INFINITY PICCO POD, MODEL MS16734

K073113 · Draeger Medical Systems, Inc. · DXG · Jan 3, 2008 · Cardiovascular

Device Facts

• Record ID: K073113
• Device Name: INFINITY PICCO POD, MODEL MS16734
• Applicant: Draeger Medical Systems, Inc.
• Product Code: DXG · Cardiovascular
• Decision Date: Jan 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The Draeger Infinity PICCO Pod 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 Infinity PICCO Pod measures systolic, 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 monitor to which, the PICCO Pod is connected, presents the derived parameters indexed to body surface area.

Device Story

Infinity PICCO Pod is an accessory for Draeger Infinity patient monitors (Delta, Delta XL, Kappa); acquires cardiac output thermal and invasive blood pressure data from Pulsion Medical transducers; transmits data to host monitor for processing. Host monitor runs Pulsion algorithms to calculate cardiopulmonary/circulatory variables; provides continuous cardiac output via pulse contour analysis and intermittent output via thermodilution. Measures systolic/diastolic pressure; derives mean arterial pressure; analyzes thermodilution curves (mean transit time, downslope time) to determine intravascular/extravascular fluid volumes. If patient height/weight provided, calculates parameters indexed to body surface area. Used in clinical settings by healthcare professionals to monitor hemodynamic status; output assists in clinical decision-making regarding fluid management and circulatory support.

Clinical Evidence

No clinical data. Evidence consists of extensive bench testing and simulator-based testing to demonstrate hardware and software equivalence to the predicate device.

Technological Characteristics

Modular signal acquisition pod; interfaces with Draeger Infinity patient monitors. Uses Pulsion Medical transducers for thermal and invasive blood pressure data. Implements Pulsion-proprietary algorithms for hemodynamic calculations. Connectivity: wired interface to host monitor. Sterilization: not specified.

Indications for Use

Indicated for patients requiring determination and monitoring of cardiopulmonary and circulatory variables, including cardiac output, blood pressure, and fluid volumes.

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

• Pulsion PICCO Plus System (K060898)

Submission Summary (Full Text)

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K073//3

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JAN

- 3 2008

# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CFR 807.87, 21 CFR 807.92, Format for Traditional and Abbreviated 510(k) s.

1. Name of Submitter, Contact Person and Date Summary Prepared:

| Name: | Draeger Medical Systems, Inc. |
|----------------|-------------------------------|
| Address: | 6 Tech Dr Andover MA 01810 |
| Phone:<br>Fax: | 978.379.8124<br>978.379.8330 |

Official Contact: Genci Omari, Regulatory Affairs Manager

Date of Preparation: 18 October 2007

2. Device Trade Name and Common Name:

Trade Name:

Infinity PICCO Pod

21 CFR 870.1435

Common/Usual Name: Single-function, preprogrammed diagnostic computer

Classification:

- 3. Product Code: DXG
Device Class: Class II

#### Legally Marketed Equivalent Device Names: 4.

Substantial equivalence is claimed to the Pulsion PICCO Plus System 510(k) k060898

### COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 Tel: [phone] Fax: [phone]

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tage and Element Comp

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#### న్. Performance Standards: None

- Description of the Device: The Infinity PICCO Pod is an optional accessory 6. to Draeger Medical Systems' Infinity patient monitoring series (Delta, Delta XL, and Kappa) that provides for determination and monitoring of cardiopulmonary and circulatory variables.
The Infinity PICCO Pod acquires cardiac output thermal and invasive blood pressure data from Pulsion Medical transducers and sends this data to the Draeger patient monitors. The Draeger patient monitors contain Pulsion algorithms which are run on this data to calculate a number of cardiopulmonary and circulatory variables.

#### 7. Intended Use of the Device:

The Infinity PICCO Pod 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 Pod measures 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 Plus presents the derived parameters indexed to body surface area.

#### 8. Comparison of technological characteristics with Predicate Devices:

The Draeger Infinity PICCO Pod uses the same algorithms as its predicate, the Pulsion PiCCO Plus. The Pulsion PiCCO plus integrates all functionality into one device, where the Infinity PICCO Pod is a separate pod for signal acquisition from the patient, the data from the pod is sent to the Drager patient monitor for algorithm processing and display.

### 9. Discussion of Non-clinical Studies:

Extensive bench testing has been performed to insure that the hardware of the Infinity PICCO Pod is equivalent to the hardware of the Pulsion PiCCO Plus.

Extensive bench testing has been performed to insure that the software as implemented in the Infinity PICCO Pod is equivalent to that of the Pulsion PiCCO Plus.

Extensive simulator based testing has been performed to insure that the Infinity PICCO Pod as a complete device is equivalent to that of the Pulsion PiCCO Plus as a complete device.

### COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 Tel: [phone] Fax: [phone]

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Image /page/2/Picture/1 description: The image shows the logo for Dräger medical. The text "Dräger" is in a bold, sans-serif font, with an umlaut over the "a". The text "medical" is in a thinner, sans-serif font. Below the logo is the text "A Dräger and Siemens Company" in a smaller font.

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### 10. Conclusion:

The Infinity PICCO Pod is as safe and effective as its predicate, the Pulsion PiCCO Plus, and it provides a convenient means to continuously monitor a variety of circulatory parameters.

## COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 Tel: [phone] Fax: [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 3 2008

Dräger Medical Systems, Inc. c/o Mr. Genci Omari Regulatory Affairs Manager 6 Tech Drive Andover, MA 01810

Re: K073113

Infinity PiCCO Pod, Model MS16734 Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function Preprogrammed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: October 18, 2007 Received: November 5, 2007

Dear Mr. Omari:

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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Page 2 - Mr. Genci Omari

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,

Blymmuma 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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510(k) Number (if known): KO73113

Device Name: Infinity PICCO Pod

Indications for Use:

The Draeger Infinity PICCO Pod 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 Infinity PICCO Pod measures systolic, 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 monitor to which, the PICCO Pod is connected, presents the derived parameters indexed to body surface area.

Prescription Use_ く (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimma

ular Devices

COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA - 01810 Tel: [phone] Fax: [phone]