(28 days)
The MEDRAD Continuum MR Compatible Infusion System (3T Proximity) is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
The Medrad Continuum Infusion System maintains the same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device. A label will be affixed to the system stating that when using the Continuum Infusion System in the MR environment it's casters brakes should be on and the system should not be placed in a static magnetic field exceeding 2000 gauss. The user's manual has also been updated to include this warning. The Continuum MR Compatible Infusion System (3.0T) is comprised of the same components as the predicate device.
The provided text describes a 510(k) premarket notification for an infusion pump, the MEDRAD Continuum MR Compatible Infusion System (3T Proximity). This submission aims to demonstrate substantial equivalence to a predicate device, the MEDRAD Continuum MR Compatible Infusion System - 1.5T. The information primarily focuses on comparing the new device to its predicate, rather than providing detailed acceptance criteria and study results for a novel device.
The study presented is not a typical clinical trial to assess diagnostic or treatment effectiveness, but rather a benchmarking comparison and safety assessment to demonstrate that the new device (3T Proximity) performs equivalently to an existing, legally marketed predicate device (1.5T). The goal is to show that the minor modifications, particularly its compatibility with a 3.0T MR environment, do not introduce new safety or effectiveness concerns while maintaining the same performance characteristics.
Here's an analysis based on the provided text, addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for the new device is substantial equivalence to the predicate device. This means the new device must have the "same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device."
The "reported device performance" is a direct comparison of parameters between the new device (MEDRAD Continuum MR Compatible Infusion System - 3.0T) and the predicate device (MEDRAD Continuum MR Compatible Infusion System - 1.5T). The key finding is that all listed performance parameters are "Same" between the two devices, except for the explicit mention of MRI compatibility up to "2000 gauss" for the new device, whereas the predicate was simply "Yes".
| Parameter (Acceptance Criteria: Must be "Same" as Predicate unless otherwise specified) | Predicate Device (1.5T) Performance | New Device (3.0T Proximity) Performance | Meets Acceptance Criteria? |
|---|---|---|---|
| Classification | Type CF | Same | Yes (Implicitly) |
| Compatible IV Administration Set | Standard PVC Single Use Y-Site Set Free Flow Protection | Same | Yes (Implicitly) |
| Flow Rate | Continuous: 1 to 99.9 ml/h in 0.1 ml/h increments, 100 to 1200 ml/h in 1 ml/h increments | Same | Yes (Implicitly) |
| Total Infused Volume | Continuous: 1 to 9,999 ml | Same | Yes (Implicitly) |
| Housing | ABS | Same | Yes (Implicitly) |
| Microprocessor Controlled | Yes | Same | Yes (Implicitly) |
| KVO Infusion Rate | 1 to 5 ml/h | Same | Yes (Implicitly) |
| System Accuracy | +/- 10% | Same | Yes (Implicitly) |
| Occlusion Pressure | User Selectable: Low-0.3 bar (5 psi) Medium-0.5 bar (7.5 psi) High-0.7 bar (10 psi) | Same | Yes (Implicitly) |
| Battery | Li-Ion Rechargeable | Same | Yes (Implicitly) |
| Battery Operation | 4 hr @ 1200 ml/h | Same | Yes (Implicitly) |
| Battery Charging | ~6 hr to 95% maximum battery capacity | Same | Yes (Implicitly) |
| Air-In-Line Detector | User Selectable | Same | Yes (Implicitly) |
| Total Time Setting | 100 hours | Same | Yes (Implicitly) |
| Air Sensor | Ultrasonic | Same | Yes (Implicitly) |
| Prime Rate | 1600 to 1800 ml/h | Same | Yes (Implicitly) |
| Bolus Rate | 0.1 to 1200 ml/h | Same | Yes (Implicitly) |
| Bolus Volume | 0.1 to 100 ml | Same | Yes (Implicitly) |
| Alarm Conditions (All sub-points) | Yes (for each: Air-In-Line, Down Occlusion, Pump Unattended, Low Battery, End Battery, Fatal Error, End Program, Missing Key, Lock Mode) | Yes (for each) | Yes (Implicitly) |
| Program Modes (All sub-points) | Yes (for each: Continuous, Dose, Non-Weight Dose) | Yes (for each) | Yes (Implicitly) |
| Integrated Mounting Clamp for IV Pole | Yes | Same | Yes (Implicitly) |
| Built in Free Flow Protection | Yes | Same | Yes (Implicitly) |
| Automatic Bolus Function (Safety Feature) | Yes | Same | Yes (Implicitly) |
| User Selectable Alarm Volume | Yes | Same | Yes (Implicitly) |
| Comprehensive Safety Features | Yes | Same | Yes (Implicitly) |
| Low Battery | Yes | Same | Yes (Implicitly) |
| MRI Compatible | Yes | Yes (up to 2000 gauss) | Yes (Explicitly extended compatibility) |
Note: The primary "study" proving acceptance is the detailed comparison table that asserts the physical and functional identity of the new device with the predicate, with the added MR compatibility for 3.0T environments (up to 2000 gauss static magnetic field) being the key difference and point of assessment.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of human clinical data. This is a technical comparison for substantial equivalence. The "test set" would refer to the new device itself (MEDRAD Continuum MR Compatible Infusion System - 3.0T), which was designed and tested against the specifications of the predicate.
- Data Provenance: The data provenance is from the manufacturer's (MEDRAD, Inc.) engineering and testing documentation, comparing the design and performance specifications of their existing 1.5T compatible device with the proposed new 3.0T compatible device. This is inherently prospective in the sense of designing and testing the new device to meet predicate performance, but the comparison is based on retrospective knowledge of the predicate's performance. The country of origin of the data is implicitly the USA, as MEDRAD, Inc. is located in Pennsylvania.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of submission. "Ground truth" in this context is established by the engineering specifications and performance characteristics of the predicate device, which have already been deemed safe and effective by the FDA. The submission relies on the manufacturer's internal engineering and quality assurance processes to confirm the new device meets these established specifications and the new MRI compatibility requirements. There are no "experts" establishing a clinical ground truth for a test set in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable. There is no multi-reader adjudication process described, as it's not a clinical diagnostic performance study. The adjudication is essentially the FDA's review determining if the provided technical comparison demonstrates substantial equivalence to the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC study was done. This is not an AI-enabled device or a diagnostic imaging device requiring human reader interpretation. It is an infusion pump.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, in a conceptual sense. The "study" here is the technical comparison and engineering validation of the device itself (the "algorithm only" being the device's operational design and components). The device functions somewhat autonomously according to its programming (flow rate, alarms, etc.), but it requires human users (trained medical staff) for setup and monitoring. The "performance" is based on its ability to meet the established operational parameters, not on human-in-the-loop diagnostic accuracy.
7. The Type of Ground Truth Used
The ground truth used is the engineering specifications and established performance characteristics of the legally marketed predicate device (MEDRAD Continuum MR Compatible Infusion System - 1.5T), combined with new safety testing to confirm compatibility with the higher magnetic field environment (3.0T). The implicit ground truth is that if the new device performs identically to a predicate already cleared for market, and addresses the new environmental concerns, it is also safe and effective.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The device is hardware-based with embedded software, and its design principles are based on established medical device engineering.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device.
§ 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).