DUAL CHAMBER TPN CONTAINER

K073538 · B.Braun Medical, Inc. · KPE · Mar 12, 2008 · General Hospital

Device Facts

• Record ID: K073538
• Device Name: DUAL CHAMBER TPN CONTAINER
• Applicant: B.Braun Medical, Inc.
• Product Code: KPE · General Hospital
• Decision Date: Mar 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dual Chamber TPN Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The Dual Chamber TPN Container can be filled either by gravity or in conjunction with automated compounding equipment.

Device Story

Dual Chamber TPN Container is a sterile, ethylene vinyl acetate (EVA) pharmacy compounding container; features two chambers separated by a flexible tube and rigid separator bar. Upper chamber holds lipid emulsion; lower chamber holds dextrose, amino acids, and electrolytes. Additives introduced via latex-free injection ports. Device filled via gravity or automated compounding equipment. Prior to administration, separator bar and tube are removed to combine contents. Administered to patient via intravascular administration set connected to lower chamber port. Available in 1500 mL, 3000 mL, and 4000 mL sizes. Used in pharmacy/clinical settings for parenteral nutrition storage and delivery.

Clinical Evidence

Bench testing only. Testing included biocompatibility, functional performance, package integrity, shipping, impermeability to microorganisms, and chemical testing.

Technological Characteristics

Material: Ethylene vinyl acetate (EVA). Design: Dual-chambered container with flexible tube and rigid separator bar. Ports: Latex-free injection/medication ports and set port. Sizes: 1500 mL, 3000 mL, 4000 mL. Sterilization: Sterile.

Indications for Use

Indicated for the compounding and storage of parenteral nutrition solutions for patients requiring intravenous administration. No specific age or gender restrictions provided.

Regulatory Classification

Identification

An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

Predicate Devices

• B. Braun EVA TPN Container (K041415)
• Churchill Medical Dual Chamber Empty Container (K041038)

Submission Summary (Full Text)

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K07-3538

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MAR 1 2 2008

#### 510(k) Summary 5.

#### SUBMITTER:

B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341

Contact: Tracy Maddock, RAC Regulatory Affairs Analyst Phone [phone] Fax [phone] E-mail: tracy.maddock(@bbraun.com

### DEVICE NAME:

Dual Chamber TPN Container

TPN Bag

COMMON OR USUAL NAME:

DEVICE CLASSIFICATION:

PREDICATE DEVICE:

DESCRIPTION:

I.V. Container Class II, CFR Title 21 § 880.5025

B. Braun EVA TPN Container (K041415) Churchill Medical Dual Chamber Empty Container (K041038)

The Dual Chamber TPN (Total Parenteral Nutrition) Container is an empty, sterile pharmacy compounding container composed of ethylene vinyl acetate (EVA). The container is divided into two chambers separated by a flexible tube and rigid separator bar. Both chambers are designed to be filled via the tubing set attached to each chamber. The upper chamber is used for filling lipid emulsion. The lower chamber is used for filling other solutions such as dextrose, amino acids, and electrolytes. Additives may be introduced via the latex-free injection/medication port present on each chamber. Once both chambers are filled, the container is stored with the flexible tube and rigid separator bar in place until the time of administration to the patient.

At the time of patient use, the flexible tube and rigid separator bar are removed and the contents of the two chambers are combined. The contents are then administered to the patient using an intravascular administration set which is connected via the set port

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K073538 page 2 of 2

located on the lower chamber. The Dual Chamber TPN Container will be offered in three sizes: 1500 mL, 3000 mL, and 4000 mL.

## INTENDED USE:

# SUBSTANTIAL EQUIVALENCE:

The Dual Chamber TPN Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The Dual Chamber TPN Container can be filled either by gravity or in conjunction with automated compounding equipment.

The B. Braun Medical Inc. Dual Chamber TPN Container has the same indications for use, similar materials of construction and similar manufacturing processes as the B. Braun EVA TPN Container, covered under K041415.

The B. Braun Medical Inc. Dual Chamber TPN Container has similar indications for use and is similar in design to the predicate device, the Churchill Medical Dual Chamber Empty Container, covered under K041038.

The Dual Chamber TPN Container was subjected to a variety of tests to demonstrate substantial equivalence with the two predicate devices and to demonstrate the safety and effectiveness of the proposed device. The following tests were conducted: biocompatibility, functional performance, package integrity, shipping, impermeability to microorganisms, and chemical testing.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, representing care and protection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy Maddock Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

MAR 12 2008

Re: K073538

Trade/Device Name: Dual Chamber TPN Container Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: December 14, 2007 Received: December 17, 2007

Dear Ms. Maddock:

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 - Ms. Maddock

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,

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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K0 73538

#### Indications for Use Statement 4.

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510(k) Number (if known):

Device Name:

Dual Chamber TPN Container

Indications For Use:

The Dual Chamber TPN Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The Dual Chamber TPN Container can be filled either by gravity or in conjunction with automated compounding equipment.

Prescription Use X (Per 21 CFR 801.109)

OR

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)

Anthony D. m

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k-973538

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