(44 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and basic software control for blood pumping, with no mention of adaptive algorithms or learning capabilities.
Yes
The device is intended to pump blood through an extracorporeal bypass circuit, which is a therapeutic intervention for cardiopulmonary bypass procedures.
No
The device description and intended use state that the Medtronic centrifugal blood pumping system is intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of a Base Unit with a display, User Interface, and flow control knob, and is compatible with external hardware components like a drive motor, pump, and transducer. This indicates it is a hardware device with integrated software, not a software-only medical device.
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 for "pumping blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures." This describes a device used during a medical procedure to support bodily function, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a blood pumping console and its components, all of which are involved in the physical process of moving blood during bypass. There is no mention of analyzing blood or other biological samples for diagnostic purposes.
- 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 condition
- Using reagents or assays
Therefore, the Medtronic centrifugal blood pumping system is a medical device used for therapeutic support during surgery, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
DWA
Device Description
The Bio-Console® 560 is an extracorporeal blood pumping console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and Emergency Handcrank.
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)
Software verification and validation testing confirms that 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 specifications.
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
510(k) SUMMARY of Safety and Effectiveness
MAY - 7 2008
l. Applicant Information:
| Date Prepared: | March 21, 2008 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Address: | 7611 Northland Drive |
| Brooklyn Park, MN 55428 | |
| Establishment | |
| Registration No. | 2184009 |
| Contact Person: | Preeti Jain |
| Director of Regulatory and Clinical Affairs | |
| Telephone Number: | (763) 391-9533 |
| Fax Number: | (763) 391-9100 |
II. Device Information:
.
| Trade Name: | Bio-Console® 560 |
|---|---|
| Common Name: | Cardiopulmonary bypass pump speed control |
| Classification Name: | Control, Pump Speed, Cardiopulmonary Bypass |
| Classification: | Class II, 21 CFR 870.4380 |
| Product Code: | DWA |
| Predicate Device: | Medtronic Bio-Console® 560 |
| 510(k) No. K070286, Reg. No. 870.4380; Product Code: DWA | |
| Device 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). |
1
- The Bio-Console® 560 is an extracorporeal blood pumping Device Description: console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and Emergency Handcrank.
- The Medtronic centrifugal blood pumping system is intended to Intended Use: pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
- Comparison to The Bio-Console 560 has the same intended use, hardware Predicate Device: design and basic software as the previously cleared Bio-Console 560. The only change to the device is the incorporation of some minor software modifications, which modify the way the Base Unit and User Interface control sensors and alarms, control the Coast Speed and ensure that the Pump Speed is greater than the Coast Speed to open the clamp.
- Software verification and validation testing confirms that the Test Data: 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 specifications.
- Based upon the technical information, intended use, and in Summary: vitro verification and validation information provided in previous pre-market notifications, the Bio-Console 560 addressed in this submission has been shown to be substantially equivalent to the currently marketed predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2008
Medtronic, Inc. c/o Ms. Preeti Jain Director of Regulatory and Clinical Affairs 7601 Northland Drive Minneapolis, MN 55428
Re: K080824
Bio-Console® 560 Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II (two) Product Code: DWA Dated: March 21, 2008 Received: March 24, 2008
Dear Ms. Jain:
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.
3
Page 2 - Ms. Preeti Jain
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 sct 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ouna R. Kirchner
/ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Ko80824
Bio-Console® 560 Device Name:
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) 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)
Dana E. Lechner
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number_Ko&ox24