(30 days)
Not Found
No
The description mentions a microprocessor and basic monitoring/alarm functions, but no indication of AI/ML algorithms for data analysis or decision-making beyond standard control logic.
Yes
The device is indicated to "pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support". This function directly treats a medical condition by assisting or replacing the function of the heart and lungs, which qualifies it as therapeutic.
No
The device is indicated to pump blood through an extracorporeal bypass circuit and for circulatory support, which are therapeutic and support functions, not diagnostic.
No
The device description explicitly states that the CentriMag Primary and Back-Up Consoles are "microprocessor-based devices" with physical components like screens and sensors, indicating they are hardware devices containing software, not software-only devices.
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 "pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support." This describes a device that interacts directly with the patient's blood flow outside the body for therapeutic or supportive purposes.
- Device Description: The description details a microprocessor-based device that controls a motor, monitors sensors, and provides displays and alarms related to the pumping system. This aligns with the function of a blood pump console.
- 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.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The device's function is to move blood, not analyze it.
Therefore, the Levitronix CentriMag Primary and Back-Up Consoles are classified as a medical device used for extracorporeal circulatory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Levitronix CentriMag Primary and Back-Up Consoles 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
DWA
Device Description
The CentriMag Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.
The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.
The CentriMag Primary Console uses single phase AC power and is capable of a flow rate of up to 9.9 LPM. Each Primary Console contains a rechargeable internal battery that is capable of maintaining Primary Console functionality in the event of a loss of AC Power.
The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.
Identical to the predicate device, the Back-Up Console uses single phase AC power and is capable of controlling the Motor and Pump to produce a flow rate of up to 9.9 LPM at maximum pressure head of 600 mmHg when used with the CentriMag Blood Pump. In addition each Back-Up Console contains a non-rechargeable, field replaceable internal battery that is capable of powering the Back-Up Console in the event of a loss of AC Power.
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)
The proposed labeling change did not require any performance characteristics testing.
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
§ 870.4380 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
i093832
Attachment 3 - 510(k) Summary
510(k) Summary for Levitronix CentriMag Primary Console
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular $807.92.
| A. Application Information: | JAN 1 3 2010 |
|---|---|
| Date Prepared: | December 11, 2009 |
| Submitter's Name & Address: | Levitronix LLC |
| 45 First Avenue | |
| Waltham, MA 02451 | |
| Contact Person: | Susan K. Hamann |
| Regulatory Affairs Manager | |
| Ph: (781) 466-6553 | |
| Fax: (781) 622-5090 | |
| e-mail: shamann@levitronix.com | |
| B. Device Information: | |
| Trade or Proprietary Name: | Levitronix CentriMag® Primary Console |
| Levitronix CentriMag® Back-Up Console | |
| Common or Usual Name: | Cardiopulmonary Bypass Pump |
| Console | |
| Classification Name: | Class II, DWA, 21 CFR - 870.4380 |
| Control, Pump Speed, Cardiopulmonary | |
| Bypass | |
| Performance Standard: | Performance standards do not currently |
| exist for these devices. None | |
| established under section 514 of the | |
| Food, Drug and Cosmetic Act. |
C. Predicate Devices:
Levitronix CentriMag Primary Console - 510(k) (K083340) Levitronix CentriMag Back-Up Console - 510(k) (K090004)
Levitronix LLC
1
D. Device Description
The CentriMag Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.
The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.
E. Intended Use
The Levitronix CentriMag Primary and Back-Up Consoles are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentrilMag 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).
ய் Technological Characteristics
CentriMag Primary Console has technological The Levitronix characteristics identical to the predicate device.
The Levitronix CentriMag Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal. monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.
The CentriMag Primary Console uses single phase AC power and is capable of a flow rate of up to 9.9 LPM. Each Primary Console contains a
2
rechargeable internal battery that is capable of maintaining Primary Console functionality in the event of a loss of AC Power.
The Levitronix CentriMag Back-Up Console has technological characteristics identical to the predicate device.
The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.
Identical to the predicate device, the Back-Up Console uses single phase AC power and is capable of controlling the Motor and Pump to produce a flow rate of up to 9.9 LPM at maximum pressure head of 600 mmHg when used with the CentriMag Blood Pump. In addition each Back-Up Console contains a non-rechargeable, field replaceable internal battery that is capable of powering the Back-Up Console in the event of a loss of AC Power.
G. Comparison to Predicate Device
The Levitronix CentriMag Primary and Back-Up Consoles have indications for use which are substantially equivalent to the predicate devices. are composed of the same or equivalent materials as the predicate devices. have equivalent design features as the predicate devices, and have functional characteristics which are the same or equivalent to those of the predicate devices. Due to the equivalency of indications for use, materials of composition, design features, and functional characteristics, the devices raises no new safety or effectiveness issues.
H. Summary of Performance Data
The proposed labeling change did not require any performance characteristics testing.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 3 2010
Levitronix LLC c/o Ms. Susan K. Hamann 45 First Avenue Waltham, MA 02451
Re: K093832
Trade/Device Name: CentriMag Primary Console and Back-Up Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: II Product Code: DWA Dated: December 11, 2009 Received: December 14, 2009
Dear Ms. Hamann:
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
4
Page 2 -- Ms. Susan K. Hamann
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/CDRH/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,
R. Vohrer
Sram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 1 - Indications for Use Statement
| Applicant: | Levitronix LLC |
|---|---|
| 510(k) Number (if known): | K093832 |
.
Device Name:
CentriMag® Primary and Back-Up Consoles
Indications for Use:
The Levitronix CentriMag Primary and Back-Up Consoles 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).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dune R. belmer
(Division Sian-Oif) Division of Cardiovascular Devices
510(k) Number K0
Page 1 of 1
Levitronix LLC
Special 610(k): Labeling Change Consolidated CentriMag® Primary Console and Back-Up Console Operating Manuals