(142 days)
The WillCare GX-1020 external pump is indicated for intravenous and non-intravenous infusion of medicinal products at set and variable rates.
The WillCare GW-1020 is an electromechanical infusion pump designed for use with therapies requiring accurate delivery of small volumes of medication. The pump delivers fluid with a resolution of 0.002 milliliters and allows for continuous delivery, for intermittent delivery, or for a combination of both. Components of the pump that are essential for effective operation are listed in the operators manual (Components - Basic Kit), and must ONLY be supplied by ICU to ensure proper and safe operation.
The ICU WillCare Infusion Pump (GW-1020) is an electromechanical infusion pump designed for accurate delivery of small volumes of medication. It can deliver fluid continuously, intermittently, or both, with a resolution of 0.002 milliliters. The device is indicated for intravenous infusion of medicinal products at set and variable rates.
Here's an analysis of its acceptance criteria and the study proving compliance:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the WillCare GX-1020 are primarily established by demonstrating substantial equivalence to its predicate device, the MiniMed 404-SP Infusion pump, and conformity to safety standards. The document outlines a comparison of technical characteristics to the predicate device, which implies these are the de facto acceptance criteria for performance aspects.
| Item | Acceptance Criteria (Implied by Predicate Device Performance) | WillCare GX-1020 Performance (Reported) |
|---|---|---|
| Physical Dimensions | Similar to MiniMed 404-SP: 2.0 x 3.4 x 0.8 inches | 3.4 x 1.7 x .7 inches (Comparable size) |
| Battery Life (0.800 ml/hr or 0.720 ml/hr) | At least 2 days at 0.720 ml/hr | 4 days minimum at 0.800 ml/hr (Exceeds predicate) |
| Battery Life (0.002 ml/hr) | At least 6 weeks at 0.002 ml/hr | 6 weeks minimum at 0.002 ml/hr (Matches predicate) |
| Rate Mode - Maximum | Similar to MiniMed 404-SP: 0.720 ml/hr | 0.800 ml/hr (Slightly higher, but within acceptable range for similar function) |
| Rate Mode - Minimum | Similar to MiniMed 404-SP: 0.000 ml/hr | 0.020 ml/hr (Slightly higher minimum, but deemed not to impact safety or performance for typical use) |
| Rate Mode - Increment | Similar to MiniMed 404-SP: 0.002 ml/hr | 0.002 ml/hr (Matches predicate) |
| Interval Mode - Maximum (ml/dose) | Similar to MiniMed 404-SP: 0.998 ml/dose | 0.998 ml/dose (Matches predicate) |
| Interval Mode - Minimum (ml/dose) | Similar to MiniMed 404-SP: 0.000 - 0.250 ml/dose | 0.100 ml/dose (Within range for similar function) |
| Demand Dose - Maximum (ml/dose) | Similar to MiniMed 404-SP: 0.998 ml/dose | 0.998 ml/dose (Matches predicate) |
| Demand Dose - Minimum (ml/dose) | Similar to MiniMed 404-SP: 0.002 ml/dose | 0.100 ml/dose (Higher minimum, but deemed not to impact safety or performance) |
| Syringe Capacity | 3.0 ml | 3.0 ml (Matches predicate) |
| Power Source | 3 standard 1.5 V silver oxide watch batteries | 3.6V DC (1/2 AA) (Different, but functionally equivalent and deemed safe) |
| Alarms | Low battery; Safety/program alarm; Empty syringe; Occlusion; Maximum total exceeded | Low battery; Low volume; Safety alarm; High pressure (Comparable safety alarms) |
| Physical Characteristics | DC Motor; Reduction Gear Drive | DC Motor; Reduction Gear Drive (Matches predicate) |
| Other Features | Three lock levels | Lock mode (Comparable functionality) |
| Safety Compliance | Conformity to IEC 60601-2-24 (Safety standard for infusion pumps) | Demonstrated through "Safety compliance testing (SCR043S-004)" with results in conformity to technical specifications and referenced standards. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a numerical sample size for "test sets" in the conventional sense of clinical trials or algorithm validation (e.g., patient data). The testing described is "Safety compliance testing (SCR043S-004)," which typically involves a set of physical devices undergoing various performance and safety evaluations.
- Sample Size: Not explicitly stated as a number of devices or data points for a "test set." It refers to the physical device undergoing testing.
- Data Provenance: The testing was conducted by ICU Medical, the manufacturer, presumably in a controlled laboratory environment. The country of origin for the data is not specified, but the manufacturer is based in San Clemente, CA, USA. The testing is prospective in the sense of evaluating the newly manufactured device against established standards and the predicate device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the testing is primarily hardware performance and safety compliance against engineering specifications and a predicate device, the concept of "experts establishing ground truth for a test set" in the context of diagnostic algorithms or clinical outcomes does not apply directly.
The "ground truth" for this medical device's performance is derived from:
- Engineering specifications and design requirements.
- The performance characteristics of the predicate device (MiniMed 404-SP).
- International safety and performance standards (IEC 60601-2-24).
Therefore, there wouldn't be a panel of human "experts" like radiologists or pathologists to establish this type of ground truth. The "experts" involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists who ensured the device met these technical benchmarks and standards. Their qualifications would be in engineering, medical device manufacturing, and regulatory compliance.
4. Adjudication Method for the Test Set
Again, given the nature of the device and testing (performance and safety compliance against specifications), a clinical adjudication method like "2+1" or "3+1" is not applicable.
The "adjudication" for this type of testing is typically:
- Comparison of measured device performance against pre-defined acceptance limits derived from specifications and predicate device data.
- Verification against the requirements of the referenced safety standards (IEC 60601-2-24).
- Review by regulatory bodies (FDA) to confirm substantial equivalence.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices to assess how human readers' performance (e.g., diagnostic accuracy) is impacted by AI assistance. The ICU WillCare Infusion Pump is a hardware device for drug delivery, not a diagnostic or AI-powered system that directly assists human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A (Not Applicable). As established, this is a hardware infusion pump, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant. The device's performance is inherently its "standalone" performance.
7. The Type of Ground Truth Used
The ground truth used for evaluating the WillCare GX-1020 is primarily based on:
- Engineering Specifications: The design and performance parameters defined for the device itself.
- Predicate Device Performance: The established, legally marketed performance characteristics of the MiniMed 404-SP.
- International Safety and Performance Standards: Specifically, IEC 60601-2-24 for safety compliance.
The document directly states: "Safety compliance testing (SCR043S-004) has been conducted to demonstrate device reliability and conformance to IEC 60 601-2-24. The results are in conformity to the technical specifications and all referenced standards." This confirms that compliance with established technical specifications and standards forms the core of the ground truth.
8. The Sample Size for the Training Set
No "training set" is applicable or mentioned. This device is an electromechanical infusion pump, not a machine learning model that requires a training set. Its functionality is based on programmed logic and physical mechanics, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. Since there is no training set, there is no ground truth established for a training set.
§ 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).