(103 days)
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.
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.
The provided text describes the regulatory clearance for the "Belmont Rapid Infuser, RI-2" and its substantial equivalence to a predicate device. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy (like sensitivity, specificity, accuracy, etc., which are common for AI/ML medical devices). The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device, primarily through comparison of technical specifications and non-clinical performance testing.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for test and training sets) are not explicitly present in this regulatory submission.
The acceptance criteria mentioned are related to:
- Flow rate accuracy: ± 10% from 20 – 1000 mL/min, ± 25% for 2.5, 5.0, 10 mL/min.
- Steady state fluid output temperature: 37.5°C at high flow (60 mL/min and higher); 39°C at low flow (less than 60 mL/min).
- High temperature alarm condition: Output temperature >42°C for 20 mL of fluid pumped or fluid temperature >45°C for 0.25 seconds.
- Maximum speed for steady state 37°C: 1000 mL/min.
- Pressure limit: 300 mmHg standard (user adjustable).
- High pressure alarm: At 400 mmHg.
- Battery running time: 30 minutes @ 50 mL/min.
- Compliance with various international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62304, ISO 10993-1.
Here's the information that can be extracted, along with explanations for unavailable data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Fluid Infusion (Pump) Characteristics | |
| Flow rate accuracy | ± 10% from 20 – 1000 mL/min |
| ± 25% for 2.5, 5.0, 10 mL/min | |
| Max pressure at which set flow maintained | 300 mmHg standard (Operator can change to 100 or up to 300 mmHg, in 50 mmHg increments) |
| Warming Characteristics | |
| Steady state fluid output temperature | 37.5°C at high flow (60 mL/min and higher); 39°C at low flow (less than 60 mL/min) (Higher temperature at low flow to compensate for cooling in patient line.) |
| High temperature alarm condition | Output temperature >42°C for 20 mL of fluid pumped or fluid temperature >45°C for 0.25 seconds. |
| Maximum speed for steady state 37°C | 1000 mL/min |
| Alarms and System Surveillance | |
| High pressure alarm | Yes, at 400 mmHg |
| Alarm if pump stops due to pressure limit | Yes |
| Alarm if pressure ramps too quickly | Yes |
| System response to alarm condition | Stop pump, close diversion valve (revert to recirculate), stop heat |
| Battery Operation | |
| Battery running time | 30 minutes @ 50 mL/min |
| Regulatory & Safety Compliance | |
| Electrical Safety | Meets ANSI/AAMI ES60601-1:2005/A1:2012 (Current FDA recognized version of standard), with all applicable predetermined acceptance criteria met. |
| Electromagnetic Compatibility | Meets IEC 60601-1-2:2020 (Current FDA recognized version of standard), with all applicable predetermined acceptance criteria met. |
| Ingress protection | Overall device is IPX2; IPX6 where the power cord is connected to the device per IEC 60529 (Higher ingress protection where the power cord is connected to the device), with all applicable predetermined acceptance criteria met. |
| Biocompatibility including Hemocompatibility | Meets ISO 10993-1:2018 (Current FDA recognized version of standard and FDA Guidance document regarding use of ISO 10993-1), with all applicable predetermined acceptance criteria met. Biocompatibility conducted on current disposable set. Testing demonstrates an appropriate biocompatibility profile for the device. |
| Software Validation | Conforms with IEC 62304 and FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Software considered "moderate" level of concern). |
2. Sample size used for the test set and the data provenance:
Not applicable/Provided. The document describes "Non-clinical performance testing" and "Bench / Performance Testing" but does not specify sample sizes for these tests in terms of patient data or clinical cases. The tests are focused on device specifications and regulatory compliance rather than statistical performance on a clinical dataset. The nature of the device (infusion pump) typically relies on engineering and laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Provided. This type of information is typically relevant for AI/ML devices where human experts establish ground truth for diagnostic or prognostic tasks. For an infusion pump, "ground truth" is established by instrument calibration and physical measurement standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Provided. This is specific to human-read diagnostic tasks.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This device is an infusion pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/relevant for this type of medical device functionality. The concept of "standalone performance" is typically applied to AI/ML algorithms performing diagnostic or analytical tasks. This device is a mechanical-electronic system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For performance parameters like flow rate, temperature, pressure, etc., the "ground truth" is established by precise physical measurements using calibrated equipment and reference standards in a laboratory setting. For safety and regulatory compliance (e.g., electrical safety, EMC, biocompatibility), the ground truth is adherence to the specified international standards.
8. The sample size for the training set:
Not applicable/Provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable/Provided, as there is no training set for this type of device.
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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.
