(14 days)
Not Found
No
The description focuses on microprocessor control, safety monitoring, and mechanical systems, with no mention of AI or ML.
Yes
The device is described as a "Fluid Management System" intended for "Infusion of crystalloid, colloid, or blood product" and "Infusion of warmed fluid to rewarm patients after surgery or for hypothermia," which directly relates to treating medical conditions and restoring physiological function.
No
The device is described as an infusion system used for rapid replacement of warmed blood or fluids, rewarming patients, and delivering irrigation fluids. Its functions primarily involve fluid management and delivery, not diagnosing medical conditions.
No
The device description clearly outlines a system with mechanical components (pump), heating elements, sensors (temperature, pressure, air), a touch screen display, and a battery backup. This is a hardware-based medical device with integrated software for control and monitoring.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "Infusion of crystalloid, colloid, or blood product... as volume replacement," "Infusion of warmed fluid to rewarm patients," and "Infusion of warmed fluid for irrigation." These are all therapeutic or supportive procedures performed on the patient, not diagnostic tests performed on samples taken from the patient.
- Device Description: The description details a system for warming and infusing fluids, monitoring temperature, pressure, and air in the fluid path. This aligns with a fluid management and warming system used in a clinical setting for patient treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device's function is to deliver fluids to the patient.
Therefore, the Belmont Fluid Management System (7MS2000) is a therapeutic/supportive medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use of the Jus 2000 (Unchanged by the modification):
Infusion of crystalloid, colloid, or blood product, including packed red 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 purposes.
Intended Use of the reservoir (Unchanged by the modification):
The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.
The Belmont 7MS2000is 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. The reservoir is used to increase the fluid supply capacity of the Belmont instrument 7MS2000 3-Spike disposable Set.
Product codes (comma separated list FDA assigned to the subject device)
LGZ, FRN
Device Description
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 SMS2000 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.
The new reservoir, our own design, will be used instead of Gish Biomedical Inc. reservoir. The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The ability of the system to warm cold fluids to physiological temperature over a. the full range of flow rate and operating conditions.
b. 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.
C. The ability of the new reservoir not to damage blood.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, bold line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Uraiwan P. Labadini Quality Assurance Regulatory Affairs Manager Belmont Instrument Corporation 780 Boston Road Billerica, Massachusetts 01821
JAN 1 0 2017
Re: K032778
Trade/Device Name: Large Volume Fluid Reservoir Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: September 4, 2003 Received: September 8, 2003
Dear Mr. Labadini:
This letter corrects our substantially equivalent letter of September 22, 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
1
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 8091 ), 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
2
Page 1 Of 1
510(k) number: K032776
Device Name: Reservoir
Indications For Use:
Intended Use of the Jus 2000 (Unchanged by the modification):
Infusion of crystalloid, colloid, or blood product, including packed red 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 purposes.
Intended Use of the reservoir (Unchanged by the modification):
The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pattison Cuscinite
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K032778
Prescription Use✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
3
SEP 2 2 2003
Attachment 2
Image /page/3/Picture/3 description: The image shows the logo for Belmont Instrument Corporation. The logo features a stylized "B" followed by the word "elmont" in a bold, sans-serif font. Below this is the text "Instrument Corporation" in a smaller font. Underneath the logo is the tagline "Creating a New Standard of Care".
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(c)]
Date prepared: September 4, 2003
-
- Submitter & Belmont Instrument Corporation Manufacturing Site: 780 Boston Road Billerica, MA 01821
Establishment Registration Number: 1219702
- Submitter & Belmont Instrument Corporation Manufacturing Site: 780 Boston Road Billerica, MA 01821
-
- Contact Person: Uraiwan P. Labadini, Quality Assurance/Regulatory Affairs Manager
- Telephone: (978) 663-0212 Ext. 28 Fax: (978) 663-0214
-
- Trade Name: The Belmont Fluid Management System (FMS2000)
-
- Common name: Infusion Pump with Warmer.
-
- Classification name: Infusion Pump (per 21 CFR section 880.5725)
-
રે. Product Code: 80 FRN Infusion Pump Device Class: Class II
-
- Performance Standards:
No performance standards have been officially adopted by the F.D.A.
-
- 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 and the accessory kits received F.D.A 510(k) concurrence to market in August 1999, 510(k) #K992672.
4
Summary of Safety and Effectiveness Page 2 of 3 Aug 22, 2003
-
- Brief Description of the JMS2000 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 SMS2000 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.
- Brief Description of the JMS2000 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 SMS2000 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.
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.
The new reservoir, our own design, will be used instead of Gish Biomedical Inc. reservoir. The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.
-
- Intended Use (Unchanged by the Modification): The Belmont 7MS2000is 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. The reservoir is used to increase the fluid supply capacity of the Belmont instrument 7MS2000 3-Spike disposable Set.
-
- Summary of the technological characteristics of the Modifies Belmont Disposable Set and our current Disposable Set.
The modified Belmont disposable set and our current disposable set are similar in design and concept.
5
Summary of Safety and Effectiveness Page 3 of 3 Aug 22, 2003
-
- Summary of Nonclinical Tests and Results
In order to verify performance of the Belmont 714 S2000 in support of substantial equivalence, the following tests were carried out:
- Summary of Nonclinical Tests and Results
-
The ability of the system to warm cold fluids to physiological temperature over a. the full range of flow rate and operating conditions.
-
b. 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.
-
C. The ability of the new reservoir not to damage blood.
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.
-
- Conclusion: The new reservoir is substantially equivalent to our current reservoir which received 510(k) approval in August 1999.