(14 days)
The AP 34 is a multi-therapy infusion pump system designed for the volumetric infusion of medication and nutritional fluids to patients in the hospital, homecare and outpatient environments in the following delivery modes: CONTINUOUS; INTERMITTENT; PCA (Patient Control Analgesia) and TPN (Total Parenteral Nutrition). The AP 34 is not intended for the following use or substances:
- Delivery of blood or cellular blood products .
- . Intra-cardiac use.
The AP 34 infusion pump includes the following accessories:
- Bolus cable .
- Q--Core approved AC/DC adaptor (external)] .
- Cradle (optional) and power cable for cradle .
- Rechargeable battery pack for pump .
- . PCA cover box
- Communication cables .
The dedicated Q-Core Administration Sets for the AP 34 infusion pump are intended for single-patient use only.
The AP 34 infusion pump system is for prescription use only.
The Q-CORE AP 34 multi-therapy Infusion Pump is a software driven, volumetric, ambulatory infusion pump for the delivery of measured amounts of medication or parenteral nutrition at a controlled rate. The AP 34 uses Q-Core approved disposable Administration Sets, including the Q-Core designed Magic Straw™ cassette. The AP 34 operates by means of an electro-mechanical pumping mechanism based on Q-Core patented Electromagnetic Flow Control (EFC™) valve technology. The pumping mechanism is a single channel, with an integral pressure sensor and real time flow correction capacity; the pumping mechanism produces a peristaltic pumping action.
Here's an analysis of the Q-Core AP 34 multi-therapy Infusion Pump following your requested format:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Note: This document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. It typically focuses on non-clinical testing and comparison to standards, rather than extensive clinical efficacy trials. Therefore, information regarding human reader studies, ground truth involving experts for large datasets, or effect sizes for AI assistance are not applicable to the context of this device and documentation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Q-Core AP 34 multi-therapy Infusion Pump are primarily based on compliance with international standards for medical electrical equipment and infusion pumps, along with standards for administration sets and biocompatibility. The reported device performance is that it meets these standards.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| For AP 34 Pump: | |
| IEC 60601-1 (Electrical Safety) | Complies with IEC 60601-1 |
| IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 |
| IEC 60601-2-24 (Particular requirements for infusion pumps, including accuracy of delivery and functional performance at different flow rates over various intervals) | Complies with IEC 60601-2-24, demonstrating accuracy of delivery and functional performance. |
| For AP 34 Administration Sets: | |
| ISO 8536-4 (Infusion equipment for single use, gravity feed) | Complies with ISO 8536-4 |
| ISO 8536-8 (Infusion equipment for use with pressure infusion apparatus) | Complies with ISO 8536-8 |
| For Biocompatibility: | |
| ISO 10993-1 (Biological evaluation of medical devices, Part 1: Evaluation and Testing for components in indirect contact with patient's body) | Complies with ISO 10993-1 |
2. Sample Size Used for the Test Set and the Data Provenance
The document indicates "extensive bench testing" was performed by an independent testing laboratory. However, it does not specify the exact sample sizes (e.g., number of pumps, administration sets, or test repetitions) used for these non-clinical tests.
Data Provenance: The testing was conducted by an independent testing laboratory, as stated. The country of origin of the data is not explicitly mentioned, but the submitting company is Q-Core Ltd. from Israel. The data is retrospective in the sense that it reflects tests conducted before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of non-clinical device testing. "Ground truth" in this context refers to the defined parameters and expected outcomes of the engineering and performance standards themselves (e.g., a pump should deliver a certain volume within a defined accuracy range). The experts involved would be the engineers and technicians at the independent testing laboratory, qualified to perform the specified standard tests.
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers. For bench testing, the results are objectively measured against the specified criteria of the relevant standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (infusion pump) and not an AI/imaging diagnostic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an "algorithm only" component in the sense of a standalone AI diagnostic tool. Its performance is inherent in its mechanical and electronic functions.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by the performance specifications outlined in the referenced international standards (IEC 60601-2-24 for infusion pumps, ISO 8536-4/8 for administration sets, and ISO 10993-1 for biocompatibility). For example, the accuracy of delivery is measured against predefined acceptable ranges specified within IEC 60601-2-24.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device with embedded software, not a machine learning or AI system that requires a "training set" in the conventional sense. The "training" for such a device involves its design, engineering, and manufacturing processes, guided by established principles and standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design and expected performance is established through comprehensive engineering specifications, adherence to relevant industry standards, risk analysis, and regulatory requirements.
§ 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).