MICROHEATER by BELMONT INSTRUMENT CORP.

The Microheater 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. The system is not meant for the infusion of drugs, or platelet or granulocyte suspensions.

Device Description

The Belmont Microheater 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 heating technology used is resistive heating of two plates within the heater unit. The Microheater 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 cartridge, 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 Microheater is not meant to be used with pressurized infusers. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.

AI/ML Overview

This document is a 510(k) premarket notification for the Belmont Microheater, a blood and fluid warmer. The provided text describes the device, its intended use, and a summary of nonclinical tests performed to support its substantial equivalence to a predicate device. However, it does not provide the detailed acceptance criteria and study results in the format requested.

Specifically, the document states:

"11. Summary of Nonclinical Tests and Results" lists two verification tests:
- "Verify the ability of the system to warm cold fluids to physiological temperature."
- "Verify the ability of the system to detect and alarm at unsafe or ineffective operating conditions."
It also states: "In order to verify performance of the Belmont Microheater in support of substantial equivalence, the following tests were carried out."
Under "12. Conclusion," it mentions: "Both systems have the same intended use, and are capable of heating blood products or intravenous fluids prior to administration to physiological temperature. Both systems have an independent fail-safe circuit which stops heating and alarms if the system overheats."

This summary indicates that tests were performed to verify performance against certain implicit criteria (e.g., reaching physiological temperature, detecting and alarming unsafe conditions, implementing a fail-safe circuit). However, the document does not explicitly define specific numerical acceptance criteria (e.g., a target temperature range, alarm thresholds), nor does it present the reported device performance data against such criteria in a table format.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or stated as "not provided" based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated/Inferred)	Reported Device Performance (Summary in document)
Warm cold fluids to physiological temperature	"Capable of heating blood products or intravenous fluids prior to administration to physiological temperature."
Detect and alarm at unsafe or ineffective operating conditions	"System provides the user with alarm, alarm message... The device stops heating and alarms if an alarm or fault condition occurs."
Independent fail-safe circuit stops heating and alarms if system overheats	"Both systems have an independent fail-safe circuit which stops heating and alarms if the system overheats."
Compliance with listed standards (e.g., ANSI/AAMI/ISO 11135-1994, UL 2601-1, EN 60601-1)	"Verify that the device is in compliance with the following standards." (No specific results stated, only that verification was done).

Note: The document provides a summary of tests and a conclusion of capability, but not the specific numerical acceptance criteria (e.g., "target temperature of 37 ± 1°C") or the detailed performance results that demonstrate meeting these criteria (e.g., "average temperature achieved was 37.2°C with a standard deviation of 0.5°C").

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document states "the following tests were carried out" but does not give the number of trials, units tested, or data points collected for these nonclinical tests.
Data Provenance: The tests were "carried out" by Belmont Instrument Corporation. It's an internal company study for regulatory submission. It's prospective in the sense that the testing was performed specifically for this submission. Country of origin not explicitly stated for the testing, but the company is based in Billerica, MA, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This device is a fluid warmer, and the described tests are nonclinical performance validations (e.g., heating to a certain temperature, alarm function). The "ground truth" for these tests would be objective measurements (e.g., temperature probes, electrical sensors), not expert interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. As mentioned above, the tests are objective performance validations, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is a hardware device (fluid warmer), not an AI-assisted diagnostic or imaging device used by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a hardware device. The "standalone" performance would be its ability to warm fluids and alarm, which is implicitly what the nonclinical tests addressed, but the term "standalone" typically refers to AI algorithm performance without human intervention. The device operates autonomously to achieve its intended function (warming fluids) and has an "independent fail-safe circuit."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance tests (warming, alarming): The "ground truth" would be objective physical measurements (e.g., temperature readings from calibrated sensors, verification of alarm activation under specific faulty conditions).
For compliance with standards: The ground truth is successful adherence to the requirements outlined in the referenced standards (e.g., ethylene oxide sterilization efficacy, biological compatibility, electrical safety requirements).