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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)
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| Date: | December 17, 2024 | |
|---|---|---|
| Company: | Belmont Medical Technologies780 Boston RoadBillerica, MA 01821 | |
| Official Contact: | Lida ReedDirector Quality Assurance and Regulatory AffairsPhone: 978.696.9245Email: Ireed@belmontmedtech.com | |
| Proprietary or Trade Name: | Belmont® Rapid Infuser, RI-2 | |
| Common/Usual Name: | Infusion Pump | |
| Classification Name: | 21 CFR 880.5725, Class IIClassification Product Code: FRNSubsequent Product Code: LGZ | |
| Predicate Device: | K141654: The Belmont Rapid InfuserThis 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® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
|---|---|---|---|
| 1.0 General: | |||
| • Common/Classification | Infusion Pump/Pump, InfusionWarmer Thermal InfusionFluid Warmer | Infusion Pump/Pump, InfusionWarmer ThermalInfusion Fluid Warmer | SAME |
| • Regulation Number | 21 CFR 880.5725FRN | 21 CFR 880.5725FRN | 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® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| • 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. | SIMILARThe 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® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| • 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® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| • Alternate fluid path | Yes, recirculate mode,controlled by diversionvalve, routes fluid back tosystem reservoir to purgeany air in the main fluidcircuit back into thereservoir to be vented. | Yes, recirculate mode,controlled by diversionvalve, routes fluid backto system reservoir topurge any air in the mainfluid circuit back into thereservoir to be vented. | SAME |
| 3.0 Warming Characteristics: | |||
| • Steady state fluidoutput temperature | 37.5°C at high flow, 60mL/min and higher; and39°C at low flow, lessthan 60 mL/min (Highertemperature at low flowto compensate forcooling in patient line.) | 37.5°C at high flow, 60mL/min and higher; and39°C at low flow, lessthan 60 mL/min (Highertemperature at low flowto compensate forcooling in patient line.) | SAME |
| • High temperaturealarm condition(Infusate OverTemp) | Output temperature>42°C for 20 mL of fluidpumped or fluidtemperature >45°C for0.25 seconds. | Output temperature>42°C for 20 mL of fluidpumped or fluidtemperature >45°C for0.25 seconds. | SAME |
| • Maximum speed forsteady state 37°C | 1000 mL/min | 1000 mL/min | SAME |
| • Measure anddisplay outputtemperature ofinfusate | Yes | Yes | SAME |
| • Heat exchangertype | Inductively heatedstainless steel annularrings | Inductively heatedstainless steel annularrings | SAME |
| • Method oftemperature control | Measure input andoutput temperaturesfrom the temperaturesensors, computerequired power to theheat exchanger tomaintain the targetedtemperature. Redundantcheck using flow rate,input power, inputtemperature. | Measure input andoutput temperaturesfrom the temperaturesensors, computerequired power to theheat exchanger tomaintain the targetedtemperature. Redundantcheck using flow rate,input power, inputtemperature. | SAME |
| 4.0 Alarms and System Surveillance: | |||
| 510(k) Summary Summary-6 | |||
| Element of Comparison | Predicate Device:Belmont® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| Air detection | |||
| • Air detection atinput to machine todetect emptyreservoir | Yes | Yes | SAME |
| • Redundant in-lineair bubble detectionnear output | Yes | Yes | SAME |
| • Method to eliminateair from system,without disassembly | Yes | Yes | SAME |
| • Type of Air Bubbledetector | Ultrasonic | Ultrasonic | SAME |
| • Automatic AirElimination whilepumping | Yes, via "recirculation"mode | Yes, via "recirculation"mode | SAME |
| Element of Comparison | Predicate Device:Belmont® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| Line Pressuremonitoring | |||
| • Monitor & Displayline pressure | Yes | Yes | SAME |
| • Pressure limit | 300 mmHg, standard.User can adjust duringsetup. | 300 mmHg, standard.User can adjust duringsetup. | SAME |
| • Automatic flow ratecontrol of pump tomaintain linepressure belowpressure limit | Yes | Yes | SAME |
| • Message toOperator when flowrate is pressurelimited | Yes | Yes | SAME |
| • Alarm at highpressure | Yes, at 400 mmHg | Yes, at 400 mmHg | SAME |
| • Alarm if pump stopsdue to pressure limit | Yes | Yes | SAME |
| • Alarm if pressureramps too quickly | Yes | Yes | SAME |
| • Time to occlusionalarm | Immediate | Immediate | SAME |
| TemperatureMonitoring | |||
| • High temperaturealarm: stoppumping, heating,display message | Yes | Yes | SAME |
| • Display true outputfluid temperature | Yes | Yes | SAME |
| 510(k) Summary | Summary-8 | ||
| Element of Comparison | Predicate Device:Belmont® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| System failuresurveillance | |||
| • Set-up problemalarms | System door open, heatexchanger not in place | System door open, heatexchanger not in place | SAME |
