(180 days)
No
The device description focuses on hardware features, safety systems, and user interface elements typical of a heart-lung machine, with no mention of AI or ML capabilities.
No
The device, a heart-lung machine, is used for extracorporeal circulation during cardiopulmonary bypass procedures, which is a supportive function during surgery rather than directly treating a disease or condition.
No
Explanation: The device is an extracorporeal circulatory support system used for cardiopulmonary bypass procedures, not for diagnosing medical conditions. It performs functions such as pumping blood and monitoring integrated parameters, but these are for supporting a procedure, not for diagnostic purposes.
No
The device description clearly outlines numerous hardware components, including pumps, sensors, a printer, and a physical machine with a small footprint and adjustable height. While it mentions software updates and a GUI, the core functionality and description are centered around a physical extracorporeal circulatory support system.
Based on the provided information, 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". This describes a system that supports the body's circulation during surgery, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description focuses on the mechanical and electronic components of a heart-lung machine, including pumps, monitoring systems (like SatO2/Hct and Temperature), and safety features. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic information or results
- Calibration with reference materials
The device is clearly intended for therapeutic and life-support purposes during surgery, not for providing diagnostic information based on in vitro analysis.
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
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.l., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.
It's initial configuration and features are optimized for use with the Medtronic Resting Heart System (K03170).
The key differences between the competitive heart lung machines and the Performer CPB arc:
- . A small foot print for the machine and pump's layout optimized (vertical orientation) for extracorporcal volume reduction. Collapsible feature for storage and easy transportation.
- . Electrically adjustable height and stability system.
- . Integrated Active Air Removal System.
- . A built in printer.
- Pre configured roller pump rotation . (unidirectional) and built in Handcrank in roller pumps for emergencies.
- . Integrated "Memory Card" for treatment data recording and software updates.
- . Integrated SatO2/Hct and Tcmperature monitoring system.
- . Cardioplegia delivery air detector with pump stop feed back.
- Selectable alcrt/alarm tones (including voice). .
- . Active Air removal with arterial flow servo control.
- . Predominant 'icon' based GUI.
- Independent status colored LED system (traffic . light style) for alerts and alarms in addition to the audio and visual set ups on the actual user interface screen.
- Roller pump cover sensors.
- . . Real time integrated parameters' trending.
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, air handling capabilities, blood trauma, cardioplegia delivery have been provided in the 510(k) submission to show equivalence of the Medtronic Performer CPB System, when working with Resting Heart Disposable Module to COBE Century System and other referenced devices. 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)
COBE Century Perfusion Pump (K960974), Terumo Advanced Perfusion System 1 (K022947)
Reference Device(s)
Medtronic Resting Heart System (K031700), Medtronic 560 BioConsuole System (K051303), Medtronic Oxygen Saturation and Hematocrit System (K954501), CSS Cardioplegia Safety System (K973237), Medtronic Pressure Display Box and Tubing Set (K852232)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 1 5 2006
Medtronic Performer CPB 510(k) Submission
APPENDIX I
05 2555
page 1 of 3
510(k) Summary
Medtronic Performer CPB System
(As required by 21CFR 807.92)
A. Submitter Information
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: | September 15, 2005 |
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 | |
| Pending | |
| FDA Classification | Class II |
| FDA Product Classification Code | DTQ |
| FDA Regulation Number | 21 CFR 870.4220 |
| FDA Classification Panel | Cardiovascular |
Predicate Devices:
The Performer CPB has incorporated capabilities from five stand alone Medtronic devices which are:
- Medtronic Resting Heart System (K031700) .
1
Image /page/1/Picture/0 description: The image shows the text "Medtronic Performer CPB 510(k) Submission" on the left side of the image. On the right side of the image, the text "K052555" and "page dof 3" are written in a handwritten font. The text on the left side of the image is written in a more formal font. The image appears to be a page from a document.
- Medtronic 560 BioConsuole System (K051303) .
- Medtronic Oxygen Saturation and Hematocrit System (K954501) .
- CSS Cardioplegia Safety System (K973237) .
- Medtronic Pressure Display Box and Tubing Set (K852232) .
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.l., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.
It's initial configuration and features are optimized for use with the Medtronic Resting Heart System (K03170).
The key differences between the competitive heart lung machines and the Performer CPB arc:
- . A small foot print for the machine and pump's layout optimized (vertical orientation) for extracorporcal volume reduction. Collapsible feature for storage and easy transportation.
- . Electrically adjustable height and stability system.
- . Integrated Active Air Removal System.
- . A built in printer.
- Pre configured roller pump rotation . (unidirectional) and built in Handcrank in roller pumps for emergencies.
- . Integrated "Memory Card" for treatment data recording and software updates.
- . Integrated SatO2/Hct and Tcmperature monitoring system.
- . Cardioplegia delivery air detector with pump stop feed back.
- Selectable alcrt/alarm tones (including voice). .
- . Active Air removal with arterial flow servo control.
- . Predominant 'icon' based GUI.
- Independent status colored LED system (traffic . light style) for alerts and alarms in addition to the audio and visual set ups on the actual user interface screen.
2
Medtronic Performer CPB 510(k) Submission
- Roller pump cover sensors.
- . . Real time integrated parameters' trending.
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).
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 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, air handling capabilities, blood trauma, cardioplegia delivery have been provided in the 510(k) submission to show equivalence of the Medtronic Performer CPB System, when working with Resting Heart Disposable Module to COBE Century System and other referenced devices. 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
Rand S.R.L. c/o Ms. Preeti Jain Director, Regulatory/Clinical Affairs 7611 Northland Drive Minneapolis, MN 55428
Re: K052555
Performer CPB Heart Lung Machine Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart Lung Machine Console Regulatory Class: Class II (Two) Product Code: DTQ Dated: March 3, 2006 Received: March 6, 2006
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, Fi)A 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Bhummar for
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):
05d555
Device Name:
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).
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use X AND/OR
(Part 21 CFR 801 Subpart D)
510(k) Number KO50555
(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) | |
|---|---|
| (Division Sign-Off) | Page 1 of 1 |
| Division of Cardiovascular Devices |
Confidential