MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

K024373 · Elltec Co., Ltd. · LGZ · Jan 28, 2003 · General Hospital

Device Facts

• Record ID: K024373
• Device Name: MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
• Applicant: Elltec Co., Ltd.
• Product Code: LGZ · General Hospital
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

LIFORT LT-1-4 and LT-1-5 are electrically powered, dry heat warmers; designed for enteral nutrition administration sets. Device features 4mm or 5mm channels to accommodate tubing. Operates by applying external heat to tubing during low flow rate applications (0-7 ml/min). Used in clinical settings to maintain temperature of enteral nutrition fluids. Benefits patient by preventing cold fluid delivery during intermittent feeding.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrically powered dry warmer; 4mm and 5mm channel sizes for administration sets; designed for low flow rate (0-7 ml/min) enteral nutrition delivery.

Indications for Use

Indicated for warming enteral nutrition administration sets during intermittent use and low flow rate applications (0-7 ml/min) to provide external heat to the plastic tubing.

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.

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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- 1 Can Band Band a 17 Coas II Lad II T Shirakawa No.6 Bldg. 2-18-5, Nishiki Naka-ku, Nagoya Japan Tel: [phone] Fax: [phone]

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