EVA TPN CONTAINER

K041415 · B.Braun Medical, Inc. · KPE · Aug 4, 2004 · General Hospital

Device Facts

• Record ID: K041415
• Device Name: EVA TPN CONTAINER
• Applicant: B.Braun Medical, Inc.
• Product Code: KPE · General Hospital
• Decision Date: Aug 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

EVA TPN container; single-chamber bag; 250mL-4000mL capacity; composed of Ethylene Vinyl Acetate (EVA) copolymer. Used for compounding and storage of parenteral nutrition solutions. Two configurations: gravity-fill or compounder-compatible (with unique adapter). Tubing made of DEHP-free polyvinyl chloride. Medication port allows additive injection. After filling, container attaches to intravascular administration set. Used in clinical settings for patient nutrition delivery.

Clinical Evidence

Bench testing only. Device tested in accordance with current international standards for containers for intravenous injections.

Technological Characteristics

Ethylene Vinyl Acetate (EVA) copolymer container; DEHP-free polyvinyl chloride tubing. Single-chamber bag design. Available in two configurations: gravity-fill or compounder-specific adapter. Volume range 250mL-4000mL. Mechanical filling via gravity or automated compounding equipment.

Indications for Use

Indicated for patients requiring parenteral nutrition solutions. Used for compounding and storage of solutions prior to and during administration via an intravascular administration set.

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

• Baxter Healthcare Corporation; All-in-One Container (K983294)

Submission Summary (Full Text)

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K041415

AUG - 4 2004

## 510(k) Summary 7.0

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| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2597 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Amy Smith, RAC<br>Regulatory Affairs Specialist |
| DEVICE NAME: | EVA TPN Container |
| COMMON OR USUAL<br>NAME: | TPN Bag |
| DEVICE<br>CLASSIFICATION: | I.V. Container, 21 CFR Part 880.5025, Product Code KPE |
| PREDICATE DEVICE: | K983294<br>Baxter Healthcare Corporation; All-in-One Container |
| DESCRIPTION: | The EVA TPN container is for use in compounding and<br>storage of parenteral nutrition solutions prior to and during<br>administration to a patient using an intravascular<br>administration set. The EVA TPN container can be filled<br>either by gravity or in conjunction with compounding<br>equipment. |
| | The EVA TPN container is composed of Ethylene Vinyl<br>Acetate copolymer (EVA). The containers will be available<br>as a single chamber bag in two configurations. One<br>configuration will be used for filling the container by<br>gravity. The second configuration is for use with a B.<br>Braun Medical Inc. compounder. The containers will range<br>in volume capacity from 250mL - 4000mL. The gravity<br>containers can be filled using standard admixture products<br>(spikes, tubing), and clamped after filling. The container<br>for use with the compounder will have an adapter unique to<br>the compounder. The tubing is composed of a DEHP-free<br>polyvinyl chloride material. Additional medications can be<br>added to the gravity or compounder container using the |

medication port. After filling, the container can then be

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attached to an intravascular administration set via the set port.

## INTENDED USE:

The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.

SUBSTANTIAL EQUIVALENCE:

The B. Braun Medical Inc. EVA TPN Mixing Container has similar indications for use, materials of construction, labeling and sterilization methods as the predicate device, The EVA TPN Baxter All-in-One Mixing Container. Mixing Container was tested in accordance with current international standards for containers for intravenous injections.

There are no differences between the B. Braun Medical Inc. EVA TPN Mixing Container and the predicate device that raise new issues of safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2004

Ms. Amy Smith, RAC Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K041415

Trade/Device Name: EVA TPN Container Regulation Number: 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: May 27, 2004 Received: May 27, 2004

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinonens, or to as tround Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, das Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provinces or 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 (1 wr t), it may of our 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. Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 12 a determination that your device complies with other requirements mount that I DA nas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal butates and reguirements, including, but not limited to: registration 1 ou mast comply with an all the Process (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set form in are quartify ion 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) This letter will anow you to ough finding of substantial equivalence of your device to a promatics notification. - The PDF 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), If you desire specific at 100 los your we 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 may obtain 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

Sincerely yours,

Q

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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## Indications for Use Statement 2.0

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

EVA TPN Container Device Name:

Indications For Use:

The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The EVA 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)

Cintia D mo

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

510(k) Number: كالة | الأوروب | الأوروب