(195 days)
No
The summary describes a mechanical perfusion system with sensors and controls, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as a blood oxygenation and carbon dioxide removal system used to pump blood for circulatory and/or pulmonary support, which directly addresses a medical condition or function.
No
The CARDIOHELP System is described as a blood oxygenation and carbon dioxide removal system used to pump blood and provide circulatory and/or pulmonary support during medical procedures. While it monitors and controls extracorporeal circulation, its primary function is therapeutic (support) rather than diagnostic (identifying a condition or disease). The included venous probe for blood gas monitoring and measurement of venous temperature acts more as a monitoring component for the therapeutic intervention than a standalone diagnostic tool for identifying a disease.
No
The device description explicitly lists multiple hardware components, including a drive, emergency drive, sensors, cables, and disposables (tubing sets and oxygenators). While it mentions software validation, the device is clearly a system with significant hardware elements.
Based on the provided text, the CARDIOHELP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the system as a blood oxygenation and carbon dioxide removal system used to pump blood through an extracorporeal bypass circuit for circulatory and/or pulmonary support. This involves directly interacting with the patient's blood outside the body for therapeutic purposes.
- Device Description: The components listed are related to pumping blood, oxygenating it, and monitoring parameters within the extracorporeal circuit (flow, level, temperature, pressure). These are all functions related to supporting the patient's circulation and respiration.
- No mention of analyzing samples: There is no indication that the device is used to analyze biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status. While it monitors some blood parameters (blood gas, venous temperature), this is for controlling the extracorporeal circuit, not for diagnosing a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CARDIOHELP System's function is therapeutic support, not diagnostic analysis of samples.
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
DTO, DYB, DTS, DTQ, DTN, DTZ, DTCD, DTGC, DTM
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
- level sensor including level sensor pad
- venous probe for blood gas monitoring and measurement of venous temperature
- external sensors for temperature and pressure
- different holders
- connection cables
- various disposables, that can be driven by CARDIOHELP-i
- HLS/ HIT Set Advanced are tubing sets, that contain the HLS Module Advanced oxygenator with integrated centrifugal pump, which fits into the CARDIOHELP-i. These sets are available in different configurations and will be compiled as customized tubing sets
- QUADROX-iR is an oxygenator with integrated centrifugal pump and will be provided with or without integrated arterial filter
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
used within the hospital environment and outside the hospital environment (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: technical data, measurement ranges and measurement accuracy, construction, features, interfaces, handling, critical situations and interventions.
To evaluate the safety and effectiveness of the CARDIOHELP-i with accessories and disposable components the following areas have been tested:
- Electrical and mechanical Safety
- Electromagnetic Compatibility
- Software Validation
- Usability
- Verification of Alarms
- Tests for Inter-hospital transportation
- Packaging
- Verification of Operating Data and Accuracy of Measurements
To evaluate the safety and effectiveness of the HLS/HIT Set Advanced and QUADROX-iR the following areas have been tested:
- Integrity
- Performance
- Tightness
- Biocompatibility
- Shelf life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K943803, K991864, K090006, K083111, K020271, K061369
Reference Device(s)
K080470, K071774, K082117, K093522, K080592, K090533, K090147
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
MAQUET
GETINGE GROUP
APR - 4 2011
510 (K) Summary [as required by 21 CFR 807.92(c) ]
Submitter: Maquet Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germany
Roland Jehle Contact Person: Phone: +49 7478 921-373 Fax: E-mail: roland.jehle@maquet-cp.com
September 13, 2010 Date Prepared:
CARDIOHELP System Device Trade Name:
Cardiopulmonary Support System Common/Usual name:
Classification names:
Cardiopulmonary bypass heart/lung machine console (21CFR 870.4220) Non-roller type cardiopulmonary bypass blood pump (21CFR 870.4360) Cardiopulmonary bypass level sensing monitor and /or control (21CFR 870.4340) Cardiopulmonary bypass bubble detector (21CFR 870.4205) Cardiopulmonary bypass pump speed control (21CFR 870.4380) Cardiopulmonary bypass oxygenator (21CFR 870.4350) Cardiopulmonary bypass heat exchanger (21CFR 870.4240) Cardiopulmonary bypass arterial line blood filter (21CFR 870.4260) Cardiopulmonary bypass vascular catheter, cannulae, or tubing (21CFR 870.4210) Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting (21CFR 870.4290) Cardiopulmonary bypass accessory equipment (21CFR 870.4200) Cardiopulmonary bypass on-line blood monitor (21CFR 870.4330)
