(65 days)
Not Found
No
The description details standard signal processing and a "proprietary algorithm called the nomogram" for calculations, but does not mention any AI or ML techniques.
No
The device provides real-time information for monitoring purposes and feedback on the effect of therapeutic interventions, but it does not directly perform a therapeutic function.
Yes
The device provides clinicians with "real-time information about left-ventricular blood flow" and "beat-to-beat data on cardiovascular status and circulating blood volume," which is used to monitor and provide feedback on the effect of therapeutic interventions. This function of gaining information to understand a patient's physiological state falls under the definition of a diagnostic device.
No
The device description explicitly lists hardware components including a monitor, patient interface cable, and a probe, which are essential for its function.
Based on the provided information, the CardioQ cardiac output and fluid status monitoring system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- CardioQ Function: The CardioQ system uses esophageal Doppler ultrasound to directly measure blood flow in the descending thoracic aorta within the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes monitoring left-ventricular blood flow and cardiovascular status in real-time within a clinical setting, not the analysis of biological samples.
Therefore, the CardioQ is an in vivo diagnostic and monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CardioQ cardiac output and fluid status monitoring system is designed to provide clinicians with real-time information about left-ventricular blood flow. The CardioQ is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The CardioQ offers the anesthetist and intensive care physician with beat-to-beat data on cardiovascular status and circulating blood volume, providing immediate feedback on the effect of any therapeutic intervention.
Product codes
74 DPW, 74 DPT, 74 DSA
Device Description
The CardioQ cardiac output and fluid status monitoring system is designed to provide clinicians with real-time information about left-ventricular blood flow. The CardioQ is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The CardioQ offers the anesthetist and intensive care physician with beat-to-beat data on cardiovascular status and circulating blood volume, providing immediate feedback on the effect of any therapeutic intervention.
The CardioQ system employs esophageal Doppler using 4 MHz continuous wave ultrasound to monitor and quantify the blood flow in the descending thoracic aorta, displaying this data as a maximum velocity curve, a velocity spectrum and derived measurements. Thus, real-time information about cardiac function and haemodynamic status, in particular flow, is displayed continuously.
The CardioQ system transmits the 4 MHz ultrasonic 'carrier' signal from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. Blood flow away from the probe results in frequencies less than 4 MHz being present in the received signal. Conversely, any reverse flow will produce frequencies higher than the carrier.
The received signal is first demodulated, such that those frequencies corresponding to the blood flow are extracted and displayed as a real-time velocity spectrum. The spectrum displays the distribution of red blood cell velocities at a given point in time, i.e. a histogram of velocities over time. Thus, the brightness at any point in the spectrum is directly proportional to the number of red blood cells traveling at a given velocity at a given time in the cardiac cycle.
The CardioQ automatically traces the maximum velocity of the spectrum at each time point. By calculating the area under this maximum-velocity curve during systole, a beat-to-beat value for Stroke Distance (SD) is given, being the distance a column of blood moves in the aorta during systole. Using a proprietary algorithm called the nomogram, the CardioQ estimates Stroke Volume (SV) using the measured SD and the size and age of the patient. The Stroke Volume is the volume of blood output by the heart during systole. Since the machine automatically calculates the patient's heart rate (HR) from the spectrum, it can also provide a beat-to-beat measurement of Cardiac Output (SV*HR). Other parameters calculated include:
- . Peak Velocity (PV) - highest blood velocity recorded during systole
- Mean Acceleration (MA) acceleration of the blood at the beginning of systole ●
- Corrected Flow Time (FTc) systolic flow time (normalized to 60 bpm) .
- Cardiac Index (CI) cardiac output normalized to body surface area o
- Minute Distance (MD) a linear surrogate for cardiac output, being the distance a . column of blood moves in the aorta in one minute
The CardioQ Cardiac Output and Fluid Status Monitoring System is comprised of the following components:
CardioQ monitor
Esophageal Doppler monitor (including power cord) which generates and processes the transmitted and received ultrasound signals, displays the resulting velocity spectrum and calculates the associated cardiac parameters. It is connected to the probe via the patient interface cable. The monitor displays the waveform and numerical data on a 10.4" color TFT LCD screen, which also provides the user interface and 'help' text. The monitor is operated by a large rotary 'encoder' knob and six 'soft' buttons whose function depends on the current screen mode. The monitor operates from a 100 – 240V A.C. supply.
