BELMONT BUDDY PLUS FLUID WARMER

• K Number: K062774
• Device Name: BELMONT BUDDY PLUS FLUID WARMER
• Manufacturer: BELMONT INSTRUMENT CORP.
• Date Cleared: 2006-10-19 ( 31 days)
• Product Code: BSB , 81B
• Regulation Number: 864.9205
• Type: Special
• Panel: Hematology
• Reference & Predicate Devices: K031899
• Predicate For: N/A

Intended Use

buddy plus™ Fluid Warmer intended 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 Description

The Belmont buddy plus™ Fluid Warmer is a portable in-line 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.

AI/ML Overview

The Belmont buddy plus™ Fluid Warmer is a nonelectromagnetic blood or fluid warming device intended for warming blood, blood products, and intravenous solutions to physiological temperature prior to administration. It is designed for use by healthcare professionals in clinical environments to prevent hypothermia, specifically for applications where the flow rate is 6 liters/hour (100 ml/min) or less.

Here's a breakdown of the acceptance criteria and the study information presented:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Requirements/Features)	Reported Device Performance
Ability to warm cold fluids to physiological temperature.	Stated as performing "as intended according to the specifications of the device" for heating blood products or intravenous fluids to physiological temperature.
Ability to protect the patient and detect/alarm at unsafe or ineffective operating conditions.	The device "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 study verified the "ability of the system to protect the patient and to detect and alarm at unsafe or ineffective operating conditions."
Intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.	This is an intended use specification, not a direct performance result from the verification testing described. The device is designed for this flow rate.
Sterile, non-pyrogenic fluid path for the disposable set.	The disposable set "has a sterile, non-pyrogenic fluid path, and is for single-patient use only." This is a design characteristic, not a direct performance result from the functional tests mentioned.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify a numerical sample size for the "nonclinical tests." It only states that "the following tests were carried out."
• Data Provenance: Not specified, but the testing was conducted by Belmont Instrument Corporation, presumably in-house or through a contracted laboratory to demonstrate performance. The testing is implied to be prospective, as it was done to "verify performance" for K062774.

3. Number of Experts and their Qualifications for Ground Truth of Test Set

This type of information is not applicable to this device. The Belmont buddy plus™ Fluid Warmer is a medical device for warming fluids, and its performance and safety are typically evaluated through engineering and functional tests against established physical and safety criteria, rather than through expert consensus on qualitative assessments or diagnostic interpretation. Therefore, there are no "experts" establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image analysis) where ambiguous cases require expert resolution. The nonclinical tests described for the fluid warmer are objective, measurable performance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to assess the impact of AI assistance on human performance. The Belmont buddy plus™ Fluid Warmer is a therapeutic/supportive care device, not a diagnostic one involving human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed in the sense that the device's technical specifications and functional capabilities were tested independently to verify its performance against design requirements. The "nonclinical tests" fall under this category, evaluating the device's ability to warm fluids and its safety features directly.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective engineering specifications and safety standards. For example:

• Physiological temperature: This is a defined temperature range (e.g., 37°C ± a certain tolerance). The device's ability to achieve and maintain this temperature is measured directly.
• Alarm conditions: These are defined fault conditions, and the "ground truth" is whether the device accurately detects them and triggers the appropriate alarm.

8. Sample Size for the Training Set

This information is not applicable. The Belmont buddy plus™ Fluid Warmer is not an AI/ML-driven device that requires a training set. Its design and operation are based on conventional engineering principles of resistive heating and electronic control, not machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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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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K062774

Attachment 4

Belmont Instrument CorporationPage 3 of 3

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Summary of Nonclinical Tests and Results 11.

In order to verify performance of the Belmont buddy plus™ Fluid Warmer in support of substantial equivalence, the following tests were carried out:

• Verify the ability of the system to warm cold fluids to physiological a. temperature.
• Verify the ability of the system to protect the patient and to detect and alarm b. at unsafe or ineffective operating conditions.
• Conclusion: The modified Belmont buddy plus™ Fluid Warmer Blood/Fluid 12. Warmer is substantially equivalent to the buddy™ Fluid Warmer which received 510(k) approval on July 2, 2003. Both systems have the same intended use, and are capable of heating blood products or intravenous fluids to physiological temperature. Both systems perform as intended according to the specifications of the device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the side. The bird is depicted in a simple, abstract manner, with bold lines forming its shape.

·

OCT 1 9 2006

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: K062774

Trade/Device Name: Belmont buddy plus™ Fluid Warmer Regulation Number: 21 CFR 864.9205 Regulation Name: Blood and Plasma Warming Device Regulatory Class: II Product Code: BSB Dated: September 15, 2006 Received: September 22, 2006

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 mount that I D. I has mass and regulations administered by other Federal agencies. of the For any I vith 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 and insing (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrenic 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), nlease contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Quts

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Коба774

Device Name: Belmont buddy plus™ Fluid Warmer

Indications For Use:

buddy plus™ Fluid Warmer intended 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.

Prescription Use X (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)

ia Dla for now 10/19/02

on Siar sion of Anesthesiology, General Hospital, Intection Control, Dental Devices

) Number. K0609774

Regulation Number and Section

§ 864.9205 Blood and plasma warming device.

(a)
Nonelectromagnetic blood or plasma warming device —(1)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.(2)
Classification. Class II (performance standards).(b)
Electromagnetic blood and plasma warming device —(1)Identification. 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.(2)
Classfication. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.