(103 days)
Not Found
No
The description mentions "advanced microprocessor technology" and safety monitoring, but there is no mention of AI or ML algorithms, training data, or performance metrics typically associated with AI/ML devices.
Yes
The device is designed to provide warmed blood and fluids for volume replacement, rewarming, and irrigation in medical procedures, which are therapeutic interventions.
No
The device is described as an infuser for warming and delivering fluids to patients, not for diagnosing medical conditions. It provides therapeutic support rather than diagnostic information.
No
The device description clearly outlines a physical device with mechanical components (pump), heating elements, sensors (temperature, pressure, air), a touch screen display, and a battery backup. While it utilizes microprocessor technology and software for control and monitoring, it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Belmont Rapid Infuser RI-2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used to provide warmed blood and fluids to patients for various clinical purposes (volume replacement, rewarming, irrigation). This involves direct interaction with the patient's body.
- Device Description: The description details a system for infusing fluids into the patient, monitoring parameters like temperature and pressure within the fluid path during infusion.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Belmont Rapid Infuser does not perform any such analysis of patient specimens.
The device is a therapeutic device used for administering fluids directly to a patient.
N/A
Intended Use / Indications for Use
The Belmont Rapid Infuser RI-2 is designed to be used in general or alternative care environments to provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min.
- 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.
The 3.0L reservoir is an optional accessory for use in adults only.
Product codes
FRN, LGZ
Device Description
The Belmont® Rapid Infuser, RI-2 combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluids. The Rapid Infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 1000 milliliters per minute (mL/min). Low infusion rates of 2.5 mL/min (150 mL/hr) and 5.0 mL/min (300 mL/hr) are also available to keep the venous line open.
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 of the infusate, 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 limited to 50mL/min 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
patients ≥ 10 kg
The 3.0L reservoir is an optional accessory for use in adults only.
Intended User / Care Setting
general or alternative care environments
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)
Non-clinical performance testing:
Biocompatibility / Materials - Biocompatibility testing was conducted in accordance with FDA quidance. Use of International Standard ISO 10993-1. Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Testing of the patient-contacting parts of the Belmont® Rapid Infuser RI-2 demonstrates an appropriate biocompatibility profile for the device.
Electrical Safety: Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1:2005 Ed.3+A1:2012 and IEC 60601-1-2:2020 Ed.4.1 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.
Software Verification and Validation Testing: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern.
Bench / Performance Testing - Comparative performance testing included:
- Verification testing of product requirements
- IPX Water Intrusion testing in conformity with IEC 60529
- Testing for basic safety and essential performance in conformity with IEC 60601-1
- Testing for electromagnetic disturbances in conformity with IEC 60601-1-2
- Testing for alarm systems in conformity with IEC 60601-1-8
- Software validation in conformity with IEC 62304
- Testing for biocompatibility in conformity with FDA Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
The results demonstrated that the device performance was met and was substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 23, 2024
Belmont Medical Technologies Lida Reed Director Quality Assurance and Regulatory Affairs 780 Boston Road Billerica, Massachusetts 01821
Re: K242735
Trade/Device Name: Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, LGZ Dated: November 21, 2024 Received: November 21, 2024
Dear Lida Reed:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242735
Device Name
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min) Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
Indications for Use (Describe)
The Belmont Rapid Infuser RI-2 is designed to be used in general or alternative care environments to provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min. - 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.
The 3.0L reservoir is an optional accessory for use in adults only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| Date: | December 17, 2024 | |
|---|---|---|
| Company: | Belmont Medical Technologies | |
| 780 Boston Road | ||
| Billerica, MA 01821 | ||
| Official Contact: | Lida Reed | |
| Director Quality Assurance and Regulatory Affairs | ||
| Phone: 978.696.9245 | ||
| Email: Ireed@belmontmedtech.com | ||
| Proprietary or Trade Name: | Belmont® Rapid Infuser, RI-2 | |
| Common/Usual Name: | Infusion Pump | |
| Classification Name: | 21 CFR 880.5725, Class II | |
| Classification Product Code: FRN | ||
| Subsequent Product Code: LGZ | ||
| Predicate Device: | K141654: The Belmont Rapid Infuser | |
| This predicate has not been subject to a design-related recall |
Device Description:
The Belmont® Rapid Infuser, RI-2 combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluids. The Rapid Infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 1000 milliliters per minute (mL/min). Low infusion rates of 2.5 mL/min (150 mL/hr) and 5.0 mL/min (300 mL/hr) are also available to keep the venous line open.
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 of the infusate, 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 limited to 50mL/min and safety monitoring remain active.
Indications for Use:
The Belmont Rapid Infuser RI-2 is designed to be used in general operation in hospital or alternative care environments to provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min.
- 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. .
The 3.0L reservoir is an optional accessory for use in adults only.
