(237 days)
The Science Incorporated Personal Infusor is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation.
The flexibility offered by the Personal Infusor will enable physicians to choose from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients.
The Science Incorporated Personal Infusor is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36 inch tubing set that adjoins a preexisting venous access site. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in seven volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities.
The manufacturer, Science Incorporated, demonstrated the performance of their Personal Infusor through studies showing its flow linearity.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flow Linearity | Not explicitly stated, but assumed to be within clinically acceptable bounds for infusion pumps for safe and accurate drug delivery. Industry standards for elastomeric pumps often target ±5% or ±10% variation over specified temperature and viscosity ranges. | ±10% over a temperature range of 10-40° C when used with various diluents. This is explicitly stated. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The document refers to "our studies" and "prototype models" but does not give specific numbers for the test sets.
- Data Provenance: The studies were conducted by Science Incorporated ("In our studies"). The specific country of origin is not explicitly stated beyond Science Incorporated being located in Bloomington, MN, USA. The studies appear to be prospective as they were conducted by the manufacturer to demonstrate the performance of their new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is an infusion pump, and its performance is evaluated based on physical measurements of fluid flow and linearity, not on interpretation by human experts. Ground truth would be derived from calibrated measurement instruments, not expert consensus.
4. Adjudication Method for the Test Set:
Not applicable. Performance was measured objectively, not through human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data. The Personal Infusor is a drug delivery device, and its performance is assessed mechanically.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the performance data presented is that of the device itself, functioning as a standalone unit. The description states, "The Science Incorporated Personal Infusor exhibits improved flow performance when compared to the predicate devices. In our studies, the new devices displayed linearity of ±10%..." This refers to the intrinsic performance of the pump.
7. The Type of Ground Truth Used:
The ground truth used would be based on objective measurements from calibrated laboratory equipment. For example, flow rate would be measured using precise mass balances or volumetric sensors over time, and temperature would be controlled and verified with calibrated thermometers. The linearity would be calculated based on these measured flow rates compared to the expected flow rates.
8. The Sample Size for the Training Set:
Not applicable. The Personal Infusor is a mechanical device, not an AI/ML algorithm that requires a training set. Its performance is based on its engineering design and manufacturing, not on learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8.
§ 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).