(58 days)
Not Found
No
The description focuses on conventional electromechanical safety features (level detection, automatic clamping) and does not mention any AI or ML algorithms for control, analysis, or prediction.
Yes
The device is a heart-lung machine used for cardiopulmonary bypass procedures, which directly supports and maintains physiological functions during surgery, making it a therapeutic device.
No
The device is an extracorporeal circulatory support system used for cardiopulmonary bypass procedures, which involves performing the functions of the heart and lungs externally during surgery. It is a therapy delivery device, not one that diagnoses conditions.
No
The device description explicitly details hardware components like a heart-lung machine, centrifugal pump, level detectors, and an AutoClamp System, indicating it is not software-only.
Based on the provided text, the Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "extracorporeal circulation of fluids for cardiopulmonary bypass procedures" and "pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support." This describes a system that circulates blood and fluids outside the body during surgery, not a device that tests samples of blood or other bodily fluids in vitro (in a lab setting).
- Device Description: The description details a "heart lung machine" that integrates functions for cardiopulmonary bypass. It mentions components like oxygenators, reservoirs, centrifugal pumps, filters, and tubing. These are all components of a system designed to support circulation during surgery, not to perform diagnostic tests on samples.
- Lack of IVD Characteristics: The text does not mention any features related to analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Medtronic Performer CPB system's function is to mechanically support circulation during a medical procedure.
N/A
Intended Use / Indications for Use
The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System 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.
The centrifugal pump is indicated for use in pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).
Product codes (comma separated list FDA assigned to the subject device)
DTQ
Device Description
The Performer CPB, is a next generation heart lung machine that integrates the primary functions and safety features needed to perform cardiopulmonary bypass and related circulatory support procedures, along with enhanced user conveniences, into a reduced sized instrument. The product is designed and manufactured by RAND S.r.1., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.
This version of the device has been changed to add conventional bypass capability to the existing device which previously only supported the use of Medtronic Resting Heart Disposable Module. The conventional bypass refers to already marketed cardiopulmonary circuits that utilize a reservoir. Typical conventional circuits include oxygenators, reservoirs, centrifugal pump, filters, tubings, connectors etc. This updated version of the Performer only supports the Medtronic Bio-Medicus centrifugal Pump as the arterial pump.
The changes included in Version 1.5 of the device include the following:
- . Optional Level Detection capability for reservoirs: Level detectors have been added to monitor changes in fluid or blood volume in the reservoirs. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. The level detection system is only utilized when operating with the reservoirs in the conventional cardiopulmonary bypass mode.
- Optional Retrograde Detection and Occlusion capability: An AutoClamp System . has been added that utilizes a Remote Tube Clamp (RTC), placed on the arterial line which serves to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. The AutoClamp System can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, prevent retrograde flow and thereby prevent the potential to entrainment air around the aortic cannulation site. The AutoClamp System is only utilized when operating in the conventional cardiopulmonary bypass mode.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data, such as, level sensing capabilities and AutoClamp retrograde detection capabilities have been provided in the 510(k) submission to show equivalence of the Medtronic Performer CPB System to RMR Automatic Tubing Clamp System, Terumo System 1 and Cobe system. In addition comprehensive testing has been completed on the machine including performance and Software Verification and Validation.
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.
K052555, K960974, K022947, 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
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).
0
APPENDIX I
510(k) Summary
KO702/3
Medtronic Performer CPB System
MAR 2 1 2007
(As required by 21CFR 807.92)
Submitter Information A.
