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The Advantis ASC is intended to be used for intravascular administration of drugs, fluids, blood and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.

The Advantis™ ASC (Alternate Site Care) is a multi-mode large volume infusion pump suitable for general and homecare applications. The instrument is a microprocessorcontrolled device designed to use a standard, single use, administration set (dedicated and non-dedicated). The large volume infusion pump provides control of infusion rates (0.1 ml/hr to 999 m/hr) due to the positive displacement action of the linear peristaltic mechanism. The instrument's features include multi programs (standard, micro, primary, secondary modes), TPN and 10-P delivery, free flow protection, user selectable occlusion pressures, automatic priming, and an anti-bolus system. This instrument incorporates both audible and visual alarms for Air-in-line, Upstream and Downstream Occlusion, Low Battery, Electrical or Mechanical Failure, Open Door and Incorrect IV Administration Set.

The provided text is related to a 510(k) premarket notification for an infusion pump, which is a medical device. This type of document is for regulatory clearance and does not typically include information about "acceptance criteria" and "studies" in the context of AI/ML device performance, as outlined in your request.

The questions you are asking (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are specific to the evaluation and validation of Artificial Intelligence/Machine Learning (AI/ML) medical devices, particularly those involving diagnostic or prognostic algorithms.

The document discusses:

• Device Name: Advantis™ ASC Infusion System
• Intended Use: Intravascular administration of drugs, fluids, blood, and blood products; also indicated for epidural applications.
• Technological Characteristics: Similar to predicate devices (Sabratek 3030 Volumetric Infusion Pump and Baxter Flo-Gard 6201 Infusion Pump), using similar technologies, software, materials, electronics, energy sources, and mechanical components, including standard PVC administration sets.
• Regulatory Clearance: A 510(k) premarket notification indicating substantial equivalence to predicate devices.

Since the Advantis ASC Infusion Pump is a traditional electromechanical medical device and not an AI/ML diagnostic or prognostic device, the information you've requested regarding AI/ML-specific acceptance criteria and validation studies (like those involving ground truth, expert consensus, MRMC studies, training/test sets) is not applicable to this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about AI/ML study design, as the provided text does not contain that kind of information.

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The Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets create an infusion system intended for parenteral and enteral administration. This includes, but is not limited to standard I.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, nitroglycerin, Total Parenteral Nutrition (TPN), lipids, enteral fluids, I.V. drugs such as paclitaxel and other chemotherapeutic agents, and epidural administration of anesthetic and analgesic drugs. The pump is capable of drawing fluid from containers or syringes and administering the fluid to a patient through the administration set.

The Millennium CRT™ Infusion Pump Administration Sets can also be used as stand-alone devices without the Millennium CRT™ Infusion Pump. When used without the Millennium CRT™ Infusion Pump, the Millennium CRT™ Infusion Pump Administration Sets are also intended for parenteral and enteral administration. However, administration of these fluids is accomplished through gravity infusion. When used for gravity infusion, these sets may be used for administration of standard I.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, lipids, nitroglycerin, TPN, I.V. drugs including paciltaxel and other chemotherapeutic agents, and enteral fluids.

The Millennium CRT™ pump and associated administration sets are intended for, but are not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Millennium CRT™ Infusion Pump is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Millennium CRT™ Infusion Pump is performed by the trained healthcare provider per a physician's order.

The subject devices include an electrical, external, linear peristaltic, volumetric infusion pump called the Millennium CRT™ Infusion Pump and administration sets called the Millennium CRT™ Infusion Pump Administration Sets. The Millennium CRT™ Infusion Pump can only be used with the Millennium CRT™ Infusion Pump Administration Sets. The Millennium CRTM Infusion Pump Administration Sets do not contain a dedicated cassette. However, these sets do contain a free-flow clip that is a special slide clamp that interfaces with the pump. The Millennium CRTTM pump will not function as intended without the Millennium CRT™ sets. The Millennium CRT™ sets can be used either with the pump for pump infusion or without the pump for gravity infusion.

The system created by using the Millennium CRT™ Infusion Pump Administration Set with the Millennium CRT™ Infusion Pump is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The pump is software controlled and operates using linear peristaltic crushing action against a straight piece of plastic tubing threaded through the pump mechanism. The system detects occlusions in the patient line downstream.

The Millennium CRT™ Infusion Pump Administration Sets are sterile single use devices. The sets are composed of a straight piece of standard tubing, a free-flow clip and various combinations of other standard I.V. set components including filters, check valves, spikes, drip chambers, injection sites (standard needle injection sites and needle free injection sites such as the SafeLine® pre-slit septum injection site and the Clave® Connector luer activated injection site), clamps, measured volume burets, caps or protectors, and luer connectors. All of these standard set components are used in McGaw's currently marketed 510(k) cleared standard gravity and pump I.V. administration sets. The administration set components are welded or bonded and assembled using current McGaw manufacturing procedures to form the completed sets.

The Millennium CRT™ Infusion Pump Enteral Administration Set is a non-sterile single use device. This enteral administration set is composed of standard administration set components including a straight piece of standard tubing, a free-flow clip, luers, and a drip chamber. The enteral set also includes a pre-attached enteral fluid bag.

The infusion pump contains the following hardware subassemblies: linear peristaltic mechanism assembly, power supply assembly, pole clamp assembly, air-in-line detector assembly, free-flow receptacle assembly, display assembly, and electronics assembly. The linear peristaltic mechanism assembly contains additional subassemblies for downstream occlusion detection. The power supply assembly includes two identical NiMH (Nickel Metal Hydride) batteries. One battery is permanently mounted inside the pump: whereas, the other battery is optional and can be inserted or removed by the user as required to provide additional battery capacity.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets. It focuses on establishing substantial equivalence to predicate devices, describing the device, its intended use, and its technological characteristics. There is no mention of specific performance acceptance criteria or a study demonstrating their fulfillment.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies.

Ask a specific question about this device