TRUCATH.IP

K023368 · Aortech Critical Care , Ltd. · DFG · Oct 28, 2002 · Immunology

Device Facts

• Record ID: K023368
• Device Name: TRUCATH.IP
• Applicant: Aortech Critical Care , Ltd.
• Product Code: DFG · Immunology
• Decision Date: Oct 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

The TruCATH.IP 'S 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 allows for sampling of venous blood. In addition the TCH 5100 product provides an additional infusion lumen that allows for continuous infusion.

Device Story

TruCATH.IP is a flow-directed catheter used for hemodynamic monitoring and fluid management. It facilitates direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, venous blood sampling, and solution infusion. The TCH 5100 variant includes an additional lumen for continuous infusion. Used in clinical settings by healthcare professionals to assess patient hemodynamic status and guide therapeutic interventions.

Technological Characteristics

Flow-directed catheter; includes distal port for blood sampling and infusion lumens; TCH 5100 model features an additional infusion lumen for continuous infusion.

Indications for Use

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

Regulatory Classification

Identification

An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is facing left, and the text is in all caps.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 28 2002

AorTech Critical Care Limited c/o Mr. Paul Burns Phoenix Crescent Strathclycle Business Park Bellshill Scotland ML4 3NJ

Re: K023368

TruCATH.IP Regulation Number: 870.1240 Regulation Name: Flow-Directed Catheter Regulatory Class: II (two) Product Code: 74 DFG Dated: October 4, 2002 Received: October 8, 2002

Dear Mr. Burns:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (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. 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

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### Page 2 - Mr. Paul Burns

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 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

I Qulater

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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# AorTech Critical Care Ltd. Special 510(K) Device Modification Attachment 2 AttaChinent 2

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| 510(k) Number (if known) | K023368 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TruCATH.IP |
| Indications for Use | The TruCATH.IP 'S 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 allows for sampling of venous blood. In addition the TCH 5100 product provides an additional infusion lumen that allows for continuous infusion. |

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 | Over-The-Counter Use |
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Vision of Cardiovascular & Respiratory Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ کان تاج