Indications for use E-PiCCO Continuous Cardiac Output Module: The E-PiCCO 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 E-PiCCO 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 compatible patient monitor presents the derived parameters indexed to body surface area. The E-PiCCO is intended for hospitalized patients. The E-PiCCO and accessories are for use by qualified medical personnel only. The E-PiCCO patient module is intended for use on one patient at a time. Cardiac output measurement with E-PiCCO is intended for patients weighing over 2 kg (4.4 lb) and therefore it is not available for smaller patients. E-PiCCO indexed values are available for patients weighing over 15 kg (33 lb) only.

Indications for use PiCCO Continuous Cardiac Output Cable (M1154585): The reusable, continuous cardiac output adapter cables are intended to be used for connecting a continuous cardiac output catheter to GE Medical Systems Information Technologies monitoring equipment requiring a rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.

Indications for use PiCCO Injectate Sensor Cable (M1182448): The reusable PiCCO Injectate Sensor Cable (M1182448) is intended to be used for connecting the PiCCO Injectate Sensor Housing (PV4046) to PiCCO Continuous Cardiac Output Cable (M1154585) of GE Healthcare monitoring equipment. These accessories are indicated for use by qualified medical personnel only.

Device Description

The E-PiCCO Continuous Cardiac Output Module and accessories is a new, single width E-series plug-in parameter module for pulse contour continuous cardiac output (PCCO) measurement and associated parameters. E-PiCCO Continuous Cardiac Output Module and accessories uses interconnect cables for both for injected bolus temperature measurement and for continuous cardiac output measurement. Patient access is via a clinician inserted arterial catheter, provided by Pulsion Medical Systems AG. The E-PiCCO Continuous Cardiac Output Module and accessories can be used with the CARESCAPE Monitor B850 with ESP V2 software, the CARESCAPE Monitor B650 with ESP V2 software and CARESCAPE Monitor B450 with ESP V2 software.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is a 510(k) summary for the GE Healthcare E-PiCCO Continuous Cardiac Output Module and accessories, focusing on regulatory information, device description, intended use, and a determination of substantial equivalence to a predicate device.

Specifically, the document states: "The subject of this premarket submission, the E-PiCCO Continuous Cardiac Output Module and accessories did not require clinical studies to support substantial equivalence." This means no clinical study, with acceptance criteria, sample sizes, ground truth, or MRMC analysis, was conducted or reported in this submission for this device.

The study described here relates to non-clinical tests focused on quality assurance, risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety) to ensure compliance with relevant IEC standards. However, these are not tied to specific performance metrics or acceptance criteria as would be found in a clinical study report.

Summary

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K132528

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white.

GE Healthcare Finland Oy Kuortaneenkatu 2, P.O. Box 900 00031 GE Finland T: +358 10 39411
F: +358 9 1463310

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Owner/Contact/Date (807.92(a)(1):

Date:	August 10, 2013
Owner/Submitter:	GE Healthcare Finland Oy.Kuortaneenkatu 200510 HelsinkiFINLANDPhone: +358 10 39411Fax: +358 9 1463310
Primary Contact Person:	Joel KentManager, Quality and Regulatory AffairsGE HealthcarePhone: 781-449-8685Fax: 781-433-1344E-mail: joel.kent@ge.com
Secondary Contact Person:	Janne MarvolaRegulatory Affairs LeaderGE Healthcare Finland OyKuortaneenkatu 200510 HelsinkiFinlandPhone: + 358 10 394 2172Fax: +358-92726532E-mail: janne.marvola@ge.com
Device names (807.92(a)(2)):
Trade Name:	E-PiCCO Continuous Cardiac Output Module and accessories
Common/Usual Name:	Single-function, preprogrammed diagnostic computer
Classification Names:	21 CFR 870.1435 Single-function, preprogrammed diagnostic computer.
Product Code:	DXG
Predicate Device(s)(807.92(a)(3)):	K060898 Pulsion PiCCO Plus
Device Description(807.92(a)(4))::	The E-PiCCO Continuous Cardiac Output Module and accessories is a new,single width E-series plug-in parameter module for pulse contour continuouscardiac output (PCCO) measurement and associated parameters. E-PiCCOContinuous Cardiac Output Module and accessories uses interconnect cables

for both for injected bolus temperature measurement and for continuous

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K132528

cardiac output measurement. Patient access is via a clinician inserted arterial catheter, provided by Pulsion Medical Systems AG. The E-PiCCO Continuous Cardiac Output Module and accessories can be used with the CARESCAPE Monitor B850 with ESP V2 software, the CARESCAPE Monitor B650 with ESP V2 software and CARESCAPE Monitor B450 with ESP V2 software.

