(27 days)
No
The summary describes a standard electromechanical, software-controlled blood pumping console and does not mention any AI or ML capabilities. The performance studies focus on software verification and validation against a predicate device, not on the performance of an AI/ML algorithm.
Yes
The device is intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures, which is a therapeutic intervention.
No
The device is described as an "Extracorporeal Blood Pumping Console" intended to "pump blood through the extracorporeal bypass circuit." Its function is to control a centrifugal blood pump, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states it is an "electromechanical, software-controlled device," indicating it includes hardware components in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "pumping blood through the extracorporeal bypass circuit for extracorporeal support." This is a direct interaction with the patient's blood outside the body for therapeutic support during surgery, not for analyzing a sample of blood or other bodily fluid to diagnose a condition.
- Device Description: The description reinforces this by explaining it controls a blood pump to return blood to the patient.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
This device is a medical device used in a surgical setting for direct patient support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
Product codes
DWA
Device Description
The Bio-Console® 560 Extracorporeal Blood Pumping Console is an electromechanical, software-controlled device intended to allow the user to control a Bio-Pump® or Affinity® CP centrifugal blood pump that is used to return the blood to the body of a patient on cardiopulmonary bypass. As part of the blood pumping circuit, the patient's blood is typically pumped through an oxygenator and a filter on its return path to the patient. The Bio-Console 560 is a reusable non-sterile device.
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
Software verification and validation testing confirms the function of the Bio-Console 560 and its software-controlled functional characteristics are substantially equivalent to the predicate device. All test data obtained satisfied the documented product and performance specification.
Key Metrics
Not Found
Predicate Device(s)
Bio-Console® 560 Extracorporeal Blood Pumping Console (K080824)
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).
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JUL 2 4 2013
510(k) Summary of Safety and Effectiveness
| Date Prepared: | June 26, 2013 |
|---|---|
| Applicant: | Medtronic. Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Brooklyn Park, MN 55428 | |
| Establishment Registration No. 2184009 | |
| Contact Person: | Lisa Stone |
| Principal Regulatory Affairs Specialist | |
| Medtronic, Inc. | |
| Cardiovascular | |
| 8200 Coral Sea Street NE, MVS 83 | |
| Mounds View, MN 55112 | |
| Phone: (763) 514-9866 | |
| Fax: (763) 367-8147 | |
| Email: lisa.j.stone@medtronic.com | |
| Trade Name: | Bio-Console® 560 Extracorporeal Blood Pumping Console |
| Common Name: | Cardiopulmonary bypass pump speed control |
| Classification Name: | Control, Pump Speed, Cardiopulmonary Bypass |
| Classification: | Class II, 21 CFR 870.4380 |
| Product Code: | DWA |
| Name of Predicate Device: | Bio-Console® 560 Extracorporeal Blood Pumping Console |
| (K080824) |
Device Description
The Bio-Console® 560 Extracorporeal Blood Pumping Console is an electromechanical, software-controlled device intended to allow the user to control a Bio-Pump® or Affinity® CP centrifugal blood pump that is used to return the blood to the body of a patient on cardiopulmonary bypass. As part of the blood pumping circuit, the patient's blood is typically pumped through an oxygenator and a filter on its return path to the patient. The Bio-Console 560 is a reusable non-sterile device.
1
Intended Use
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
Comparison to the Predicate Device
The Bio-Console 560 has the same intended use, hardware design and basic software as the previously cleared Bio-Console 560. The only change to the device is the incorporation of software enhancements to correct anomalies and to incorporate IEC 60601-1 (3d Edition) compliant alarm and alert tones.
Summary of Performance Data
Software verification and validation testing confirms the function of the Bio-Console 560 and its software-controlled functional characteristics are substantially equivalent to the predicate device. All test data obtained satisfied the documented product and performance specification.
Conclusion
Based upon the technical information, intended use, and in-vitro verification and validation information for the Bio-Console 560 software enhancements addressed in this submission, the Bio-Console 560 has been shown to be substantially equivalent to the currently marketed predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2013
Medtronic, Inc. Lisa Stone 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K131964
Trade/Device Name: Bio-Console 560 Extracorporeal Blood Pumping Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II Product Code: DWA Dated: June 26, 2013 Received: June 27, 2013
Dear Lisa Stone:
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 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
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Page 2 - Lisa Stone
forth in the quality systems (OS) regulation (2) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
M.A. Stilleman
for Bram D. Zuckerman, M.D. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K131964
Bio-Console® 560 Extracorporeal Blood Pumping Console
Indications for use:
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up 10 6 hours).
Prescription Use X (Part 21 CFR 801 Subpart D) OR Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
M. A. Lillehem