The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's data are entered, the PulsioFlex monitor presents the derived parameters indexed.

With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.

With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.

The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.

Device Description

The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components:
a) PulsioFlex Monitor
b) CeVOX Optical Module
c) PICCO Module

The PulsioFlex Monitor receives incoming signals from the patient through the connections with the modules and the accessories applied to the patient. The measurement hardware in the PulsioFlex Monitoring System provides the PulsioFlex host application (software) all data from the modules via USB protocol. The algorithms embedded in the monitor host application process the signals and provide parameter calculations. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the PulsioFlex Monitoring System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or a study solely proving the algorithm's performance.

Therefore, the information required to answer the prompt cannot be fully extracted from the provided text. The document states: "Clinical data was not required for this device." and the "Performance Data" section primarily addresses system verification, electrical safety, software verification, cybersecurity, and usability testing, all aimed at demonstrating that updates do not adversely affect safety and effectiveness compared to the predicate device.

Here's a breakdown of why each section of your request cannot be fully answered and what little information is available:

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

Cannot be provided. The document does not specify quantitative acceptance criteria for new derived parameters or overall device performance in the form of a table. Its focus is on showing equivalence for already cleared parameters and verifying the functionality of newly added derived parameters (GEF, CPO, PVPI, O2ER, and ITBV) which are calculated from previously cleared parameters. The performance data section refers to "measurements of Cardiac Output parameters and Oximetry parameters were performed with the subject device," but does not provide specific values or acceptance criteria for these measurements.

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

Not applicable/Not provided. Since "Clinical data was not required," there isn't a test set of patient data in the typical sense for evaluating diagnostic accuracy or algorithm performance derived from patient outcomes. The "System Verification" describes testing "individual modules... at a system level," but this refers to technical verification, not a clinical data test set.

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):

Not applicable/Not provided. As no clinical data test set was required or used for direct performance evaluation, there was no need for expert-established ground truth.

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

Not applicable/Not provided. No clinical test set to adjudicate.

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/Not provided. This is not a study of AI assistance to human readers. It's a monitoring system that calculates physiological parameters.

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

Partially applicable, but no detailed performance metrics. The document states that new derived parameters are "calculated by the PulsioFlex Monitors host application (software) based on the previous cleared parameters." This implies algorithm-only performance for these calculations. However, no specific performance metrics (e.g., accuracy against a gold standard for these calculated parameters) or a stand-alone study showing statistical results are provided. The "System Verification" section mentions "Measurements of Cardiac Output parameters and Oximetry parameters were performed with the subject device," but provides no details on the study design or results.

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

Not explicitly stated for the "new derived parameters." Given that they are "calculated by the PulsioFlex Monitors host application (software) based on the previous cleared parameters," the implicit ground truth for the calculation logic would be physiological principles and mathematical correctness, likely verified through internal testing against known inputs and expected outputs, rather than clinical outcomes or expert consensus on raw patient data. For the original parameters, the ground truth would have been established during the predicate device's clearance.

8. The sample size for the training set:

Not applicable/Not provided. This device is not described as being based on a machine learning model that requires a "training set" in the common sense (e.g., for image recognition). The "algorithms" mentioned process signals and calculate parameters, implying deterministic algorithms, not learned from a training dataset.

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

Not applicable/Not provided. (See point 8).

In summary, the provided document is a regulatory submission for a device modification, demonstrating substantial equivalence. It does not contain the kind of detailed performance study data, acceptance criteria, ground truth establishment methods, or sample sizes related to clinical validation of AI algorithms or diagnostic accuracy that your prompt requests.

Summary

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January 18, 2018

PULSION Medical Systems SE % Mark Smith Manager, Regulatory Affairs Maquet Cardiovascular 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K172259

Trade/Device Name: PulsioFlex Monitoring System Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: December 18, 2017 Received: December 19, 2017

Dear Mark Smith:

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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Willehemen
for

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

510(k) Number (if known) K172259

Device Name PulsioFlex Monitoring System

Indications for Use (Describe)

With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.

The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.

