CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM

{0}------------------------------------------------ OCT 2 8 1999 K993245 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:<br>Name: | Alba Critical Care Ltd. | |------------------------|------------------------------------------------------------------------------------------------------| | Address: | Phoenix Crescent<br>Strathclyde Business Park<br>Bellshill<br>Lanarkshire ML4 3 NJ<br>Scotland<br>UK | | Telephone: | 44 1698 746699 | | Facsimile: | 44 1698 748474 | | Contact: | Ted Vander Wiede<br>Managing Director, Alba Critical Care Ltd. | | Date of summary: | 27th September 1999 | ## D | Trade Name: | Continuous Cardiac Output Pulmonary Artery<br>Catheter and Continuous Cardiac Output Monitor | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Pulmonary Artery Catheter and Cardiac Output<br>Monitor | | Classification Name: | Flow-directed catheter and Single-function, pre-<br>programmed diagnostic computer per 21 CFR<br>870.1240 and 870.1435 respectively | | Predicate Device: | The modified device is substantially equivalent to the<br>previously cleared Ami-MED Continuous Cardiac<br>Output Pulmonary Artery Catheter and Continuous<br>Cardiac Output Monitor, 510(k) number K925444 | | Device Description: | The Continuous Cardiac Output Pulmonary Artery<br>Catheter, (catalogue # TruCATH), is a six-lumen,<br>heparin-coated, polyvinyl chloride (PVC) flow-directed<br>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<br>K925544 | |---------------------------|--------------------| |---------------------------|--------------------| Page of of Device Name:___ ## INDICATIONS FOR USE STATEMENT 510(k) number (original): K925444- K993245 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)