(13 days)
The Levitronix CentriMag Back-Up 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).
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 provided document is a 510(k) summary for the Levitronix CentriMag Back-Up Console. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving those criteria are met. This document is a regulatory submission for premarket notification, not a clinical trial report or a performance validation study report.
Here's what information can be extracted and what is missing:
Information Present:
- Device Name: Levitronix CentriMag Back-Up Console
- Intended Use: To pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours, both for complete cardiopulmonary bypass and other circulatory support systems.
- Comparison to Predicate Device: The document states that the device has "technological characteristics similar to the predicate device," "indications for use which is substantially equivalent," "is composed of the same or equivalent materials," "has equivalent design features," and "has functional characteristics which are the same or equivalent to those of the predicate device." It concludes that "Due to the equivalency of indications for use, materials of composition, design features, and functional characteristics, the device raises no new safety or effectiveness issues."
- Summary of Performance Data: The document briefly mentions: "The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device."
Information NOT Present (and likely not found in a 510(k) summary of this type):
The document does not provide the following:
- A table of specific acceptance criteria and the reported device performance against those criteria.
- Sample sizes used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of human readers with/without AI assistance. (This is a medical device, not an AI diagnostic tool).
- Details of a standalone (algorithm only) performance study. (Again, this is a hardware console, not an AI algorithm).
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
Based on the provided text, I cannot complete the requested tables and sections related to specific acceptance criteria, study sizes, expert involvement, and AI performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validations with quantitative acceptance criteria.
The "Summary of Performance Data" section (H) only states that tests were performed "compared with Levitronix performance specifications established for the device and with the commercially available predicate device." It doesn't present those specifications or the detailed test results.
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Attachment 3 - 510(k) Summary
JAN 1 5 2009
510(k) Summary for Levitronix CentriMag Back-Up 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.
Application Information: A.
Date Prepared:
Submitter's Name & Address:
Contact Person:
December 30, 2008
Levitronix LLC 45 First Avenue Waltham, MA 02451
Susan K. Hamann Regulatory Affairs Manager (781) 466-6553 Ph: (781) 622-5090 Fax: e-mail: shamann@levitronix.com
B. Device Information:
Trade or Proprietary Name:
Common or Usual Name:
Classification Name:
Performance Standard:
Levitronix CentriMag® Back-Up Console
Cardiopulmonary Bypass Pump Console
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.
். Predicate Device:
Levitronix CentriMag Back-Up Console Software Version 1.01 - 510(k) (K051209)
Levitronix LLC
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D. Device Description
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 Back-Up 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).
F. Technological Characteristics
The Levitronix CentriMag Back-Up Console has technological characteristics similar 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 mmHq when used with the CentriMag Blood Pump. 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 Back-Up 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
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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 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 Back-Up Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2009
Levitronix LLC c/o Susan Hamann Regulatory Affairs Manager 45 First Avenue Waltham, MA 02451
K090004 Re:
Levitronix CentriMag Backup Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II Product Code: DWA Dated: December 30, 2008 Received: January 2, 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.
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.
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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.
D. Wuhner
\ Bram 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): | K090004 |
| Device Name: | CentriMag ® Back-Up Console (with V2. Application Software) |
Indications for Use:
The Levitronix CentriMag Back-Up 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)
.00
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. V. Hines
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko90004
Page 1 of 1
Levitronix LLC
§ 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).