(23 days)
No
The summary describes standard physiological monitoring and impedance cardiography, with no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as a monitor for cardiac output and airway management, displaying physiological parameters. It does not provide treatment or modify body function.
Yes
The device is described as monitoring various physiological parameters such as cardiac output, stroke volume, heart rate, and pressures, and displaying waveforms. Monitoring these parameters allows healthcare professionals to assess a patient's condition, which is a diagnostic activity.
No
The device description explicitly states the system consists of an "ECOM CV4 Endotracheal Tube and an integrated ECOM CV4 Monitor," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- ECOM CV4 System Function: The ECOM CV4 System directly monitors physiological parameters (cardiac output, heart rate, blood pressure) within the patient's body using electrical signals applied to the tracheal mucosa. It does not analyze samples taken from the body.
The ECOM CV4 System is a monitoring device that provides real-time physiological data from the patient.
N/A
Intended Use / 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 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.
Product codes
DSB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal mucosa
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
Clinical Performance: The ECOM CV4 System performance was tested with clinical data and the results met the acceptance criteria.
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.
0
:
510(k) Summary - ECOM CV4 System
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Imagyn Medical Technologies, Inc.
1 Park Plaza, Suite 1100
Irvine, CA 92614 |
| Contact Person | Julie Powell
Vice President Quality Assurance / Regulatory Affairs
Imagyn Medical Technologies, Inc.
1 Park Plaza, Suite 1100
Irvine, CA 92614
Phone: 269 623 6836
Fax: 269 623 6836
E Mail: julie.powell@imagyn.com |
| Date Prepared | August 8, 2003 |
| Name | ECOM™ CV4 Endotracheal Cardiac Output Monitor |
| Classification
Names | Impedance plethysmograph |
| Device
Classification | Regulatory Class: II
Product Code: DSB
Classification Panels: Cardiovascular Device Panel
Regulation Number: 21 CFR 870.2770 |
| Predicate
Device(s) | Imagyn Medical Technologies, Inc.
ECOM Endotracheal Cardiac Output Monitor
510(k) number K021174
Clearance date April 29, 2003 |
1
| Performance
Standards | Performance standards have not been established by the FDA under section
514 of the Federal, Food, Drug and Cosmetic Act |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | 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. |
| 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 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. |
| Nonclinical
Performance | The ECOM CV4 System was tested and passed all required electrical safety,
ASTM, and biocompatibility testing. |
| Clinical
Performance | The ECOM CV4 System performance was tested with clinical data and the results
met the acceptance criteria. |
| Conclusion | The ECOM CV4 System is substantially equivalent to the 510(k) cleared
(K021174) ECOM System. |
2
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
3
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
4
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