| • Automatic systemcheck of Airdetectors | At beginning of each set-up | At beginning of each set-up | SAME |
| • Fluid out alarm | Yes | Yes | SAME |
| • Missing disposablealarm | Yes | Yes | SAME |
| • Low Battery alarm | Yes | Yes | SAME |
| • Monitor pumpspeed duringoperation ("PumpFault" alarm) | Yes, via digital encoderon shaft of pump motor | Yes, via digital encoderon shaft of pump motor | SAME |
| • Recirc/Infuse Valvefailure alarm | Yes | Yes | SAME |
| • Hardware SenseComputer Failureand Stop Pump andHeat | Yes | Yes | SAME |
| • System response toalarm condition forpressure over limit,air detected, pumpfault, system setupproblem. | Stop pump, closediversion valve (revert torecirculate), stop heat | Stop pump, closediversion valve (revert torecirculate), stop heat | SAME |
| • Audible Alarm withmessage at eachcondition | Yes | Yes | SAME |
| • Operator cansilence alarm tone,as alarm is serviced | Yes | Yes | SAME |
| 510(k) Summary | |||
| Element of Comparison | Predicate Device:Belmont® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| 5.0 Operator Interface: | |||
| Parameters monitored anddisplayed continuously. | Flow Rate, VolumeInfused, Outputtemperature, LinePressure. | Flow Rate, VolumeInfused, Outputtemperature, LinePressure. | SAME |
| Fluid infusion rate control atfront panel with digitalreadout. | Yes | Yes | SAME |
| Fixed volume infusion(bolus) with monitor of bolusvolume. | Yes, bolus volume canbe set between 100 to1000 mL and can bechanged to intermediatevalues of 200, 400 and500 by pressing theBOLUS button, or in thesystemservice/calibrationroutine. | Yes, bolus volume canbe set between 100 to1000 mL and can bechanged to intermediatevalues of 200, 400 and500 by pressing theBOLUS button, or in thesystemservice/calibrationroutine. | SAME |
| Operating modes | Load disposablePrime (Automatic)Patient Line PrimeInfuseBolus InfuseRecirculate | Load disposablePrime (Automatic)Patient Line PrimeInfuseBolus InfuseRecirculate | SAME |
| Readout | High contrast displayusing anelectroluminescentdisplay with extremelywide viewing angle | High contrast displayusing anelectroluminescentdisplay with extremelywide viewing angle | SAME |
| Languages selectable fromfront panel | Multiple languageselection available | Multiple languageselection 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® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| Ingress protection | IPX2 per IEC 60529 asrequired by IEC 60601-1 | Overall device is IPX2with IPX6 where thepower cord is connectedto the device per IEC60529 as required byIEC 60601-1 | SIMILARSubject deviceconfirmed to have higheringress protection wherethe power cord isconnected to the device,with all applicablepredeterminedacceptance 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 batterymode | No warming in batterymode | SAME |
| Battery running time | 30 minutes @ 50 mL/min | 30 minutes @ 50mL/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. (12kg) | 13.5" x 7.5" x 12"(34 cm x 19 cm x 31 cm)weight: app. 26 lb. (12kg) | SAME |
| Electrical Safety | Meets UL 60601-1, EN60601-1 (2005, 3rdedition), CAN/CSA C22.2No. 60601.1 (2008) | Meets ANSI/AAMIES60601-1:2005/A1:2012 | SIMILARSubject deviceconfirmed to comply withcurrent FDA recognizedversion of standard, withall applicablepredeterminedacceptance criteria met. |
| ElectromagneticCompatibility | Meets EN 60601-1-2(2007) and IEC 60601-1-2 (2007) | Meets IEC 60601-1-2:2020 | SIMILARSubject deviceconfirmed to comply withcurrent FDA recognizedversion of standard, withall applicablepredeterminedacceptance criteria met. |
| Power Consumption | 1440 watts | 1440 watts | SAME |
| Element of Comparison | Predicate Device:Belmont® RapidInfuser, RI-2[510(k) K141654] | Subject Device:Modified Belmont®Rapid Infuser, RI-2 | SubstantialEquivalence |
| Sterile Fluid Path | Preconnected systemwith sterile, non-pyrogenic fluid path. | Preconnected systemwith sterile, non-pyrogenic fluid path. | SAME |
| Sterilization | Ethylene Oxide | Ethylene Oxide | SAME |
| Biocompatibility includingHemocompatibility | Meets ISO 10993-1:1994(Note: Data submittedwith 510(k) K972284) | Meets ISO 10993-1:2018Biocompatibilityincludinghemocompatibilityconducted on currentdisposable set with allpredetermined | SIMILARSubject deviceconfirmed to comply withcurrent FDA recognizedversion of standard andFDA Guidancedocument regarding useof ISO 10993-1 with all |
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510(k) Summary
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510(k) Summary
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510(k) Summary
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510(k) Summary
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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
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- . 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.
§ 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).