(22 days)
No
The summary describes a blood pump speed controller and mentions only functional, hardware, and software testing, with no indication of AI/ML technology.
Yes
The device is described as a "cardiopulmonary bypass pump" and is intended to "pump blood through the extracorporeal bypass circuit for extracorporeal support," which are therapeutic interventions.
No
Explanation: The device is described as a blood pumping system and a cardiopulmonary bypass pump speed controller, used for circulating blood during bypass procedures. It does not identify or diagnose medical conditions.
No
The device description explicitly states it is a "cardiopulmonary bypass pump speed controller" and mentions "hardware and software testing," indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pump blood through the extracorporeal bypass circuit for extracorporeal support." This describes a device that is used during a medical procedure to support bodily functions, not to diagnose a condition by examining samples in vitro (outside the body).
- Device Description: The description reinforces the intended use, stating it's a "cardiopulmonary bypass pump speed controller" used for pumping blood during bypass procedures.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
The device is clearly a medical device used for therapeutic support during surgery, not for 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 is a cardiopulmonary bypass pump speed controller. It is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
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
Functional, hardware and software testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices.
Key Metrics
Not Found
Predicate Device(s)
Bio-Console® 550 K924205, Bio-Console® 550M K936091
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
JUN 1 0 2005
510(k) Summary
| Date Prepared: | May 18, 2005 |
|---|---|
| Submitter: | Medtronic Perfusion Systems |
| 7611 Northland Boulevard | |
| Brooklyn Park, MN 55428 | |
| Contact Person: | Dawn M. Stenstrom |
| Principle Regulatory Affairs Specialist | |
| Phone: (763) 391-9604 | |
| Fax: (763) 391-9603 |
Device Name and Classification:
| Trade Name: | Bio-Console® 560 |
|---|---|
| Common Name: | Cardiopulmonary bypass pump speed control |
| Classification: | Class II |
| Predicate Devices: | Bio-Console® 550 |
| K924205 | |
| Bio-Console® 550M | |
| K936091 |
Device Description:
The Bio-Console® 560 is a cardiopulmonary bypass pump speed controller. It is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
Indication 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).
Comparison to Predicate Devices
The Bio-Console® 550 and Bio-Console® 550M are cardiopulmonary bypass pump speed controllers with the same design characteristics. The modification to the current Bio-Console® 550 adds an additional pressure monitor and a remote touch screen user interface. Currently a remote user interface is used in the Bio-Console® 550M.
1
Summary of Performance Data
Functional, hardware and software testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices.
Conclusion
Medtronic Perfusion Systems has demonstrated that the Bio-Console® 560 is substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JUN 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Ms. Dawn M. Stenstrom Principle Regulatory Affairs Specialist 7611 Northland Boulevard Brooklyn Park, MN 55428
Re: K051303
Bio-Console® 560 Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II Product Code: DWA Dated: May 18, 2005 Received: May 19, 2005
Dear Ms. Stenstrom:
We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave rowed your your 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 for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the 114) 2011-11-11 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). and Cosmetter For (10) that to device, subject to the general controls provisions of the Act. The I ou may, iteres, maxs 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.
3
Page 2 - Ms. Dawn M. Stenstrom
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dona R. Lochner
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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Indications for Use
510(k) Number (if known): ¥ 05130 3
Device Name:
Bio-Console® 560
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).
Prescription Use x________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
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