The PULSION PICCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVOX™ oximetry module connected to a compatible oximetry probe, the PiCCO-2 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 thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial 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 PiCCO-2 monitor presents the derived parameters indexed to body surface area.

Device Description

The PULSION PiCCO-2 is a microprocessor-based instrument intended for the determination and monitoring of cardiopulmonary and circulatory variables. When the optional CeVOX™ optical module and probe are connected to the PiCCO-2, the monitor measures oxygen samuation in adults or pediatrics. In addition, the PiCCO-2 measures heart rate, systelic, 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.

AI/ML Overview

The Pulsion PiCCO-2 with Optional CeVOX Accessories is a device intended for measuring and monitoring cardiopulmonary and circulatory variables. The provided text, K091786, describes the device and claims substantial equivalence to predicate devices, but does not include any study data or detailed acceptance criteria for the quantitative performance of the device based on a clinical or non-clinical study involving a specific test set. Instead, it lists specifications for various parameters.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document lists "Accuracy" and "Remark" for each parameter, which can be interpreted as the acceptance criteria and the stated performance. However, it's crucial to note that these are specifications for "actual production output" and not the results of a specific study comparing the device to a ground truth as typically understood in a performance study.

Label	Unit	Lower limit	Upper limit	Acceptance Criteria (Accuracy*)	Reported Device Performance
CO	l/min	0.25	25	Coefficient of variation ≤ 2%	Coefficient of variation ≤ 2% (Valid over full range)
GEDV	ml	40	4800	Coefficient of variation ≤ 3%	Coefficient of variation ≤ 3% (Valid over full range)
ITBV	ml	50	6000	Coefficient of variation ≤ 3%	Coefficient of variation ≤ 3% (Valid over full range)
EVLW	ml	10	5000	Coefficient of variation ≤ 6%	Coefficient of variation ≤ 6% (Valid over full range)
PCCO	l/min	0.25	25	Coefficient of variation ≤ 2%	Coefficient of variation ≤ 2% (Valid over full range)
SV	ml	1	250	Coefficient of variation ≤ 2%	Coefficient of variation ≤ 2% (Valid over full range)
SO2	%	1	99	±2%	±2% (Valid from 40 - 99%)
SvO2	%	1	99	±2%	±2% (Valid from 40 - 99%)
ScvO2	%	1	99	±2%	±2% (Valid from 40 - 99%)

Note: The "Reported Device Performance" column directly mirrors the "Acceptance Criteria" because the document states these are "Statistical evaluation based on random examination of actual production output," implying these are the designed and expected performance characteristics, rather than empirically derived results from a specific clinical study detailed in this submission.

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

The provided document does not describe a specific clinical or non-clinical study with a defined test set, sample size, or data provenance for the purpose of demonstrating device performance against specific acceptance criteria. The performance claims are based on "Statistical evaluation based on random examination of actual production output," which is primarily a manufacturing quality control statement rather than a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical study or test set with expert-established ground truth is described in the provided document.

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

Not applicable. No clinical study or test set requiring adjudication is described in the provided document.

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

Not applicable. The PULSION PiCCO-2 is a microprocessor-based instrument for measuring physiological variables, not an AI-assisted diagnostic imaging device that typically involves human readers. No MRMC study is mentioned or implied.

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

The device functions as a standalone monitor, providing measurements of cardiopulmonary and circulatory variables. The "Functional/Safety Testing" section states, "The PULSION PiCCO-2 with optional CeVOX™ accessories has successfully undergone functional testing demonstrating equivalence to the predicate devices. The subject and predicate devices are similar in design, principle of operation, materials of construction, intended use, labeling and manufacturing processes. In vivo non-clinical testing, sterilization validation and biocompatibility testing was conducted. Results of all non-clinical testing met associated acceptance criteria and did not raise new issues of safety and/or effectiveness."

While functional testing and "in vivo non-clinical testing" were conducted, the document does not detail the results against the specific performance metrics listed in the table or explicitly state a "standalone performance study" in a quantifiable manner as understood for diagnostic algorithms. The primary claim is substantial equivalence to predicate devices, supported by functional and safety testing.

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

The document does not specify the type of ground truth used for the "Statistical evaluation based on random examination of actual production output" or for the "in vivo non-clinical testing." For a device measuring physiological parameters, ground truth would typically come from highly accurate reference instruments or established clinical gold standards, but this is not detailed in the submission provided.

