(126 days)
For the administration of fluids from a container into a patient's vascular system through a vascular access device.
The proposed device consists of an IV Extension Set (Light Resistant Extension Set). It is a single use disposable, non-pyrogenic, sterile device intended for the administration of fluids from a container into the patient's vascular system. This IV extension set can be directly attached to a syringe but also used as an extension set to a primary set that is connected to a syringe (primarily to add length). The Light Resistant Extension Set consists of non-DEHP (
The provided text describes the regulatory clearance of the Baxter Healthcare Corporation's Intravascular Extension Set (Light Resistant Extension Set) (K210430). The focus is on demonstrating substantial equivalence to a predicate device (K192366) through non-clinical testing.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 80369-7 Luer Tests on male Luer Lock Connector | ISO 80369-7:2016, Clause 6.1.2 or 6.1.3, ISO 80369-7:2016, Clause 6.2, ISO 80369-7:2016, Clause 6.3, ISO 80369-20:2015, Annex E, ISO 80369-7:2016, Clause 6.4, ISO 80369-7:2016, Clause 6.5, ISO 80369-7:2016, Clause 6.6, ISO 80369-7:2016, Clause 5 | All tests met the acceptance criteria. |
| ISO 80369-7 Luer Tests on female Luer Lock Connector | ISO 80369-7:2016, Clause 6.1.2 or 6.1.3, ISO 80369-7:2016, Clause 6.2, ISO 80369-7:2016, Clause 6.3, ISO 80369-20:2015, Annex E, ISO 80369-7:2016, Clause 6.4, ISO 80369-7:2016, Clause 6.5, ISO 80369-7:2016, Clause 6.6, ISO 80369-7:2016, Clause 5 | All tests met the acceptance criteria. |
| Tensile Strength Test | BS EN ISO 8536-9, Clause 5.3 | All tests met the acceptance criteria. |
| Leak Test | BS EN ISO 8536-9: 2015, Section A.4 | All tests met the acceptance criteria. |
| Notch Clamp Activation Force Test | Per Baxter Test Method | All tests met the acceptance criteria. |
| Notch Clamp Shut-Off Test | Per Baxter Test Method | All tests met the acceptance criteria. |
| Non-DEHP Claim Verification ( |
§ 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.