COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS

K060316 · Fresenius Kabi Deutschland GmbH · LZH · Jun 23, 2006 · General Hospital

Device Facts

• Record ID: K060316
• Device Name: COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
• Applicant: Fresenius Kabi Deutschland GmbH
• Product Code: LZH · General Hospital
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

Compat GOTM Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets are intended for Enteral feeding exclusively. The purpose of this administration system is the delivery of Enteral nutrition at controlled rates (pump assisted) to patients gastrointestinal system. Intended for us for patient with any condition requiring Enteral feeding and Enteral hydration. The Compat GOTM Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets are intended to use by adults or paediatric in hospital and home care environments, both in stationary and ambulatory ways.

Device Story

Compat GO Enteral Feeding Pump is a linear peristaltic pump designed to deliver enteral nutrition and hydration liquids to patients unable to ingest food orally. The system consists of the pump and dedicated Compat GO Enteral Administration Sets. It operates by delivering fluids at controlled, pump-assisted rates into the patient's gastrointestinal system. The device is intended for use by adults and pediatric patients in both hospital and home care environments, supporting both stationary and ambulatory use. Healthcare providers or patients use the device to ensure consistent nutritional delivery, which benefits patients by maintaining hydration and nutritional status when oral intake is not possible.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Linear peristaltic infusion pump; Class II device; intended for enteral use; compatible with standard prefilled formula containers and enteral access devices; supports stationary and ambulatory operation.

Indications for Use

Indicated for adults and pediatric patients requiring enteral feeding and hydration due to conditions preventing oral ingestion. Used in hospital and home care settings, both stationary and ambulatory.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Enteralite (K954735)
• ClearStar (K981541)
• Kendall (Kangaroo) Control (K040196)

Submission Summary (Full Text)

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510(k) Premarket Notification Fresenius Applix Smart/Compat GO

JUN 2 3 2006

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## 510 (k) Summary

This summary is submitted by:

## Fresenius Kabi AG D-61346. Bad Homburg Date: 12th of January 2006

- 1. Contact Person
Barbara Breuer-Thal (Senior Manager, Head of Production Operations) (++49 (0) 6172 686 7785)

- 2. Name of the Medical Devices

| Classification Name: | Infusion Pump |
|----------------------|------------------------------------------------------|
| Usual Name: | Enteral Feeding Pump |
| Trade Name: | Compat GO ^TM |
| | Enteral Feeding Pump and Enteral Administration Sets |

### Identification of Legally Market Devices 3.

The proposed Compat GOTM Enteral Feeding Pump and Enteral Administration Sets are substantially equivalent in intended use, function and mode of operation to the currently marked Enteral Feeding Pumps and Administration Sets:

| 510 (k) Number | Name | Applicant |
|----------------|-------------------------------|-------------------------|
| K954735 | Enteralite | Zexex Intl. Inc. |
| K981541 | ClearStar | Frantz Medical Devel. |
| K040196 | Kendall (Kangaroo)<br>Control | Tyco Healthcare/Kendall |

#### 4. Device Description

The Compat GOTM Enteral Feeding Pump ( a Class II device) and Enteral Administration Sets are designed to deliver formulas and Enteral hydration liquids via linear peristaltic pumping to provide nutrition for patients which are not able to ingest food orally.

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The Compat GOTM Enteral Feeding_System is working with the Compat GO™ Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets only caused by its adapted safety and effectiveness concept.

The Compat GOTM Enteral Administration Sets are compatible with the standard prefilled formula containers presently available on the market. The Compat GO™ Enteral Administration Sets are designed to compatible with present market Enteral access devices and accessories.

- ನ. Device Intended Use
Compat GOTM Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets are intended for Enteral feeding exclusively. The purpose of this administration system is the delivery of Enteral nutrition at controlled rates (pump assisted) to patients gastrointestinal system.

Intended for us for patient with any condition requiring Enteral feeding and Enteral hydration. The Compat GOTM Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets are intended to use by adults or paediatric in hospital and home care environments, both in stationary and ambulatory ways.

- .6. Product Comparison
The Compat GOTM Enteral Administration system including the instruction for use (Manual) are substantially equivalent regarding safety and effectiveness to the compared feeding pumps as well as instruction for use and there administration sets (listed see point 3.).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

Fresenius Kabi Deutschland GmbH C/O Mr. Stefan Preiss Responsible Third Party Official TUV Product Service 1775 Old Highway 8 New Brighton, Minnesota 55112

Re: K060316

Trade/Device Name: Compat GOTM Feeding Pump with Compat™ GO Administration Sets Regulation Number: 21 CFR 884.5725 Regulation Name: Enteral Infusion Pump Regulatory Class: II Product Code: LZH Dated: June 1, 2006 Received: June 8, 2006

Dear Mr. Preiss:

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. Tn addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Preiss

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 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.

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

KOGC316 510(k) Number (if known):

Device Name:

Compat GOTAL Feeding Pump with Compat GOTM Administration Sets

Indications For Use:

The Compat GOTA4 feeding pump with the administration sets are intended exclusively for enteral feeding

The purpose of this administration system is the delivery of Enteral I he purpose of this administration (pump assisted) to patients gastrointestinal nutition at controled for us for patient with any condition requiring Enteral feeding and Enteral hydration.

The Compat GOTN Enteral Feeding Pump and the Compat GOTN Enteral The Compat GV7 - Enteration or oved to use by adults or paediatric in hospital Authinsulation Sets are intentionaly and ambulatory and ambulatory ways

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subparl C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.L. Chapman for Arc

...rgin City

The Anesthesiology, General Hospital, Jon Control, Dental Devices

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