting voltage directly from the tracheal mucosaby way of an ECOM CV4 Endotracheal Tube. The ECOM CV4 Monitor willdisplay the tube and surface R-Wave and the Impedance Waveforms as wellas the patient's Caridac Output (CO), Heart Rate (HR), Stroke Volume (SV),Systolic and Diastolic Pressures. | |
| Indications forUse | The ECOM CV4 (Endotracheal Cardiac Output Monitor) System is intendedfor the monitoring of cardiac output by impedance cardiography whileproviding airway management by oral intubation with an ECOM EndotrachealTube. The ECOM CV4 System is indicated for use in patients who areexpected to be intubated for 24 hours or less and in whom an arterial pressureline is used. |
| The ECOM CV4 System will display the R-Wave Detection and theImpedance Waveforms as well as the patient's Cardiac Output (CO), StrokeVolume (SV), Heart Rate (HR), Systolic and Diastolic Pressures. | |
| NonclinicalPerformance | The ECOM CV4 System was tested and passed all required electrical safety,ASTM, and biocompatibility testing. |
| ClinicalPerformance | The ECOM CV4 System performance was tested with clinical data and the resultsmet the acceptance criteria. |
| Conclusion | The ECOM CV4 System is substantially equivalent to the 510(k) cleared(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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
Page 1 of 1
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K032491
(Optional Format 3-10-98)
Prescription Use Only
§ 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.