B.
| Submitter's Name: | RAND S.r.l. |
|---|---|
| Address: | Via Sparato, 60 |
| 41036 Medolla (MO) – ITALY | |
| Telephone Number: | 763.391.9533 (for contact) |
| Contact Person: | Preeti Jain |
| Date Submission Prepared: | January 19, 2007 |
Device Information
| Trade Name | Performer Cardiopulmonary Bypass System |
|---|---|
| Common Name | Cardiopulmonary bypass heart-lung machine console |
Address of Manufacturing
| Facilities | Manufacturing Site |
|---|---|
| RAND S.r.l. | |
| Via Sparato, 60 | |
| 41036 Medolla (MO) – ITALY | |
| Establishment Registration Number | |
| 3003793891 | |
| FDA Classification | Class II |
| FDA Product | |
| Classification Code | DTQ |
| FDA Regulation Number | 21 CFR 870.4220 |
| FDA Classification Panel | Cardiovascular |
Predicate Devices:
- · Medtronic Performer CPB Advanced Extracoporeal Circulatory Support System (K052555)
- COBE Century Precision Blood Pump (K960974) ●
- Terumo Advanced Perfusion System 1 (K022947) .
- RMR Automatic Tubing Clamp System (K961364) .
Device Description:
1
The Performer CPB, is a next generation heart lung machine that integrates the primary functions and safety features needed to perform cardiopulmonary bypass and related circulatory support procedures, along with enhanced user conveniences, into a reduced sized instrument. The product is designed and manufactured by RAND S.r.1., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.
This version of the device has been changed to add conventional bypass capability to the existing device which previously only supported the use of Medtronic Resting Heart Disposable Module. The conventional bypass refers to already marketed cardiopulmonary circuits that utilize a reservoir. Typical conventional circuits include oxygenators, reservoirs, centrifugal pump, filters, tubings, connectors etc. This updated version of the Performer only supports the Medtronic Bio-Medicus centrifugal Pump as the arterial pump.
The changes included in Version 1.5 of the device include the following:
- . Optional Level Detection capability for reservoirs: Level detectors have been added to monitor changes in fluid or blood volume in the reservoirs. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. The level detection system is only utilized when operating with the reservoirs in the conventional cardiopulmonary bypass mode.
- Optional Retrograde Detection and Occlusion capability: An AutoClamp System . has been added that utilizes a Remote Tube Clamp (RTC), placed on the arterial line which serves to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. The AutoClamp System can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, prevent retrograde flow and thereby prevent the potential to entrainment air around the aortic cannulation site. The AutoClamp System is only utilized when operating in the conventional cardiopulmonary bypass mode.
Indications for Use:
The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System 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.
The centrifugal pump is indicated for use in pumping blood through an extracomoreal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).
C. Comparison of Required Technological Characteristics
Medtronic Performer CPB System is a system comprised of standard components of an extracorporeal circuit for use during cardiopulmonary circulatory support. The
2
system has the same technological characteristics as a traditional circuit and the single components have the same technological characteristics as the predicate.
D. Performance Data
Performance data, such as, level sensing capabilities and AutoClamp retrograde detection capabilities have been provided in the 510(k) submission to show equivalence of the Medtronic Performer CPB System to RMR Automatic Tubing Clamp System, Terumo System 1 and Cobe system. In addition comprehensive testing has been completed on the machine including performance and Software Verification and Validation.
E. Conclusion
Medtronic Performer CPB System is substantially equivalent to the noted predicate devices based on the similarities of technological characteristics, indications for use and the results of performance comparative testing and is safe and effective for its intended use.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or bird-like figure. The emblem is composed of three curved lines that form the shape of the bird's head, body, and tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2007
Rand S.R.L. c/o Ms. Preeti Jain Director, Regulatory/Clinical Affairs 7611 Northland Drive Minneapolis, MN 55428
Re: K070213
Performer CPB System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary bypass heart-lung machine Regulatory Class: Class II Product Code: DTQ Dated: January 19, 2007 Received: January 22, 2007
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.
4
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 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.
Bram B. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix II
Indications for Use
510(k) Number (if known):
Device Name: ___ Performer CPB
Indications For Use:
The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System 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.
The centrifugal pump is indicated for use in pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).
Prescription Use X
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
| Page 1 of | |
|---|---|
| (gn-Off) of Cardiovascular Devices Lot Number | K070213 |
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