BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) by BELMONT INSTRUMENT CORP.

A. Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.
B. Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
C. Infusion of warmed fluid for irrigation in urology procedures.

Device Description

The Belmont Fluid Management System (7MS2000) combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluid. The Belmont 7MS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at userset rates from 10 to 500 milliliters per minute (ml/min). A low infusion rate at 2.5 ml/min (150 ml/hr) is also available without heating.

The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.

A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.

AI/ML Overview

The Belmont Fluid Management System (FMS2000) is an infusion pump with a warmer designed for rapid infusion of warmed fluids in high blood loss surgical procedures, trauma, and situations requiring rapid replacement of warmed blood or replacement fluid. The reported information focuses on the nonclinical tests conducted to verify the device's performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Claim	Reported Device Performance
Pumping Accuracy	Performed "within specification" across full range of flow rates and operating conditions (different input fluid temperatures, back pressure, ambient temperature, fluid viscosity).
Fluid Warming to Physiological Temperature	Performed "within specification" across full range of flow rates and operating conditions.
Detection and Alarm for Unsafe/Ineffective Conditions	Performed "within specification" for detecting and alarming on operator errors, sensor failures, system software/computer failures, and other internal system malfunctions.
Hemocompatibility (Red Cell Hemolysis & Fragility)	Found to have "negligible effect on anticoagulated blood" and considered "non-hemolytic" according to ASTM F756-93.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size for the test set in terms of number of devices or number of test conditions run. It mentions "full range of flow rate and operating conditions" for the pumping and warming tests. The tests were non-clinical, implying they were laboratory-based tests. The country of origin for the data is implicitly the United States, as the submitting company is based in Billerica, MA, USA, and the submission is to the FDA. The testing was prospective, conducted to verify the performance of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided. For non-clinical performance and safety tests of this nature (pumping accuracy, warming, alarm functions, hemocompatibility), ground truth is typically established by established engineering specifications, industry standards (like ASTM F756-93 for hemocompatibility), and established medical parameters (e.g., "physiological temperature"). Human experts would be involved in designing the test protocols and evaluating the results against these objective criteria, but the document does not specify their number or qualifications as "ground truth experts" in the typical AI/diagnostic sense.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective performance tests against predefined specifications and standards, not evaluations requiring human adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is an infusion pump/warmer, not an AI diagnostic tool that assists human readers in interpreting medical images or data. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The tests described are standalone performance tests of the device itself (hardware and embedded software) without human intervention in the continuous operation for which the performance is being measured. The device's safety features autonomously detect and alarm at unsafe conditions.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests was established by:

Engineering Specifications: For pumping accuracy, fluid warming to target temperatures, and pressure/air detection.
Industry Standards: Specifically, ASTM F756-93 for the assessment of hemolytic properties.
Predefined Operating Conditions: The "full range of flow rate and operating conditions" serve as the defined parameters against which performance is measured.
Safety Requirements: The ability to detect and alarm at unsafe conditions against predefined failure modes and operational limits.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning algorithm that requires a "training set" in the context of data-driven model development. Its functionality is based on direct engineering design and control logic.

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

Not applicable. As noted above, this device does not utilize a training set in the AI sense.

Summary

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K983975

Attachment 3

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Belmont Instrument Corporation

780 Boston Road, Billerica, MA 01821 Tel (978) 663-0212 Fax (978) 663-0214

Registered In Accordance with ISO-9001 (Certificate # 041007407)

PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [As Required By 21 CFR 807.92(c)]

Date prepared: November 6, 1998

1. Belmont Instrument Corporation Submitter & 780 Boston Road Manufacturing Site: Billerica, MA 01821
  Establishment Registration Number: 1219702
1. Uraiwan P. Labadini, Quality Assurance/Requlatory Affairs Contact Person: Manager
  (978) 663-0212 Ext. 28 Fax: (978) 663-0214 Telephone:
The Belmont Fluid Management System (FMS2000) 3. Trade Name:
Common name: Infusion Pump with Warmer. 4.
Infusion Pump (per 21 CFR section 880.5725) ട. Classification name:
Product Code: 80 FRN Infusion Pump 6. Class II Device Class:
1. Performance Standards:

No performance standards have been officially adopted by the F.D.A.

1. The Modified Belmont Fluid Management Disposable Set System is substantially equivalent to the Belmont Fluid Management Disposable Set System, which was the subject of Premarket Notification #K972284 submitted in June 1997.
1. Brief Description of the Device (Unchanged by the Modification): The Belmont Fluid Management System (7MS2000) combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluid. The Belmont 7MS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at userset rates from 10 to 500 milliliters per minute (ml/min). A low infusion rate at 2.5

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Summary of Safety and Effectiveness Page 2 of 3 Nove 6, 1998

ml/min (150 ml/hr) is also available without heating.

A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.

1. Intended Use (Unchanged by the Modification): The Belmont 7MS2000 is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 -500 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 500 ml/min.
Summary of the technological characteristics of the Modifies Belmont Disposable Set 11. and our current Disposable Set.

The modified Belmont disposable set and our current disposable set are similar in design and concept. The main difference is the modified disposable set has a small piece of Polyester film material added to the flow outlet port of the heat exchanger. This material is added to better mix the fluid which will better control deviation in manufacturing of the heat exchanger resulting in better consistency of the output temperature.

1. Summary of Nonclinical Tests and Results
  In order to verify performance of the Belmont 7MS2000 in support of substantial equivalence, the following tests were carried out:
The ability of the system to pump fluids accurately over the full range of flow a. rate and operating conditions including different input fluid temperatures, different back pressure, change in ambient temperature, and change in fluid viscosity.
The ability of the system to warm cold fluids to physiological temperature over b. the full range of flow rate and operating conditions.
C. The ability of the system to detect and alarm at unsafe or ineffective operating conditions including operator errors, the failure of the system sensors, the failure of the system software or computer, and other internal system malfunctions.

The Belmont 7MS2000 performed within specification in all of the above tests.

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Summary of Safety and Effectiveness Page 3 of 3 Nove 6, 1998

The system was tested also for hemocompatibility by testing for red cell hemolysis, and red cell fragility. The system was found to have negligible effect on anticoagulated blood and the system is considered "non-hemolytic" according to ASTM F756-93: Standard Practice for Assessment of Hemolytic Properties of Materials.

1. Conclusion: The Modified Belmont Disposable Set is substantially equivalent to our current Disposable Set which received 510(k) approval in November 1997. The Fluid Management System, JMS2000, has not changed, and is capable of high infusion flow rates, while maintaining infusate at physiological temperature, and is suitable for use with blood products. The FMS2000 monitors flow rate, temperature, line pressure, and the presence of air at the input line or within the system, and alarms and stops the system at all unsafe conditions.

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle's head and neck, with the head facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.

NOV 30 1998

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 : K983975 Belmont Fluid Management System (FMS2000) Trade Name: Regulatory Class: II Product Code: FRN Dated: November 6, 1998 Received: November 9, 1998

Dear Ms. Labadini:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Paqe 2 - Ms. Labadini

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

Page 1 Of 1

510(k) number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Belmont Fluid Management System (JMS2000)

Indications For Use:

Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as A. volume replacement for patients suffering from blood loss due to trauma or surgery.
Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. B.
Infusion of warmed fluid for irrigation in urology procedures. ்.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Brendan Dulle
Division of Death, Infection Control,
and General Hospital Der reger

510022 x 90639 25510(k) Number K183975

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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).