Patient Interface Cable
6' 3" long interconnect cable between the CardioQ monitor and probe, providing signal amplification and electrical isolation.
CardioQ probe
Esophageal Doppler monitor probe is placed orally and inserted to a depth of 35 – 40 cm. (approx. 14" - 16") for insonation of the descending thoracic aorta at the 60 thoracic vertebra (approximately). The CardioQ probe is the only component in contact with the patient and is manufactured with an outer insulating cover of medical grade silicone rubber. The probe is flexible and has a shaft diameter of 17 French (~5.5 mm, approx. 0.22"). The probe is supplied sterile and is for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Esophageal Doppler using 4 MHz continuous wave ultrasound
Anatomical Site
left-ventricular, descending thoracic aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians, clinical setting, patients are under general anesthesia or are sedated in the intensive care unit, anesthetist and intensive care physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
AUG - 6 2003
K031706
page 1 of 3
CardioQ
CARDIAC OUTPUT AND FLUID STATUS MONITORING SYSTEM
Appendix 2A
510(k) SUMMARY
(1) Submitter's information
| Name: | Deltex Medical Limited |
|---|---|
| Address: | Terminus Road |
| Chichester | |
| West Sussex | |
| PO19 8TX | |
| U.K. | |
| Official Correspondent: | Lawrence Brookfield - Quality Assurance & |
| Regulatory Affairs Manager | |
| Telephone: | 011 44 1243 523174 |
| Fax: | 011 44 1243 532534 |
May 29, 2003 Date prepared:
(2) Device Identification
| Proprietary name: | CardioQ |
|---|---|
| Common/usual name: | Cardiac Output and Fluid Status Monitoring System |
| Classification name: | Cardiovascular blood flow-meter |
(3) Identification of predicate devices
The CardioQ is substantially equivalent to the following previously cleared devices:
Deltex Medical Esophageal Doppler Cardiac Function Monitor - 510(k) No. K951369
Arrow International Hemosonic 100 Cardiac Output Monitor (originally approved as the Sometec, Inc. DYNEMO 3000) - 510(k) No. K972798
Appendix 2A
1
(4) Device Description and Intended Use
The CardioQ cardiac output and fluid status monitoring system is designed to provide clinicians with real-time information about left-ventricular blood flow. The CardioQ is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The CardioQ offers the anesthetist and intensive care physician with beat-to-beat data on cardiovascular status and circulating blood volume, providing immediate feedback on the effect of any therapeutic intervention.
The CardioQ system employs esophageal Doppler using 4 MHz continuous wave ultrasound to monitor and quantify the blood flow in the descending thoracic aorta, displaying this data as a maximum velocity curve, a velocity spectrum and derived measurements. Thus, real-time information about cardiac function and haemodynamic status, in particular flow, is displayed continuously.
The CardioQ system transmits the 4 MHz ultrasonic 'carrier' signal from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. Blood flow away from the probe results in frequencies less than 4 MHz being present in the received signal. Conversely, any reverse flow will produce frequencies higher than the carrier.
The received signal is first demodulated, such that those frequencies corresponding to the blood flow are extracted and displayed as a real-time velocity spectrum. The spectrum displays the distribution of red blood cell velocities at a given point in time, i.e. a histogram of velocities over time. Thus, the brightness at any point in the spectrum is directly proportional to the number of red blood cells traveling at a given velocity at a given time in the cardiac cycle.
The CardioQ automatically traces the maximum velocity of the spectrum at each time point. By calculating the area under this maximum-velocity curve during systole, a beat-to-beat value for Stroke Distance (SD) is given, being the distance a column of blood moves in the aorta during systole. Using a proprietary algorithm called the nomogram, the CardioQ estimates Stroke Volume (SV) using the measured SD and the size and age of the patient. The Stroke Volume is the volume of blood output by the heart during systole. Since the machine automatically calculates the patient's heart rate (HR) from the spectrum, it can also provide a beat-to-beat measurement of Cardiac Output (SV*HR). Other parameters calculated include:
- . Peak Velocity (PV) - highest blood velocity recorded during systole
- Mean Acceleration (MA) acceleration of the blood at the beginning of systole ●
- Corrected Flow Time (FTc) systolic flow time (normalized to 60 bpm) .