Type of Use (Select one or both, as applicable)
❌ Prescription Use (Part 21 CFR 801 Subpart D)	❍ Over-The-Counter Use (21 CFR 801 Subpart C)

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Page 1 of 7 K172259

510(K) SUMMARY

Prepared in accordance with 21 CFR Part 807.92

Date Prepared:	January 18, 2018
Device Owner:	PULSION Medical Systems SEHans-Riedl-Str. 1785622 FeldkirchenGermany
Contact Personnel:	Mr. Mark SmithRegulatory Affairs
Email:	mark.n.smith@getinge.com
Phone:	(585) 272-5274
Fax:	(585) 272-5066
Device/System Name:	PulsioFlex Monitoring System
Trade name(s):	PulsioFlex MonitorPiCCO Module CeVOXModule
Device GenericName:	Single-function, pre-programmed diagnosticcomputer.
Classification:	According to 21 CFR 870.1435 the device classification is Class II,Product code DXG.
Predicate Device:	K122121, PulsioFlex Monitoring System with PiCCO Module

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GETING

Intended Use:	The PulsioFlex Monitoring System is a diagnostic aid for themeasurement and monitoring of blood pressure,cardiopulmonary, circulatory and organ function variables. ThePulsioFlex Monitoring System is indicated in patients wherecardiovascular and circulatory volume status monitoring isnecessary. If a patient's biometric data are entered, thePulsioFlex Monitor presents the derived parameters indexed.
	■ With the PiCCO Module cardiac output is determinedboth continuously through pulse contour analysis andintermittently through thermodilution technique. Bothare used for the determination of other derivedparameters.
	■ With the CeVOX oximetry module connected to acompatible oximetry probe, the PulsioFlex MonitoringSystem measures continuous venous oxygen saturationto assess oxygen delivery and consumption.
Indications for Use:	The use of the PulsioFlex Monitoring System is indicated inpatients where cardiovascular and organ monitoring is useful.This includes patients in surgical, medical, and other hospitalunits.
Device Description:	The PulsioFlex Monitoring System is a patient monitoring systemthat consists of the following components:a) PulsioFlex Monitorb) CeVOX Optical Modulec) PICCO Module

Description of functionality:

The PulsioFlex Monitor receives incoming signals from the patient through the connections with the modules and the accessories applied to the patient. The measurement hardware in the

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PulsioFlex Monitoring System provides the PulsioFlex host application (software) all data from the modules via USB protocol. The algorithms embedded in the monitor host application process the signals and provide parameter calculations. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed.

Description of the components:

a) The PulsioFlex Monitor displays various hemodynamic parameters depending on which module(s) is/are connected, i.e. the touch screen graphical user interface (GUI) is adaptable and automatically detects what modules are connected.
b) The PulsioFlex Monitor with the PiCCO Module provides the possibility to monitor cardiac output, both continuously (pulse contour analysis) and intermittently (thermodilution). A comprehensive list of parameters (absolute and indexed to patient biometric data) available while monitoring with the PulsioFlex Monitor connected to the PiCCO Module is shown below. The new parameters in this submission are marked in bold and indicated with an asterisk (*).

Thermodilution:

Parameter	Abbr.	Index
Cardiac Output, transpulmonary	CO	CI
Global End-Diastolic Volume	GEDV	GEDI
Extravascular Lung Water	EVLW	ELWI
Cardiac Function Index	CFI
*Global Ejection Fraction	GEF
*Pulmonary Vascular Permeability Index	PVPI
*Intrathoracic Blood Volume	ITBV	ITBI

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Pulse Contour Analysis:

Parameter	Abbr.	Index
Heart Rate	HR
Mean Arterial Blood Pressure	MAP
Systolic Arterial Blood Pressure	APsys
Diastolic Arterial Blood Pressure	APdia
Continuous Cardiac Output	COPC	CIPC
Stroke Volume	SV	SVI
Systemic Vascular Resistance	SVR	SVRI
Stroke Volume Variation	SVV
Pulse Pressure Variation	PPV
*Cardiac Power Output	CPO	CPI

c) The PulsioFlex Monitor together with the CeVOX Optical
- Module continuously measures central venous oxygen saturation or mixed venous oxygen saturation depending on the position of the fibre optic oximetry probe. In combination with continuous cardiac output and by entering a value for arterial oxygen saturation and hemoglobin additional parameters can be calculated. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed. A comprehensive list of parameters available while monitoring with the PulsioFlex Monitor with the connected CeVOX Optical Module and a fibre optic oximetry probe are listed below. The new parameter in this submission is marked in bold and indicated with an asterisk (*).

