(38 days)
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No
The summary describes a standard enteral nutrition pump with no mention of AI or ML capabilities.
No
The device delivers enteral nutrition, which is a supportive treatment, but the device itself does not treat a disease or condition.
No
Explanation: The device is described as an "Enteral Nutrition Pump" designed to "deliver programmed doses of enteral nutrition solutions". This indicates a therapeutic function (delivering treatment) rather than a diagnostic one (identifying a disease or condition).
No
The device description explicitly lists hardware components: "Infusion Pump, Battery Charger."
Based on the provided information, the NOA III Enteral Nutrition Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver programmed doses of enteral nutrition solutions. This is a therapeutic function, delivering substances into the body, not a diagnostic function that analyzes samples from the body to provide information about a person's health.
- Device Description: The device is an infusion pump and battery charger. This aligns with a device used for delivering fluids, not for performing in vitro diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or test kits
Therefore, the NOA III Enteral Nutrition Pump is a medical device used for delivering nutrition, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The NOA III Enteral Nutrition Pump is designed to deliver programmed doses of enteral nutrition solutions at selected rates.
The NOA III Enteral Nutrition Pump can 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.
Product codes
LZH
Device Description
NOA III Enteral Nutrition Pump
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hospital and home care environments
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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
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