8. The sample size for the training set

Not applicable. This device is described as a "microprocessor-based instrument" that measures and monitors physiological variables. It is not an artificial intelligence or machine learning model that typically undergoes "training" on a dataset in the conventional sense. Therefore, no training set sample size is applicable or mentioned.

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

Not applicable. As noted in point 8, no training set is described for this device.

Summary

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Pulsion Medical Systems AG K091786 Pulsion PiCCO-2 with Optional CeVox Accessories

K091786

JUN 1882010

Image /page/0/Picture/3 description: The image shows the words "PULSION" and "Medical Systems" stacked on top of each other. The word "PULSION" is in a larger, bolder font than the words "Medical Systems". The words are black and the background is white. The image appears to be a logo or branding for a medical company.

Section 3.0

510(k) Summary or Statement

Preparation Date:	May 24, 2010
Applicant/Sponsor:	Pulsion Medical Systems AG20 Joseph-Wild-StrasseMunich, Germany81829
Contact Person:	Christoph Manegold, Director Research and DevelopmentPhone: 214-557-8730Fax: +49 89 459 914 18
Trade name:	PULSION PICCO-2 with Optional CeVOX™ Accessories
Common Name:	• Computer, Diagnositic, Pre-programmed
Classification Name:	• Single-function, preprogrammed diagnostic computer(21 CFR 870.1435)
Device Product Code:	• DXG
Legally Marketed Devices to Which Substantial Equivalence Is Claimed:
PULSION PICCO-2, MODEL 8500	K072735
VIGILEO ARTERIAL PRESSURE CARDIACOUTPUT/OXIMETRY MONITOR	K062134
EDWARDS LIFESCIENCES LLC PRESEP ANDPEDIASAT OXIMETRY CATHETERS	K053609

May, 2010

CeVOX™ Accessories to PICCO-2

Page 3-1

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Device Description:

Indications for Use:

The PULSION PiCCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVOX™ oximery module connected to an oximetry probe, the PiCCO-2 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 PiCCO-2 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 PiCCO-2 monitor presents the derived parameters indexed to body surface area.

Comparative Analysis:

The PULSION PiCCO-2 with optional CeVOX™ accessories has been demonstrated to be as safe and effective as the predicate devices for its intended use.

Functional/SafetyTesting:

The PULSION PiCCO-2 with optional CeVOX™ accessories has successfully undergone functional testing demonstrating equivalence to the predicate devices. The subject and predicate devices are similar in design, principle of operation, materials of construction, intended use, labeling and manufacturing processes. In vivo non-clinical testing, sterilization validation and biocompatibility testing was conducted. Results of all non-clinical testing met associated acceptance criteria and did not raise new issues of safety and/or effectiveness.

Conclusion:

The PULSION PiCCO-2 with optional CeVOX™ accessories are substantially equivalent to the predicate devices.

May, 2010

CeVOX™ Accessories to PiCCO-2

Page 3-2

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Image /page/2/Picture/0 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 a stylized eagle with its wings spread, with three lines extending from the eagle's body. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUN 1 8 2010

Pulsion Medical Systems Ag C/O Dr. Jamie Sulley, President Triangulum Consulting Services, Inc. 7220 Sparhawk Rd. Wake Forest, North Carolina 27587

Re: K091786

Trade/Device Name: PULSION PiCCO-2 with Optional CeVOX Accessories Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function Pre-Programmed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: May 15, 2010 Received: May 25, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling, must be truthful and not misleading.

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.

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

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Page 2 - Dr. Jamie Sulley

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 (QS) regulation (2) 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/ucm 115809.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 (800) 638-2041 or (301) 796-7100 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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Medical Systems

Section 1.0

Indications for Use Statement

510(k) Number (If known): K091786

Device Name: Pulsion PiCCO-2 with Optional CeVOX™ Accessories

Indications for Use:

The following tabular shows the parameters measured by the PICCO2 patient monitor and their specifications:

Label	Unit	Lower limit	Upper limit	Accuracy*	Remark
CO	l/min	0.25	25	Coefficient of variation ≤ 2%	Valid over full range
GEDV	ml	40	4800	Coefficient of variation ≤ 3%	Valid over full range
ITBV	ml	50	6000	Coefficient of variation ≤ 3%	Valid over full range
EVLW	ml	10	5000	Coefficient of variation ≤ 6%	Valid over full range
PCCO	l/min	0.25	25	Coefficient of variation ≤ 2%	Valid over full range
SV	ml	1	250	Coefficient of variation ≤ 2%	Valid over 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 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

May, 2010

ARYTH Arcessaries to t

Page 1-1

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510(k) Number K091786

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).