BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 by BELMONT INSTRUMENT CORP.

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. в.
Infusion of warmed fluid for irrigation in urology procedures. ்.

The Belmont FMS2000 is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 -750 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 750 ml/min.

Device Description

The Belmont Fluid Management System, JMS2000, 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 JMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 750 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 provided document is a 510(k) Premarket Notification for the Belmont Fluid Management System (FMS2000). This document describes a medical device (an infusion pump with warmer) and its equivalence to a predicate device, as required by the FDA.

Based on the content of the document, the following information regarding acceptance criteria and the study is available:

1. A table of acceptance criteria and the reported device performance:

The document does not present a formal table of acceptance criteria with specific quantitative thresholds alongside reported device performance. Instead, it describes general capabilities and a qualitative statement of performance.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to pump fluids accurately over the full range of flow rate and operating conditions (different input fluid temperatures, back pressure, ambient temperature, fluid viscosity).	"The Belmont FMS2000 performed within specification in all of the above tests."
Ability to warm cold fluids to physiological temperature over the full range of flow rate and operating conditions.	"The Belmont FMS2000 performed within specification in all of the above tests."
Ability to detect and alarm at unsafe or ineffective operating conditions (operator errors, sensor failure, internal system malfunctions).	"The Belmont FMS2000 performed within specification in all of the above tests."
Hemocompatibility (negligible effect on anticoagulated blood, test for red cell hemolysis and fragility).	"The system was found to have negligible effect on anticoagulated blood."

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

The document does not specify exact sample sizes for the tests conducted (e.g., number of fluid pumping tests, warming cycles, alarm triggers, or blood samples). It states "the following tests were carried out" but doesn't quantify the repetitions or specific test conditions in detail beyond "full range of flow rate and operating conditions." The data provenance is implied to be from laboratory testing performed by Belmont Instrument Corporation. No information is provided regarding country of origin of the data or if it was retrospective or prospective, though for device performance testing, it would inherently be prospective.

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

This is not applicable to the type of device and testing described. The "ground truth" for an infusion pump's performance (e.g., flow rate accuracy, temperature accuracy, alarm function) is established by physical measurements using calibrated equipment, not by expert consensus or interpretation of ambiguous data.

4. Adjudication method for the test set:

Not applicable. The tests described involve objective measurements and comparisons against specifications, not subjective assessments 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. The Belmont Fluid Management System (FMS2000) is an infusion pump, which is a physical medical device, not an AI-based diagnostic or assistive technology that would involve "human readers" or "AI assistance."

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

Not applicable for an infusion pump. The device operates automatically to infuse fluids and warm them, with monitoring and alarms. While the device's software operates standalone, the entire system is a physical device, not an "algorithm only" in the context of typical AI medical device evaluation. The "standalone performance" is essentially the device's functional performance as tested.

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

The ground truth for the performance tests (flow rate, temperature, alarm function) would be established by objective physical measurements using calibrated instruments and comparing these measurements against predetermined engineering specifications and regulatory standards. For hemocompatibility, the "Sigma Diagnostics, Plasma Hemoglobin' Procedure No. 527" was used to establish the ground truth for red cell hemolysis.

8. The sample size for the training set:

Not applicable. This device is an infusion pump, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of such a device is through its design, engineering, and manufacturing processes.

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

Not applicable, as there is no "training set" for this type of device. The specifications and design principles are based on engineering standards, physiological requirements for fluid resuscitation, and safety regulations.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

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

JAN 1 0 2017

Re: K032674

Trade/Device Name: The Belmont Fluid Management System (FMS2000) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: August 27, 2003 Received: September 3, 2003

Dear Ms. Labadini:

This letter corrects our substantially equivalent letter of September 16, 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 (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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), 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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Page 1 Of 1

510(k) number: K032674

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. в.
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)

Siva Russo

ion Sign-Off n of Anesthesiology, General Hospital, Infection Control. Dental D

510(k) Number. Ko23674

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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Image /page/3/Picture/0 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 Instrument Corporation" is the tagline "Creating a New Standard of Care" in a smaller font.

SEP 1 6 2003

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)]

Date prepared: August 27, 2003

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: (508) 663-0212 Ext. 28 Fax: (508) 663-0214
1. Trade Name: The Belmont Fluid Management System, JMS2000
1. Common name: Infusion Pump with Warmer.
1. Classification name: Infusion Pump (per 21 CFR section 880.5725)
e. Product Code: 80 FRN Infusion Pump Device Class: Class II

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

1. The Modified Belmont Fluid Management System, MS2000, is substantially equivalent to the Belmont Fluid Management System , JMS2000, which was the subject of Premarket Notification #K972284 submitted in June, 1997.

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510(k) Summary of Safety and Effectiveness Page 2 of 3

1. Brief Description: The Belmont Fluid Management System, JMS2000, 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 JMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed
  to physiologic temperature at user-set rates from 10 to 750 milliliters per minute (ml/min). A low infusion rate at 2.5 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
  The Belmont FMS2000 is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 -750 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 750 ml/min.
1. Summary of the technological characteristics of the modified Belmont 7MS2000 compared to the current Belmont FMS2000.
  There are no changes to the operating principle, energy type, environmental specifications, or performance specifications. There are no changes to the Belmont FMS2000 hardware, changes in software only,
1. Summary of Nonclinical Tests and Results
  In order to verify performance of the Belmont JMS2000 in support of substantial equivalence, the following tests were carried out:
a. The ability of the system to pump fluids accurately over the full range of flow rate and operating conditions including different input fluid temperatures. different back pressure, change in ambient temperature, and change in fluid viscosity.
b. The ability of the system to warm cold fluids to physiological temperature over the full range of flow rate and operating conditions.

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510(k) Summary of Safety and Effectiveness Page 3 of 3

The ability of the system to detect and alarm at unsafe or ineffective C. operating conditions including operator errors, the failure of the system sensors, and other internal system malfunctions.
The Belmont 7MS2000 performed within specification in all of the above tests.

The system was tested for hemocompatibility by testing for red cell hemolysis, and red cell fragility. The system was found to have negligible effect on anticoagulated blood. Hemolysis assessment was done using 'Sigma Diagnostics, Plasma Hemoglobin' Procedure No. 527.

1. Conclusion: The Modified Belmont JMS2000 is substantially equivalent to the Belmont Fluid Management System , FMS2000, which was the subject of Premarket Notification #K972284 and received 510(k) approval in November 1997.

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).