(135 days)
The Compat GOTM feeding pump with the administration sets are intended exclusively for enteral feeding. 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.
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. 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.
The provided text is a 510(k) Premarket Notification for the Fresenius Applix Smart/Compat GO enteral feeding pump and administration sets. It does not contain information about studies proving the device meets acceptance criteria. The document is primarily focused on demonstrating substantial equivalence to legally marketed predicate devices, outlining the device description, intended use, and product comparison to predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details because it is not present in the provided text. The document is a regulatory submission for market clearance, not a clinical study report.
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510(k) Premarket Notification Fresenius Applix Smart/Compat GO
JUN 2 3 2006
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Image /page/0/Picture/3 description: The image shows a series of alphanumeric characters in a bold, sans-serif font. The characters appear to be "K060316", with the "0" looking like a diamond shape. The characters are closely spaced and have a slightly irregular appearance, as if they were handwritten or printed with a worn-out stamp.
510 (k) Summary
This summary is submitted by:
Fresenius Kabi AG D-61346. Bad Homburg Date: 12th of January 2006
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- Contact Person
Barbara Breuer-Thal (Senior Manager, Head of Production Operations) (++49 (0) 6172 686 7785)
- Contact Person
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- 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)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.
Image /page/0/Picture/16 description: The image contains the words "Fresenius Kabi" stacked on top of each other. The word "Fresenius" is on top, and the word "Kabi" is directly below it. The text is in a simple, sans-serif font and appears to be part of a logo or brand name.
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Image /page/1/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence starts with the letter 'K', followed by what appears to be the number '969', and then the numbers '316'. The handwriting is somewhat stylized, with some of the numbers and letters being slightly distorted.
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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.).
Image /page/1/Figure/10 description: The image contains the text "Fresenius Kabi" stacked on top of each other. The text is in a simple, sans-serif font and appears to be part of a logo or label. The text is black and the background is white.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the symbol.
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
Counter K12 C 3/6
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).