PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE

K122121 · Pulsion Medical Systems SE · DXG · Aug 2, 2012 · Cardiovascular

Device Facts

• Record ID: K122121
• Device Name: PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
• Applicant: Pulsion Medical Systems SE
• Product Code: DXG · Cardiovascular
• Decision Date: Aug 2, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1435
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.

Device Story

PulsioFlex Monitoring System with PiCCO Module monitors cardiopulmonary/circulatory variables. Inputs: arterial pressure waveforms (pulse contour analysis), thermodilution curves (via thermistor-tipped catheter), and oximetry signals (via CeVox module/probe). Device processes inputs to calculate cardiac output (CO), stroke volume (SV), global end-diastolic volume (GEDV), extravascular lung water (EVLW), and oxygen saturation (SO2/SvO2/ScvO2). Used in clinical settings by healthcare professionals. Output displayed on monitor for real-time hemodynamic assessment. Enables clinicians to manage fluid status and oxygen delivery, supporting critical care decision-making for hemodynamically unstable patients.

Clinical Evidence

Bench testing only; accuracy specifications provided for CO, GEDV, EVLW, PCCO, SV, and oxygen saturation parameters based on random examination of production output.

Technological Characteristics

Multi-parameter hemodynamic monitor; utilizes pulse contour analysis and thermodilution techniques. Connectivity includes optional CeVox oximetry module. Parameters derived include CO, GEDV, EVLW, SV, and oxygen saturation. System supports indexing parameters to body surface area based on patient weight and height.

Indications for Use

Indicated for determination and monitoring of cardiopulmonary and circulatory variables, including oxygen saturation, cardiac output, heart rate, blood pressure, and fluid volumes in adult and pediatric patients.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings forming a protective shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 2 2012

Pulsion Medical Systems, Inc. c/o Dr. Jamie Sulley , US Agent 1511 Essex Road Westbrook, CT 06498

Re: K122121

> Trade/Device Name: PulsioFlex Monitoring System with PiCCO Module Regulatory Number: 21 CFR 870.1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: II (two) Product Code: 74 DXG Dated: July 12, 2012 Received: July 17, 2012

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 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 - Dr. Jamie Sulley

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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PULSION
Medical Systems

## Appendix B

## Indications for Use Statement

510(k) Number (if known):

Device Name: PulsioFlex Monitoring System with PiCCO Module

## Indications for Use:

The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.

The following tabular shows the parameters measured by the PulsioFlex Monitoring System with PiCCO Module and CeVox Accessories and their specifications:

| Label | Unit | Lower<br>Limit | Upper<br>Limit | Accuracy* | Remark |
|-------|-------|----------------|----------------|-------------------------------|-------------------------|
| CO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over a full range |
| GEDV | ml | 40 | 4800 | Coefficient of variation ≤ 3% | Valid over a full range |
| EVLW | ml | 10 | 5000 | Coefficient of variation ≤6% | Valid over a full range |
| PCCO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over a full range |
| SV | ml | 1 | 250 | Coefficient of variation ≤ 2% | Valid over a full range |
| SO2 | % | 1 | 99 | +2% | Valid from 40-99% |
| SvO2 | % | 1 | 99 | +2% | Valid from 40-99% |
| ScvO2 | % | 1 | 99 | +2% | Valid from 40-99% |

* Statistical evaluation based on random examination of actual production output

| 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)

Page 1 of 1

f CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

12 July, 2012

510(k) Nt