PERFORMER CBP SYSTEM

K070213 · Rand S.R.L. · DTQ · Mar 21, 2007 · Cardiovascular

Device Facts

• Record ID: K070213
• Device Name: PERFORMER CBP SYSTEM
• Applicant: Rand S.R.L.
• Product Code: DTQ · Cardiovascular
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Performer CPB is a heart-lung machine console for cardiopulmonary bypass and circulatory support. Version 1.5 adds conventional bypass capability using standard extracorporeal circuits (oxygenators, reservoirs, filters, tubing) and Medtronic Bio-Medicus centrifugal pumps. New safety features include: 1) Level Detection system monitoring reservoir fluid/blood volume, configurable to stop/coast the pump or trigger alarms to prevent air entrainment; 2) AutoClamp System using a Remote Tube Clamp (RTC) on the arterial line to prevent retrograde flow from the aorta during pump speed changes. Used in clinical settings by perfusionists or qualified medical professionals. Output includes visual/audible alarms and automated pump/clamp control. Benefits include reduced risk of air entrainment and retrograde flow during bypass procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including performance testing of level sensing and AutoClamp retrograde detection capabilities, and software verification and validation.

Technological Characteristics

Heart-lung machine console for extracorporeal circulation. Integrates centrifugal pump control, reservoir level sensing, and automated arterial line clamping. System components are standard for extracorporeal circuits. Software-controlled safety features for pump management and flow occlusion.

Indications for Use

Indicated for patients requiring cardiopulmonary bypass procedures for up to 6 hours. Must be operated by qualified medical professionals experienced in extracorporeal circulatory support equipment.

Regulatory Classification

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.

Predicate Devices

• Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System (K052555)
• COBE Century Precision Blood Pump (K960974)
• Terumo Advanced Perfusion System 1 (K022947)
• RMR Automatic Tubing Clamp System (K961364)

Submission Summary (Full Text)

{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<br>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<br>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 [phone]. 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 [phone] or [phone] 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 |

Page 71 of 71