THE BELMONT RAPID INFUSER by BELMONT INSTRUMENT CORPORATION

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.

Device Description

The Belmont® Rapid Infuser, RI2, (same as the existing Rapid Infuser) combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluid. . The Rapid Infuser 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). A low infusion rate at 2.5 ml/min (150 ml/hr) is also available without heating. The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation. A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Belmont® Rapid Infuser, RI2. It is a submission for substantial equivalence to an existing device, not a new device. Therefore, the information provided focuses on demonstrating that the modified device performs as well as the predicate device.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner as might be expected for an AI/software-as-a-medical-device (SaMD) submission. Instead, it details a series of non-clinical tests performed to verify that the modified device (RI2) meets the specifications of the predicate device. The performance is described qualitatively as "performed within specifications."

Acceptance Criteria (Inferred from Test Descriptions)	Reported Device Performance
a. Pumping Accuracy: Ability to pump fluids accurately over the full range of flow rate and operating conditions (different input fluid temperatures, back pressure, ambient temperature, fluid viscosity for crystalloid and packed red blood cells).	"The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests."
b. Fluid Warming Performance: Ability to warm cold fluids to physiological temperature over the full range of flow rate and operating conditions.	"The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests."
c. Safety Detection and Alarm: Ability to detect and alarm at unsafe or ineffective operating conditions (over-temperature, unsafe high line pressure, out of fluid, air in the line, internal fault conditions).	"The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests."
d. Risk Assessment & Mitigation (Keypad): Verification and validation to ensure risks related to the keypad (key stick, bounce/failure, operator error, unintentional activation, fluid spillage) are mitigated and controls implemented correctly.	"We performed the verification and validation tests to ensure that these risks were mitigated and method of controls were implemented correctly." (Implied performance is successful mitigation).
e. Software Validation: Software life cycle in accordance with IEC 62304; validation of each algorithm for each function element; extensive system testing with software to ensure hardware and software functions meet all system requirements.	"We validated each algorithm for each function element in the software specification using an approved procedure. We also performed extensive testing for the entire system with software in place to test both the hardware and software functions to ensure that all system requirements are met." (Implied performance is successful validation and meeting requirements).
f. Medical Electrical Equipment Standard (Basic Safety & Essential Performance): Compliance with IEC 60601-1.	"The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests."
g. Electromagnetic Compatibility Standard: Compliance with relevant collateral standard.	"The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a "sample size" in terms of how many devices were tested or how many data points were collected during each test. It refers to testing the system "over the full range of flow rate and operating conditions."
Data Provenance: Not applicable in the context of device performance testing. The tests are for device functional performance, not clinical data analysis. The testing appears to have been conducted by the manufacturer, Belmont Instrument Corporation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This is a hardware and software performance verification, not a diagnostic or AI-driven medical imaging device that requires expert ground truth for interpretation. The "ground truth" here is the defined functional specifications of the device.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous data requiring adjudication for this type of device performance testing. The tests are objective and based on whether the device operates according to its specifications.

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

Not applicable. This device is an infusion pump, which is a therapeutic rather than a diagnostic device, and it does not involve human "readers" or AI assistance in the interpretation of medical data. The submission is for hardware and software updates to an existing infusion pump, not a new AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

A form of standalone testing was done for the device's systems, particularly its software. The document states:

"We generated a software life cycle in according to the IEC 62304."
"We validated each algorithm for each function element in the software specification using an approved procedure."
"We also performed extensive testing for the entire system with software in place to test both the hardware and software functions to ensure that all system requirements are met."

This indicates that the software was thoroughly tested in isolation (algorithms) and within the full system, without human intervention in the primary operational functions it controls.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is its predefined engineering and performance specifications. For example, the criteria for "pumping fluids accurately" means the output flow rate must fall within a specified tolerance of the targeted flow rate under given conditions. "Warming cold fluids to physiological temperature" means achieving a specific temperature range. These are objective, measurable performance targets.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model that requires a "training set" in the conventional sense. The "software life cycle" and "algorithm validation" mentioned refer to traditional software development and testing, not AI model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI training set. The ground truth for the software and hardware validation is based on the documented design specifications and engineering requirements of the device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Belmont Instrument Corporation. The logo features a stylized letter "B" in a bold, flowing font. To the right of the "B" is the word "Belmont" in a bold, sans-serif font, and below that is the phrase "Instrument Corporation" in a smaller, sans-serif font.

was with the the one would but the restended

K141654

1 8 2014

PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [As Required By 21 CFR 807.92(c)]

Submitter Name and Address:	Belmont Instrument Corporation780 Boston RoadBillerica, MA 01821
Contact Person:	Uraiwan P. LabadiniQuality Assurance/Regulatory Affairs Manager(508) 663-0212 Ext. 128Telephone:(508) 663-0214Fax:Email address: ulabadini@belmontinstrument.com
Date Summary Prepared:	July 17, 2014
Trade/Proprietary Name of Device: The Belmont® Rapid Infuser. R12
Common Name:	Infusion Pump
Classification Name:	Infusion Pump, 21 CFR 880.5725Warmer, Thermal, Infusion Fluid
Legally Marketed Device UnderWhich Substantial Equivalence isClaimed:	The Belmont® Rapid Infuser cleared for marketentry originally under 510(k) K972284,18 modification cleared under 510(k) K032674, and200 modification cleared under 510(k) K091855.

