(30 days)
No
The description focuses on traditional thermodynamic principles and microprocessor-based calculations, with no mention of AI or ML terms or concepts.
No.
The device is used for monitoring and assessment of a patient's haemodynamic condition, not for treating a condition.
Yes
The device is described as assessing a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, and cardiac output determination. This information helps in understanding a patient's physiological state, which is a key aspect of diagnosis.
No
The device description clearly outlines both a physical catheter (TruCATH) and a physical 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 is for assessing a patient's hemodynamic condition through direct pressure monitoring, cardiac output determination, and infusing solutions. While it allows for sampling of venous blood, the primary function is not to perform tests on the blood sample to diagnose or monitor a condition.
- Device Description: The device is a catheter and a monitor that works together to measure physiological parameters (pressure and cardiac output) in vivo (within the patient's body). It uses a thermodynamic principle for measurement, not a chemical or biological reaction on a sample.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or analysis of a biological sample outside the body, which are hallmarks of IVD devices.
The blood sampling capability is a secondary function and doesn't make the entire system an IVD. The core function is direct physiological measurement within the patient.
N/A
Intended Use / Indications for Use
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system's intended use is for the assessment of a patient's 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 allows for sampling of venous blood.
Product codes
74 DYG, 74 KFN
Device Description
The Continuous Cardiac Output Pulmonary Artery Catheter, (catalogue # 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 Continuous Cardiac Output Monitor, (catalogue # TruCCOM), is a microprocessor-based computer which, when interfaced with the TruCATH, continuously calculates and displays cardiac output. The Monitor calculates cardiac output based on the thermodynamic principle of heat transfer using thermal power produced by the thermal 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac (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)
a) Catheter
- i. Functional Bench Testing
- ii. Functional and visual testing
- iii. Pull test
b) Monitor - i. Electromagnetic compatibility testing
- ii. Software validation
The above test results confirmed that the modified Conclusion: device met the same specifications as the predicate device, and is therefore substantially equivalent with respect to safety and effectiveness to the predicate device.
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
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
0
OCT 2 8 1999
Attachment 4
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92( c ). Submitted I
| Submitted by:
| Name: | Alba Critical Care Ltd. |
|---|---|
| Address: | Phoenix Crescent |
| Strathclyde Business Park | |
| Bellshill | |
| Lanarkshire ML4 3 NJ | |
| Scotland | |
| UK | |
| Telephone: | 44 1698 746699 |
| Facsimile: | 44 1698 748474 |
| Contact: | Ted Vander Wiede |
| Managing Director, Alba Critical Care Ltd. | |
| Date of summary: | 27th September 1999 |
D
| 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 substantially equivalent to the
previously cleared Ami-MED Continuous Cardiac
Output Pulmonary Artery Catheter and Continuous
Cardiac Output Monitor, 510(k) number K925444 |
| Device Description: | The Continuous Cardiac Output Pulmonary Artery
Catheter, (catalogue # TruCATH), is a six-lumen,
heparin-coated, polyvinyl chloride (PVC) flow-directed
Pulmonary Artery Catheter. Once placed, the proximal |
Alba Critical Care Ltd Special 510(k): Device Modification
1
extensions of the catheter are attached to the second part of the system, the Monitor. The Continuous Cardiac Output Monitor, (catalogue # TruCCOM), is a microprocessor-based computer which, when interfaced with the TruCATH, continuously calculates and displays cardiac output. The Monitor calculates cardiac output based on the thermodynamic principle of heat transfer using thermal power produced by the thermal 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. Intended Use: The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system's intended use is for the assessment of a patient's 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 allows for sampling of venous blood. Comparison to Predicate Device: The modifications in comparison with the previously cleared device are as follows (these modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device): a) Catheter i. Re-position the heat transfer device (HTD) to assist the user in correctly positioning the HTD. ii. Change to a more flexible material for the extension tubes. iii. Change the solvent used to bond the luer locks to provide a better bond. b) Monitor i. Change in mechanical display ii. Changes in user interface software These changes improved the clecromagnetic compatibility (EMC) performance of the monitor.
2
Summary of non-Clinical Tests: The following outlines the testing performed, as a result of the risk analysis, to demonstrate substantial equivalence to the predicate device: a) Catheter
- i. Functional Bench Testing
- ii. Functional and visual testing
- iii. Pull test
- b) Monitor
- i. Electromagnetic compatibility testing
- ii. Software validation
The above test results confirmed that the modified Conclusion: device met the same specifications as the predicate device, and is therefore substantially equivalent with respect to safety and effectiveness to the predicate device.
Alba Critical Care Ltd Special 510(k): Device Modification
3
DEPARTMENT OF HEALTII & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.
OCT 2 8 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ted Vander Wiede Managing Director Alba Critical Care Limited Phoenix Crescent Strathclyde Business Park Bellshill SCOTLAND ML4 3NJ
Re : K993245 Continuous Cardiac Output Pulmonary Artery Catheter and Continous Cardiac Output Monitor Regulatory Class: II (Two) Product Code: 74 DYG, 74 KFN Dated: September 27, 1999 Received: September 28, 1999
Dear Mr. Vander Wiede
We have reviewed your Section 510(k) 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
4
Page 2 - Mr. Ted Vander Wiede
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
A. A. A. Carlowshi.
J Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| 510(k) Number (if known): | K993245
K925544 |
| --------------------------- | -------------------- |
|---|
Page of of
Device Name:___
INDICATIONS FOR USE STATEMENT
510(k) number (original): K925444-
Device Name: Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor
Indications For Use:
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system's intended use is & croster of earler and continue haemodynamic condition through direct intracardiac (right beart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also allows for sampling of venous blood.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K985444 K993245
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)