PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE by PULSION MEDICAL SYSTEMS SE

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 Description

AI/ML Overview

The provided text describes the PulsioFlex Monitoring System with PiCCO Module and its intended use, along with a table of performance specifications. However, it does not contain details about a specific study proving the device meets its acceptance criteria, nor does it describe the methodology of such a study.

The table presented is a list of acceptance criteria (or "specifications" as labeled in the document) rather than a direct report of a study's results. The "Accuracy*" column states "Coefficient of variation ≤ 2%" or "+2%", which are the target performance metrics the device is expected to meet, not observed performance from a study. The "Remark" states "Statistical evaluation based on random examination of actual production output," which hints at some form of quality control or validation, but does not provide details of a formal study.

Therefore, many of the requested details cannot be extracted from the provided document.

Here's a summary of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides the acceptance criteria (specifications) for various parameters. It does not provide a separate column for "Reported Device Performance" from a dedicated study. The "Accuracy*" column represents the target criteria.

Label	Unit	Lower Limit	Upper Limit	Acceptance Criteria (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%

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any particular test set. The remark "Statistical evaluation based on random examination of actual production output" does not specify a sample size.
Data Provenance: Not specified.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not specified.

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:

MRMC Study: Not mentioned or applicable. This device is a monitoring system for physiological variables, not an AI-assisted diagnostic tool for human readers.

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

The device itself is a standalone monitoring system. The document lists its performance specifications, implying standalone performance. However, there is no detailed description of a "standalone study" with specified methodology.

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

For physiological measurements like cardiac output, volumes, and oxygen saturation, ground truth would typically be established by validated reference methods or gold standards (e.g., direct Fick method, thermodilution from pulmonary artery catheter, blood gas analysis). The document does not specify how the accuracy was determined, only the target accuracy.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable in the context of this document. The device descriptions pertain to a physiological monitoring system and not a machine learning model that would require a "training set."

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

Ground Truth for Training Set: Not applicable.

Summary

{0}------------------------------------------------

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.

{1}------------------------------------------------

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 (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

{2}------------------------------------------------

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

Label	Unit	LowerLimit	UpperLimit	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

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).