(29 days)
Not Found
No
The description mentions a "microprocessor based device" and "processor based device" for control and display functions, but there is no mention of AI, ML, or related concepts like learning, training, or complex pattern recognition beyond basic system monitoring and control.
No
Explanation: The CentriMag Primary Console and Monitor are components of the CentriMag Extracorporeal Blood Pumping System, which is a therapeutic device. However, the console and monitor themselves are control and display units that facilitate the operation of the blood pumping system. They do not directly perform the therapeutic action (pumping blood) but rather manage and monitor the device that does. Therefore, these specific components are not therapeutic devices on their own.
No
The device is indicated for pumping blood through an extracorporeal bypass circuit for circulatory support, and the description focuses on its function in controlling and monitoring this process. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly details hardware components such as a microprocessor, battery, power connectors, graphical screen, and touch pads for both the Primary Console and the Monitor. While software is involved in controlling these components and displaying information, the device is fundamentally a hardware system with integrated software.
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 system is used to "pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support." This is a direct interaction with the patient's blood outside the body for therapeutic support, not for diagnostic purposes.
- Device Description: The description details a system for controlling a blood pump and monitoring its performance. It focuses on mechanical and electronic functions related to blood circulation support.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition. IVDs are designed to perform tests on these samples.
- Clinical Use: The device is used in a hospital setting (OR and bed-side) for providing circulatory support, which is a treatment, not a diagnostic procedure.
In summary, the Levitronix 2nd Generation CentriMag Primary Console and Levitronix Monitor are components of a system designed for extracorporeal circulatory support, which is a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Levitronix 2ⁿᵈ Generation CentriMag Primary Console and Levitronix Monitor are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
Product codes (comma separated list FDA assigned to the subject device)
DWA
Device Description
2nd Generation CentriMag Primary Console
The 2nd Generation CentriMag Primary Console is a microprocessor based device. The microprocessor generates the primary motor control signal, monitors system sensors, generates display outputs, interprets the inputs through the front keypad, provides alarm functions and handles the Levitronix Monitor interface. The Console is intended to be operated on single phase AC power; however, it also has a built-in rechargeable battery with a battery charger. The rechargeable battery is field replaceable. In addition, an optional external modular battery (UPS) can be used to power the CentriMag Primary Console. The human interface of the CentriMag Primary Console consists of a graphical screen to display data and system options and touch pads to change the system status. The 2nd Generation CentriMag Primary Console is intended to be used together with the Levitronix Monitor; however it can be also operated as a stand-alone unit.
Levitronix Monitor
The Levitronix Monitor provides a redundant user interface containing a display and touch pads. The Primary and Back-Up Consoles also provide a fully-functional user interface containing a display and touch pads. The Levitronix Monitor is a non-sterile, reusable device that is designed to work only with the 2ⁿᵈ Generation CentriMag Primary Console; therefore, it does not support the 1st Generation CentriMag Primary Console or the CentriMag Back-Up Console. The Levitronix Monitor is a 12V DC-powered device and receives its power directly from 2ⁿᵈ Generation CentriMag Primary Console via a power connector that mates with a connector on the back-panel of 2nd Generation CentriMag Primary Console. Based on the design of its power connector, the Levitronix Monitor cannot be plugged into a hospital AC power outlet. The Levitronix Monitor's core function is to provide multi-color alpha-numerical and graphical displays of information it receives from the 2nd Generation CentriMag Primary Console. The Levitronix Monitor is intended for use as a hospital-based unit (OR and bed-side) and is not intended for use during patient transport from one hospital to another.
The Levitronix Monitor is a processor based device, with a flat color screen (e.g. LCD). In addition, it is equipped with touch pad to allow the user to enter commands. In the hospital-setting configuration, the user is able to operate and monitor the performance of the CentriMag System through the Levitronix Monitor. The Levitronix Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Levitronix Monitor only displays data and stores user commands without interacting directly with the orimary motor control which is managed by the 2ⁿᵈ Generation CentriMag Primary Console. The Levitronix Monitor is connected to the 2ⁿᵈ Generation CentriMag Primary Console through one cable, which includes data and power lines. Power is provided by the 2nd Generation CentriMag Primary Console.
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-based unit (OR and bed-side)
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)
The Levitronix 2ⁿᵈ Generation CentriMag Primary Console and the Levitronix Monitor have successfully undergone functional testing demonstrating substantial equivalence to the predicate devices.
The risk management methods used to assess the operational integrity of the 2ⁿᵈ Generation CentriMag Primary Console and the Levitronix Monitor were a Risk Analysis and a Failure Modes and Effects Analysis (FMEA).
Clinical testing was not performed. The 2nd Generation Console and Levitronix Monitor were CE Mark approved on February 5, 2010 and have been successfully used clinically in Europe in the commercial market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).
0
K102129
AUG 2 7 2010
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in This Summary of Federal Regulations, Part 807, and in particular §807.92.
Application Information A.
Date Prepared:
July 28, 2010
Levitronix LLC
Submitter's Name & Address:
45 First Avenue Waltham, MA 02451
Contact Person:
Farzad Parsaie V.P., RA/QA (781) 622-5075 Ph: (781) 622-5090 Fax: e-mail: fparsaie@levitronix-us.com
Device Information в.