Parameter	Abbr.
Central Venous Oxygen Saturation	ScvO2
Mixed Venous Oxygen Saturation	SvO2
Oxygen Delivery	DO2
Oxygen Delivery Index	DO2I
Oxygen Consumption	VO2
Oxygen Consumption Index	VO2I
*Oxygen Extraction Ratio	O2ER

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GETIL

Comparison to Predicate Device:

The PulsioFlex Monitoring System uses the same monitoring technology (COPC, CO and Oximetry), the same components (PulsioFlex Monitor, PiCCO Module and CeVOX Optical Module), the same measured parameters and the same default alarm limits as the predicate device PulsioFlex Monitoring System with PiCCO Module (K122121, cleared August 02, 2012).

Updates made to the PulsioFlex Monitoring System include:

■ Compliance to Electrical Safety Requirements Minor hardware changes to the PulsioFlex Monitor and PiCCO Module in order to comply with the requirements in recognized electrical safety and electromagnetic compatibility standards.

New Graphical User Interface visualizations (GUI) ■ Organ View – shows selected parameters visualized in relationship to the lung, heart and vessels. Spider View - shows the continuous parameters dynamically. Profiles View – shows the measured parameters in respect to their position to the normal or target value. Help Screens – containing information about Setup, Parameter Info, Decision Model, Physio Overview, and General Information. Volume Test – supports fluid management by tracking the parameters over a predefined time span when volume

responsiveness test methods are in use.

■ HIPAA Compliance

PulsioFlex Monitoring System has included an option for the responsible organization to exclude patient information in printout and data recording to fulfil HIPAA requirements.

■ HL7

The data in the PulsioFlex Monitor can be transmitted via Ethernet to external Patient Data Management Systems (PDMS) using HL7 standard. HL7 for the PulsioFlex Monitoring System is limited to connecting and sending patient data to external Medical Systems.

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GETIL

■ New derived parameters

The additional derived parameters (GEF, CPO, PVPI, O2ER, and ITBV) are calculated by the PulsioFlex Monitors host application (software) based on the previous cleared parameters in the predicate device PulsioFlex Monitoring System with PiCCO Module (K122121).

. New Operating System

The subject device PulsioFlex Monitoring System is built on a Windows 7 Embedded Operating System whereas the predicate device PulsioFlex Monitoring System with PiCCO Module used a Windows XP Embedded Operating System.

Performance Data: The following verification activities were performed in support of a substantial equivalence determination.

System Verification

All hardware requirements were verified. Measurements of Cardiac Output parameters and Oximetry parameters were performed with the subject device. Individual modules were tested at a system level to verify safety and effectiveness.

Electrical Safety and Electromagnetic Compatibility (EMC)

The PulsioFlex Monitoring System is tested to be in compliance with the following standards: IEC 60601-1 (with US deviation according to AAMI/ANSI ES60601-1:2005/(R) 2012), IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 62366-1, IEC 60601-2-34, and IEC 60601-2-49.

Software Verification

The PulsioFlex Monitoring System's software is considered a Moderate Level of Concern. Software verification was performed considering FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and according to the standard IEC 62304 "Medical device software - Software life-cycle processes".

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Cybersecurity Information
---------------------------	--

Threats and vulnerabilities have been assessed according FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". Appropriate Methods of Control (MOC) were implemented and verified to reduce cybersecurity risks as far as possible. Throughout the lifecycle of the PulsioFlex Monitor, it is assured that the device maintains its safety and effectiveness.

Usability Testing

A Summative Usability Evaluation including new GUI visualizations and derived parameters was performed considering FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices" and according to the standard IEC 62366-1 "Medical devices – Part 1: Application of usability engineering to medical devices". The PulsioFlex Monitoring System has been found to be safe and effective for the intended users, uses, and use environments.

Non-ClinicalPerformance:	Completion of all verification activities demonstrated that thesubject device meets all design and performance requirements.Verification activities performed confirmed that the differences inthe design did not adversely affect the safety and effectiveness ofthe subject device.
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Clinical Performance:

Clinical data was not required for this device.

Conclusion: The PulsioFlex Monitoring System is substantially equivalent to the legally marketed predicate PulsioFlex Monitoring System with PiCCO Module (K122121).

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).