(180 days)
No
The document describes a mechanical blood oxygenation and carbon dioxide removal system with standard monitoring and control components. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for circulatory and/or pulmonary support, which directly relates to treating medical conditions, specifically during procedures requiring cardiopulmonary bypass.
No
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood and provide circulatory and/or pulmonary support; it does not diagnose medical conditions.
No
The device description explicitly lists multiple hardware components, including a drive, emergency drive, sensors, holders, cables, and disposables. The performance studies also mention hardware testing and validation.
Based on the provided information, the CARDIOHELP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used for "blood oxygenation and carbon dioxide removal" and to "pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support." This describes a system that directly interacts with and supports the patient's physiological functions, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The components listed (pump, sensors, tubing sets, oxygenators) are all consistent with a system designed for extracorporeal circulation and gas exchange, not for analyzing biological samples. While it mentions a "venous probe for blood gas monitoring," this is a sensor integrated into the system to monitor the blood flowing through the circuit, not a separate device for analyzing a collected sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) for diagnostic purposes. The focus is on supporting the patient's circulation and respiration.
Therefore, the CARDIOHELP System 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 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).
Product codes
DTQ
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).
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
hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.
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)
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
No clinical evaluation of the modified device was conducted or required.
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
§ 870.4220 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).
0
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: .
1
- 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 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).
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
2
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.
3
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
4
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
5
Indications for Use
510(k) Number: K133598
Device Name: CARDIOHELP System
Indications For Use:
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).
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