(28 days)
Not Found
No
The description focuses on microprocessor control, safety monitoring, and mechanical systems, with no mention of AI or ML algorithms.
Yes
The device is described as an "Infuser" for "volume replacement" and "rewarming patients," indicating direct medical intervention for treatment purposes.
No.
The device is designed for the rapid infusion of warmed fluids (crystalloids, colloids, blood products) for volume replacement, rewarming, or irrigation. It monitors temperature, line pressure, and air, but these are for safe operation of the infusion, not for diagnosing a medical condition. Its function is therapeutic/supportive rather than diagnostic.
No
The device description explicitly details a mechanical system, hardware components (pump, heater, sensors, touch screen), and battery backup, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device's function as infusing fluids (crystalloid, colloid, blood products, irrigation fluids) into a patient for volume replacement, rewarming, or irrigation. This is a direct therapeutic or procedural intervention on the patient's body.
- Device Description: The description focuses on the mechanical and electronic aspects of pumping and warming fluids, monitoring pressure and air, and displaying information. It does not mention any analysis of biological samples or substances outside of the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's condition
- Using reagents or test kits
The device is designed to deliver fluids to the patient, not to analyze samples from the patient. Therefore, it falls under the category of a therapeutic or procedural medical device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRN, LGZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
high blood loss surgical procedures, trauma
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/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.
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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 Corporation
780 Boston Road
Billerica, MA 01821 |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Uraiwan P. Labadini
Quality Assurance/Regulatory Affairs Manager
(508) 663-0212 Ext. 128
Telephone:
(508) 663-0214
Fax:
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 880.5725
Warmer, Thermal, Infusion Fluid |
| Legally Marketed Device Under
Which Substantial Equivalence is
Claimed: | The Belmont® Rapid Infuser cleared for market
entry originally under 510(k) K972284,
18 modification cleared under 510(k) K032674, and
200 modification cleared under 510(k) K091855. |
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
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.
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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'