Device Description:

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

MADE IN USA

7-1

{1}------------------------------------------------

of system computer failure. A touch screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.

A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.

The Belmont® Rapid Infuser, R12, is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 - 1000 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 1000 ml/min.

Corporation is claiming Belmont Instrument substantial equivalence of the Belmont® Rapid Infuser, RI2, to the Belmont® Rapid Infuser which was originally cleared to market under 510(k) K972284 on November 13, 1997, and to the Belmont® Rapid Infuser 750 ml/min flow rate was cleared to market under 510(k) K032674 on September 16, 2003, and to the Belmont® Rapid Infuser 1000 ml/min flow rate was cleared to market under 510(k) K091855 on July 1, 2009.

The Belmont® Rapid Infuser has been in clinical use for more than 14 years; consequently a component used in the system had become obsolete and hard to obtain. Therefore, the system hardware (chip replacement), and software (to correspond with the chip changes) have been upgraded. At the same time, we are using a brighter monochromatic display with a higher contrast LCD to improve visibility. We have performed a rigorous validation to ensure that these updates are backward compatible with our existing system and no major functions have been altered.

Intended Use:

Comparison of Technological Characteristics of the Device vs. the Legally Marketed Device:

Specific Modifications being reviewed in this submission:

{2}------------------------------------------------

Brief Discussion of Nonclinical Tests and their Results Submitted in the Application:

In order to verify performance of the Belmont® . Rapid Infuser, R12, in support of substantial equivalence, the following tests were carried out:

a. The ability of the system to pump fluids accurately over the full range of flow rate and operating conditions including different input fluid temperatures, different back pressure levels, change in ambient temperature, and changes in fluid viscosity including that of crystalloid solution and packed red blood cells.
b. The ability of the system to warm cold fluids to physiological temperature over the full range of flow rate and operating conditions.
c. The ability of the system to detect and alarm at unsafe or ineffective operating conditions including over temperature, the unsafe high line pressure condition, out of fluid, air in the line and at any of several internal fault conditions.
d. We performed risk assessment regarding the keypad, i.e., key stick, key bounce/failure, operator error by pressing the wrong key, unintentional activation of the keypad, and fluid spillage on the keypad. We performed the verification and validation tests to ensure that these risks were mitigated and method of controls were implemented correctly.
e. We generated a software life cycle in according to the IEC 62304. We validated each algorithm for each function element in the software specification using an approved procedure. We also performed extensive testing for the entire system with software in place to test both the hardware and software functions to ensure that all system requirements are met.
Medical Electrical Equipment Part 1: General ﺖ Requirements for Basic Safety and Essential Performance.
Equipment Collateral g. Medical Electrical Standard: Electromagnetic Compatibility
The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests.

{3}------------------------------------------------

. :

Conclusion:

The Belmont® Rapid Infuser, RI2, is substantially equivalent to the Belmont® Rapid Infuser which received 510(k) approval at various times. Both systems are capable of high infusion flow rates, infusate at physiological while maintaining temperature, and both systems are suitable for use with blood products. Both systems monitor flow rate, temperature, line pressure, and the presence of air at the input line or within the system, and alarm and stop the system at all unsafe conditions.

The tests demonstrate that the Belmont® Rapid Infuser, R12, is substantial equivalent and performs as well as the legally marketed device.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 18, 2014

Belmont Instrument Corporation Uraiwan Labadini Quality Assurance / Regulatory Affairs Manager 780 Boston Road Billerica, Massachusetts 01821

Re: K141654

Trade/Device Name: Belmont® Rapid Infuser, R12 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, LGZ Dated: June 18, 2014 Received: June 20, 2014

Dear Ms. Labadini:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Ms. Labadini

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.
Tejashri Purohit Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRH FOR

Erin 1. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K141654

Device Name: The Belmont® Rapid Infuser, RI2

Indications for Use:

Infusion of crystalloid, colloid, or blood product, including packed red A. blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.
B. Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
். Infusion of warmed fluid for irrigation in urology procedures.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/6/Picture/12 description: The image shows the FDA logo. The logo is made up of the letters FDA, with each letter being formed by three parallel lines. The letters are arranged in a slightly slanted fashion, with the F on the left, the D in the middle, and the A on the right.

Mary E. Brooks -A 2014.07.17 Page 1 of 1 15:27:47 -04'00'

Regulation Number and Section

§ 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).