ALL-IN-ONE CONTAINER

K090096 · Baxter Healthcare Corporation · KPE · Jan 30, 2009 · General Hospital

Device Facts

• Record ID: K090096
• Device Name: ALL-IN-ONE CONTAINER
• Applicant: Baxter Healthcare Corporation
• Product Code: KPE · General Hospital
• Decision Date: Jan 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The All-In-One Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

Device Story

All-In-One Container is an empty EVA (Ethylene Vinyl Acetate) bag used for compounding and storing parenteral nutrition solutions. It serves as a reservoir for these solutions prior to and during intravascular administration to patients. The device is used in clinical settings by healthcare professionals. It functions as a passive storage vessel; it does not perform active processing, sensing, or analysis. The container facilitates the delivery of nutrition to patients who cannot receive adequate oral intake.

Clinical Evidence

Bench testing only. Risk analyses and design verification tests were conducted; all results met acceptance criteria.

Technological Characteristics

Empty container constructed of Ethylene Vinyl Acetate (EVA). Available in various volumes (250 mL to 4000 mL) with single or three-lead transfer sets. Passive storage device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring parenteral nutrition solutions; used for compounding and storage of these solutions prior to and during intravascular administration.

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

• Modified All-In-One Container (K983294)

Submission Summary (Full Text)

{0}------------------------------------------------

Traditional 510(k) Premarket Notification All-In-One Container

11:12 PM

Section 5, 510(k) Summary

న్నారు.

# KORDAL 1822

### 5. 510(k) SUMMARY

December 12, 2008

### OWNER:

باب تيان لا

i

JAN 3 0 2009

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

## CONTACT PERSON:

Nanette Hedden Sr. Manager, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, IL 60085 Telephone: [phone] Fax: [phone]

### DEVICE NAME:

Trade name: All-In-One Container Name

| Code number | Size | Name |
|-------------|---------|--------------------------------------------------------|
| 2B8114 | 1000 mL | All-In-One Empty Container, (Three Lead Transfer Set) |
| 2B8124 | 2000 mL | All-In-One Empty Container, (Three Lead Transfer Set) |
| 2B8134 | 3000 mL | All-In-One Empty Container, (Three Lead Transfer Set) |
| 2B8144 | 4000 mL | All-In-One Empty Container, (Three Lead Transfer Set) |
| 2B8112 | 1000 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8122 | 2000 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8132 | 3000 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8142 | 4000 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8152 | 500 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8172 | 250 mL | All-In-One Empty Container, (Single Lead Transfer Set) |

### Table 5-1. Product Codes for All-In-One Container

2

{1}------------------------------------------------

۲۰۴ ﺗﺎ ۱۰۰

Image /page/1/Picture/2 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The top line seems to read 'K090096', while the bottom line reads '2011'. The handwriting is somewhat stylized, with some characters being more distinct than others.

Traditional 510(k) Premarket Notification All-In-One Container

Section 5, 510(k) Summary

### Common Name: Compounding Container

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Classification Name: Intravenous Container (21 CFR 880.5025, Product Code KPE)

Predicate Device:

### Table 5-2. Predicate Device

| Device | Company | Previous 510(k) | Clearance date |
|-------------------------------|----------------------|-----------------|---------------------|
| Modified All-In-One Container | Baxter<br>Healthcare | K983294 | November 3,<br>1998 |

#### DESCRIPTION OF THE DEVICE:

The All-In-One Container is an empty EVA (Ethylene Vinyl Acetate) container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

### STATEMENT OF INTENDED USE:

The All-In-One Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The All-In-One Container is substantially equivalent to Baxter's current legally marketed All-In-One Container cleared November 3, 1998 (K983294).

### DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.

#### CONCLUSION:

The All-In-One Container is substantially equivalent to the predicate devices.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Baxter Healthcare Corporation C/o Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

JAN 3 0 2009

Re: K090096

> Trade/Device Name: All-In-One Container Regulation Number: 21 CFR 880.5025 Regulation Name; I.V. Container Regulatory Class: II Product Code: KPE Dated: January 15, 2009 Received: January 15, 2009

Dear Mr. Devine:

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.

{3}------------------------------------------------

Page 2 - Mr. Devine

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Anthony D. ask for

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE

11:22:

510(k) Number (if known):

Device Name: All-In-One Container

Indications for Use:

1 / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /

The All-In-One Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

મન્તરમાન

K090096

1

.

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

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

K090090 510(k) Number: