Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)

{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<br>780 Boston Road<br>Billerica, MA 01821 | | | Official Contact: | Lida Reed<br>Director Quality Assurance and Regulatory Affairs<br>Phone: 978.696.9245<br>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<br>Classification Product Code: FRN<br>Subsequent Product Code: LGZ | | | Predicate Device: | K141654: The Belmont Rapid Infuser<br>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:<br>Belmont® Rapid<br>Infuser, RI-2<br>[510(k) K141654] | Subject Device:<br>Modified Belmont®<br>Rapid Infuser, RI-2 | Substantial<br>Equivalence | |------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1.0 General: | | | | | • Common/<br>Classification | Infusion Pump/<br>Pump, Infusion<br>Warmer Thermal Infusion<br>Fluid Warmer | Infusion Pump/<br>Pump, Infusion<br>Warmer Thermal<br>Infusion Fluid Warmer | SAME | | • Regulation Number | 21 CFR 880.5725<br>FRN | 21 CFR 880.5725<br>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:<br>Belmont® Rapid<br>Infuser, RI-2<br>[510(k) K141654] | Subject Device:<br>Modified Belmont®<br>Rapid Infuser, RI-2 | Substantial<br>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,<br>• Infusion of warmed fluid to rewarm patients after surgery or for hyperthermia, and<br>• 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.<br>• 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,<br>• Infusion of warmed fluid to rewarm patients after surgery or for hyperthermia, and<br>• Infusion of warmed fluid for irrigation in urology procedures.<br>The 3.0L reservoir is an optional accessory for use in adults only. | SIMILAR<br>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:<br>Belmont® Rapid<br>Infuser, RI-2<br>[510(k) K141654] | Subject Device:<br>Modified Belmont®<br>Rapid Infuser, RI-2 | Substantial<br>Equivalence | | • Flow rate accuracy | ± 10% from 20 – 1000 mL/min<br>± 25% for 2.5, 5.0, 10 mL/min | ± 10% from 20 – 1000 mL/min<br>± 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.<br>Can be changed by the Operator to 100 or up to 300 mmHg, in 50 mmHg increments. | 300 mmHg standard.<br>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:<br>Belmont® Rapid<br>Infuser, RI-2<br>[510(k) K141654] | Subject Device:<br>Modified Belmont®<br>Rapid Infuser, RI-2 | Substantial<br>Equivalence | | • Alternate fluid path | Yes, recirculate mode,<br>controlled by diversion<br>valve, routes fluid back to<br>system reservoir to purge<br>any air in the main fluid<br>circuit back into the<br>reservoir to be vented. | Yes, recirculate mode,<br>controlled by diversion<br>valve, routes fluid back<br>to system reservoir to<br>purge any air in the main<br>fluid circuit back into the<br>reservoir to be vented. | SAME | | 3.0 Warming Characteristics: | | | | | • Steady state fluid<br>output temperature | 37.5°C at high flow, 60<br>mL/min and higher; and<br>39°C at low flow, less<br>than 60 mL/min (Higher<br>temperature at low flow<br>to compensate for<br>cooling in patient line.) | 37.5°C at high flow, 60<br>mL/min and higher; and<br>39°C at low flow, less<br>than 60 mL/min (Higher<br>temperature at low flow<br>to compensate for<br>cooling in patient line.) | SAME | | • High temperature<br>alarm condition<br>(Infusate Over<br>Temp) | Output temperature<br>>42°C for 20 mL of fluid<br>pumped or fluid<br>temperature >45°C for<br>0.25 seconds. | Output temperature<br>>42°C for 20 mL of fluid<br>pumped or fluid<br>temperature >45°C for<br>0.25 seconds. | SAME | | • Maximum speed for<br>steady state 37°C | 1000 mL/min | 1000 mL/min | SAME | | • Measure and<br>display output<br>temperature of<br>infusate | Yes | Yes | SAME | | • Heat exchanger<br>type | Inductively heated<br>stainless steel annular<br>rings | Inductively heated<br>stainless steel annular<br>rings | SAME | | • Method of<br>temperature control | Measure input and<br>output temperatures<br>from the temperature<br>sensors, compute<br>required power to the<br>heat exchanger to<br>maintain the targeted<br>temperature. Redundant<br>check using flow rate,<br>input power, input<br>temperature. | Measure input and<br>output temperatures<br>from the temperature<br>sensors, compute<br>required power to the<br>heat exchanger to<br>maintain the targeted<br>temperature. Redundant<br>check using flow rate,<br>input power, input<br>temperature. | SAME | | 4.0 Alarms and System Surveillance: | | | | | 510(k) Summary Summary-6 | | | | | Element of Comparison | Predicate Device:<br>Belmont® Rapid<br>Infuser, RI-2<br>[510(k) K141654] | Subject Device:<br>Modified Belmont®<br>Rapid Infuser, RI-2 | Substantial<br>Equivalence | | Air detection | | | | | • Air detection at<br>input to machine to<br>detect empty<br>reservoir | Yes | Yes | SAME | | • Redundant in-line<br>air bubble detection<br>near output | Yes | Yes | SAME | | • Method to eliminate<br>air from system,<br>without disassembly | Yes | Yes | SAME | | • Type of Air Bubble<br>detector | Ultrasonic | Ultrasonic | SAME | | • Automatic Air<br>Elimination while<br>pumping | Yes, via "recirculation"<br>mode | Yes, via "recirculation"<br>mode | SAME | | Element of Comparison | Predicate Device:<br>Belmont® Rapid<br>Infuser, RI-2<br>[510(k) K141654] | Subject Device:<br>Modified Belmont®<br>Rapid Infuser, RI-2 | Substantial<br>Equivalence | | Line Pressure<br>monitoring | | | | | • Monitor & Display<br>line pressure | Yes | Yes | SAME | | • Pressure limit | 300 mmHg, standard.<br>User can adjust during<br>setup. | 300 mmHg, standard.<br>User can adjust during<br>setup. | SAME | | • Automatic flow rate<br>control of pump to<br>maintain line<br>pressure below<br>pressure limit | Yes | Yes | SAME | | • Message to<br>Operator when flow<br>rate is pressure<br>limited | Yes | Yes…