COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET

K974897 · Cobe Cardiovascular, Inc. · CAC · Mar 31, 1998 · Anesthesiology

Device Facts

• Record ID: K974897
• Device Name: COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Mar 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COBE BRAT® 2 Standard Volume Processing Set is indicated for use for recovery and/or processing of autologous blood.

Device Story

The Standard Volume Processing Set is a disposable component for the COBE BRAT® 2 Autologous Blood Salvage System. It consists of a 250 ml centrifuge bowl, tubing harness, pump/valve cartridge, waste bag, and reinfusion bag. The device processes autologous blood to recover red blood cells for reinfusion. It is used in clinical settings by healthcare professionals. The modification includes a design change to the internal spacer of the Baylor centrifuge bowl and the addition of a one-year expiration date based on accelerated aging testing. The device functions as a mechanical blood processing set; it does not involve software or automated algorithms.

Clinical Evidence

No clinical testing was performed. Bench testing included in vitro bovine blood testing for Blood Salvage and Plasma Sequestration protocols, and accelerated aging studies to validate the one-year expiration date.

Technological Characteristics

Disposable plastic processing set including a 250 ml centrifuge bowl, tubing harness, and bags. Features a modified internal spacer in the Baylor centrifuge bowl. Operates via mechanical centrifugation. No software, electronics, or energy sources are integral to the disposable set itself.

Indications for Use

Indicated for recovery and/or processing of autologous blood in patients requiring autologous blood transfusion.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• Current BRAT® 2 Standard Volume Processing Set (K933625, K933625, K962689)

Reference Devices

• Modified Standard Volume processing set (K973627)

Submission Summary (Full Text)

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K974897

# MAR 3 1 1998

#### 510(k) Summary

| SUBMITTER: | COBE Cardiovascular, Inc.<br>14401 W. 65th Way<br>Arvada, CO 80004 |
|--------------------|--------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard |
| Phone: | (303)-467-6586 |
| FAX: | (303)-467-6429 |
| DATE PREPARED: | December 28, 1997 |
| DEVICE TRADE NAME: | Standard Volume Processing Set for the COBE BRAT® 2 Autologous Blood Salvage System |
| COMMON NAME: | Standard Volume Processing Set for Autologous Blood Salvage System |
| PREDICATE DEVICE: | Currently Marketed Standard Volume Processing Set for the COBE BRAT® 2 Autologous Blood Salvage System |

### DEVICE DESCRIPTION:

A Standard Volume BRAT® 2 Processing Set consists of a plastic disposable 250 ml centrifuge bowl, a tubing harness to connect the centrifuge bowl with other disposables, a waste bag, and a reinfusion bag. The tubing harness consists of tubing, a pump/valve cartridge, and various connectors.

Modifications to the BRAT® 2 Standard Volume Processing Set covered in this 510(k) consist of addition of a one-year expiration date to the Modified Standard Volume processing set covered in 510(k) K973627 and a design change to the internal spacer of the Baylor centrifuge bowl.

#### INDICATIONS FOR USE:

The COBE BRAT® 2 Standard Volume Processing Set is indicated for use for recovery and/or processing of autologous blood.

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### TECHNOLOGICAL CHARACTERISTICS:

The Modified BRAT® 2 Standard Volume Processing Set is a modification of its predicate device, (510(k) # K933625, K933625, K962689) the Current BRAT® 2 Standard Volume Processing Set and was cleared for marketing per 510(k) K973627. This 510(k) covers the addition of a one-year expiration date to the product.

### NONCLINICAL TEST RESULTS:

The Modified BRAT® 2 Standard Volume Processing Set was tested to assure that it met its functional specifications. In vitro blood testing was done to assure the performance of the modified device was comparable to the predicate device. In vitro bovine blood testing consisted of Blood Salvage test protocols and Plasma Sequestration test protocols. Devices tested in this 510(k) were exposed to an accelerated aging process which produces a one year expiration date.

The results find improved wash efficiency for the modified device based on reduction in estimated Heparin Load to Patient found in bovine Blood Salvage tests.

## CLINICAL TEST RESULTS:

No clinical testing was performed.

#### CONCLUSION:

The Modified BRAT® 2 Standard Volume Processing Set is substantially equivalent to its predicate device, the Current BRAT 2 Standard Volume Processing Set.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that suggest a profile. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

MAR 3 1 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 144Q1 W. 65th Way Arvada, CO 80004-3599

Re: K974897

COBE® BRAT® 2 System with Modified Standard Volume Processing Set Requlatory Class: II (Two) Product Code: CAC Dated: December 30, 1997 Received: December 31, 1997

Dear Ms. Leonard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Lynne Leonard

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,
Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CAC-

Pg.7143

#### 2. Indications For Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K97 4897

COBE® BRAT® 2 System with Modified Standard Volume Processing Set Device Name:

Indications For Use:

The COBE BRAT 2 is indicated for use for recovery and/or processing of autologous blood.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ago 2000

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

K 97489 510(k) Number

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use