(14 days)
Intended Use of the Jus 2000 (Unchanged by the modification):
Infusion of crystalloid, colloid, or blood product, including packed red 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 purposes.
Intended Use of the reservoir (Unchanged by the modification):
The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.
The Belmont 7MS2000is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 -500 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 500 ml/min. The reservoir is used to increase the fluid supply capacity of the Belmont instrument 7MS2000 3-Spike disposable Set.
The Belmont Fluid Management System (7MS2000) 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 Belmont SMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 500 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.
The new reservoir, our own design, will be used instead of Gish Biomedical Inc. reservoir. The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.
This document is a 510(k) premarket notification for a medical device – specifically a "Large Volume Fluid Reservoir" to be used with the Belmont Fluid Management System (FMS2000). The purpose of this notification is to demonstrate that the new reservoir is "substantially equivalent" to an already legally marketed predicate device.
The provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets them because:
- It's a "substantial equivalence" claim, not a performance study: A 510(k) primarily aims to show that a new device is as safe and effective as a predicate device, not necessarily to set and meet specific, quantitative performance acceptance criteria in the way a novel device might.
- The "study" cited is for nonclinical tests: The document mentions "nonclinical tests" (section 12) rather than a formal clinical study with human subjects, which is often what "acceptance criteria" relate to in terms of performance metrics.
Therefore, many of the requested details are not present. However, I can extract what is available.
Here's a breakdown of the information that can be extracted, and where the requested information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| a. Ability to warm cold fluids to physiological temperature over the full range of flow rate and operating conditions. | The system warms blood, replacement IV fluids, or irrigation fluids to physiological temperature at user-set rates from 10 to 500 ml/min. (This is a statement of function, the specific physiological temperature value or acceptable range isn't given as an explicit acceptance criterion). |
| b. Ability to detect and alarm at unsafe or ineffective operating conditions, including operator errors, sensor failure, system software/computer failure, and other internal system malfunctions. | 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. (Again, a statement of function, not specific detection/alarm thresholds or success rates as acceptance criteria). |
| c. Ability of the new reservoir not to damage blood. | The system was tested for hemocompatibility by testing for red cell hemolysis and red cell fragility. The system was found to have negligible effect on anticoagulated blood. Hemolysis assessment was done using 'Sigma Diagnostics, Plasma Hemoglobin' Procedure No. 527. (This is the most specific performance result, though the acceptance threshold for "negligible effect" isn't quantified). |
Study Information Based on Provided Text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The tests are "nonclinical" and likely involved lab samples of fluids or blood, not human subjects.
- Data Provenance: Not specified, but given it's a submission to the FDA from a US company (Belmont Instrument Corporation, Billerica, Massachusetts), it's highly probable the testing was conducted in the USA.
- Retrospective/Prospective: Not applicable, as these are nonclinical laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This was a nonclinical engineering and biochemical performance test, not one requiring expert human interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 is not an AI/diagnostic imaging device, and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not an algorithm-based device in the AI sense. The "standalone" performance refers to the device's functional tests (warming, alarming, blood compatibility).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the nonclinical tests:
- Temperature warming: Likely instrumental measurements against known physiological temperature ranges.
- Alarm detection: Engineering validation using simulated unsafe conditions or induced failures.
- Blood damage: Laboratory testing for hemolysis and fragility, using established biochemical assays (e.g., 'Sigma Diagnostics, Plasma Hemoglobin' Procedure No. 527).
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device and Study:
The Belmont Large Volume Fluid Reservoir is an accessory for the Belmont Fluid Management System (FMS2000). The FMS2000 is an infusion pump with a warmer, designed for rapid infusion of warmed fluids (blood, IV fluids, irrigation fluids). The "study" described are nonclinical tests focused on three main areas:
- Fluid Warming: Ensuring the system can warm cold fluids to physiological temperatures across its operational range.
- Safety Monitoring & Alarms: Verifying the system's ability to detect and alarm for unsafe conditions, including operator errors, sensor malfunctions, and internal system failures.
- Blood Compatibility: Assessing the new reservoir's impact on blood, specifically testing for red cell hemolysis and fragility.
The key outcome of these nonclinical tests, particularly for blood compatibility, was that the system had a "negligible effect on anticoagulated blood" as assessed by a specific diagnostic procedure. The overall conclusion of the submission is that the new reservoir is "substantially equivalent" to a previously approved reservoir.
§ 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).