BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000

K032674 · Belmont Instrument Corp. · LGZ · Sep 16, 2003 · General Hospital

Device Facts

• Record ID: K032674
• Device Name: BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
• Applicant: Belmont Instrument Corp.
• Product Code: LGZ · General Hospital
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Belmont Fluid Management System (FMS2000) is an infusion pump with integrated fluid warmer. Inputs: crystalloid, colloid, or blood products. Operation: microprocessor-controlled pump and heating system; monitors temperature, line pressure, and air in fluid path. Outputs: warmed fluids at user-set rates (10-750 ml/min); low-rate (2.5 ml/min) non-warmed infusion; touch screen displays flow rate, volume, temperature, pressure, and alarm status. Used in surgical/trauma settings by clinicians. Safety features: hardware override circuit for computer failure; battery backup for transport (warming disabled on battery). Benefits: rapid, controlled delivery of warmed fluids to manage hypothermia and blood loss.

Clinical Evidence

Bench testing only. Testing verified fluid pumping accuracy across flow rates, pressures, and viscosities; warming performance to physiological temperatures; and alarm functionality for sensor/system failures. Hemocompatibility testing (red cell hemolysis and fragility) using Sigma Diagnostics Procedure No. 527 showed negligible effects on anticoagulated blood.

Technological Characteristics

Infusion pump with integrated fluid warmer; microprocessor-controlled; touch screen interface; battery backup for mobile operation. Flow rates: 10-750 ml/min (warmed) and 2.5 ml/min (non-warmed). Safety: hardware override circuit, air-in-line detection, pressure monitoring, temperature monitoring.

Indications for Use

Indicated for infusion of crystalloid, colloid, or blood products (including packed red blood cells) for volume replacement in patients with blood loss due to trauma or surgery; rewarming patients post-surgery or with hypothermia; and irrigation during urology procedures.

Regulatory Classification

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.

Predicate Devices

• Belmont Fluid Management System (K972284)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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

- 2. Contact Person: Uraiwan P. Labadini, Quality Assurance/Regulatory Affairs Manager
Telephone: [phone] Ext. 28 Fax: [phone]

- 3. Trade Name: The Belmont Fluid Management System, JMS2000
- 4. Common name: Infusion Pump with Warmer.
- 5. Classification name: Infusion Pump (per 21 CFR section 880.5725)
- e. Product Code: 80 FRN Infusion Pump Device Class: Class II

7.

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

- 8. 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

- 9. 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.

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.

- 10. 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.

- 11. 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,

- 12. 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.

- 13. 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.