(160 days)
Disposable Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The applicant device is plastic, single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of Polyvinyl chloride and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel. The proposed device is provided sterilized.
The provided text describes a 510(k) summary for a Disposable Infusion Set and does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document discusses:
- Device Name: Disposable Infusion Set
- Intended Use: To administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
- Device Description: Plastic, single-use, sterile infusion device with components like a protective cap, puncturing needle, catheter (no DEHP), drip with filtration mesh, flow regulator, and infusion needle.
- Test Conclusion: "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device."
- Predicate Device: Tianjin Medis Disposable Infusion Set (K060082)
- Substantial Equivalence Conclusion: The subject device is substantially equivalent to the predicate device.
Therefore, I cannot provide the requested information as it is not present in the given text. The information provided focuses on the regulatory submission process and the declaration of substantial equivalence based on unspecified "laboratory testing" and "design specifications."
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.