(88 days)
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No
The summary describes a mechanical infusion pump and administration set with no mention of AI or ML capabilities.
No
The device is an infusion pump and administration set, which is used for delivering substances to the body, not for treating a disease or condition itself.
No
The device is an infusion pump designed for delivering medication, not for diagnosing conditions. Its primary function is to administer substances, not to identify diseases or medical conditions.
No
The device description explicitly mentions a "SoloPak® Sidekick Infusion Pump" and an "Administration Set," which are physical hardware components used for infusion.
Based on the provided information, the SoloPak® Sidekick Infusion Pump and Administration Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "general use infusion of small volumes (50 - 100 ml)". This describes a device used to deliver fluids directly into a patient's body, which is a therapeutic or diagnostic procedure performed in vivo (within a living organism).
- Device Description: The description focuses on the physical components and their function in delivering fluids.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside of the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples taken from the body to provide diagnostic information. The SoloPak® Sidekick Infusion Pump and Administration Set's function is to administer substances into the body.
N/A
Intended Use / Indications for Use
The SoloPak® Sidekick Infusion Pump and Administration Set is intended to be used for the general use infusion of small volumes (50 - 100 ml) . The infusion pump is reusable, however the administration set is intended for single use.
Product codes
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Device Description
The SoloPak® Sidekick Infusion Pump is individually packaged and can be cleaned and reused for multiple infusions. The Administration Set is sterile, non-pyrogenic, and packaged in a tyvek/polyethylene pouch. It is a single use set. The materials used to manufacture the SoloPak Sidekick Infusion Pump and Administration Set are the same as those used in currently legally marketed products with the same intended uses.
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
The infusion sets have been tested and have been found to accurately deliver medication within ±15%.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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/1 description: The image shows the logo for Douglas Medical Products, a SoloPak Company. The logo features a geometric shape on the left, followed by the company name in a stylized font. Below the company name is the tagline "A SoloPak Company" in a smaller font. The logo is simple and professional, conveying a sense of quality and reliability.
OCT - 4 1996
June 10, 1996
To Whom it may concern:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92:
Trade Name - SoloPak® Sidekick Infusion Pump and Administration Set Common Name - Ambulatory Infusor/Infusion Pump and Infusion Set Classification Name - Infusion Pump with Administration Set
The SoloPak® Sidekick Infusion Pump and Administration Set is intended to be used for the general use infusion of small volumes (50 - 100 ml) . The infusion pump is reusable, however the administration set is intended for single use. The infusion sets have been tested and have been found to accurately deliver medication within ±15%.
The SoloPak® Sidekick Infusion Pump is individually packaged and can be cleaned and reused for multiple infusions. The Administration Set is sterile, non-pyrogenic, and packaged in a tyvek/polyethylene pouch. It is a single use set. The materials used to manufacture the SoloPak Sidekick Infusion Pump and Administration Set are the same as those used in currently legally marketed products with the same intended uses. The indicated use of the SoloPak® Sidekick Infusion Pump and Administration Set are the same as the predicate device named in this submission. The named predicate device in this submission is the I-Flow VIVUS 50 and VIVUS 100 marketed under 510(k) #K915646. The SoloPak® Sidekick Administration Set is sterilized per AAMI guidelines to a 10 sterility assurance level. Each production lot is LAL tested per USP guidelines.
Based on the fact that the SoloPak® Sidekick Infusion Pump and Administration Set utilize the same design, materials, and manufacturing processes as the named predicate device, they are safe and effective when used as intended.
Sincerely,
Ron Haselhorst
Ron Haselhorst Director of RA/QA Douglas Medical Products Corporation A SoloPak® Company