(14 days)
Not Found
No
The device description mentions a microprocessor for control, monitoring, and alarms, but there is no mention of AI, ML, or related concepts.
Yes
The device is indicated for use in extracorporeal circulatory support to pump blood, which directly impacts a patient's physiological function to treat a condition.
No
The device is described as a blood pump used for extracorporeal circulatory support, monitoring system sensors, and providing alarm functions, but not for diagnosing medical conditions.
No
The device description explicitly states it is a "microprocessor-based device" and describes hardware components like sensors, a front display, and an alphanumeric screen, indicating it is not software-only.
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 describes a device that directly interacts with the patient's blood flow outside the body for therapeutic or supportive purposes.
- Device Description: The description focuses on the console's function in controlling the blood pump and monitoring system parameters. It doesn't mention any analysis of biological samples or diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. The Levitronix CentriMag system, as described, is a life support device that manages blood flow, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Levitronix CentriMag Primary Console is 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
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.
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 performance characteristics of the Levitronix CentriMag Primary Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device.
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
KOr3340
NOV 2 6 2008 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:
| Date Prepared: | November 11, 2008 |
|---|---|
| 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 | |
| Device Information: | |
| Trade or Proprietary Name: | Levitronix CentriMag® Primary 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 |
C. Predicate Device:
Levitronix CentriMag Console Software Version 2.02 – 510(k) (K081221)
established under section 514 of the Food, Drug and Cosmetic Act.
в.
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.
ட். Intended Use
The Levitronix CentriMag Primary Console is 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).
ட Technological Characteristics
Levitronix CentriMag Primary Console has technological The characteristics similar 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 displav 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,
G. Comparison to Predicate Device
The Levitronix CentriMag Primary Console has indications for use which is substantially equivalent to the predicate device, is composed of the same or equivalent materials as the predicate device, has equivalent design features as the predicate device, and has functional characteristics which are the same or equivalent to those of the predicate device. Due to the
2
equivalency of indications for use, materials of composition, design features, and functional characteristics, the device raises no new safety or effectiveness issues.
H. Summary of Performance Data
The performance characteristics of the Levitronix CentriMag Primary Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2008
Levitronix LLC c/o Susan Hamann Regulatory Affairs Manager 45 First Avenue Waltham, MA 02451
K083340 Levitronix CentriMag Primary Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II Product Code: DWA Dated: November 11, 2008 Received: November 12, 2008
Dear Ms. Hamann:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Susan Hamann
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
uma R. Vachus
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment 1 - Indications for Use Statement
| Applicant: | Levitronix LLC |
|---|---|
| 510(k) Number (if known): | K083340 |
| Device Name: | CentriMag Primary Console (with V3.00 Application Software) |
Indications for Use:
The Levitronix CentriMag Primary Console is 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)
R. Vmmmm
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k o83340
Page 1 of 1
Levitronix LLC
Special 510(k): Device Modification CentriMag® Primary Console
Page 25 of 138