1
Predicate Devices:
Systems:
Jostra HL20 Integrated Perfusion System, K943803 RotaFlow Centrifugal Pump System, K991864 LIFEBRIDGE B2T, K090006 Impella 5.0 Catheters, K083111 Levitronix CentriMag Extracorporeal Blood Pumping System, K020271 TandemHeart Escort Controller, K061369
Disposables:
RotaFlow Centrifuqal Pump with Bioline Coating, K080470 Jostra QuadroxD Diffusion Membrane Oxygenator with Bioline Coating, K071774 Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating, K082117 Quadrox-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Bioline Coating, K093522 HLM- Tubing Set with BIOLINE Coating, K080592 HLM- Tubing Set with SOFTLINE Coating, K090533
Accessory:
Venous Probe accessory (Blood Monitoring Unit BMU40), K090147
2
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: ।
- o flow/bubble sensor
- o level sensor including level sensor pad
- o venous probe for blood gas monitoring and measurement of venous temperature
- external sensors for temperature and pressure ဝ
- o different holders
- o connection cables
- various disposables, that can be driven by CARDIOHELP-i
- o HLS/ HIT Set Advanced are tubing sets, that contain the HLS Module Advanced oxygenator with integrated centrifugal pump, which fits into the CARDIOHELP-i. These sets are available in different configurations and will be compiled as customized tubing sets
- o QUADROX-iR is an oxygenator with integrated centrifugal pump and will be provided with or without integrated arterial filter
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).
3
Comparison of Technical Characteristics to Predicates:
The CARDIOHELP System has indications for use which are substantially equivalent to those of the predicate devices. The predicate devices with a clearance as a system (HL20, Rotaflow, Impella 5.0, Lifebridge B2T, Centrimag, TandemHeart) are designed as extracorporeal circulation systems for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. The predicate devices Impella 5.0, Centrimag and TandemHeart are also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.
The CARDIOHELP System has similar technical characteristics, performance specifications and materials as the following predicates: Lifebridge B2T (K090006), CentriMag (K020271), Rotaflow (K991864).
CARDIOHELP-i:
The CARDIOHELP-i is a microprocessor based device. The CARDIOHELP-i acts as a drive unit for a suitable disposable (HLS Set Advanced, HJT Set Advanced or QUADROX-iR) by electronically creating a rotating magnetic field. The CARDIOHELP-i provides a user interface including a touch screen, a rotary knob, illuminated push buttons and LED indicator lights to control and display the various parameters. The information can be displayed in various ways to optimize the handling of CARDIOHELP for the user.
The CARDIOHELP-i provides various interconnection possibilities for external sensors and data communication ports for external data acquisition devices. The CARDIOHELP-i also provides an internal battery backup.
Venous Probe:
The Venous Probe as accessory for the CARDIOHELP-i is identical to the Venous Probe accessory of the Blood Monitoring Unit BMU40 (K090147). The Venous Probe measures the venous blood parameters SyO2 (Oxygen Saturation), Hb (Hemoglobin), Hct (Hematocrit) and temperature. For the blood gas measurements, the probe is connected to the disposables measuring cell.
Flow-Bubble Sensor:
The Flow-Bubble Sensor as an accessory for the CARDIOHELP-i is identical in function and technology to the Flow-Bubble Sensor in the Rotaflow Centrifugal Pump System (K991864). The Flow Bubble Sensor must be clamped on a tubing system for contact less volumetric measurement of the flow. The measurement principle is the ultrasonic transit time technique (UST) which guarantees a safe and precise blood flow measurement. The sensor is also used for bubble monitoring.
4
External Level Sensors:
The external capacitive level sensor kit for the CARDIOHELP-i is identical to the established external capacitive level sensor kit for the HL20 Integrated Perfusion System (K943803) and the Rotaflow Centrifuqal Pump System (K991864).
External Temperature Sensors:
The external temperatures probe for oxygenators as an accessory for the CARDIOHELP-i is identical in function and technology to the external temperature probe for oxygenators of the HL20 Integrated Perfusion System (K943803).
External Pressure Sensors:
The external pressure sensor kit as an accessory for the CARDIOHELP-i is identical to the external pressure sensors of the HL20 Integrated Perfusion System (K943803).
Disposables:
HLS Set Advanced:
The HLS Set Advanced consists of the following components: HLS Module Advanced, Tube Connections and Priming set. The HLS Set Advanced has a BIOLINE Coating which is identical to the HLM Tubing Set with BIOLINE Coating (K080592).
HIT Set Advanced:
The HIT Set Advanced consists of the following components: HLS Module Advanced. Tube Connections and Priming set. The HIT Set Advanced has a SOFTLINE Coating which is identical to the HLM Tubing Set with SOFTLINE Coating (K090533).
