THE BELMONT BUDDY LITE FLUID WARMER

K090508 · Belmont Instrument Corp. · BSB · Mar 26, 2009 · Hematology

Device Facts

• Record ID: K090508
• Device Name: THE BELMONT BUDDY LITE FLUID WARMER
• Applicant: Belmont Instrument Corp.
• Product Code: BSB · Hematology
• Decision Date: Mar 26, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.9205
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

Device Story

Belmont buddy lite Fluid Warmer is a portable device designed to warm blood, blood products, and IV fluids. Operated by healthcare professionals in clinical environments; device warms fluids prior to administration to prevent patient hypothermia. Device functions as a heat exchanger; fluid passes through warming mechanism before delivery to patient. Output is warmed fluid; clinical benefit is maintenance of normothermia during infusion therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Fluid warming device; heat exchanger technology; portable form factor. Designed for clinical use. No specific materials or software algorithms described.

Indications for Use

Indicated for warming blood, blood products, and IV solutions prior to administration to prevent hypothermia in patients requiring fluid therapy in clinical settings.

Regulatory Classification

Identification

A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes forming its body and wing. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

MAR 2 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Uraiwan P. Labadini Quality Assurance/ Regulatory Affairs Manager Belmont Instrument Corporation 780 Boston Road Billerica. Massachusetts 01821

Re: K090508

> Trade/Device Name: The Belmont® buddy lite™ Fluid Warmer Regulation Number: 21 CFR 864.9205 Regulation Name: Blood and Plasma Warming Device Regulatory Class: II Product Code: BSB Dated: February 25, 2009 Received: February 26, 2009

Dear Ms. Labadini:

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 Federal Register.

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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 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snette y. Michau David.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known):

Device Name: _ The Belmont® buddy lite™ Fluid Warmer

Indications For Use:

The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

f CDRH, Office of DST

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K090508