(202 days)
The CompuFlo is intended for use in delivering medication and other fluids in a controlled manner. The CompuFlo is indicated for use in adults for the continuous or intermittent delivery of medications and other fluids through intravenous, intra-arterial, subcutaneous, epidural and enteral routes.
The CompuFlo unit consists of a motor-driven piston syringe pump with an internal pressure transducer, an external pressure transducer (Meritrans™ Disposable Pressure Transducer (K920977)), a syringe retainer, a computer processor, a liquid crystal display (LCD), and a power supply. All but the external pressure transducer are contained in a plastic cabinet. A foot pedal and power cord are also included. The unit operates with a variety of user-provided disposable supplies, including Luer Lock plastic piston syringes, plastic syringe tubing, and needles.
The CompuFlo 510(k) submission describes the device and its testing, but it does not provide specific acceptance criteria or a detailed study report in the format requested. The document is a 510(k) summary, which is a high-level overview.
Based on the provided text, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the types of performance evaluated, but does not provide specific quantitative acceptance criteria or the actual numerical results against those criteria. It only states that "the CompuFlo functioned as intended" with minor exceptions not related to performance.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Travel distance of syringe plunger | Not specified | Functioned as intended |
| Volume dispensed | Not specified | Accurately dispense a desired quantity of medication or fluid |
| Flow rates | Not specified | Functioned as intended |
| Force measurements on syringe platform | Not specified | Functioned as intended |
| Accuracy of internal pressure sensor | Not specified | Capable of calculating the pressure at the needle tip according to the equation described |
| Accuracy of external pressure sensor | Not specified | Capable of calculating the pressure at the needle tip according to the equation described |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not specified. The document mentions "test results" but does not quantify how many tests or samples were used for each performance metric.
- Data Provenance: The testing was "Machine performance of the CompuFlo was evaluated", implying it was conducted by the manufacturer or a contracted lab. Details like country of origin for the data are not provided, nor whether it was retrospective or prospective (though device performance testing is typically prospective).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. This device's performance evaluation focuses on machine operation and physical measurements (e.g., volume, pressure, flow) rather than human interpretation of data where expert consensus for ground truth would be needed.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. As the testing involved machine performance metrics and physical measurements, there would be no need for an adjudication method by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is relevant for diagnostic or interpretive devices where human readers are making assessments. The CompuFlo is an infusion pump, and its performance is evaluated based on its mechanical and electronic accuracy in delivering fluids and measuring pressure.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: Yes, in essence. The "Machine performance of the CompuFlo was evaluated" directly refers to the device's inherent functional performance without human intervention during the dispensing process. The entire "Performance Data" section describes this standalone testing. The device's ability to "accurately dispense a desired quantity of medication or fluid" and its "capability of calculating the pressure at the needle tip" are direct measures of its standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: Physical measurements and engineering specifications. For example, for "volume dispensed," the ground truth would be the known, expected volume based on the pump's settings and calibrated measurement equipment. For "pressure sensors," the ground truth would be the actual pressure applied as measured by a highly accurate reference instrument.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. The CompuFlo is described as a "motor-driven piston syringe pump with an internal pressure transducer, an external pressure transducer, a syringe retainer, a computer processor, a liquid crystal display (LCD), and a power supply." This description suggests a classic electromechanical device with an embedded computer processor, likely controlled by deterministic software and calibrated rather than an AI/ML system that requires a "training set" in the modern sense. It is highly probable that the software and system were developed using traditional engineering principles and testing, not AI/ML training data.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as it's not an AI/ML device in the context of requiring a "training set" with ground truth in the AI/ML paradigm. The "ground truth" for its development would be engineering specifications, physical laws, and expected operational parameters against which the device's mechanical and electronic components were designed and calibrated.
§ 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).