(39 days)
The SoloPak Medical Products, Paragon Infusion Pump and Administration Sets are intended to be used as a system for the purpose of delivering drugs and solutions through an in-dwelling catheter.
The pump is made of two cylindrical high impact plastic shells with a pressure plate assembly in the top shell. It is packaged individually and can be cleaned after each use and reused. The Administration Sets that function with the pump consists of a 110mL PVC drug container, PVC tubing, a fill valve, PVC tubing, an onloff clamp, a 1.2 Micron Filter, a male Luer lock adapter with an integrated flow restrictor and tip protectors. The administration Sets are individually packaged as single use devices in tyvek and mylar pouches. They are EtO stenlized per AAMI guidelines and meet the requirements of the Federal Register Vol. 43, No. 122, June 23,1978, pp 27482-3 for ethylene oxide residuals.
This document is a 510(k) summary for the SoloPak Medical Products Paragon Infusion Pump and Administration Sets. It does not contain the detailed information required to answer your specific questions regarding acceptance criteria and study design for a device's AI performance.
The document discusses the device's technical specifications, intended use, and claims of substantial equivalence to a predicate device based on manufacturing processes and design, not AI performance. It mentions a performance claim related to flow rate accuracy but this is a traditional medical device performance metric, not an AI-related one.
Therefore, an answer fulfilling your request cannot be generated from the provided text.
To answer your questions, I would need a document that describes the development, testing, and validation of an AI-powered medical device, including information on its performance against specific acceptance criteria, details on training and test datasets, ground truth establishment, and if applicable, MRMC studies.
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Image /page/0/Picture/0 description: The image shows the logo for SoloPak Medical Products. The logo consists of a geometric shape on the left, followed by the word "SoloPak" in bold, and then the words "Medical Products" in a smaller font. The geometric shape is a black cube with a white maze-like design on its faces.
August 18, 1996
4 1996
To whom it may concern:
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Trade Name - SoloPak Medical Products, Paragon Infusion Pump and Administration Sets Common Name - Infusor, Infusion Pump, and Administration Sets Classification Name - Infusion Pump and Intravascular Administration Set
The SoloPak Medical Products, Paragon Infusion Pump and Administration Sets are intended to be used as a system for the purpose of delivering drugs and solutions through an in-dwelling catheter. When a filled fluid container of the administration set is placed into the bottom shell and the two shells are threaded together, internal pressure is generated on the administration set drug container. This internal pressure and the flow restrictor in the distal end of the Paragon Administration Set provide components that control the flow of fluid from the administration set. This system has been tested and has demonstrated it can consistently deliver within + or - 10% of the labled flow rate.
The pump is made of two cylindrical high impact plastic shells with a pressure plate assembly in the top shell. It is packaged individually and can be cleaned after each use and reused. The Administration Sets that function with the pump consists of a 110mL PVC drug container, PVC tubing, a fill valve, PVC tubing, an onloff clamp, a 1.2 Micron Filter, a male Luer lock adapter with an integrated flow restrictor and tip protectors. The administration Sets are individually packaged as single use devices in tyvek and mylar pouches. They are EtO stenlized per AAMI guidelines and meet the requirements of the Federal Register Vol. 43, No. 122, June 23,1978, pp 27482-3 for ethylene oxide residuals.
This pump and administration set system are substantially equivalent to the Sidekick Plus Infusion Pump and Administration Sets legally marketed by I-Flow Corporation under K#923875. Substantial equivalence can be claimed by SoloPak Medical Products for the Paragon Infusion Pump and Administration Sets because the components and the processes used to manufacture the Paragon Infusion Pump and Administration Sets are identical to those used in the predicate device. The same manufacturing site is used and the same designs employed in the manufacture of the pump and administration set. Based on these facts, the SoloPak Medical Products Paragon Pump and Administration Sets are substantially equvilent and are safe and effective when used as intended.
Sincerely.
Ron Faucheux
Ron Haselhorst Director of Regulatory Affairs\Quality Assurance
§ 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).