CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM

K081776 · Omega Critical Care Limited · DXG · Jul 22, 2008 · Cardiovascular

Device Facts

• Record ID: K081776
• Device Name: CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
• Applicant: Omega Critical Care Limited
• Product Code: DXG · Cardiovascular
• Decision Date: Jul 22, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended 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.

Device Story

System comprises truCATH (six-lumen, heparin-coated PVC flow-directed pulmonary artery catheter) and truCCOM (microprocessor-based monitor). Device measures cardiac output via thermodynamic heat transfer principle using thermal coil on catheter; also supports intermittent cardiac output measurement via injectate. Used in clinical settings for hemodynamic monitoring; operated by clinicians. Monitor processes thermal signals to calculate cardiac output; displays results and pressure data. Modifications include updated calculation equations, improved user interface, history file re-formatting, and enabled analog output. System provides real-time hemodynamic data to assist clinicians in patient management and therapeutic decision-making.

Clinical Evidence

Bench testing and in-vivo animal testing performed. Includes software verification and validation, in-vitro testing in a simulated circulatory system, and in-vivo testing in swine models. Results confirmed the modified device met or exceeded predicate device specifications.

Technological Characteristics

Six-lumen heparin-coated PVC flow-directed pulmonary artery catheter; microprocessor-based monitor. Thermodynamic heat transfer sensing principle. Connectivity includes analog output. Software-based calculation of cardiac output. Sterilization method not specified.

Indications for Use

Indicated for patients requiring hemodynamic assessment via direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and infusion of solutions. Includes venous blood sampling capability.

Regulatory Classification

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.

Predicate Devices

• Continuous Output Pulmonary Artery Catheter and Continuous Output Monitor (K993245)

Submission Summary (Full Text)

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K081776

# 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<br>West Nerston<br>East Kilbride<br>G74 4NB<br>United Kingdom |
| | Telephone: | [phone] |
| | Facsimile: | [phone] |
| | Contact: | Alan Short,<br>Director of Quality & Regulatory Affairs<br>Omega Critical Care |
| | Date of Summary: | 19th June 2008 |

### Device Information:

| Trade Name: | Continuous Cardiac Output Pulmonary<br>Artery Catheter and Continuous<br>Cardiac Output Monitor |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Pulmonary Artery Catheter and<br>Cardiac Output Monitor |
| Classification<br>Name: | Flow-directed catheter and single<br>function, pre-programmed diagnostic<br>computer per 21 CFR 870.1240 and<br>870.1435 respectively |
| Predicate Device: | The modified device is substanttially<br>equivalent to the previously cleared<br>Continuous Output Pulmonary Artery<br>Catheter and Continuous Output<br>Monitor, 510(k) number K993245 |

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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:

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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:

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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)

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ivision Sign-Off) sion of Cardiovascular Devices

**510(k) Number** K081776

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