The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Device Description

The Heater-Cooler Unit HCU 40 is used to supply temperature-controlled water to regulate the patient temperature during extracorporeal circulation (ECC). Further application areas are warming and/or cooling therapies. The device can also be used to control the temperature of a cardioplegia solution. Therefore the Heater-Cooler Unit HCU 40 contains two independent water circuits. One circuit (main circuit) can be connected to the blood heat exchanger (part of the oxygenator) and/or to the warming/cooling blanket. The other circuit (cardioplegia circuit) can be connected to the cardioplegia heat exchanger. The use of an UV treatment does significantly enhance the water quality between the water change intervals. The heat exchange with the patient and the cardioplegia fluid occurs when the water passes the heat exchangers and/or the blanket. The water temperature of the main and the cardioplegia circuit can be regulated independently from each other.

AI/ML Overview

Here's an analysis of the provided text regarding the MAQUET HCU 40 Heater-Cooler Unit, focusing on the acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than conducting extensive clinical efficacy studies as one might find for a novel drug or a high-risk Class III device. Therefore, the information regarding acceptance criteria and performance studies will be different from what you might expect for an AI/ML-based diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the "acceptance criteria" for the HCU 40 are primarily demonstrated through its substantial equivalence to its predicate device, the HCU 30. The performance is assessed through non-clinical tests verifying that the device meets its design requirements and is safe and effective.

Acceptance Criterion (Implicit)	Reported Device Performance/Evidence
Substantial Equivalence to Predicate Device (HCU 30)	The HCU 40 is asserted to be substantially equivalent to the HCU 30 (K031544) in function, intended use, and fundamental scientific technology. Modifications are described as: Polished stainless steel housingFull color touch screen with rotary knobTwo-tank construction for faster body temperature adjustment and cold cardioplegiaMore effective ice-buildingImproved heating performanceIndependent and precise flow regulation of the patient and cardioplegia circuitPermanent working UV lamp (significantly enhances water quality)These modifications are stated not to raise new issues of safety and effectiveness.
Compliance with Voluntary Standards	The HCU 40 complies with voluntary standards identified in Section 3 of the submission (details of specific standards are not included in the provided excerpt, but this is a standard regulatory requirement).
Functional/Performance Requirements (Derived from HCU 30)	Demonstrated through a series of non-clinical tests: Requirements specification reviewHardware and software testingCode design and code reviewsEnvironmental testingSafety testingPerformance testing (implicitly demonstrating it meets the functional requirements of a heater-cooler unit, such as temperature control, water circulation, and safety features comparable to the HCU 30)Hardware and software validationSpecific quantitative performance metrics (e.g., heating/cooling rates, temperature accuracy, flow rates) are not provided in this summary but would have been part of the full submission's performance testing section.
Safety and Effectiveness (Relative to Predicate)	The conclusion states that the HCU 40 "does not raise new issues of safety and effectiveness" compared to the predicate device, the HCU 30. This is based on the technical changes described and the non-clinical testing performed.
Intended Use Fulfillment	The device's intended use is to "circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less." The non-clinical tests (performance, hardware, software validation) would verify the device's ability to perform these functions reliably and safely within the stated parameters.

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

This document describes a medical device (Heater-Cooler Unit), not an AI/ML diagnostic system. Therefore, the concept of a "test set" in the context of an algorithm's performance is not applicable here.

Test Set Sample Size: Not applicable. The device undergoes engineering verification and validation testing, not a "test set" of patient data for AI model evaluation.
Data Provenance: Not applicable in the AI/ML sense. The non-clinical tests are performed on the device itself and its components. The device manufacturer is MAQUET Cardiopulmonary AG, located in Rastatt, Germany, and the contact person is in Wayne, NJ, USA.

