← Product Code [MEB](/productcode/MEB) · K963355 # SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET (K963355) _Solopak Medical Products, Inc. · MEB · Oct 4, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K963355 ## Device Facts - **Applicant:** Solopak Medical Products, Inc. - **Product Code:** [MEB](/productcode/MEB.md) - **Decision Date:** Oct 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use 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. ## Device Story System comprises reusable high-impact plastic pump and single-use administration sets; used for drug/solution delivery via in-dwelling catheter. Pump consists of two threaded cylindrical shells; internal pressure generated on drug container when shells are joined. Flow control achieved via internal pressure and distal flow restrictor. Administration set includes 110mL PVC container, PVC tubing, fill valve, on/off clamp, 1.2-micron filter, and male Luer lock adapter. Operated by clinicians in clinical settings. System delivers fluids within +/- 10% of labeled flow rate. ## Clinical Evidence Bench testing only; system demonstrated consistent delivery within +/- 10% of labeled flow rate. ## Technological Characteristics Materials: High-impact plastic (pump), PVC (container/tubing). Components: Pressure plate assembly, 1.2-micron filter, flow restrictor, Luer lock. Sterilization: EtO per AAMI guidelines; meets Federal Register Vol. 43, No. 122 (June 23, 1978) for ethylene oxide residuals. Mechanical flow control via pressure and restrictor. ## Regulatory 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. ## Predicate Devices - Sidekick Plus Infusion Pump and Administration Sets ([K923875](/device/K923875.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SoloPak® Medical Products K963355 August 18, 1996 OCT 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 labeled 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 on/off 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 sterilized 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 equivalent and are safe and effective when used as intended. Sincerely, ![img-0.jpeg](img-0.jpeg) Ron Haselhorst Director of Regulatory Affairs\Quality Assurance 1840 Industrial Drive, Suite 100, Libertyville, Illinois 60048 • Telephone: 847-949-7387 • Telefax: 847-949-7388 --- **Source:** [https://fda-staging.innolitics.com/device/K963355](https://fda-staging.innolitics.com/device/K963355) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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