(12 days)
AccuFlo & AccuFlux devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert.
The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes
The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.
The AccuFlo & AccuFlux models are both disposable, non-electric infusion pumps that deliver precise volume of medication at predetermined flow rate for IV therapy.
The provided text describes a 510(k) premarket notification for the AccuFlo & AccuFlux disposable infusion pumps. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance.
The document primarily focuses on:
- Device Description and Intended Use: Disposable, non-electric infusion pumps for precise medication delivery.
- Technological Characteristics: Equivalence to predicate devices and compliance with various international standards (IEC, ISO) related to medical devices, biocompatibility, packaging, sterilization, and risk management.
- Regulatory Information: 510(k) summary, contact information, date prepared, proprietary and common names, classification, predicate devices, and the FDA's clearance letter stating substantial equivalence.
Therefore, I cannot provide the requested information as it is not present in the given text.
The prompt's questions (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth) are typically relevant for AI/ML-based diagnostic devices, which this product (a non-electrically powered disposable infusion pump) is not. Its "performance" would be related to its flow rate accuracy, duration of infusion, material biocompatibility, and manufacturing quality, not diagnostic accuracy based on an algorithm.
§ 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).