(113 days)
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).
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.
The provided document (K070286) describes the 510(k) summary for the Medtronic Bio-Console® 560, specifically focusing on modifications made to version 1.5. This device is a cardiopulmonary bypass pump speed control system.
Based on the document, here's a summary of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Functional, hardware and software testing was used to establish the performance characteristics for the modifications of this device compared to previously marketed devices." It does not provide a specific table of quantitative acceptance criteria or detailed reported performance figures for the new features (Bubble Detector, Level Sensors, AutoClamp options). Instead, it makes a general statement about testing being performed.
The "modifications for version 1.5 add optional Safety Systems: Bubble Detector, 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." The performance is implied to be acceptable if it is "substantially equivalent" to the predicate devices.
Acceptance Criteria (Implied): The new features (Bubble Detector, Level Sensors, AutoClamp) and user-selectable options must perform their intended functions reliably and safely, demonstrating substantial equivalence to similar features in predicate devices.
Reported Device Performance: The document only states that "Functional, hardware and software testing was used to establish the performance characteristics." No specific metrics (e.g., sensitivity, specificity, accuracy, detection limits) are provided.
| Feature / Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bubble Detection | Reliable detection of air in the circuit, comparable to predicate. | "Functional, hardware and software testing was used to establish the performance characteristics for the modifications... Air detection... are features that are already available on the Terumo System 1." (Implies satisfactory performance through testing and comparison to an established predicate device.) |
| Level Sensing | Reliable detection of low fluid levels, comparable to predicate. | "Functional, hardware and software testing was used to establish the performance characteristics for the modifications... level sensing are features that are already available on the Terumo System 1." (Implies satisfactory performance through testing and comparison to an established predicate device.) |
| AutoClamp Activation | Reliable activation for air detection/low fluid, comparable to predicate. | "Functional, hardware and software testing was used to establish the performance characteristics for the modifications... the automatic arterial clamp is already available as the Rocky Mountain Research, Inc. Automatic Tubing Clamp System." (Implies satisfactory performance through testing and comparison to an established predicate device.) |
| Pump Speed Control | Reliable control based on user-selected options for safety systems. | "Functional, hardware and software testing was used to establish the performance characteristics for the modifications... 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." (Implies satisfactory performance through testing.) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing was not required to establish substantial equivalence." This indicates that no human test set data was used. The testing described was "Functional, hardware and software testing." The provenance of this internal testing data (e.g., country of origin) is not provided, but it would typically be conducted internally by Medtronic. It is prospective testing of the device itself, not retrospective analysis of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Since no clinical testing or human test set was performed, no experts were used to establish ground truth in this context. The "ground truth" for functional, hardware, and software testing would be derived from engineering specifications and established test protocols, rather than expert judgment on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. No human test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device, the Bio-Console® 560, is a physical medical device with hardware and software, not a standalone algorithm in the typical sense of AI/machine learning. The "performance" assessment was of the integrated system's functions. Therefore, a standalone algorithm performance study, as understood in AI, was not conducted. The functional, hardware, and software testing would assess the device's ability to operate the pump, detect air/low levels, and activate the clamp independently of a human operator, but this isn't framed as an "algorithm only" study.
7. The Type of Ground Truth Used
For the "Functional, hardware and software testing," the ground truth would be based on:
- Engineering Specifications: The device's design requirements and intended operational parameters.
- Predicate Device Performance: The known and established performance characteristics of the legally marketed predicate devices (Medtronic Bio-Console® 560 (K051303), Terumo System 1 (K022947), Rocky Mountain Research, Inc. Automatic Tubing Clamp System (K961364)). The new features were compared to these established devices for substantial equivalence.
8. The Sample Size for the Training Set
The document does not mention any training set. This suggests that the device's logic for the new functions (Bubble Detector, Level Sensors, AutoClamp) was not based on machine learning or AI that would require a distinct training set. The functionality would have been developed using traditional engineering principles and programmed software.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the context of AI/machine learning) was mentioned or implied.
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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,
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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.
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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.
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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)
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(Division Sign-Off
(Division Sign-Off) Division of Cardiovascular Devices
510(K) Number_ko70286
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§ 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).