SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG

K050111 · Cobe Cardiovascular, Inc. · DTN · Mar 8, 2005 · Cardiovascular

Device Facts

• Record ID: K050111
• Device Name: SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTN · Cardiovascular
• Decision Date: Mar 8, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SMARXT® BMR1900™ Closed Venous Reservoir Bag is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

Device Story

The SMARxT BMR1900 is a sterile, single-use, soft-shelled venous reservoir bag for cardiopulmonary bypass surgery. It manages blood volume (300 mL to 1900 mL) at flow rates up to 6 L/min. Blood enters through an inlet port, passes through an internal polyester screen filter to remove large air bubbles, and exits through an outlet port. The device features integrated connectors for external temperature and saturation/hematocrit monitoring equipment. A dual four-way stopcock assembly on the top edge allows for air purging and administration of drugs or solutions. Used in the OR by perfusionists/surgeons, the device provides a reservoir for blood during bypass, facilitating air removal and fluid management to support patient stability during cardiac procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Soft-shelled reservoir bag; polyester screen filter; dual four-way stopcock assembly; integrated ports for temperature and saturation/hematocrit monitoring. Sterile, non-pyrogenic fluid pathway. Single-use. Flow rate capacity up to 6 L/min; volume capacity 300-1900 mL.

Indications for Use

Indicated for patients undergoing cardiac surgical procedures requiring extracorporeal support for up to six hours.

Regulatory Classification

Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• SMARxT® VRB® 1800™ Closed Venous Reservoir Bag (K980786)

Submission Summary (Full Text)

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510(k) Pre-Market Notification: SMARxT BMR1900™ Closed Venous Reservoir Bag

WAR - 2005

KOSO////

### 510(k) Summary

| SUBMITTER: | COBE Cardiovascular, Inc.<br>14401 W. 65th Way<br>Arvada, CO 80004 |
|----------------------|--------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Edward E. Newton<br>Director, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | January 10, 2005 |
| DEVICE TRADE NAME: | SMARxT® BMR1900™Closed Venous Reservoir Bag |
| COMMON/USUAL NAME: | Venous Reservoir Bag |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Blood Reservoir |
| PREDICATE DEVICE: | SMARxT® VRB® 1800™ Closed Venous Reservoir Bag |

#### DEVICE DESCRIPTION AND INDICATIONS FOR USE:

The SMARxT BMR1900 Closed Venous Reservoir Bag is a sterile device with a non-pyrogenic fluid pathway, for single use only, and is not intended to be resterilized by the user. The device is a soft-shelled blood reservoir designed for use in cardiopulmonary bypass surgery for periods up to six hours. The SMARxT BMR1900 can be operated at flow rates up to 6 liters per minute. The maximum operating volume is 1900 mL. The minimum operating volume is 300 mL.

The SMARxT BMR1900 has a blood inlet port with an integral cardiotomy inlet on one side of the bag and a blood outlet port on the opposite side of the bag. Integral to the blood inlet port are connectors for measuring the temperature and saturation/hematocrit of the incoming blood using external monitoring equipment. The top edge of the bag has a dual four-way stopcock assembly that is used to purge air from the bag. The stopcock assembly may also be used for the administration of drugs or other solutions, as needed during the cardiopulmonary bypass procedure. Blood enters the bag through the inlet port and passes through a polyester screen filter before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood.

# STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

A comparison of device features and in-vitro test data demonstrate that the COBE SMARxT BMR1900 Closed Venous Reservoir Bag is substantially equivalent to the currently marketed COBE SMARxT VRB1800 Closed Venous Reservoir Bag (K980786).

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#### Truthful and Accurate Statement

A statement attesting to the truthfulness and accuracy of the information contained in this submission is attached as Appendix O.

## Further Information

In the event that additional information is required, please contact:

Edward E. Newton Director, Regulatory Affairs SORIN Group, Cardiac Surgery, North America (COBE Cardiovascular, Inc. and Carbomedics, Inc.) 1300 E. Anderson Lane, Austin, Texas 78752-1793 USA Phone: [phone] [phone] Fax: E-mail: [e-mail]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 - 2005

Cobe Cardiovascular, Inc. c/o Mr. Edward E. Newton Director, Regulatory Affairs 14401 W. 65th Way Arvada, CO 80004-3599

Re: K050111

> SMARxT BMR 1900 Closed Venous Reservoir Bag Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: January 17, 2005 Received: January 18, 2005

Dear Mr. Newton:

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.

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Page 2 - Mr. Edward E. Newton

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincercly yours,

Diane R. Weiner

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

Kosom 510(k) Number (If known):

SMARxT® BMR1900™ Closed Venous Reservoir Bag Device Name:

Indications For Use:

The SMARXT® BMR1900™ Closed Venous Reservoir Bag is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

Prescription Use × (Per 21 CFR 801.109)

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diura R. Vicher

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K (15 U || |