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510(k) Data Aggregation
(26 days)
BELMONT INSTRUMENT CORPORATION
The intended use of the Belmont® Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.
The Belmont® Hyperthermia Pump combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid perfusion of warmed fluid. It can raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.
The system monitors fluid temperature, patient 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 pumped, output fluid temperature, target temperature, patient 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® Hyperthermia Pump, as described in the provided document, is a medical device for raising the temperature of the thoracic or peritoneal cavity by continuously lavaging with warmed sterile solution. The information relevant to acceptance criteria and the study is outlined below.
No AI/Algorithm-specific information is available in the provided document. The document describes a traditional medical device (Hyperthermia Pump) and its 510(k) submission, which focuses on hardware and software updates to an existing device, and non-clinical performance testing. Therefore, sections pertaining to AI/Algorithm performance (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size for training set, etc.) are not applicable in this context and cannot be extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Belmont® Hyperthermia Pump are derived from its functional specifications and safety requirements. The document describes nonclinical tests performed to verify these aspects.
| Acceptance Criterion (Test Objective) | Reported Device Performance (Result) |
|---|---|
| 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). | Performed within specifications. |
| Warming Capability: Ability to warm cold fluids to the user-set temperature over the full range of flow rate and operating conditions. | Performed within specifications. |
| Safety Alarms & Detection: 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). | Performed within specifications. |
| Risk Mitigation: Verification and validation tests to ensure risks were mitigated and control methods implemented correctly. | Performed within specifications. (Implicitly, as the conclusion states performance within specifications). |
| Algorithm Validation (Software): Validation for each function element in the software specification, and extensive system testing with software. | Performed within specifications. (Implicitly, as the conclusion states performance within specifications). |
| Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance. | Performed within specifications. |
| Medical Electrical Equipment - Electromagnetic Compatibility: Collateral Standard. | Performed within specifications. |
Study Demonstrating Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of nonclinical verification and validation tests. These tests were carried out to ensure that the updated hardware (chip replacement) and software, along with a brighter monochromatic display, maintained or improved performance and safety compared to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document describes nonclinical laboratory testing of the device itself.
- Sample Size for Test Set: Not explicitly stated as "sample size" in the context of patient data. For medical devices undergoing nonclinical testing, the "test set" would refer to the number of devices or test conditions used. This information is not explicitly quantified (e.g., "tested 5 devices across X conditions").
- Data Provenance: The tests are nonclinical, conducted as part of the device manufacturer's verification and validation process. Therefore, data provenance is internal laboratory testing. It is not patient data from a specific country, nor is it retrospective or prospective in the clinical trial sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for device performance in nonclinical testing is established by engineering specifications, regulatory standards, and objective measurements using calibrated instruments. It does not involve expert human interpretation in the way that image analysis algorithms require ground truth from clinicians.
4. Adjudication Method for the Test Set
Not applicable. As this is nonclinical device performance testing, adjudication methods typically used for human interpretation or clinical trials (e.g., 2+1, 3+1) are not relevant. Performance is measured against predefined engineering specifications and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is a type of clinical study typically used for diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images) to assess the impact of an AI algorithm on reader performance. This documentation pertains to a hyperthermia pump, a therapeutic device, and its nonclinical performance, so an MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Belmont® Hyperthermia Pump is a physical medical device with integrated software and hardware for controlling fluid warming and flow. It is not an "algorithm" in the sense of a standalone diagnostic or predictive model. Its performance is measured as a completely integrated system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the nonclinical tests is based on:
- Engineering Specifications: Predefined performance parameters for flow rate, temperature accuracy, alarm thresholds, etc.
- Regulatory Standards: Compliance with industry standards like "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance" and "Medical Electrical Equipment - Electromagnetic Compatibility."
- Objective Measurement: Using calibrated instruments to measure flow rates, temperatures, pressures, and verify alarm functions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning algorithm that requires a "training set" of data. The device's operation is based on deterministic control logic and fixed algorithms programmed into its microprocessor, developed through engineering design rather than data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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(28 days)
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.
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.
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.
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