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simplicity soft qd ii infusion set for infusion and or injection of fluids into the body below the surface of the skin
Sterling Medivations
Summary: The Simplicity Soft QD II Infusion Set is a medical device used for the infusion or injection of fluids below the skin's surface. It is primarily used by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K020990 ↗
Decision Date
April 10, 2002
Product Code
FPA
Device Class
Class 2
Evidence
0 studies
The Simplicity Soft QD II Infusion Set, manufactured by Sterling Medivations, received FDA clearance through the 510(k) pathway on April 10, 2002. It is classified as a Class 2 device under product code FPA.
What It Is
The Simplicity Soft QD II Infusion Set is designed for the subcutaneous infusion or injection of fluids. It typically consists of a needle or cannula, tubing, and a connector, allowing for the controlled delivery of medications or nutrients. This device is essential in managing conditions that require regular fluid administration, such as diabetes or certain cancer treatments.
Clinical Applications
This infusion set is commonly used in outpatient and inpatient settings for patients requiring regular subcutaneous fluid administration. It is frequently utilized in endocrinology for insulin delivery in diabetic patients and in oncology for chemotherapy administration. The device is suitable for both adult and pediatric populations, depending on the specific clinical needs.
Indications for Use
The FDA-cleared indication for this device is for the infusion or injection of fluids into the body below the skin's surface. It is particularly useful for patients who need regular medication or nutrient administration, such as those with chronic illnesses.
Practical Considerations
The Simplicity Soft QD II Infusion Set comes in various sizes to accommodate different patient needs. It is compatible with standard infusion pumps and requires proper aseptic technique during insertion to minimize infection risk. Clinicians should ensure the correct size and type are selected based on the patient's condition and treatment plan.
Frequently Asked Questions
What is the Simplicity Soft QD II Infusion Set used for?
It is used for the subcutaneous infusion or injection of fluids, such as medications or nutrients, into the body.
What specialties typically use this device?
Endocrinology, oncology, and general medicine specialties commonly use this device for fluid administration.
What are the FDA-cleared indications?
The device is indicated for the infusion or injection of fluids into the body below the skin's surface.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.