(301 days)
The Halo II Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional in clinical and nonclinical environments, such as homes. The device is intended for subcutaneous, perineural, epidural and intravenous infusion, including but not limited to patient controlled analgesia (PCA) delivery.
The Halo II Ambulatory Infusion System includes an ambulatory infusion pump and administration set. It is used to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. This is a device modified from its predicate device Halo Ambulatory Infusion System (K140783). Modifications include allowing users to change battery therefore enabling pump use beyond 240 hours / 1500mL. The original motor was replaced with a longer life one to support extended pump life. Software was updated accordingly to realize the changes. The administration set remains exactly the same.
The Halo II Ambulatory Infusion Pump has a microprocessor controlled motor that drives a peristaltic pumping mechanism to deliver fluid at a controlled rate, same as the Halo ambulatory infusion pump (K140783) and CADD-Solis VIP ambulatory infusion pump (K11275).
The pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for the Halo II pump components are widely used in the medical industry.
The pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA).
The Halo II Administration Set is exactly the same as Halo Administration Set (K140783). It is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient.
The administration set can be used with Halo II Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets (K120685), which can be used with Z-800 Infusion Pump or gravity infusion.
The provided text is a 510(k) premarket notification summary for the Halo II Ambulatory Infusion System. It details the device's substantial equivalence to previously marketed predicate devices.
However, the questions regarding acceptance criteria and study proving acceptance criteria for medical AI/ML devices typically refer to performance metrics for an algorithm (e.g., sensitivity, specificity, AUC) and clinical validation studies comparing the algorithm's performance, alone or with human users, to a ground truth.
The provided document describes a traditional medical device (an infusion pump), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (like "multi reader multi case (MRMC) comparative effectiveness study," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," "sample size for training set," etc.) are not applicable to this document.
The document focuses on demonstrating substantial equivalence of the Halo II Ambulatory Infusion System to its predicate devices through engineering and performance testing, safety standards compliance, and biocompatibility, as is standard for an infusion pump.
Therefore, I cannot fulfill the request as the provided text does not contain information about an AI/ML device or its associated performance study criteria.
§ 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).