Trade or Proprietary Name:
Common or Usual Name:
Classification Name:
Performance Standard:
- Levitronix 2nd Generation CentriMag® Primary Console
-
- Levitronix Monitor
Cardiopulmonary Bypass Pump Console
- Levitronix Monitor
Class II, DWA, 21 CFR – 870.4380 Control, Pump Speed, Cardiopulmonary Bypass
Performance standards do not currently exist . for these devices. None established under section 514 of the Food, Drug and Cosmetic Act.
Legally Marketed Predicate Devices C.
1
.
D. Device Description
2nd Generation CentriMag Primary Console
The 2nd Generation CentriMag Primary Console is a microprocessor based device. The microprocessor generates the primary motor control signal, monitors system sensors, generates display outputs, interprets the inputs through the front keypad, provides alarm functions and handles the Levitronix Monitor interface. The Console is intended to be operated on single phase AC power; however, it also has a built-in rechargeable battery with a battery charger. The rechargeable battery is field replaceable. In addition, an optional external modular battery (UPS) can be used to power the CentriMag Primary Console. The human interface of the CentriMag Primary Console consists of a graphical screen to display data and system options and touch pads to change the system status. The 2nd Generation CentriMag Primary Console is intended to be used together with the Levitronix Monitor; however it can be also operated as a stand-alone unit.
Levitronix Monitor .
The Levitronix Monitor provides a redundant user interface containing a display and touch pads. The Primary and Back-Up Consoles also provide a fullyfunctional user interface containing a display and touch pads. The Levitronix Monitor is a non-sterile, reusable device that is designed to work only with the 200 Generation CentriMag Primary Console; therefore, it does not support the 1st Generation CentriMag Primary Console or the CentriMag Back-Up Console. The Levitronix Monitor is a 12V DC-powered device and receives its power directly from 2016 Generation CentriMag Primary Console via a power connector that mates with a connector on the back-panel of 2nd Generation CentriMag Primary Console. Based on the design of its power connector, the Levitronix Monitor cannot be plugged into a hospital AC power outlet. The Levitronix Monitor's core function is to provide multi-color alpha-numerical and graphical displays of information it receives from the 2nd Generation CentriMag Primary Console. The Levitronix Monitor is intended for use as a hospital-based unit (OR and bed-side) and is not intended for use during patient transport from one hospital to another.
The Levitronix Monitor is a processor based device, with a flat color screen (e.g. LCD). In addition, it is equipped with touch pad to allow the user to enter commands. In the hospital-setting configuration, the user is able to operate and monitor the performance of the CentriMag System through the Levitronix Monitor. The Levitronix Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Levitronix Monitor only displays data and stores user commands without interacting directly with the orimary motor control which is managed by the 200 Generation CentriMag Primary Console. The Levitronix Monitor is connected to the 2ª Generation r milling Primary Console through one cable, which includes data and power lines. Power is provided by the 2nd Generation CentriMag Primary Console.
Levitronix LLC
2
E. Intended Use
The Levitronix 2ª Generation CentriMag Primary Console and Levitronix Monitor are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
Technological Characteristics に
The technological characteristics of the Levitronix 2nd Generation CentriMag Primary Console and the Levitronix Monitor are the same as the predicate devices.
G. Comparison to Predicate Device
The Levitronix 2nd Generation CentriMag Primary Console and the Levitronix Monitor have an indication for use, design features, and functional characteristics which are substantially equivalent to the predicate devices. Due to the equivalency of indications for use, design features, and functional characteristics, these devices raise no new safety or effectiveness issues.
Summary of Performance Data H.
The Levitronix 2014 Generation CentriMag Primary Console and the Levitronix Monitor have successfully undergone functional testing demonstrating substantial equivalence to the predicate devices.
The risk management methods used to assess the operational integrity of the 200 Generation CentriMag Primary Console and the Levitronix Monitor were a Risk Analysis and a Failure Modes and Effects Analysis (FMEA).
l. Clinical Performance
- Clinical testing was not performed. The 2nd Generation Console and Levitronix Monitor were CE Mark approved on February 5, 2010 and have been successfully used clinically in Europe in the commercial market.
Conclusion J.
The Levitronix 2nd Generation CentriMag Primary Console and the Levitronix Monitor are substantially equivalent to the Levitronix CentriMag Primary Console (K083340) and the Levitronix CentriMag System (K020271).
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Levitronix LLC c/o Mr. Farzad Parsaie VP Regulatory Affairs/Quality Assurance 45 First Avenue Waltham, MA 02451
AUG 2 7 2010
K102129 Levitronix 2nd Generation CentriMag Primary Console, Levitronix Monitor Regulation Number: 21 CFR 870.4380 Regulation Name: Control, Pump Speed, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWA Dated: July 28, 2010 Received: July 29, 2010
Dear Mr. Parsaie:
Re:
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.
4
Page 2 - Mr. Farzad Parsaie
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Bra D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K102129
Indications for Use Statement
Applicant: Levitronix LLC K102129 510(k) Number (if known): CentriMag® Suq Generation Primary Device Name: Console દ્વ Levitronix® Monitor
Indications for Use:
The Levitronix 200 Generation CentriMag Primary Console and Levitronix Monitor are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
OR Prescription Use (per 21 CFR 801.109)
Over-the Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Division Sign Off Division of Obrdiovascular Devices 510(k) Number
(Optional Format 1-2-96)