ANIMEC, MODELS AM-2S-4 AND AM-2S-5

• K Number: K012906
• Device Name: ANIMEC, MODELS AM-2S-4 AND AM-2S-5
• Manufacturer: ELLTEC CO., LTD.
• Date Cleared: 2001-10-09 ( 41 days)
• Product Code: LGZ , BSB
• Regulation Number: 880.5725
• Type: Special
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.

Device Description

The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.

AI/ML Overview

The provided document describes an FDA 510(k) premarket notification for infusion/blood warmers (Animec, Models AM-2S-4 and AM-2S-5). It establishes substantial equivalence to a predicate device but does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a more comprehensive technical document for a medical device.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (effect size).
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is primarily an FDA clearance letter and an "Indications For Use" statement, not a scientific or clinical study report.

Summary

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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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Genshiro Ogawa President Elltec Company Limited Shirakawa No. 6 Bldg. Rm. 206 2-18-5, Nishiki, Naka-Ku Nagoya, JAPAN

Re: K012906

Trade/Device Name: Animec, Models AM-2S-4 and AM-2S-5 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: September 26, 2001 Received: October 3, 2001

Dear Mr. Genshiro Ogawa:

This letter corrects our substantially equivalent letter of October 9, 2001.

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.

JAN 1 0 2017

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Genshiro Ogawa

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 (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.

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/ReportaProblem/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 yours,

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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Shirakawa No 6 Bldo. 2-18-5 Naka-ku, Nagoya Japan Tel: [phone] Fax: [phone]

Date

September 25, 2001

Applicant: Elltec Co., Ltd. 510(k) Number: K012906 Device Name: Infusion/blood warmer ANIMEC AM-2S-4, AM-2S-5

Indications For Use:

The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.

Sincerely, Elltec Co., Ltd.

Z. Ogiens

Genshiro Ogawa President

Voo Usterlydams for 3x2

(Division Sign-Off Division of Dental, Infection Control, and General Hospital Devices 110{k) Number -NO 1241

Regulation Number and Section

§ 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).