(144 days)
No
The summary describes a device that regulates water temperature for patient warming/cooling during bypass procedures. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes.
The device description explicitly states "Further application areas are warming and/or cooling therapies," indicating its use in treating patients.
No
The device is a Heater-Cooler Unit that circulates temperature-controlled water to regulate a patient's temperature during medical procedures. It does not perform any diagnostic functions by identifying, detecting, or measuring a medical condition or disease. Its function is therapeutic/supportive.
No
The device description clearly outlines physical components like water circuits, heat exchangers, and a UV treatment system, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "circulate water through heat exchange circuits to warm or cool a patient" and "regulate the patient temperature during extracorporeal circulation." This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description reinforces this by explaining how the device supplies temperature-controlled water to regulate patient temperature and cardioplegia solution temperature. It describes the physical process of heat exchange with the patient and cardioplegia fluid.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. The device's function is entirely focused on external temperature control during a medical procedure.
Therefore, the HCU 40 falls under the category of a therapeutic or life support device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
DWC
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.
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 ice-building, improved heating performance, independent and precise flow regulation of the patient and cardioplegia circuit, and permanent working UV lamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical evaluation of the modified device was conducted or required.
Non-clinical tests were conducted:
- Requirements specification review
- Hardware and software testing
- Code design and code reviews
- Environmental testing
- Safety testing
- Performance testing
- Hardware and software validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
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.
1
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.
2
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
3
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
4
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