5
Contraindications:
- . The system should not be used to warm platelets, cryoprecipitates, granulocyte suspensions or unprocessed / non-anti-coagulated blood products.
- This system is not intended for drug administration.
- . Calcium containing solutions (ex. Lactated Ringer's solution), dextrose in water, and hypotonic sodium chloride solutions should not be added to blood components.
Substantial Equivalence:
The Belmont® Rapid Infuser RI-2 is substantially equivalent to the predicate device, the Belmont® Rapid Infuser RI-2 (510(k) K141654). The table below presents the similarities and differences between the products for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence.
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.0 General: | | | |
| • Common/
Classification | Infusion Pump/
Pump, Infusion
Warmer Thermal Infusion
Fluid Warmer | Infusion Pump/
Pump, Infusion
Warmer Thermal
Infusion Fluid Warmer | SAME |
| • Regulation Number | 21 CFR 880.5725
FRN | 21 CFR 880.5725
FRN | SAME |
| • FDA Product Codes | LGZ | LGZ | SAME |
| • Trade name | Rapid Infuser | Rapid Infuser | SAME |
| • Model Number | RI2 | RI2 | SAME |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| • Indications for use | • 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 hyperthermia, and
• Infusion of warmed fluid for irrigation in urology procedures. | The Belmont Rapid Infuser RI-2 is designed to be used in general operation in hospital or alternative care environments to provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min.
• 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 hyperthermia, and
• Infusion of warmed fluid for irrigation in urology procedures.
The 3.0L reservoir is an optional accessory for use in adults only. | SIMILAR
The subject device clarifies that the device is for use in patients ≥ 10 kg. This clarification does not impact the intended use which is rapid infusion of warmed blood, blood products and fluids. |
| • Device description | High speed infusion pump with fluid warming. | High speed infusion pump with fluid warming. | SAME |
| • Infusate | Blood, blood product, crystalloid and colloid solutions. | Blood, blood product, crystalloid and colloid solutions. | SAME |
| 2.0 Fluid Infusion (Pump) Characteristics: | | | |
| • Available flow rates | 2.5, 5.0, 10 to 1000 mL/min | 2.5, 5.0, 10 to 1000 mL/min | SAME |
| 510(k) Summary | | | |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| • Flow rate accuracy | ± 10% from 20 – 1000 mL/min
± 25% for 2.5, 5.0, 10 mL/min | ± 10% from 20 – 1000 mL/min
± 25% for 2.5, 5.0, 10 mL/min | SAME |
| • Type of Fluid Pump | Roller type peristaltic pump | Roller type peristaltic pump | SAME |
| • Digital readout of flow rate | Yes | Yes | SAME |
| • Automatic reduction of pump speed, if required, to maintain user-set line pressure limit | Yes | Yes | SAME |
| • Digital setting of speed by user from front panel | Yes | Yes | SAME |
| • Control and maintain pump speed with variable pressure head | Yes | Yes | SAME |
| • Maximum pressure at which set flow maintained (mmHg) | 300 mmHg standard.
Can be changed by the Operator to 100 or up to 300 mmHg, in 50 mmHg increments. | 300 mmHg standard.
Can be changed by the Operator to 100 or up to 300 mmHg, in 50 mmHg increments. | SAME |
| • Display total volume infused | Yes | Yes | SAME |
| • Continuous infuse and fixed bolus volume modes (fill until a fixed volume of fluid is delivered) | Yes | Yes | SAME |
| • Monitor pump speed and alarm if speed not equal to setting. | Yes | Yes | SAME |
| Summary-4 | | | |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| • Alternate fluid path | Yes, recirculate mode,
controlled by diversion
valve, routes fluid back to
system reservoir to purge
any air in the main fluid
circuit back into the
reservoir to be vented. | Yes, recirculate mode,
controlled by diversion
valve, routes fluid back
to system reservoir to
purge any air in the main
fluid circuit back into the
reservoir to be vented. | SAME |
| 3.0 Warming Characteristics: | | | |
| • Steady state fluid
output temperature | 37.5°C at high flow, 60
mL/min and higher; and
39°C at low flow, less
than 60 mL/min (Higher
temperature at low flow
to compensate for
cooling in patient line.) | 37.5°C at high flow, 60
mL/min and higher; and
39°C at low flow, less
than 60 mL/min (Higher
temperature at low flow
to compensate for
cooling in patient line.) | SAME |
| • High temperature
alarm condition
(Infusate Over
Temp) | Output temperature
42°C for 20 mL of fluid
pumped or fluid
temperature >45°C for
0.25 seconds. | Output temperature
42°C for 20 mL of fluid
pumped or fluid
temperature >45°C for
0.25 seconds. | SAME |
| • Maximum speed for
steady state 37°C | 1000 mL/min | 1000 mL/min | SAME |
| • Measure and
display output
temperature of
infusate | Yes | Yes | SAME |
| • Heat exchanger
type | Inductively heated
stainless steel annular
rings | Inductively heated
stainless steel annular
rings | SAME |
| • Method of
temperature control | Measure input and
output temperatures
from the temperature
sensors, compute
required power to the
heat exchanger to
maintain the targeted
temperature. Redundant
check using flow rate,
input power, input
temperature. | Measure input and
output temperatures
from the temperature
sensors, compute
required power to the
heat exchanger to
maintain the targeted
temperature. Redundant
check using flow rate,
input power, input
temperature. | SAME |
| 4.0 Alarms and System Surveillance: | | | |
| 510(k) Summary Summary-6 | | | |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| Air detection | | | |
| • Air detection at
input to machine to
detect empty
reservoir | Yes | Yes | SAME |
| • Redundant in-line
air bubble detection
near output | Yes | Yes | SAME |
| • Method to eliminate
air from system,
without disassembly | Yes | Yes | SAME |
| • Type of Air Bubble
detector | Ultrasonic | Ultrasonic | SAME |
| • Automatic Air
Elimination while
pumping | Yes, via "recirculation"
mode | Yes, via "recirculation"
mode | SAME |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| Line Pressure
monitoring | | | |
| • Monitor & Display
line pressure | Yes | Yes | SAME |
| • Pressure limit | 300 mmHg, standard.