8. The sample size for the training set:

Not Applicable. This is a hardware device, not a machine learning or AI model that requires a training set. The device's operational parameters and safety features are designed and engineered, not "trained" on data.

9. How the ground truth for the training set was established:

Not Applicable. (See #8).

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, stacked vertically.

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

Mr. Uraiwan P. Labadini QA & RA Manager Belmont Instrument Corporation 780 Boston Road Billerica, Massachusetts 01821

JAN 1 0 2017

Re: K031478

Trade/Device Name: Microheater Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: BSB, LGZ Dated: May 9, 2003 Received: May 12, 2003

Dear Mr. Labadini:

This letter corrects our substantially equivalent letter of July 2, 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 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 of

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Page 2 - Ms. Uraiwan P. Labadini

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 8091 ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Attachment V

Page 1 Of 1

510(k) number: _ K 03/478

Device Name: Microheater

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use_

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

510(k) Number:

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K03 1478

Image /page/3/Picture/2 description: The image shows the logo for Belmont Instrument Corporation. The logo features a stylized "B" followed by the word "Belmont" in a bold, sans-serif font. Below "Belmont" is the text "Instrument Corporation" in a smaller font. Underneath the logo is the text "Creating a New Standard of Care".

Attachment Ill

Registered in Accordance with ISO-9001 and EN 46001

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
1. Contact Person: Uraiwan P. Labadini, Quality Assurance/Regulatory Affairs Manager
  Telephone: (978) 663-0212 Ext. 28 Fax: (978) 663-0214
1. Trade Name: Belmont Microheater
1. Common name: Nonelectromagnetic Blood or Fluid Warming Device
ട. Classification name: Blood/Fluid Warmer
1. Product Code: 81BSB Device Class: Classified as a Class II device per Federal Register July, 1978.
1. Legally marketed predicate device to which substantial equivalence is claimed: Estill Medical Technologies, Inc. Thermal Angel™ Blood/Fluid Warmer.
1. Brief Description: The Belmont Microheater 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 heating technology used is resistive heating of two plates within the heater unit.

780 Boslon Road. Billerica, MA 01821 tel 978.663.0214 www.belmonlinstrument.com

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The Microheater 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 cartridge, 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 Microheater is not meant to be used with pressurized infusers.

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

1. Intended Use: The Microheater 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. The system is not meant for the infusion of drugs, or platelet or granulocyte suspensions.

10. Summary of the technological characteristics of the Belmont Microheater:

The heater unit is powered with 15 V pulsed DC which is derived from 120 or 230 VAC, 47 - 63 Hz AC/DC Converter. 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.

11. Summary of Nonclinical Tests and Results

In order to verify performance of the Belmont Microheater 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.
b. Verify the ability of the system to detect and alarm at unsafe or ineffective operating conditions.

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the fluid.

Verify that the device is in compliance with the following standards:

ANSI/AAMI/ISO 11135-1994. Medical Devices. Validation and Routine ● Control of Ethylene Oxide Sterilization; SAL 10°. . ANSI/AAMI/ISO 10993-1: 1995 Biological Evaluation of Medical devices - Part 1: Guidance on selection of tests. . UL 2601-1, Underwriter Laboratories, Medical Electrical Equipment, Part 1, General requirements for Safety. . CAN/CSA C22.2 No. 601-1-M90, Medical Electrical Equipment, Part 1, General requirements for Safety. . EN 60601-1, Medical Electrical Equipment, Part 1, General requirements for Safety. . EN 60601-1-2 Medical Electrical Equipment, Part 1, General
1. Conclusion: The Belmont Microheater Blood/Fluid Warmer is substantially equivalent to the Estill Medical Technologies, Inc. Thermal Angel™ Blood/Fluid Warmer which received 510(k) approval on July 1, 1999. Both systems have the same intended use, and are capable of heating blood products or intravenous fluids prior to administration to physiological temperature. Both systems have an independent fail-safe circuit which stops heating and alarms if the system overheats

compatibility.

requirements for Safety 2. Collateral Standard: Electromagnetic

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.