PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

K072364 · Pulsion Medical Systems AG · KRB · Sep 19, 2007 · Cardiovascular

Device Facts

• Record ID: K072364
• Device Name: PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
• Applicant: Pulsion Medical Systems AG
• Product Code: KRB · Cardiovascular
• Decision Date: Sep 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1915
• Device Class: Class 2

Intended Use

The Pulsion Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

Device Story

Pulsion Pulsiocath Thermodilution Catheters and Pressure Monitoring Kit with Injectate In-Line Sensor function as components of the Pulsion PiCCO Cardiac Output System. Device inputs include thermal signals from thermodilution and arterial pressure waveforms. System transforms these inputs via thermodilution method and arterial pulse contour analysis to calculate cardiac output and monitor blood pressure. Used in clinical settings (surgical, cardiac, burn units) by healthcare professionals for hemodynamic monitoring. Output provides real-time cardiovascular data to assist clinicians in assessing circulatory volume status and guiding clinical decision-making for critically ill or surgical patients.

Technological Characteristics

Thermodilution catheter and pressure monitoring kit with in-line injectate sensor. Designed for integration with the Pulsion PiCCO Cardiac Output System. Utilizes thermodilution sensing and arterial pressure monitoring. Class II device under 21 CFR 870.1915 (Thermodilution probe).

Indications for Use

Indicated for patients requiring cardiovascular and circulatory volume status monitoring, including those in surgical, cardiac, and burn units, or undergoing major surgical interventions.

Regulatory Classification

Identification

A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2007

Pulsion Medical Systems AG c/o Dr. Jamie Sulley President Triangulum Consulting Services, Inc. 7220 Sparhawk Rd. Wake Forest, NC 27587

Re: K072364

> Pulsion Pulsiocath Thermodilution Catheters and Accessories Regulation Number: 21 CFR 870.1915 Regulation Name: Thermodilution Probe Regulatory Class: Class II Product Code: KRB Dated: August 20, 2007 Received: August 22, 2007

Dear Dr. Sulley:

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 Amendmouts, or to devices that have been reclassified in accordance with the provisions of the Federal Foold, Dr u 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 1.01 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, TDA movie publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Jamie Sulley

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan that FDA has made a determination that your device complies with other requirements of the Act 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 (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 logal/y 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 Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may bitain other general information on your responsibilities under the Act 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/industry/support/index.html .

Sincerely yours.

R. bacher

\ Dr. Bram Zuckerman 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): | K072364 |
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Pulsion Pulsiocath Thermodilution Catheters and Accessories Device Name:

Indications for Use:

The Pulsion Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susna R. behner
(Printed)

(Division Sinn-Off) Division J. Cardiovascular Devices

510(k) Number K072364

Pulsion Medical Systems, AG Pulsion Pulsiocath Thermodilution Catheters and Accessories

August 2007 Page 17