COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION

K991986 · Cobe Cardiovascular, Inc. · CAC · Sep 9, 1999 · Anesthesiology

Device Facts

• Record ID: K991986
• Device Name: COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Sep 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COBE® BRAT® 2 Autologous Blood Salvage System in indicated for use for the recovery and/or processing of autologous blood. The CRIT-LINE™ Hematocrit Sampling System option is used in conjunction with the COBE® BRAT® 2 Autologous Blood Salvage System to measure the hematocrit of the finished product in the reinfusion bag.

Device Story

The COBE® BRAT® 2 is an autologous blood salvage system modified with the CRIT-LINE™ Hematocrit Sampling System. The device processes autologous blood for reinfusion. The CRIT-LINE™ component provides noninvasive, real-time hematocrit measurement of the finished red cell product as it enters the reinfusion bag. It samples blood ten times per second, capturing hematocrit changes as blood exits the centrifuge bowl. This provides a representative hematocrit result based on multiple samples, eliminating the need for manual sampling and reducing clinician exposure to blood. The system is used in clinical settings where autotransfusion is performed. The output is displayed to the clinician, allowing for monitoring of the blood product quality during the collection process.

Clinical Evidence

Bench testing only. Performance was validated through electrical safety testing (EN 60601-1), electromagnetic immunity testing (EN 60601-1-2), electromagnetic emissions testing (EN 55011), and hematocrit performance testing conducted in accordance with CRIT-LINE™ product specifications using human blood.

Technological Characteristics

The device integrates a hematocrit sampling system into the existing COBE® BRAT® 2 autologous blood salvage platform. It utilizes noninvasive sensing technology to measure hematocrit in the reinfusion line. Compliance with EN 60601-1 (electrical safety), EN 60601-1-2 (electromagnetic immunity), and EN 55011 (electromagnetic emissions) is maintained.

Indications for Use

Indicated for recovery and/or processing of autologous blood in patients requiring autotransfusion; includes real-time hematocrit monitoring of the finished blood product in the reinfusion bag.

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

• COBE® BRAT® 2 Autologous Blood Salvage System

Submission Summary (Full Text)

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a 1999

# 510(k) Summary

| SUBMITTER: | COBE Cardiovascular®, Inc.<br>14401 W. 65th Way<br>Arvada, CO 80004 |
|----------------------|---------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | June 10, 1999 |
| DEVICE TRADE NAME: | COBE® BRAT® 2 Autologous Blood Salvage System with<br>CRIT-LINE™ Hematocrit Sampling System |
| COMMON/USUAL NAME: | Autologous Blood Salvage System with Hematocrit Sampling Option |
| CLASSIFICATION NAME: | Autotransfusion Apparatus |
| PREDICATE DEVICE: | COBE® BRAT® 2 Autologous Blood Salvage System |

# DEVICE DESCRIPTION:

The COBE® BRAT® 2 Autologous Blood Salvage System is being modified to add the CRIT-LINE™ Hematocrit Sampling System, which will be used to measure the finished red cell product as it is being emptied into the reinfusion bag. The CRIT-LINE™ Hematocrit Sampling System will be offered as an option for the COBE® BRAT® 2 Autologous Blood Salvage System.

The purpose of the CRIT-LINE™ Hematocrit Sampling System is to give the user a noninvasive, real-time measurement of the hematocrit of the red cell product in the reinfusion bag. It eliminates exposure of the clinician to collection of a blood sample. Because the CR/T-L/NE™ Hematocrit Sampling System measures the hematocrit of the blood ten times per second as it is being collected in the reinfusion bag, the system is able to capture changes in hematocrit as the blood is exiting the centrifuge bowl, and is able to provide a more representative hematocrit result based upon multiple sampling of the blood product, rather than on a single sample.

# INDICATIONS FOR USE

The COBE® BRAT® 2 Autologous Blood Salvage System in indicated for use for the recovery and/or processing of autologous blood. The CRIT-LINE™ Hematocrit Sampling System option is used in conjunction with the COBE® BRAT® 2 Autologous Blood Salvage System to measure the hematocrit of the finished product in the reinfusion bag.

### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematoorit Sampling System is substantially equivalent to the currently marketed COBE® BRAT® 2 Autologous Blood Salvage System. The two devices are identical with the exception of the CRIT-LINE™ Hematocrit Sampling System option with its associated hardware, software, and disposables. Otherwise, the intended use,

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specifications, method of operation, accessories, design, and features, of the COBE® BRAT® 2 Autologous Blood Salvage System remain the same.

Testing of the COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System consisted of:

- Electrical safety testing in accordance with EN 60601-1: International Standard for Medical 1. Electrical Equipment, Part 1
- Electromagnetic immunity testing in accordance with EN60601-1-2: International Standard for 2. Medical Electrical Equipment, Part 1.2
- 3. Electromagnetic emmisions testing in accordance with EN 55011: Limits and Methods of Measurement of Radio Distrubance Characteristics of Industrial, Scientific, and Medical Radio-Frequency Equipment
- 4. Hematocrit performance testing in accordance with the CRIT-LINE™ product specifications using human blood

These data support substantial equivalence of the COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### SEP 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004-3599

Re: K991986

> Trade Name: COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System Option

Regulatory Class: II Product Code: CAC, KOC Dated: June 10, 1999 Received: June 14, 1999

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 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications For Use 1.

| 510(k) Number (If known): | K991198 |
|---------------------------|---------|
|---------------------------|---------|

COBE® BRAT® 2 System with CRIT-LINE™ Hematocrit Sampling System Option Device Name:

Indications For Use:

The COBE BRAT 2 is indicated for use for the recovery and/or processing of autologous blood. The CODE BRAT 2 is Indication in add for the roter in conjunction with the BRAT 2 The ONY -EINE Homatoon. Sampling by Stomished product in the reinfusion bag.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Myerson

Division Sign-Off Division of Clinical Laboratory De 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________