2
- Cardiac Index (CI) cardiac output normalized to body surface area o
- Minute Distance (MD) a linear surrogate for cardiac output, being the distance a . column of blood moves in the aorta in one minute
The CardioQ Cardiac Output and Fluid Status Monitoring System is comprised of the following components:
CardioQ monitor
Esophageal Doppler monitor (including power cord) which generates and processes the transmitted and received ultrasound signals, displays the resulting velocity spectrum and calculates the associated cardiac parameters. It is connected to the probe via the patient interface cable. The monitor displays the waveform and numerical data on a 10.4" color TFT LCD screen, which also provides the user interface and 'help' text. The monitor is operated by a large rotary 'encoder' knob and six 'soft' buttons whose function depends on the current screen mode. The monitor operates from a 100 – 240V A.C. supply.
Patient Interface Cable
6' 3" long interconnect cable between the CardioQ monitor and probe, providing signal amplification and electrical isolation.
CardioQ probe
Esophageal Doppler monitor probe is placed orally and inserted to a depth of 35 – 40 cm. (approx. 14" - 16") for insonation of the descending thoracic aorta at the 60 thoracic vertebra (approximately). The CardioQ probe is the only component in contact with the patient and is manufactured with an outer insulating cover of medical grade silicone rubber. The probe is flexible and has a shaft diameter of 17 French (~5.5 mm, approx. 0.22"). The probe is supplied sterile and is for single-use only.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "U.S. Department of Health & Human Services USA". The symbol in the center consists of three parallel, curved lines that resemble a bird in flight. The logo is black and white.
AUG - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lawrence Brookfield Quality Assurance & Regulatory Affaires Manager Deltex Medical Terminus Road Chichester, West Sussex United Kingdom PO19 8TX
Re: K031706 Cardio()" cardiac output and fluid status monitoring system Dated: May 29, 2003 Received: June 2, 2003 Regulatory Class: II 21 CFR 870.2100/Procode: 74 DPW 21 CFR 870. 2120/Procode: 74 DPT 21 CFR 870.2900/Procode: 74 DSA
Dear Mr. Brookfield:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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. 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.
This determination of substantial equivalence applies to the following transducers intended for use with the CardioQ™ cardiac output and fluid status monitoring system, as described in your premarket notification:
4
Page 2 - Mr. Lawrence Brookfield
Fransducer Model Number
CardioQ Probe 9650-7001
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting vour 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 (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.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices. requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594
5
Page 3 - Mr. Lawrence Brookfield
- Also, please note the regulation entitled. "Misbranding by reference to premarket notification'' (21 CFR Part 807.97) - Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at us Internet address **http://www.fda.gov/cdrh/dsmamain.html``.
If you have any questions regarding the content of this letter, please contact Frank Lacy at (301) 443-8517, ext. 157.
Sincerely yours,
N. Deel Tule
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
Page 1 of 1
Appendix 3C
510(k) number (if known):
Unknown - not yet assigned by FDA.
Device name:
CardioQ™ cardiac output and fluid status monitoring system
Indications for use of the device:
The CardioQ cardiac output and fluid status monitoring system is designed to provide clinicians with real-time information about left-ventricular blood flow. The CardioQ is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The CardioQ offers the anesthetist and intensive care physician with beat-to-beat data on cardiovascular status and circulating blood volume, providing immediate feedback on the effect of any therapeutic intervention.
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
ver-the-counter use
510(k) Number K031704
(Optional format 1-2-96)
7
CARDIOQ (SYSTEM)
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | |||||||||
| Transesophageal | N | |||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | ||||||||||
| Additional Comments: THE CARDIOQ MONITORS CARDIAC FUNCTION | ||||||||||
| BY MEASURING BLOOD FLOW IN THE DESCENDING AORTA | ||||||||||
| WITH A TRANSESOPHAGEAL CWD PROBE. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
NAGM
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
Division of Cardiovascular De
510(k) Number F-3