(38 days)
The NOA III Enteral Nutrition Pump is designed to deliver programmed doses of enteral nutrition solutions at selected rates. The pump is designed to be used in hospital and home care environments. The pump can be used in stationary and ambulatory ways.
The NOA III Enteral Nutrition System includes: Infusion Pump, Battery Charger.
The provided text is a 510(k) premarket notification letter from the FDA to Caesarea Medical Electronics Limited regarding their NOA III Enteral Nutrition Pump. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The document states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their submission, but the letter itself does not detail the specific performance studies or acceptance criteria.
Therefore, I cannot provide the requested information based on the input text. The document is primarily an approval letter, not a device performance report.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines, which are meant to represent the flow of people and services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2004
Mr. Gali Tzury Quality Assurance Manager Caesarea Medical Electronics Limited 16 Shacham Street Caesarea Industrial Park P.O.B. 4294 Caesarea 38900 ISRAEL
Re: K040957
Trade/Device Namc: NOA III Enteral Nutrition Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZH Dated: April 11, 2004 Received: April 14, 2004
Dear Mr. Tzury:
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 Eederal Register.
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Page 2 -Mr. Tzury
Please be advised that FDA's issuance of a substantial equivalence determination does not I least oc advised that 1 Dr. o termination that your device complies with other requirements micall that I DA mas made a aversand regulations administered by other Federal agencies. of the Act or ally I oderal backed is requirements, including, but not limited to: registration 1 ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice allu fishing (21 CFR Part 807), as alles systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation 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 whilance your contral equivalence of your device of your device to a premarket notified for - 110 wice 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 to pliance at (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Cules
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
510(k) Number: K040957
NOA III Enteral Nutrition Pump Device Name:
Indications for Use:
The I OA III Enteral Nutrition Pump is designed to deliver programmed doses a
reasonal designed and states of enjeral nutrition solutions at selected rates.
of enteral numtions at selected in hospital and home care environments. The in stationary and ambulatory ways.
The NOA III Enteral Nutrition System includes: Infusion Pump Battery Charger
Prescription Use (Part 2) CFR 801 Subpart D) AND/ OR
Over-The-Counter Use (21 CFR 807 Subpurt C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDIJD)
Device Evaluation (ODE) ORH. Offic Concurrence of
(
Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K0409
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· Cacsarea Modical Eloctronics Ltd. · Traditional $10(k) Premarkel Submission · NOA III Entoral Nutrition Pump · Confidential
7
§ 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).