User can adjust during
setup. | 300 mmHg, standard.
User can adjust during
setup. | SAME |
| • Automatic flow rate
control of pump to
maintain line
pressure below
pressure limit | Yes | Yes | SAME |
| • Message to
Operator when flow
rate is pressure
limited | Yes | Yes | SAME |
| • Alarm at high
pressure | Yes, at 400 mmHg | Yes, at 400 mmHg | SAME |
| • Alarm if pump stops
due to pressure limit | Yes | Yes | SAME |
| • Alarm if pressure
ramps too quickly | Yes | Yes | SAME |
| • Time to occlusion
alarm | Immediate | Immediate | SAME |
| Temperature
Monitoring | | | |
| • High temperature
alarm: stop
pumping, heating,
display message | Yes | Yes | SAME |
| • Display true output
fluid temperature | Yes | Yes | SAME |
| 510(k) Summary | | | Summary-8 |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| System failure
surveillance | | | |
| • Set-up problem
alarms | System door open, heat
exchanger not in place | System door open, heat
exchanger not in place | SAME |
| • Automatic system
check of Air
detectors | At beginning of each set-
up | At beginning of each set-
up | SAME |
| • Fluid out alarm | Yes | Yes | SAME |
| • Missing disposable
alarm | Yes | Yes | SAME |
| • Low Battery alarm | Yes | Yes | SAME |
| • Monitor pump
speed during
operation ("Pump
Fault" alarm) | Yes, via digital encoder
on shaft of pump motor | Yes, via digital encoder
on shaft of pump motor | SAME |
| • Recirc/Infuse Valve
failure alarm | Yes | Yes | SAME |
| • Hardware Sense
Computer Failure
and Stop Pump and
Heat | Yes | Yes | SAME |
| • System response to
alarm condition for
pressure over limit,
air detected, pump
fault, system setup
problem. | Stop pump, close
diversion valve (revert to
recirculate), stop heat | Stop pump, close
diversion valve (revert to
recirculate), stop heat | SAME |
| • Audible Alarm with
message at each
condition | Yes | Yes | SAME |
| • Operator can
silence alarm tone,
as alarm is serviced | Yes | Yes | SAME |
| 510(k) Summary | | | |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| 5.0 Operator Interface: | | | |
| Parameters monitored and
displayed continuously. | Flow Rate, Volume
Infused, Output
temperature, Line
Pressure. | Flow Rate, Volume
Infused, Output
temperature, Line
Pressure. | SAME |
| Fluid infusion rate control at
front panel with digital
readout. | Yes | Yes | SAME |
| Fixed volume infusion
(bolus) with monitor of bolus
volume. | Yes, bolus volume can
be set between 100 to
1000 mL and can be
changed to intermediate
values of 200, 400 and
500 by pressing the
BOLUS button, or in the
system
service/calibration
routine. | Yes, bolus volume can
be set between 100 to
1000 mL and can be
changed to intermediate
values of 200, 400 and
500 by pressing the
BOLUS button, or in the
system
service/calibration
routine. | SAME |
| Operating modes | Load disposable
Prime (Automatic)
Patient Line Prime
Infuse
Bolus Infuse
Recirculate | Load disposable
Prime (Automatic)
Patient Line Prime
Infuse
Bolus Infuse
Recirculate | SAME |
| Readout | High contrast display
using an
electroluminescent
display with extremely
wide viewing angle | High contrast display
using an
electroluminescent
display with extremely
wide viewing angle | SAME |
| Languages selectable from
front panel | Multiple language
selection available | Multiple language
selection available | SAME |
| 6.0 Operating Environment Requirements: | | | |
| Operating temperature | 10° to 32°C | 10° to 32°C | SAME |
| Storage temperature | -15° to 40°C | -15° to 40°C | SAME |
| Relative humidity | 10% to 90% non-
condensing | 10% to 90% non-
condensing | SAME |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| Ingress protection | IPX2 per IEC 60529 as
required by IEC 60601-1 | Overall device is IPX2
with IPX6 where the
power cord is connected
to the device per IEC
60529 as required by
IEC 60601-1 | SIMILAR
Subject device
confirmed to have higher
ingress protection where
the power cord is
connected to the device,
