(29 days)
Not Found
No
The description mentions a "microprocessor based computer" that calculates cardiac output based on a "thermodynamic principle of heat transfer." There is no mention of AI, ML, or any learning algorithms. The calculation appears to be based on a defined physical principle rather than a learned model.
No
The device is described as a diagnostic tool for assessing a patient's hemodynamic condition, not for treating a disease or condition.
Yes
The intended use explicitly states the system is "for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination," which describes a diagnostic function.
No
The device description clearly outlines both a physical catheter (truCATH) and a monitor (truCCOM), indicating it is a hardware-based system with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions." This involves direct interaction with the patient's circulatory system in vivo.
- Device Description: The description details a catheter inserted into the body and a monitor that interfaces with it to measure physiological parameters in vivo.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. While the distal port allows for venous blood sampling, the primary function and intended use are focused on in vivo measurements and interventions.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo.
N/A
Intended Use / Indications for Use
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also all ws for sampling of venous blood.
Product codes (comma separated list FDA assigned to the subject device)
DXG
Device Description
The Continuous Cardiac Ouptut Pulmonary Artery Catheter, (truCATH), is a six lumen heparin coated, polyvinyl chloride (PVC) flow directed Pulmonary Artery Catheter. Once placed the proximal extensions of the catheter are attached to the second part of the system, the monitor.
The Continous Cardiac Output Monitor, (truCCOM), is a microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output. The monitor calculates cardiac output based upon a thermodynamic principle of heat transfer using thermal power produced by the termal coil area on the Catheter. Alternatively the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.
The continuous cardiac output Pulmonary Artery Catheter and Continuous Cardiac Outoput monitor systems intended use is for the assessment of the patients haemodynamic condition though direct intra-cardiac (right heart) and pulmonary artery pressure monitoring, cardiac outut determination and for infusing solutions. The distal port on the catheter also allows for the sampling of veous blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-cardiac (right heart) and pulmonary artery
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)
The following outlines the testing performed, as a result of the risk analysis, to demonstrate substantial equivelance to the predicate device
Monitor
- Software Verification & -Validation
- In-vitro testing in Right Hand … Circulatory System .
- In-vivo testing in Swine Models t
The above test results confirmed the modified device met or exceeded the same specifications as that of the predicate device and is therefore substantially equivalent with respect to safety and efficacy to the predicate device
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
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).
0
JUL 2 2 2008
510(k) Summary
This summary information is being submitted in accordance with the requirments of
| 21 CFR 807.92(c) | ||
|---|---|---|
| Owner: | ||
| Name: | Omega Critical Care | |
| Address: | 2 Cairn Court | |
| West Nerston | ||
| East Kilbride | ||
| G74 4NB | ||
| United Kingdom | ||
| Telephone: | +44 1355 265733 | |
| Facsimile: | +44 1355 239094 | |
| Contact: | Alan Short, | |
| Director of Quality & Regulatory Affairs | ||
| Omega Critical Care | ||
| Date of Summary: | 19th June 2008 |
Device Information:
| Trade Name: | Continuous Cardiac Output Pulmonary
Artery Catheter and Continuous
Cardiac Output Monitor |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Pulmonary Artery Catheter and
Cardiac Output Monitor |
| Classification
Name: | Flow-directed catheter and single
function, pre-programmed diagnostic
computer per 21 CFR 870.1240 and
870.1435 respectively |
| Predicate Device: | The modified device is substanttially
equivalent to the previously cleared
Continuous Output Pulmonary Artery
Catheter and Continuous Output
Monitor, 510(k) number K993245 |
1
Device Description:
The Continuous Cardiac Ouptut Pulmonary Artery Catheter, (truCATH), is a six lumen heparin coated, polyvinyl chloride (PVC) flow directed Pulmonary Artery Catheter. Once placed the proximal extensions of the catheter are attached to the second part of the system, the monitor.
The Continous Cardiac Output Monitor, (truCCOM), is a microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output. The monitor calculates cardiac output based upon a thermodynamic principle of heat transfer using thermal power produced by the termal coil area on the Catheter. Alternatively the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.
The continuous cardiac output Pulmonary Artery Catheter and Continuous Cardiac Outoput monitor systems intended use is for the assessment of the patients haemodynamic condition though direct intra-cardiac (right heart) and pulmonary artery pressure monitoring, cardiac outut determination and for infusing solutions. The distal port on the catheter also allows for the sampling of veous blood.
Intended Use:
2
Comparison to Predicate Device:
The modifications in comparison to the previously cleared device are as follows (these modification do not affect the intended use of the device or alter the fundemental scientific technology of the device)
Monitor
- -User Interface Improvements
- -Re-formatting of history files
- -Enable analogue output
- Implementation of an updated equation for the calculation of cardiac output
- Optomisation of system response
- Modification of audible alarms to default enabled
- Correction of minor bugs .
The following outlines the testing performed, as a result of the risk analysis, to demonstrate substantial equivelance to the predicate device
Monitor
- Software Verification & -Validation
- In-vitro testing in Right Hand … Circulatory System .
- In-vivo testing in Swine Models t
The above test results confirmed the modified device met or exceeded the same specifications as that of the predicate device and is therefore substantially equivalent with respect to safety and efficacy to the predicate device
Summary of nonclinical tests:
Conclusion:
3
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2008
Omega Critical Care Limited c/o Mr. Lucio E. Jannetta Omega House 2 Cairn Court Nerston West East Kilbride Scotland G74 4NB
Re: K081776
Trade/Device Name: Continuous Cardiac Pulmonary Artery Catheter (truCATH & truCATH.ip) & Continuous Cardiac Output Monitor (truCCOM) Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function, preprogrammed diagnostic computer Regulatory Class: Class II Product Code: DXG Dated: June 5, 2008 Received: June 23, 2008
Dear Mr. Janetta:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerosale) w regard intent date of the Medical Device Amendments, or to conninered pror to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, devices that have boom require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 on may, therefore, mains. of the Act include requirements for annual registration, listing of general controls profice, labeling, and prohibitions against misbranding and adulteration.
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 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.
4
Page 2 – Mr. Lucio E. Jannetta
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 Fodcral 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. This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
comple
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Continuous Cardiac Output Pulmonary Artery Catheter (truCATH & truCATH.ip) & Continuous Cardiac Output Monitor (truCCOM)
The Continuous Cardiac Output Pulmonary Artery Catheter Indications for Use: and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also all ws for sampling of venous blood.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
VOR Over-The
(21 CFR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDR Office of Device Evaluation (ODE)
Q.mbe
ivision Sign-Off) sion of Cardiovascular Devices
510(k) Number K081776
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