The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

Device Description

The CARDIOHELP System is a compact perfusion system consisting of the following components:

the CARDIOHELP-i drives suitable disposables using an integrated pump, controls and monitors the extracorporeal circulation and can communicate with other devices
. the CARDIOHELP Emergency Drive is used in emergencies to manually drive the disposable if the CARDIOHELP-i fails
different accessories: .
flow/bubble sensor O
o level sensor including level sensor pad
venous probe for blood gas monitoring and measurement of venous temperature o
external sensors for temperature and pressure O
different holders o
connection cables ಂ
. various disposables, that can be driven by CARDIOHELP-i, including the previously cleared HLS/HIT tubing sets and the Quadrox-iR disposables (part of the predicate CARDIOHELP System (K102726).

AI/ML Overview

This document describes the CARDIOHELP System, a cardiopulmonary support device. The submission is a Special 510(k) for modifications to an existing device (K102726). As such, the focus of the testing is on demonstrating that the modified device is substantially equivalent to the predicate, and much of the information typically found in a clinical study for a novel device is not presented.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria with specific numerical thresholds for performance metrics. Instead, it broadly states that "Performance testing has resulted in data that demonstrates that the CARDIOHELP System performs within its specifications and within the acceptable limits of the applied performance standards."

The performance characteristics reviewed include:

Acceptance Criterion (Implicit)	Reported Device Performance
Performs within specifications	Device performs within its specifications and acceptable limits of applied performance standards.
Substantial equivalence to predicate	Determined to be substantially equivalent to the predicate CARDIOHELP System (K102726).
Safety	Device is as safe as the predicate device.
Effectiveness (performance)	Device performs as well as the predicate device.
Enhanced user interface functionality	Implemented and assessed as part of hardware/software testing.
New sensor functionality (flow/bubble, temperature, pressure)	Implemented and assessed as part of hardware/software testing and performance testing.
Emergency mode key button functionality	Implemented and assessed as part of hardware/software testing.

2. Sample Size Used for the Test Set and Data Provenance

No specific sample size for a "test set" (in the context of clinical data for AI/ML) is mentioned, as no clinical evaluation of the modified device was conducted or required. The assessment relied entirely on non-clinical testing.

The provenance of data is not applicable as the testing was non-clinical and conducted by the manufacturer, MAQUET Cardiopulmonary AG, based in Rastatt, Germany.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical studies with a "test set" requiring expert ground truth were conducted. The device is not an AI/ML diagnostic tool, but rather a medical device with an enhanced user interface and new sensors.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies with a "test set" requiring adjudication were conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was mentioned or performed. This is not an AI/ML-driven diagnostic device where human reader improvement with AI assistance would be relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The CARDIOHELP System is a physical medical device for cardiopulmonary support, not an algorithm. Its performance is assessed through hardware, software, and system-level testing, not as a standalone algorithm without human interaction, as a human operator is integral to its function.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

Requirements specifications: Defining the expected behavior and performance of the device and its components.
Engineering standards: Adherence to relevant industry and regulatory standards for medical device safety and performance.
Predicate device performance: The performance of the previously cleared CARDIOHELP System (K102726) served as the benchmark for substantial equivalence comparisons. This acts as a form of "ground truth" for comparative effectiveness.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML medical device that uses a "training set." The development process involved hardware and software engineering, testing, and validation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device.

Summary

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K133598

CARDIOHELP System 510(k) Summarv

Prepared in accordance with 21 CFR Part 807.92

GENERAL INFORMATION

Submitter's name and address:

MAQUET Cardiopulmonary AG Kehler Straße 31 D-76437 Rastatt Germany

Contact person and telephone number:

Helder A. Sousa Manager, Regulatory Affairs MAQUET Cardiovascular 45 Barbour Pond Drive Wayne, NJ 07470 USA

Phone:	(973) 709-7465
Fax:	(973) 709-6505
Email:	helder.sousa@maquetcv.com
Date prepared:	November 21, 2013

DEVICE INFORMATION:

Trade Name:	CARDIOHELP System, Model CARDIOHELP-i
Common/Generic Name:	Cardiopulmonary Support System
Classification Name:	Cardiopulmonary bypass heart/lung machine consol
Regulation Number:	21 CFR 870.4220
Product Code:	DTQ

PREDICATE DEVCE INFORMATION:

The modified CARDIOHELP System is substantially equivalent in function and intended use to the CARDIOHELP System (K102726).

DEVICE DESCRIPTION AND INTENDED USE:

The CARDIOHELP System is a compact perfusion system consisting of the following components:

the CARDIOHELP-i drives suitable disposables using an integrated pump, controls and � monitors the extracorporeal circulation and can communicate with other devices
. the CARDIOHELP Emergency Drive is used in emergencies to manually drive the disposable if the CARDIOHELP-i fails
different accessories: .

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flow/bubble sensor O
o level sensor including level sensor pad
venous probe for blood gas monitoring and measurement of venous temperature o
external sensors for temperature and pressure O
different holders o
connection cables ಂ
. various disposables, that can be driven by CARDIOHELP-i, including the previously cleared HLS/HIT tubing sets and the Quadrox-iR disposables (part of the predicate CARDIOHELP System (K102726).

Indications for Use:

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATES:

The modified CARDIOHELP system is substantially equivalent to the predicate CARDIOHELP System (K102726). The modification essentially consists of an enhanced user.interface, new sensors for detection of bubbles and additional sensor sizes for temperature and flow bubble sensor, venous probe with compatibility for additional sizes, and adding emergency mode key button to provide the user the capability to use the CARDIOHELP System without a touch screen.

NON-CLINICAL TESTS:

Performance testing has resulted in data that demonstrates that the CARDIOHELP System performs within its specifications and within the acceptable limits of the applied performance standards. The following performance characteristics of the CARDIOHELP System were extensively compared with the predicate devices to determine substantial equivalence:

Requirements specification review .
Hardware and software testing
Code design and code reviews
◆ Environmental testing
� Safety testing
Performance testing .
Hardware and software validation

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CLINICAL TESTS:

No clinical evaluation of the modified device was conducted or required.

CONCLUSION:

Based upon the information submitted in this Special 510(k) premarket notification, MAQUET's ' modified CARDIOHELP System is substantially equivalent to the currently marketed CARDIOHELP System (K102726). The modified CARDIOHELP System is similar to the predicate device in the intended use, the fundamental scientific technology of the device. The device is as safe and effective and performs as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Cibily Silver Spring, MI) 20993-0002

May 21, 2014

Maquet Cardiovascular Helder Sousa Regulatory Affairs Program Manager 45 Barbour Pond Drive Wayne, NJ 07470

Re: K133598

Trade/Device Name: CARDIOHELP System. Model CARDIOHELP-i Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Support System Regulatory Class: Class II Product Code: DTQ Dated: April 16, 2014 Received: April 17, 2014

Dear Mr. Sousa:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Helder Sousa

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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

M.A. Cipperman

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: K133598

Device Name: CARDIOHELP System

Indications For Use:

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.L.A.D.A.
CORPORATE ENDEAVOR

Regulation Number and Section

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).