PULSION PICCO-2, MODEL 8500

K072735 · Pulsion Medical Systems AG · DXG · Oct 18, 2007 · Cardiovascular

Device Facts

• Record ID: K072735
• Device Name: PULSION PICCO-2, MODEL 8500
• Applicant: Pulsion Medical Systems AG
• Product Code: DXG · Cardiovascular
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The PULSION PiCCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.

Device Story

PiCCO-2 monitors cardiopulmonary/circulatory variables; inputs include thermodilution signals and arterial pressure waveforms. Device performs continuous cardiac output calculation via pulse contour analysis and intermittent measurement via thermodilution. Computes heart rate, systolic/diastolic/mean arterial pressure, and fluid volumes (intravascular/extravascular) using thermodilution curve analysis (mean transit/downslope time). Used in clinical settings by healthcare providers to guide hemodynamic management. Outputs displayed for clinician review to inform fluid/cardiovascular therapy decisions, potentially improving patient hemodynamic stability.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications.

Technological Characteristics

Diagnostic computer for hemodynamic monitoring. Features pulse contour analysis and thermodilution processing. Measures heart rate, blood pressure, and fluid volumes. Standalone diagnostic unit.

Indications for Use

Indicated for determination and monitoring of cardiopulmonary and circulatory variables in patients requiring hemodynamic assessment. No specific age or gender contraindications provided.

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.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2007

Pulsion Medical Systems AG c/o Dr. Jamie Sullev President Triangulum Consulting Services, Inc. 7220 Sparhawks Road Wake Forest, NC 27587

Re: K072735

Trade Name: Pulsion PiCCO-2, Model 8500 Regulation Number: 21 CFR 870.1435 Regulation Name: Single Function Pre-Programmed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: September 25, 2007 Received: September 27, 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 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.

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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 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 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Gummow for

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 STATEMENT 4.0

## Indications for Use

510(k) Number (if known): _ K072735

Device Name: PiCCO-2

Indications for Use:

The PULSION PiCCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Brimmer

Division Sign-Off) Division of Cardlovascular Devices 510(k) Number

(Posted November 13, 2003)

Pulsion Medical Systems, AG Pulsion PiCCO-2 Monitoring System September 2007 Page 15 ·