BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)

{0}------------------------------------------------ AUG 24 1999 K992472 Attachment 3 Image /page/0/Picture/3 description: The image shows a black and white drawing of a complex, winding line. The line appears to be drawn on a grid, with the line traversing across the grid in a seemingly random pattern. The line is thick and dark, making it stand out against the lighter background of the grid. ## 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: August 9, 1999 - 1. Submitter & Belmont Instrument Corporation 780 Boston Road Manufacturing Site: Billerica, MA 01821 Establishment Registration Number: 1219702 - 2. Uraiwan P. Labadini, Quality Assurance/Regulatory Affairs Contact Person: Manager Telephone: (978) 663-0212 Ext. 28 Fax: (978) 663-0214 - 3. The Belmont Fluid Management System (7/MS2000) Trade Name: - 4. Common name: Infusion Pump with Warmer. - ട്. Classification name: Infusion Pump (per 21 CFR section 880.5725) - 80 FRN Infusion Pump 6. Product Code: 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 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. - ல் 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 FMS2000 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. {1}------------------------------------------------ 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 (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. - 11. Summary of the technological characteristics of the Modifies Belmont Disposable Set and our current Disposable Set. Offer three (3) new accessory kits to be used with our existing disposable set. Out of the three (3) kits, only two (2) new fittings are introduced to the current disposable set to provide a convenient way for the accessory to connect to the disposable set. - 12. 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. - b. The ability of the system to warm cold fluids to physiological temperature over the full range of flow rate and operating conditions. - The ability of the system to detect and alarm at unsafe or ineffective operating C. 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 FMS2000 performed within specification in all of the above tests. - 13. Conclusion: The Belmont Disposable Set with accessory kits are substantially equivalent to our current Disposable Set which received 510(k) approval in November 1997. The Fluid Management System, J.M.S2000, 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 5MS2000 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. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 24 1999 Mr. Uraiwn Labadini Quality Assurance and Regulatory Affairs Manager Belmont Instrument Corporation 780 Boston Road Billerica, Massachusetts 01821 Re : K992672 Belmont Fluid Management System (FMS2000) Trade Name: Requlatory Class: II Product Code: FRN Dated: Auqust 09, 1999 August 10, 1999 Received: Dear Mr. Lababini: 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Paqe 2 - Mr. Labadini This letter will allow you to begin marketing your device as Inis lecter will arow ) premarket notification. The FDA finding debertical in judinalence of your device to a legally marketed of substantial equivation on your ification for your device and thus, permits your device to proceed to the market. thus, between jocific advice for your device on our labeling II you debire Specific add and additionally 809.10 for in vitro regulation (ar critical as a contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and (301) 391 your device, please contact the Office of advertibing of Joa) 594-4639. Also, please note the regulation Compriance at (301) 531 1059 - 1625) premarket notification" (21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small ander the may as 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, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Attachment I Belmont Instrument Corporation 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. C. (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) ﺎ ﻣ OR Over-The-Counter Use_ Patricia Crescite (Division Sign-Off) Division of Dental, Infection Cor and General Hospital De 510(k) Ni in har 4