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 Description

The Infinity PICCO Pod is an optional accessory 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.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness for the Dräger Infinity PiCCO Pod. This document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical bench testing and simulator-based testing. It does not contain information about a clinical study involving human subjects, nor does it provide a table of acceptance criteria and reported device performance.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered and what cannot:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided: The document does not specify quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy). Its focus is on establishing equivalence through bench and simulator testing, not on quantifiable clinical performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Cannot be provided: The document mentions "Extensive bench testing" and "Extensive simulator based testing." It does not specify sample sizes for these tests, nor does it refer to data provenance (country, retrospective/prospective) as these were non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Cannot be provided: This information is relevant for studies involving human interpretation or clinical ground truth establishment, which is not described in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Cannot be provided: This is not applicable to the non-clinical testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Cannot be provided: The device is a diagnostic computer that processes physiological signals; it is not an AI-assisted diagnostic imaging tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Partially applicable, but details are missing: The device itself is an algorithm-only component (within the larger monitoring system) that calculates variables. The document states "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." and "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." This implies standalone testing of the algorithm's performance against the predicate, but specific performance metrics are not given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Implied ground truth for non-clinical testing: For bench and simulator testing, the "ground truth" would likely be the known, controlled inputs provided by the test equipment/simulators, and the expected outputs as predicted by the predicate device's established performance or theoretical models. The document doesn't specify the exact nature of this "ground truth" beyond stating the tests were to ensure equivalence.

8. The sample size for the training set:

Not applicable/Cannot be provided: The document does not describe the development of a novel algorithm from a training set. The device uses "the same algorithms as its predicate, the Pulsion PiCCO Plus." It's essentially implementing existing, validated algorithms in a new hardware configuration.

9. How the ground truth for the training set was established:

Not applicable/Cannot be provided: As above, this document does not describe the training of a new algorithm.

Summary of what the document states regarding "the study":

The study described in this 510(k) summary is a set of non-clinical tests conducted to demonstrate the substantial equivalence of the Infinity PiCCO Pod to its legally marketed predicate, the Pulsion PiCCO Plus System (K060898).

The tests performed include:

Extensive bench testing: "to insure that the hardware of the Infinity PICCO Pod is equivalent to the hardware of the Pulsion PiCCO Plus."
Extensive bench testing: "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: "to insure that the Infinity PICCO Pod as a complete device is equivalent to that of the Pulsion PiCCO Plus as a complete device."

The "acceptance criteria" for these tests are implicitly that the Infinity PiCCO Pod's hardware, software, and complete device performance should be equivalent to that of the Pulsion PiCCO Plus. The document's conclusion states, "The Infinity PICCO Pod is as safe and effective as its predicate, the Pulsion PiCCO Plus..." indicating that these equivalence criteria were met. No specific quantitative performance metrics or study results are detailed in this summary.

Summary

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K073//3

Page 1 of 3

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.

Name of Submitter, Contact Person and Date Summary Prepared:

Name:	Draeger Medical Systems, Inc.
Address:	6 Tech Dr Andover MA 01810
Phone:Fax:	978.379.8124978.379.8330

Official Contact: Genci Omari, Regulatory Affairs Manager

Date of Preparation: 18 October 2007

Device Trade Name and Common Name:

Trade Name:

Infinity PICCO Pod

21 CFR 870.1435

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

Classification:

1. 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: 978-379-8124 Fax: 978-379-8330

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

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: 978-379-8124 Fax: 978-379-8330

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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: 978-379-8124 Fax: 978-379-8330

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

Prescription Use_ く (Per 21 CFR 801.109)

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: 978-379-8124 Fax: 978-379-8330

Regulation Number and Section

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).