(24 days)
The Ipump™ Pain Management System is indicated for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician. Delivery may be continuous or intermittent and may be epidural, intravenous or subcutaneous.
The Ioump™ Pain Management System is an electronic infusion pump indicated for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician. Delivery may be continuous or intermittent and may be epidural, intravenous or subcutaneous.
The Ipump™ operates using a linear peristaltic pumping mechanism and a DC motor. The power source can be either a 9 Volt battery or an AC adapter. The Ipump™ provides continuous, Patient Controlled Analgesia (PCA), and combined modes of operation. The pumps have configurable input parameters. which allow institutions to pre-select which modes of operation will be available to users and which units of measure will be used for data entry.
The principal modifications described in this submission are: (1) the addition of upstream occlusion and air detection; (2) a modified downstream occlusion mechanism; (3) a modified AC Adapter; (4) addition of a configuration download feature; (5) increased the configurable continuous infusion rate and the configurable bolus volume; (6) expanded alerts and alarms; (7) enhanced security features; (8) additional timed infusion limit and dose/hour limit configuration options; (9) an automatic restart after bolus option; (10) foreign language and international date and time format options; (11) flexible audible alert call back time; (12) option to configure the "Start" key to function as a PCA button; (13) enhanced pump history; (14) option for use of previous prescription the current prescription; (15) updated labeling.
The pump system includes a custom tubing set and a flexible non-vented reservoir (bag) of up to 500 mL in addition to the pump. The disposable accessories are unchanged from the predicate device.
The provided text describes a 510(k) submission for the Ipump™ Pain Management System. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on the accuracy of fluid delivery.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Defined by IEC 601-2-24 standard | "demonstrate acceptable performance of the device" |
Note: The exact quantitative acceptance criteria from the IEC 601-2-24 standard are not detailed in this document. The submission only states that the testing was conducted according to this standard and the results were acceptable.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "testing conducted to verify the design modifications" but does not give a number for the test samples (e.g., number of pumps tested, number of infusion runs).
- Data Provenance: Not explicitly stated. Based on the context of a 510(k) submission by Baxter Healthcare Corporation (a U.S.-based company), it is highly likely the testing was conducted domestically. The study would be prospective as it's for verifying design modifications of a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The "ground truth" for infusion pump accuracy is determined by objective physical measurements (e.g., gravimetric analysis or flow sensors) against a defined standard, not by human expert opinion or consensus.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on objective physical measurements and not expert consensus, there is no need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not applicable for this device. This type of study is used for diagnostic devices where human readers interpret medical images or data. The Ipump™ is an infusion pump, and its effectiveness is determined by its mechanical performance and accuracy, not by human interpretation.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes. The tests described are inherently a standalone performance study. The "Accuracy data was generated in accordance with the testing methodology defined by the IEC 601-2-24 standard." This typically involves automated or highly controlled experimental setups to measure the infusion pump's performance (e.g., fluid delivery rate) against the programming, without human intervention affecting the outcome of the measurement itself.
7. Type of Ground Truth Used
The ground truth used is based on objective physical measurements (e.g., gravimetric analysis to measure delivered fluid volume over time) as defined by the IEC 601-2-24 standard for infusion pumps.
8. Sample Size for the Training Set
Not applicable. The Ipump™ Pain Management System is a hardware device (infusion pump) with embedded software controlling its mechanical functions. It does not use machine learning or AI algorithms that would require a "training set" in the conventional sense of AI/ML models. Its control logic and algorithms are typically pre-programmed based on engineering design and validated through testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no "training set" in the context of AI/ML for 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).