BELMONT BUDDY PLUS FLUID WARMER

K062774 · Belmont Instrument Corp. · BSB · Oct 19, 2006 · Hematology

Device Facts

• Record ID: K062774
• Device Name: BELMONT BUDDY PLUS FLUID WARMER
• Applicant: Belmont Instrument Corp.
• Product Code: BSB · Hematology
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.9205
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

buddy plus ™ Fluid Warmerintended use is for warming 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

Portable in-line blood/fluid warmer; consists of heater unit, power module with battery, and single-use disposable heat exchanger. Operates via resistive heating of two plates. Input: gravity-fed IV line; Output: warmed fluid to patient cannula. Used in clinical environments by healthcare professionals. Monitors fluid temperature, detects empty IV sets, and identifies internal faults (overheating, connection loss). Stops heating and triggers alarms during faults. Provides status/alarm messages via alphanumeric display. Benefits patient by maintaining physiological temperature during infusion, preventing hypothermia.

Clinical Evidence

Bench testing only. Verified system ability to warm cold fluids to physiological temperature and confirmed alarm functionality for unsafe or ineffective operating conditions.

Technological Characteristics

Resistive heating of two plates. Powered by 16.5 VDC (derived from 120 VAC, 50/60 Hz) with 12V battery backup. Disposable set: molded frame with bonded plastic film and microporous membrane. Electronic control of temperature and alarms. Sterile, non-pyrogenic fluid path. Single-patient use.

Indications for Use

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

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.

Predicate Devices

• Belmont Buddy™ Fluid Warmer (Microheater)

Submission Summary (Full Text)

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062774

OCT 1 9 2006

Attachment 4

Image /page/0/Picture/3 description: The image shows the logo for Belmont Instrument Corporation. The logo features the word "Belmont" in a stylized font, with the words "Instrument Corporation" underneath. Below the logo is the phrase "Creating a New Standard of Care."

Registered in Accordance with ISO 13485

### Premarket Notification 510(k) Summary of Safety and Effectiveness [As Required By 21 CFR 807.92(a)]

- 1. Submitter & Belmont Instrument Corporation Manufacturing Site: 780 Boston Road Billerica, MA 01821
Establishment Registration Number: 1219702

- 2. Contact Person: Ms. Uraiwan P. Labadini, Quality Assurance/Regulatory Affairs Manager Telephone:
- [phone] Ext. 28 Fax: [phone]
- 3. Trade Name: Belmont buddy plus™ Fluid Warmer
- Common name: 4. Nonelectromagnetic Blood or Fluid Warming Device
- 5. Classification name: Blood/Fluid Warmer
- 6. Product Code: 81BSB Device Class: Classified as a Class II device per Federal Register July, 1978.
- 7. Legally marketed predicate device to which substantial equivalence is claimed: Belmont Instrument Corporation Microheater marketed as Belmont Buddy™ Fluid Warmer.

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062774

### Attachment 4

- Brief Description: The Belmont buddy plus™ Fluid Warmer is a portable in-line 8. blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The power module also contains a built-in battery pack which automatically switches over to the battery operation when the AC power is disconnected. When the power is restored, the system reverts to AC power automatically, the battery charger is activated, and the battery is charged. The heating technology used is resistive heating of two plates within the heater unit.
The buddy plus™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty set, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display.

The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp.

The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.

- Intended Use: The buddy plus ™ Fluid Warmerintended use is for warming blood, ഗ്ഗ blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
- 10. Summary of the technological characteristics of the Belmont buddy plus™ Fluid Warmer:

The heater unit is powered with 16.5 VDC which is derived from 120 VAC, 50/60 Hz power supply with 12 volt battery back-up. The temperature of the infused fluids, visual and audible alarms, and other performance characteristics of the heater unit are controlled electronically. The disposable set consists of a molded frame to which a plastic film is bonded to one side and a microporous membrane is bonded to the other to form the fluid path. The disposable set has a sterile, non-pyrogenic fluid path, and is for single-patient use only.

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