(28 days)
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Not Found
No
The description focuses on the device's function as a dry warmer and its physical characteristics, with no mention of AI or ML technologies.
No
The device warms enteral nutrition tubing, which aids in the delivery of nutrition but does not directly treat a disease or condition.
No
Explanation: The device is described as an "enteral nutrition warmer" that "supplies external heat to the plastic tubing incorporated administration sets." Its function is to warm nutrition, not to diagnose a medical condition.
No
The device description explicitly states it is an "electrically powered, dry warmer" which supplies "external heat" to "plastic tubing." This clearly indicates a physical hardware component that provides heating, not a software-only device.
Based on the provided information, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an "enteral nutrition warmer" that supplies external heat to administration sets for delivering nutrition. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description reinforces its function as a warmer for administration sets.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. The LIFORT LT-1 does not perform this function.
N/A
Intended Use / Indications for Use
The enteral nutrition warmer LIFORT LT-1 is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7ml/min. The LT-1 is available in two sizes: 4mm and 5mm channels for administration sets.
Product codes
LGZ, BSB
Device Description
The enteral nutrition warmer LIFORT LT-1 is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7ml/min. The LT-1 is available in two sizes: 4mm and 5mm channels for administration sets.
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
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 0 2017
Mr. Reiko So Manager ELLTEC Company Limited Shirakawa No. 6, Bldg. 2-18-5 Nishiki. Naka-Ku Nagoya, JAPAN
Re: K024373
Trade/Device Name: Enteral Nutrition Warmer, LIFORT LT-1-4 and LT-1-5 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: December 27, 2002 Received: December 3 1: 2002
Dear Mr. Reiko So:
This letter corrects our substantially equivalent letter of January 28, 2003.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
Page 2 - Mr. Reiko So
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
- 1 Can Band Band a 17 Coas II Lad II T Shirakawa No.6 Bldg. 2-18-5, Nishiki Naka-ku, Nagoya Japan Tel: +81-52-201-7308 Fax: +81-52-232-2870
Date
Indications For Use
Device Name: Enteral nutrition warmer, LIFORT LT-1-4 and LT-1-5
The enteral nutrition warmer LIFORT LT-1 is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7ml/min. The LT-1 is available in two sizes: 4mm and 5mm channels for administration sets.
Sincerely, Elltec Co., Ltd.
t. Sgama
Genshiro Ogawa President
December 26, 2002
Tattine Accente
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: Y 024373