HLS Module Advanced (component of HLS/HIT Set Advanced):
The HLS Module Advanced consists of the following three subassemblies: Oxygenator, Heat Exchanger and Centrifugal Pump.
The design of the oxygenator part and heat exchanger part of the HLS Module Advanced is equivalent to the one of the QUADROX-i (K082117 and K093522). The oxygenator part of the HLS Module Advanced has a diffusion membrane identical to the membrane of the QuadroxD (K071774). The heat exchanger is made from Polyurethane hollow fiber. The HLS Module Advanced is equipped with an integrated centrifugal pump, which
5
MAQUET GETINGE GROUP
will be driven by CARDIOHELP-i in order to pump the blood through the extracorporeal circuit. The integrated centrifugal blood pump is based on the established Rotaflow centrifugal pump RF-32 (K080470). The HLS Module Advanced provides three integrated pressure sensors and two integrated temperature sensors which can be connected to the CARDIOHELP-i. Similar to the QUADROX-i the HLS Module Advanced is available in the sizes "Adult" and "Small Adult".
QUADROX-IR:
The QUADROX-iR consists of the following subassemblies: Oxygenator, Heat Exchanger, Centrifugal Pump and an optional arterial filter.
The design of the oxygenator part and heat exchanger part of the QUADROX-iR is equivalent to QUADROX-i (K082117 and K093522). The oxygenator part of the QUADROX-iR has a microporous membrane identical to the membrane of the QUADROX-i. The heat exchanger is made from Polyurethane hollow fiber. The QUADROX-iR is equipped with an integrated centrifugal pump, which will be driven by CARDIOHELP-i in order to pump the blood through the extracorporeal circuit. The integrated centrifygal blood pump is based on the established Rotaflow centrifugal pump RF-32 (K080470). The optionally available arterial filter of the QUADROX-iR is equivalent to the optional arterial filter of the QUADROX-i (K082117 and K093522). Similar to the QUADROX-i the QUADROX-iR is available in the sizes "Adult" and "Small Adult".
Non-clinical Testing and Performance:
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: technical data, measurement ranges and measurement accuracy, construction, features, interfaces, handling, critical situations and interventions.
6
MAQUET
GETINGE GROUP
To evaluate the safety and effectiveness of the CARDIOHELP-i with accessories and disposable components the following areas have been tested:
- Electrical and mechanical Safety .
- Electromagnetic Compatibility -
- -Software Validation
- Usability -
- Verification of Alarms -
- -Tests for Inter-hospital transportation
- Packaging -
- Verification of Operating Data and Accuracy of Measurements -
To evaluate the safety and effectiveness of the HLS/HIT Set Advanced and QUADROX-iR the following areas have been tested:
- Intearity -
- Performance -
- -Tightness
- Biocompatibility -
- -Shelf life
Determination of Substantial Equivalence
Testing and evaluation in regards to safety and effectiveness was conducted to demonstrate that the CARDIOHELP System described in this submission is substantially equivalent to the above mentioned predicate devices.
The following areas have been evaluated in accordance with various standards when applicable:
- -Performance
- Electrical and mechanical safety on the CARDIOHELP-i including accessories
- Software Validation on CARDIOHELP-i -
- Biocompatibility on suitable disposables -
- Sterility on suitable disposables ・
- Integrity on suitable disposables -
Conclusion
The data provided demonstrate that the CARDIOHELP System is substantially equivalent to the named predicate devices.
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Maquet Cardiopulmonary AG c/o Roland Jehle Hechinger Strasse 38 72145 Hirrlingen, Germany
APR - 4 2911
Re: K102726
Trade/Device Name: Maquet CARDIOHELP System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary bypass heart-lung machine console Regulatory Class: Class II Product Code: DTO Dated: February 16, 2011 Received: February 17, 2011
Dear Mr. Jehle:
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.
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
8
Page 2 – Mr. Roland Jehle
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Duna R. Vihner
Image /page/8/Picture/7 description: The image contains a handwritten symbol or character that resembles a stylized letter 'f' or a cursive 'h'. The character is drawn with a single, continuous stroke, featuring a loop at the top and a curved line extending downwards. The stroke varies in thickness, suggesting it was created with a pen or brush. The background is plain and white, which makes the character stand out.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K102726
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 X Over-The-Counter 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)
shuma R. Holmes
(Division Sign-Off) Page 1 of 1
Division of Cardiovascular Devices
(Posted November 13, 2003) 510(k) Number K102726