(147 days)
The U&U 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 U&U Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. The device includes the following components: Protective cap, Spike, Drip chamber, Back check valve, Pinch clamp, Slide clamp, Stopcock, Micron filter, Needleless Y-site, Male luer lock, Luer lock cap.
This document is a 510(k) premarket notification for a medical device called the "U&U Intravascular Administration Set." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device, the "Zyno Medical Administration Set" (K120685). The information provided focuses on the non-clinical testing performed.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document provides a table comparing the technological characteristics of the submission device (U&U Intravascular Administration Set) and the predicate device (Zyno Medical Administration Set). It also includes a summary of non-clinical test results for the submission device, which effectively acts as a table of acceptance criteria and reported performance.
| Acceptance Criteria (from Predicate Device/ISO 8536-4) | Reported Device Performance (U&U Intravascular Administration Set) |
|---|---|
| Intended Use: The Zyno 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 U&U 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. |
| Principle of Operation: Normal | Normal |
| Particulate contamination: Contamination index 1000ml | 1m, 10min > 1000ml |
| Tensile strength: Withstand a static tensile force of not less than 15N for 15s; | Withstand a static tensile force of not less than 15N for 15s; |
| Closure-piercing device: The closure-piercing device shall be capable of piercing and penetrating the closure without premiering. No coring should occur during this procedure. | The closure-piercing device shall be capable of piercing and penetrating the closure. No coring should occur during this procedure. |
| Air-inlet device: Air penetration rate ≥ 90% | Air penetration rate ≥ 90% |
| Tubing: The tubing shall be transparent or sufficiently translucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision. | The tubing shall be transparent or sufficiently translucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision. |
| Materials: | |
| Tubing: PVC | PVC |
| Spike: ABS | ABS |
| Back check valve: ABS | ABS |
| Roller clamp: ABS | ABS |
| Stopcock: ABS HDPE | ABS HDPE |
| Male luer lock: ABS | ABS |
| Biocompatibility: Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling: Meet the requirements of 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 |
| Fluid filter: The retention of latex particles on the filter shall be not less than 80% (from Section 7) | The retention of latex particles on the filter shall be not less than 80% |
| Dimensions of the drip chamber: There shall be a distance of not less than 30mm between the drip tube and fluid filter (from Section 7) | There shall be a distance of not less than 30mm between the drip tube and fluid filter |
| Pyrogenicity: |
§ 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.