(67 days)
No
The summary describes a level sensing system for extracorporeal bypass circuits, relying on physical sensing and bench testing for verification. There is no mention of AI, ML, image processing, or data-driven training/testing.
Yes
The device, specifically the Medtronic Bio-Console 560 System and the Medtronic Performer CPB System, is intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures, which is a therapeutic intervention to support heart and lung function during surgery. The Level Sensing System helps ensure the safe operation of these therapeutic pumps.
No
The device is described as a system for pumping blood during extracorporeal bypass procedures and includes a level sensing system for safety. Its primary function is therapeutic/supportive (pumping blood), not diagnostic (identifying or characterizing disease).
No
The device description explicitly mentions hardware components: the Level Sensor (LS100) and the Level Sensor Tape (LST). The performance studies also include bench testing of physical characteristics and functionality with hardware.
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 a patient's circulation, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a system used with a "hardshell reservoir" and as an "optional safety system" for extracorporeal blood pumping. This aligns with a device used in a surgical or medical procedure setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The device's function is mechanical (pumping blood) and safety-related (level sensing).
Therefore, the Medtronic Bio-Console 560 System and Performer CPB System with the Level Sensing System are medical devices used in a clinical setting for cardiopulmonary bypass procedures, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
"The Medtronic Bio-Console 560 System with Level Sensing System (LS100) and Level Sensing Tape [LST]) 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 Medtronic Performer CPB System with Level Sensing System (LS100) and Level Sensing Tape [LST]) is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment."
Product codes
DWA, DTQ, DTW
Device Description
Level Sensing System includes the Level Sensor (LS100) and the Level Sensor Tape (LST). The Level Sensor System is one of the optional safety systems that can be used with the Medtronic Bio Console 560 Extracorporeal Blood Pumping System and the Medtronic Performer Cardiopulmonary Bypass System. It is designed to be used only with a Medtronic hardshell reservoir.
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
"qualified medical professional who is experienced in the operation of this or similar equipment."
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
Bench testing was used to verify the performance characteristics of these devices. The following bench studies were performed:
- Visual and Dimension Inspection
- Threshold Measurements
- Free-Fall Test
- Basic Functionality with Bio-Console Test
- Tensile Strength Test
- Connector Compatibility/Wiring, Output Stage Type and Status Indicator Tests
- Splash Test
- Mounting Test (using LST adhesive tape)
- Chemical Resistance
- Basic Functionality in a circuit with bovine blood
- Electrical Safety Test
- Emissions/Immunity Test
Clinical testing was not required to establish substantial equivalence.
Verification and validation testing has demonstrated that the Level Sensing System is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
(a)
Identification. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
Medtronic, Inc. Rahul Shah Regulatory Operations Specialist 7611 Northland Drive Minneapolis, MN 55428
Re: K150530
Trade/Device Name: Medtronic Bio Console 560 System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II Product Code: DWA, DTQ, DTW Dated: April 9, 2015 Received: April 13, 2015
Dear Mr. Shah:
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.
1
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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 vours.
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150530
Device Name
Medtronic Bio Console 560 System with Level Sensor [LS100] and Level Sensor [LS100] and Level Sensing Tape [LST])
Indications for Use (Describe)
"The Medtronic Bio-Console 560 System with Level Sensing System (LS100) and Level Sensing Tape [LST]) is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours)".
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K150530
Device Name
Medtronic Performer CPB System with Level Sensor [LS100] and Level Sensor [LS100] and Level Sensing Tape [LST])
Indications for Use (Describe)
"The Medtronic Performer CPB System with Level Sensing System (LS100) and Level Sensing Tape [LST]) is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment."
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
6. Summary of Safety and Effectiveness
| Date Prepared: | May 8, 2015 |
|---|---|
| Submitter's Name and Address: | Medtronic Perfusion Systems |
| Medtronic, Inc. | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Contact Person: | Rahul Shah |
| Regulatory Operations Specialist | |
| Medtronic, Inc. | |
| Coronary and Structural Heart Disease | |
| Management | |
| 8200 Coral Sea Street NE, MVS 83 | |
| Mounds View, MN 55112 | |
| Phone: (763) 514-9846 | |
| Fax: (763) 367-8147 | |
| Email: rahul.m.shah@medtronic.com | |
| Proprietary Name of Device: | Medtronic Bio Console 560 System with Level |
| Sensing System (level Sensor [LS100] and Level | |
| Sensing Tape [LST]) | |
| Medtronic Performer CPB System with Level | |
| Sensing System (Level Sensor [LS100] and Level | |
| Sensing Tape [LST]) | |
| Common/Usual Name: | Cardiopulmonary bypass speed control |
| Classification Name: | Control, Pump Speed, Cardiopulmonary Bypass |
| Classification: | Class II |
| Product Code: | DWA, DTQ, DTW |
| Regulation Number: | 21 CFR 870.4380 |
| Predicate Device: | Medtronic Bio Console 560 System |
| Medtronic Performer CPB System | |
| Predicate 510(k): | K070286, K070213 |
Device Description
Level Sensing System includes the Level Sensor (LS100) and the Level Sensor Tape (LST). The Level Sensor System is one of the optional safety systems that can be used with the Medtronic Bio Console 560 Extracorporeal Blood Pumping System and the Medtronic Performer Cardiopulmonary Bypass System. It is designed to be used only with a Medtronic hardshell reservoir.
Indications for Use
"The Medtronic Bio-Console 560 System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours)."
5
"The Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment."
Comparison to Predicate Devices:
The Level Sensing System is substantially equivalent to the previous version (predicate) of this device. The footprint of the level sensor, cable configuration and strain relief components have changed to improve the usability of the device.
The modified sensor has the following similarities to the predicate device which received 510(k) clearance:
- . Same intended use/indications
- Same operating principle ●
- Same fundamental technological characteristics ●
- Same performance requirements
- Same packaging materials and design .
- Same sterilization requirements ●
Summary of Performance Data:
Bench testing was used to verify the performance characteristics of these devices. The following bench studies were performed:
- Visual and Dimension Inspection ●
- Threshold Measurements
- Free-Fall Test .
- Basic Functionality with Bio-Console Test ●
- o Tensile Strength Test
- o Connector Compatibility/Wiring, Output Stage Type and Status Indicator Tests
- o Splash Test
- Mounting Test (using LST adhesive tape) .
- Chemical Resistance ●
- Basic Functionality in a circuit with bovine blood ●
- Electrical Safety Test ●
- Emissions/Immunity Test ●
Clinical testing was not required to establish substantial equivalence.
Verification and validation testing has demonstrated that the Level Sensing System is substantially equivalent to the predicate device.
Conclusion:
The described labeling and engineering changes do not change the indications for use, technology and performance specifications of this device. Therefore the Level Sensing System is substantially equivalent to the currently marketed predicate device.