(147 days)
No
The device description focuses on microprocessor technology, mechanical systems, and safety monitoring based on predefined parameters (temperature, pressure, air). There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
Yes
The device is intended for the infusion of fluids (crystalloid, colloid, blood products) for volume replacement and rewarming patients, which directly treats physiological conditions.
No
The device is an infusion system designed to rapidly warm and infuse fluids into a patient. It is not used to diagnose any medical condition, but rather to treat blood loss or hypothermia.
No
The device description explicitly details a "mechanical system" and "hardware override circuit," indicating it is not solely software. The performance studies also include testing of the mechanical and hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the infusion of fluids (crystalloid, colloid, blood products, irrigation fluids) into a patient. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the mechanical and electronic aspects of pumping and warming fluids, monitoring temperature, pressure, and air. These are all related to the delivery of substances into the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition. IVDs are specifically designed for in vitro (outside the body) examination of specimens.
The device is a fluid management system for infusion, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / 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.
Product codes
FRN
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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 the full range of flow rate and operating conditions.
- 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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
-
- 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.
- Intended Use
-
- 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:
- Summary of the technological characteristics of the Belmont MS2000 compared to the Haemonetics R.I.S.®
-
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.
-
- 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
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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
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. Enclosure
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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)
OR
Over-The-Counter Use_