HAEMONETICS 40U RBC FILTER BAG

K061103 · Haemonetics Corp. · CAK · May 17, 2006 · General Hospital

Device Facts

• Record ID: K061103
• Device Name: HAEMONETICS 40U RBC FILTER BAG
• Applicant: Haemonetics Corp.
• Product Code: CAK · General Hospital
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Haemonetics 40u RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns (40μ). It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion. The 40μ RBC Filter Bag has a similar intended use as the predicate device. It is designed to be used by trained hospital personnel under the direction of a physician. Therefore, it is to be used as a prescription medical device, which is indicated by the symbol on the labeling as "Rx Only".

Device Story

The Haemonetics 40u RBC Filter Bag is a blood transfusion microfilter component used in perioperative autologous transfusion. It receives washed red blood cells from a Haemonetics cell salvage device; the bag acts as a reservoir and mechanical filter to remove microaggregates larger than 40 microns. This integrated design eliminates the need for a separate, discrete 40-micron filter during the reinfusion process. The device is used in clinical settings by trained hospital personnel under physician supervision. By filtering autotransfused blood, it helps ensure the quality of the blood product prior to reinfusion, potentially reducing the risk of microaggregate-related complications in the patient.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Blood transfusion microfilter; 40-micron filtration threshold; Class II medical device (21 CFR 880.5440); Product Code CAK. Designed as a component for an Intravascular Administration Set.

Indications for Use

Indicated for perioperative autologous transfusion patients requiring filtration of washed red blood cells from a Haemonetics cell salvage device to remove microaggregates >40 microns prior to reinfusion. For use by trained hospital personnel under physician direction.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Filter Bag, BF-40, of the Harvest® BloodStream® Recovery System (K942844)

Submission Summary (Full Text)

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# Section 5 - 510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

### Submitter

Haemonetics Corporation 400 Wood Road Braintree, MA. 02184-9114

### Contact

Gabriel J. Muraca, Jr. RA Project Manager Haemonetics Corporation 355 Wood Rd. Braintree, MA. 02184-9114 T: 781-356-9553 F: 781-356-3558 Email: [e-mail] MAY 17 2006

### Device Name

Proprietary Name: Haemonetics® 40u RBC Filter Bag Common Name: Blood Transfusion Microfilter Classification Name: Intravascular Administration Set (component)

# Predicate Device

The predicate device is the Filter Bag, BF-40, of the Harvest® BloodStream® Recovery System. The Harvest Filter Bag device was cleared in K942844 on 4/26/96. Haemonetics acquired this product line from Harvest in August 2004.

#### Description

The Haemonetics 40µ RBC Filter Bag is described as a blood transfusion microfilter with FDA Product Code CAK in the FDA Guidance Document for Intravascular Administration Sets 510(k)s dated April 15, 2005. It is defined as a Class II medical device in 21 CFR 880.5440 and is included as a component for an Intravascular Administration Set.

COMPANY CONFIDENTIAL

# HAEMONETICS

21 CFR 807

5961103

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KO61143 Page 2 of 2

The Haemonetics 40u RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns (40μ). It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion. The 40μ RBC Filter Bag has a similar intended use as the predicate device. It is designed to be used by trained hospital personnel under the direction of a physician. Therefore, it is to be used as a prescription medical device, which is indicated by the symbol on the labeling as "Rx Only".

# Indications for Use

The Haemonetics 40u RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.

# Performance Testing - Bench

Haemonetics has conducted testing to verify the safety and performance of the 40u RBC Filter Bag. A detailed list with summaries of testing is provided with the test protocols and reports.

# Substantial Equivalence

The substantial equivalence of the 40p RBC Filter Bag is supported by its similarities in intended use and performance characteristics, as compared to the currently marketed Harvest BloodStream Recovery System, Filter Bag, BF-40. They are similar in design, materials of construction, and manufacturing processes. Verification and validation testing has been completed on the 40u RBC Filter Bag and provides valid scientific evidence to demonstrate the devices are substantially equivalent in accordance with applicable standards referenced in the reports.

Gabriel C. Murray, Jr.

Gabriel J. Muraca, Jr. Regulatory Affairs Project Manager Haemonetics Corporation

Date: March 8, 2006

COMPANY CONFIDENTIAL

HAEMONETICS

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). 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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Haemonetics Corporation C/O Mr. Tamas Borsai Responsible Third Party Official TUV Rheinland of North America, Incorporated 1279 Quarry Lane, Suite A Pleasanton, California 94566

Re: K061103

Trade/Device Name: Haemonetics® 40μ RBC Filter Bag Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: CAK Dated: May 1, 2006 Received: May 2, 2006

Dear Mr. Borsai:

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. Borsai

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 vour 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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# aemonetics® 40u RBC Filter Bag

Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): ____ K06 } / \$3

Device Name:

Haemonetics® 40μ RBC Filter Bag

#### Indications for Use:

The Haemonetics 40μ RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.

Anter Vrmate

: Bion Sion-Off) Cryision of Anesthesiology, General Hospital, Infection Control, Dental Devices

512(k) Number: 496 01 4

Prescription Use X and/or (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

HAEMONETICS

COMPANY CONFIDENTIAL