(39 days)
K#923875
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No
The document describes a mechanical infusion pump and administration sets with no mention of software, algorithms, or any technology that would suggest AI/ML capabilities. The performance study focuses on flow rate accuracy, a standard metric for infusion pumps.
Yes.
The device is intended for delivering drugs and solutions, which are used for therapeutic purposes.
No
Explanation: The device is an infusion pump intended for delivering drugs and solutions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical hardware components including plastic shells, a pressure plate assembly, PVC tubing, a filter, and a Luer lock adapter, indicating it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "delivering drugs and solutions through an in-dwelling catheter." This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details a pump and administration sets designed for fluid delivery, including components like tubing, valves, filters, and a Luer lock adapter. These are typical components of infusion systems, not diagnostic devices.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for delivering substances into the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This system has been tested and has demonstrated it can consistently deliver within + or - 10% of the labled flow rate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#923875
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
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