with all applicable
predetermined
acceptance criteria met. |
| 7.0 Battery Operation, Transport, Physical Characteristics, Power Consumption: | | | |
| Battery Operation for Pump,
Alarms, with heat disabled | Yes | Yes | SAME |
| Battery Operation with heat
(warming) | No warming in battery
mode | No warming in battery
mode | SAME |
| Battery running time | 30 minutes @ 50 mL/min | 30 minutes @ 50
mL/min | SAME |
| Transport | Mounts to IV pole | Mounts to IV pole | SAME |
| Dimensions | 13.5" x 7.5" x 12"
(34 cm x 19 cm x 31 cm)
weight: app. 26 lb. (12
kg) | 13.5" x 7.5" x 12"
(34 cm x 19 cm x 31 cm)
weight: app. 26 lb. (12
kg) | SAME |
| Electrical Safety | Meets UL 60601-1, EN
60601-1 (2005, 3rd
edition), CAN/CSA C22.2
No. 60601.1 (2008) | Meets ANSI/AAMI
ES60601-
1:2005/A1:2012 | SIMILAR
Subject device
confirmed to comply with
current FDA recognized
version of standard, with
all applicable
predetermined
acceptance criteria met. |
| Electromagnetic
Compatibility | Meets EN 60601-1-2
(2007) and IEC 60601-1-
2 (2007) | Meets IEC 60601-1-
2:2020 | SIMILAR
Subject device
confirmed to comply with
current FDA recognized
version of standard, with
all applicable
predetermined
acceptance criteria met. |
| Power Consumption | 1440 watts | 1440 watts | SAME |
| Element of Comparison | Predicate Device:
Belmont® Rapid
Infuser, RI-2
[510(k) K141654] | Subject Device:
Modified Belmont®
Rapid Infuser, RI-2 | Substantial
Equivalence |
| Sterile Fluid Path | Preconnected system
with sterile, non-
pyrogenic fluid path. | Preconnected system
with sterile, non-
pyrogenic fluid path. | SAME |
| Sterilization | Ethylene Oxide | Ethylene Oxide | SAME |
| Biocompatibility including
Hemocompatibility | Meets ISO 10993-1:1994
(Note: Data submitted
with 510(k) K972284) | Meets ISO 10993-
1:2018
Biocompatibility
including
hemocompatibility
conducted on current
disposable set with all
predetermined | SIMILAR
Subject device
confirmed to comply with
current FDA recognized
version of standard and
FDA Guidance
document regarding use
of ISO 10993-1 with all |
6
7
510(k) Summary
8
9
510(k) Summary
10
11
12
510(k) Summary
13
510(k) Summary
14
applicable
predetermined
acceptance criteria met.
Summary-11
510(k) Summary
acceptance criteria met.
From the comparison form above, the subject device and predicate device have the same intended use, are both prescription use, and have the same operating principle and method of warming and infusion. The differences in the devices do not raise questions of safety or effectiveness.
Non-clinical performance testing:
Biocompatibility / Materials -
Biocompatibility testing was conducted in accordance with FDA quidance. Use of International Standard ISO 10993-1. Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Testing of the patient-contacting parts of the Belmont® Rapid Infuser RI-2 demonstrates an appropriate biocompatibility profile for the device.
Electrical Safety:
Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1:2005 Ed.3+A1:2012 and IEC 60601-1-2:2020 Ed.4.1 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern.
Bench / Performance Testing -
Comparative performance testing included:
- Verification testing of product requirements ●
- . IPX Water Intrusion testing in conformity with IEC 60529
15
- . Testing for basic safety and essential performance in conformity with IEC 60601-1
- Testing for electromagnetic disturbances in conformity with IEC 60601-1-2 .
- . Testing for alarm systems in conformity with IEC 60601-1-8
- Software validation in conformity with IEC 62304
- Testing for biocompatibility in conformity with FDA Guidance "Use of International . Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
The results demonstrated that the device performance was met and was substantially equivalent to the predicate device.
Substantial Equivalence Conclusion
The performance testing demonstrates that the subject device is substantially equivalent to the predicate device.