Intended Use: (807.92(a)(5): Indications for use E-PiCCO Continuous Cardiac Output Module: The E-PiCCO 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 E-PiCCO 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 compatible patient monitor presents the derived parameters indexed to body surface area. The E-PiCCO is intended for hospitalized patients. The E-PiCCO and accessories are for use by qualified medical personnel only. The E-PiCCO patient module is intended for use on one patient at a time. Cardiac output measurement with E-PiCCO is intended for patients weighing over 2 kg (4.4 lb) and therefore it is not available for smaller patients. E-PiCCO indexed values are available for patients weighing over 15 kg (33 lb) only.

Indications for use PiCCO Continuous Cardiac Output Cable (M1154585): The reusable, continuous cardiac output adapter cables are intended to be used for connecting a continuous cardiac output catheter to GE Medical Systems Information Technologies monitoring equipment requiring a rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.

Indications for use PiCCO Injectate Sensor Cable (M1182448): The reusable PiCCO Injectate Sensor Cable (M1182448) is intended to be used for connecting the PiCCO Injectate Sensor Housing (PV4046) to PiCCO Continuous Cardiac Output Cable (M1154585) of GE Healthcare monitoring equipment. These accessories are indicated for use by qualified medical personnel only.

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Technology (807.92(a)(6))::

The E-PiCCO Module measures the injectate temperature using a PiCCO Injectate Temperature Sensor Cable and blood temperature using a PiCCO catheter connected to the module using a PiCCO Continuous Cardiac Output Cable. The E-PiCCO Module measures invasive blood pressure using a generic invasive blood pressure transducer connected to the module using an invasive blood pressure cable. The fundamental technology of the E-PiCCO Continuous Cardiac Output

Module and accessories is the same as the predicate device. The E-PiCCO Continuous Cardiac Output Module and accessories is as safe

and effective the predicate device.

Determination of Substantial Equivalence (807.92(b)(1))::

Summary of Non-Clinical Tests:

The following quality assurance measures were applied to the development of the E-PiCCO Continuous Cardiac Output Module and accessories :

. Risk Analysis
. Requirements Reviews
. Design Reviews
. Testing on unit level (Module verification)
. Integration testing (System verification)
Final acceptance testing (Validation) .
. Performance testing (Verification)
Safety testing (Verification) .

The E-PiCCO Continuous Cardiac Output Module and accessories were designed and tested for compliance to the following standards:

1. IEC 60601-1:1988, A1:1991, A2:1995, Corr1:1995, Medical Electrical Equipment Part 1: General Requirements for Safety -Second Edition
1. IEC 60601-1-1:2000, Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems - Edition 2.0
1. IEC 60601-1-2:2001 + A1:2004, Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests -- Edition 2.1
IEC 60601-1-4:1996 + A1:1999 (AKA ed 1.1:2000), Medical 4. electrical equipment - Part 1: General requirements for safety - 4 -Collateral standard: Programmable electrical medical systems, Edition 1.1

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1. IEC60601-1-6:2006, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance collateral Standard: Usability - Edition 2
IEC 60601-1-8:2006, Medical electrical equipment Part 1-8: 6. General requirements for basic safety and essential performance -Collateral Standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems, Second Edition
1. IEC 60601-2-34:2000, Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment-Edition 2
1. IEC62304:2006, Medical device software - Software life cycle processes
1. IEC62366:2007, Medical Devices -- Application of usability engineering to medical devices (General)

Summary of Clinical Tests:

The subject of this premarket submission, the E-PiCCO Continuous Cardiac Output Module and accessories did not require clinical studies to support substantial equivalence.

Clinical (807.92(b)(2)):

Conclusion (807.92(b)(3))::

GE Healthcare considers the E-PiCCO Continuous Cardiac Output Module and accessories to be as safe, as effective, and performance is substantially equivalent to the predicate device K060898 Pulsion PiCCO Plus.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 16, 2014

GE Healthcare Finland Oy c/o Mr. Joel Kent 86 Pilgrim Road Needham, MA 02492

Re: K132528

Trade/Device Name: E-PiCCO Continuous Cardiac Output Module and accessories Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function, preprogrammed diagnostic computer Regulatory Class: Class II Product Code: DXG Dated: December 6, 2013 Received: December 9, 2013

Dear Mr. Kent:

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.

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Page 2 - Mr. Joel Kent

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Owen P. Faris -S

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): K132528

Device Name: E-PiCCO Continuous Cardiac Output Module and accessories

Indications for use:

Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ندا ای
Digitally signed by Owen
P. Farts-S
Date: 2014.01.16
10:02:17-05'00'

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).