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

Not applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this device's performance would be derived from engineering specifications, established medical device standards, and the performance characteristics of its predicate device as verified through non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of human-reviewed cases for AI ground truth adjudication. Non-clinical testing results would be reviewed and accepted by internal engineering and quality personnel according to established protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant for this type of device submission. The document explicitly states: "No clinical evaluation of the modified device was conducted or required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is effectively its ability to meet engineering specifications, safety standards, and functional requirements as verified through laboratory and bench testing, and its equivalence to a legally marketed predicate device. This is primarily based on:

Engineering Specifications: The design requirements for temperature control, flow rates, safety features, etc.
Regulatory Standards: Compliance with relevant national and international medical device standards.
Predicate Device Performance: The HCU 30's established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI algorithms, so there is no "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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MAQUET Cardiopulmonary AG Premarket Notification Special 510(k) HCU 40

K130300

HCU 40 510(k) Summary Prepared in accordance with 21 CFR Part 807.92

JUL 0 1 2013

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 Regulatory Affairs Program Manager MAQUET Cardiovascular 45 Barbour Pond Drive Wayne, NJ 07470 USA

Phone:
Fax:
Email:
Date prepared:

(973) 709-7465 (973) 807-1641 helder.sousa@maquetcv.com January 25, 2013

DEVICE INFORMATION:

Trade Name:	HCU 40 Heater-Cooler Unit
Common/Generic Name:	Heater-Cooler Unit
Classification Name:	Heater-Cooler Unit
Regulation Number:	21 CFR 870.4250
Product Code:	DWC

PREDICATE DEVCE INFORMATION:

The Heater-Cooler Unit HCU 40 is substantially equivalent in function and intended use to the Heater-Cooler Unit HCU 30 (K031544).

DEVICE DESCRIPTION AND INTENDED USE:

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MAQUET Cardiopulmonary AG Premarket Notification Special 510(k) HCU 40

One circuit (main circuit) can be connected to the blood heat exchanger (part of the oxygenator) and/or to the warming/cooling blanket. The other circuit (cardioplegia circuit) can be connected to the cardioplegia heat exchanger.

The use of an UV treatment does significantly enhance the water quality between the water change intervals.

The heat exchange with the patient and the cardioplegia fluid occurs when the water passes the heat exchangers and/or the blanket. The water temperature of the main and the cardioplegia circuit can be regulated independently from each other.

The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

TECHNOLOGICAL CHARACTERISTICS:

The HCU 40 is substantially equivalent to the HCU 30 (K031544). The modifications essentially consist of a polished stainless steel housing, full color touch screen with rotary knob, two tank construction for faster body temperature adjustment and cold cardioplegia, more effective icebuilding, improved heating performance, independent and precise flow regulation of the patient and cardioplegia circuit, and permanent working UV lamp.

NON-CLINICAL TESTS:

The HCU 40 complies with the voluntary standards identified in Section 3 of this submission. MAOUET's development process required that the following activities be completed during the development of the HCU 40:

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

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 HCU 40 is substantially equivalent to the currently marketed HCU 30 (K031544). The HCU 40 is similar to the predicate device in the intended use, the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness.

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Image /page/2/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" arranged around the perimeter. Inside the circle is an emblem featuring three stylized, curved lines that resemble a bird in flight or a flowing design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

July 1, 2013

MAOUET Cardiopulmonary AG C/O Helder A. Sousa Regulatory Affairs Program Manager 45 Barbour Pond Dr. Wayne, NJ 07470

Re: K130300

Trade/Device Name: Heater-Cooler Unit HCU 40 Regulation Number: 21 CFR 870.4250 Regulation Name: Cardiopulmonary bypass temperature controller Regulatory Class: Class II Product Code: DWC Dated: May 22, 2013 Received: May 23, 2013

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

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Page 2 - Mr. Helder Sousa

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/ReportalProblem/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.

M.A. Zillman

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): K130300

Device Name: Heater-Cooler Unit HCU 40

Indications For Use:

The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

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. A. Hillemann

Regulation Number and Section

§ 870.4250 Cardiopulmonary bypass temperature controller.

(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).