BIO-CONSOLE, MODEL 560

K051303 · Medtronic Perfusion Systems · DWA · Jun 10, 2005 · Cardiovascular

Device Facts

• Record ID: K051303
• Device Name: BIO-CONSOLE, MODEL 560
• Applicant: Medtronic Perfusion Systems
• Product Code: DWA · Cardiovascular
• Decision Date: Jun 10, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4380
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Bio-Console 560 is a cardiopulmonary bypass pump speed controller; manages blood flow through extracorporeal circuits. System inputs include pressure monitoring data; outputs include pump speed control signals. Features remote touch screen user interface for clinician interaction. Used in clinical settings (e.g., OR) by perfusionists or surgeons to maintain extracorporeal support. Device modifies previous Bio-Console 550 design by adding an additional pressure monitor and remote touch screen interface. Output allows real-time monitoring and adjustment of bypass flow, supporting patient hemodynamic stability during cardiac procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence established via functional, hardware, and software bench testing.

Technological Characteristics

Cardiopulmonary bypass pump speed controller; Class II device. Features include integrated pressure monitoring and remote touch screen user interface. Connectivity involves interface with extracorporeal bypass circuit components. Software-controlled operation for pump speed regulation.

Indications for Use

Indicated for patients requiring extracorporeal blood circulation support during cardiopulmonary bypass procedures for durations up to 6 hours.

Regulatory Classification

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.

Predicate Devices

• Bio-Console® 550 (K924205)
• Bio-Console® 550M (K936091)

Submission Summary (Full Text)

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K051303

JUN 1 0 2005

### 510(k) Summary

| Date Prepared: | May 18, 2005 |
|-----------------|--------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Boulevard<br>Brooklyn Park, MN 55428 |
| Contact Person: | Dawn M. Stenstrom<br>Principle Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |

# Device Name and Classification:

| Trade Name: | Bio-Console® 560 |
|--------------------|-------------------------------------------|
| Common Name: | Cardiopulmonary bypass pump speed control |
| Classification: | Class II |
| Predicate Devices: | Bio-Console® 550<br>K924205 |
| | Bio-Console® 550M<br>K936091 |

## Device Description:

The Bio-Console® 560 is a cardiopulmonary bypass pump speed controller. It is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

#### Indication 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® 550 and Bio-Console® 550M are cardiopulmonary bypass pump speed controllers with the same design characteristics. The modification to the current Bio-Console® 550 adds an additional pressure monitor and a remote touch screen user interface. Currently a remote user interface is used in the Bio-Console® 550M.

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# Summary of Performance Data

Functional, hardware and software testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices.

# Conclusion

Medtronic Perfusion Systems 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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JUN 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Ms. Dawn M. Stenstrom Principle Regulatory Affairs Specialist 7611 Northland Boulevard Brooklyn Park, MN 55428

Re: K051303

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 18, 2005 Received: May 19, 2005

Dear Ms. Stenstrom:

We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave rowed your your 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 for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the 114) 2011-11-11 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). and Cosmetter For (10) that to device, subject to the general controls provisions of the Act. The I ou may, iteres, maxs 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. Dawn M. Stenstrom

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,

Dona R. Lochner

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): ¥ 05130 3

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 ______x______________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

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)

R. Lochner

(Division Sign-Off) Division of Cardiovascular Devices

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