ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML

K020485 · Baxter Healthcare Corp · KPE · Mar 12, 2002 · General Hospital

Device Facts

• Record ID: K020485
• Device Name: ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
• Applicant: Baxter Healthcare Corp
• Product Code: KPE · General Hospital
• Decision Date: Mar 12, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5025
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The All-In-One® Two Chamber Container is intended for the compounding, storage, and administration of total parenteral nutrition (TPN) solutions.

Device Story

The All-In-One® Two Chamber Container is a sterile, non-invasive, single-use disposable IV container. It features two internal chambers separated by a vertical peel-seal; the left chamber stores lipid emulsions, while the right stores amino acid/dextrose admixtures. Pharmacy personnel fill the chambers; additives are introduced via a non-latex medication injection port. The container stores contents with the seal intact until administration. At the point of care, the clinician breaks the internal peel-seal to mix the contents. The mixed TPN solution is then dispensed to the patient via a secondary administration set. The device facilitates the safe storage and delivery of complex nutritional admixtures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, non-invasive, two-chambered IV container. Materials include non-latex components. Features a vertical peel-seal for mixing contents. Standalone device; no electronic or software components.

Indications for Use

Indicated for the compounding, storage, and administration of total parenteral nutrition (TPN) solutions in patients requiring parenteral nutrition.

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

• All-In-One® Two Chamber Container (K945193)

Submission Summary (Full Text)

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#### 510(K) SUMMARY

**Submitted by:**

K 020485

Mary Konkowski Senior Regulatory Affairs Associate Baxter Healthcare Corporation Medication Delivery Division, Regulatory Affairs Route 120 and Wilson Road Round Lake, IL 60073

#### Proposed Device:

All-In-One® Two Chamber Container

### Predicate Device:

All-In-One® Two Chamber Container, cleared under premarket notification K945193, May 12, 1995

## Device Description and Statement of Intended Use:

The All-In-One® Two Chamber Container is intended for the compounding, storage, and administration of total parenteral nutrition (TPN) solutions.

The All-In-One® Two Chamber Container is a sterile non-invasive fluid container used for compounding, storage and administration of total parenteral nutrition (TPN) solutions. It is an empty single use, disposable I.V. container that is vertically divided into two chambers. The left chamber is intended to store lipid emulsions. The right chamber is intended to store amino acid/dextrose admixtures. Additives may be added via the non-latex medication injection port located at the bottom of the left chamber. The chambers are designed to be filled with a total parenteral nutrition (TPN) solution by a pharmacy operation.

The contents of the container are intended to be stored with the seal intact (i.e., not broken) until the time of use (administration to the patient).

At the time of use, the contents of the two chambers are combined/mixed by opening the vertical peel-seal that runs along the inside of the container. The mixed contents of the container are then dispensed to the patient though a secondary administration set (i.e., a separate medical device that is not the subject of this submission).

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# Summary of Technological Characteristics of New Device to Predicate Device

The technological characteristics of the modified All-In-One® Two Chamber Container do not differ significantly from the currently marketed All-In-One® Two Chamber Container. The devices utilize the same fundamental scientific technology and have the same intended use.

# Discussion of Non-Clinical Tests; Conclusions Drawn from Nonclinical Tests

The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 2 2002

Ms. Mary Konkowski Senior Regulatory Affairs Associate Baxter Healthcare Corporation Rt. 120 & Wilson Road Round Lake, Illinois 60073

Re: K020485

Trade/Device Name: All-In-One® Two Chamber Container Regulation Number: 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: February 11, 2002 Received: February 13, 2002

Dear Ms. Konkowski:

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.

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.

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# Page 2 - Ms. Konkowski

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 and instills (2) Creating 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

Device Trade Name:

All-In-One® Two Chamber Container

Indication for Use:

The All-In-One® Two Chamber Container is intended for the compounding, storage, and administration of total parenteral nutrition (TPN) solutions.

Patrica Cuscente

(Division Sign-Off) (Division of Dental, Intection Control, Division Hospital Devices

510(k) Number K020485

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Baxter Confidential FEB. 1 1. 2002 *

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