(113 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware and basic software control.
Yes
The device is intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures, which is a therapeutic intervention to support a patient's heart and lung function during surgery.
No
The device description clearly states its purpose is "to pump blood through the extracorporeal bypass circuit for extracorporeal support," which is a treatment function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a Base Unit, display, User Interface (touch screen), flow control knob, External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and emergency Handcrank.
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 for periods appropriate to cardiopulmonary bypass procedures." This describes a device used during a medical procedure to support bodily functions, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a blood pumping console and its components (motor, pump, transducer, handcrank). These are all components of a system for circulating blood externally during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the Medtronic centrifugal blood pumping system is a medical device used for extracorporeal support, 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)
Functional, hardware and software testing was used to establish the performance characteristics for the modifications of this device compared to previously marketed devices. Clinical testing was not required to establish substantial equivalence.
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.
Medtronic Bio-Console® 560 (K051303), Terumo System 1 (K022947), Rocky Mountain Research, Inc. Automatic Tubing Clamp System (K961364)
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
Image /page/0/Picture/0 description: The image shows the Medtronic logo. On the left is a circular symbol with a stylized human figure inside. To the right of the symbol is the word "Medtronic" in a bold, sans-serif font.
MAY 2 2 2007
510(k) Summary
Date Prepared:
January 26, 2007
- Submitter:
Medtronic 7611 Northland Drive Brooklyn Park, MN 55428
| Contact Person: | Cheryl Norton |
|---|---|
| Principle Regulatory Affairs Specialist | |
| Phone: | (763) 391-9532 |
| Fax: | (763) 391-9100 |
Device Name and Classification:
| Trade Name: | Bio-Console® 560 |
|---|---|
| Common Name: | Cardiopulmonary bypass pump speed control |
| Regulation Number: | 21 CFR 870.4380 |
| Product Code: | DWA |
| Classification: | Class II |
Predicate Devices:
Medtronic Bio-Console® 560 (K051303) Terumo System 1 (K022947) Rocky Mountain Research, Inc. Automatic Tubing Clamp System (K961364)
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.
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).
Comparison to Predicate Devices
The Bio-Console® 560 has new technological characteristics compared to the existing device. The modifications for version 1.5 add optional Safety Systems: Bubble Detector,
1
Level Sensors, and AutoClamp. User selectable options have also been added to control the speed of the centrifugal pump and/or activate the AutoClamp when air is detected or if there is low fluid in the reservoir. Air detection and level sensing are features that are already available on the Terumo System 1 and the automatic arterial clamp is already available as the Rocky Mountain Research, Inc. Automatic Tubing Clamp System.
Summary of Performance Data
Functional, hardware and software testing was used to establish the performance characteristics for the modifications of this device compared to previously marketed devices. Clinical testing was not required to establish substantial equivalence.
Conclusion
Medtronic has demonstrated that the Bio-Console® 560 is substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2007
Medtronic, Inc. c/o Ms. Cheryl Norton Principal Regulatory Affairs Specialist 7611 Northland Drive Brooklyn Park, MN 55428
Re: K070286 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 15, 2007 Received: May 16, 2007
Dear Ms. Norton:
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. Cheryl Norton
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. La Lune
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): Ko 7 o 2 % (
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 × (Part 21 CFR 801 Subpart D) AND/OR 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)
uma R-Vclumes
(Division Sign-Off
(Division Sign-Off) Division of Cardiovascular Devices
510(K) Number_ko70286
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