FLUID MANAGEMENT SYSTEM by BELMONT INSTRUMENT CORP.

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.
Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
Infusion of warmed fluid for irrigation in urology procedures.

Device Description

The Belmont Fluid Management System (FMS2000) 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 FMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set 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. The study described in the provided text focuses on demonstrating the substantial equivalence of the FMS2000 to a predicate device, the Haemonetics Corporation Rapid Infusion System, R.I.S.®. The "acceptance criteria" discussed are essentially the specifications the device needs to meet to prove its performance and safety are comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with numerical targets as would be common in a modern clinical study. Instead, they are described in terms of functional capabilities and safety assessments. The reported performance indicates that the device met these functional specifications.

Acceptance Criteria Category	Reported Device Performance
Pumping Accuracy	The system performed within specification for pumping fluids accurately over the full range of flow rates and operating conditions (including different input fluid temperatures, back pressure, ambient temperature, and fluid viscosity).
Fluid Warming Capability	The system performed within specification for warming cold fluids to physiological temperature over the full range of flow rates and operating conditions.
Safety and Alarm System	The system performed within specification for detecting and alarming at unsafe or ineffective operating conditions, including operator errors, sensor failures, software/computer failures, and other internal system malfunctions.
Biocompatibility	The system passed tests for cytotoxicity, sensitization, irritation, and systemic toxicity (per ANSI/AAMI 10993-1: 1994).
Hemocompatibility	The system was found to have a negligible effect on anticoagulated blood and was considered "nonhemolytic" (according to ASTM F756-93).

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

The document does not explicitly mention a "test set" in the context of a dataset for AI or diagnostic performance evaluation. The "tests" described are likely engineering and laboratory bench tests performed on the device prototypes. Therefore, there is no mention of a sample size of patients or data, nor of data provenance (e.g., country of origin, retrospective/prospective). The tests were physical evaluations of the device's functionality.

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

Not applicable. The "ground truth" for these tests would be the established performance specifications for infusion pumps and warmers, and the results of the specific physical and chemical tests performed. There's no indication of human experts establishing ground truth for a diagnostic test set in this context.

4. Adjudication Method for the Test Set

Not applicable. This was not a study involving human interpretation or adjudication of outputs.

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

No. This document describes the premarket notification for a medical device (infusion pump with warmer), not an AI or diagnostic imaging product. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.

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

Yes, in a sense. The "tests" described in Section 12 ("Summary of Nonclinical Tests and Results") reflect the standalone performance of the device itself. These tests evaluated the device's ability to pump, warm, and alarm independently of human intervention during the measurement process. The device's "algorithm" (its internal microprocessor control logic) was tested within the physical system.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests was derived from:

Established engineering specifications and design requirements: For pumping accuracy, flow rates, temperature control, and alarm thresholds.
Recognized industry standards: Such as ANSI/AAMI 10993-1: 1994 for biocompatibility and ASTM F756-93 for hemocompatibility.
Direct measurement and observation: During controlled laboratory testing to confirm the device's adherence to those specifications and standards.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI product that requires a training set of data. The device's internal control parameters and logic were likely developed through engineering design, prototyping, and iterative testing, not through a "training set" in the AI sense.

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

Not applicable, as there was no "training set" in the context of a machine learning algorithm. The design and performance targets for the device were established through engineering principles, regulatory requirements, and comparison to existing predicate devices.

Summary

{0}------------------------------------------------

K972284

Attachment III

Belmont Instrument Corporation

NOV 1 3 1997

Belmont Instrument Corporation

780 Boston Road, Billerica, MA 01821 Tel (508) 663-0212 Fax (508) 663-0214

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

Date prepared: June 9, 1997

Belmont Instrument Corporation 1. Submitter & 780 Boston Road Manufacturing Site: Billerica, MA 01821
Establishment Registration Number: 1219702
Uraiwan P. Labadini, Quality Assurance/Regulatory Affairs 2. Contact Person: Manager
Fax: (508) 663-0214 (508) 663-0212 Ext. 28 Telephone:
The Belmont Fluid Management System (7/MS2000) 3. Trade Name:
Infusion Pump with Warmer. 4. Common name:
Infusion Pump (per 21 CFR section 880.5725) 5. Classification name:
80 FRN Infusion Pump ଚ. Product Code: Device Class: Class II

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

The Belmont Fluid Management System (7)MS2000) is substantially equivalent to 8. the Haemonetics Corporation Rapid Infusion System, R.I.S.®, which has been in commercial distribution since 1987, and which was the subject of Premarket Notification #K852645 submitted in June, 1985.

{1}------------------------------------------------

Brief Description: The Belmont Fluid Management System (FMS2000) 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 I Jus 2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set 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.

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 -500 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 500 ml/min.
1. Summary of the technological characteristics of the Belmont MS2000 compared to the Haemonetics R.I.S.®
  The two systems perform the identical function, both contain a high flow pump, a fluid warmer, and a safety/surveillance system to ensure safe operation. Both can operate at high flow rates. The main differences between the two systems are as follows:
Size and Weight: The Belmont 7MS2000 is a 26 pound compact, portable a. system which can be mounted on an IV pole. The Haemonetics R.I.S.® weighs 260 pounds, and is contained in a free standing console on casters.
Maximum Infusion Rate: The Belmont JMS2000 unit will infuse up to 500 b. ml/min, and will empty a one unit of blood in less than a minute. The Haemonetics R.I.S.® unit will infuse up to 1500 ml/minute, and requires a large reservoir in the disposable set.
Disposable Set. The Belmont FMS2000 and Haemonetics R.I.S.® C. disposable sets are similar in concept. The main difference is the reservoir

{2}------------------------------------------------

size. In the Belmont FMS2000 system, the reservoir serves to filter the fluid, to separate air and fluid, and to allow the air to vent via a hydrophobic filter. It serves as a conduit from the fluid bag to the system. In the Haemonetics R.I.S.® system, the reservoir acts as a filter, separates air and fluid, and also contains a large 3 liter volume for fluid storage, necessitated by the possibility of using a very high, 1500 ml/min. flow rate. In our system this volume is not needed.

Summary of Nonclinical Tests and Results 12.
In order to verify performance of the Belmont JMS2000 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 b. over the full range of flow rate and operating conditions.
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, 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.

In order to verify biocompatibility, the system was tested for cytotoxicity, sensitization, irritation, and systemic toxicity, using the per ANSI/AAMI 10993-1: 1994 Biological evaluation of medical devices - Part 1: Guidance on selection of tests. All tests were passed. 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 and the system is considered "nonhemolytic" according to ASTM F756-93: Standard Practice for Assessment of Hemolvtic Properties of Materials.

1. Conclusion: The Belmont Jus 2000 is substantially equivalent to the Haemonetics R.I.S® which received 510(k) approval in June 1985. Both systems are capable of high infusion flow rates, while maintaining infusate at physiological temperature, and both systems are suitable for use with blood products. Both systems monitor flow rate, temperature, line pressure, and the presence of air at the input line or within the system, and alarm and stop the system at all unsafe conditions.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing segments, representing the department's mission to protect and promote the health and well-being of all Americans. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1997

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

K972284 Re : Fluid Management System Trade Name: Regulatory Class: II Product Code: FRN Dated: August 12, 1997 Received: August 15, 1997

Dear Mr. 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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

{4}------------------------------------------------

Page 2 - Mr. Babadini

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,

Ulchuski

Timothy A . Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

্রি

. Enclosure

{5}------------------------------------------------

Attachment V

Page 1 Of 1

长972284 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. C.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrizio Cusconte

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

510(k) Number K972281/

Prescription Use 1 (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).