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510(k) Data Aggregation
(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 < 90 | Contamination index < 90 |
| Leakage: No Leakage | No Leakage |
| Flow rate: 1m, 10min > 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: <0.5 EU (from Section 7) | <0.5 EU |
2. Sample size used for the test set and the data provenance:
The document states, "When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results." However, the specific sample sizes used for each test (e.g., for particulate contamination, leakage, flow rate, tensile strength) are not detailed in this document.
The data provenance is from non-clinical bench testing performed by U&U Medical Technology Co., Ltd. and its contract manufacturer. The document doesn't specify the country of origin of the raw data, but the submitting company is based in China, and the contract manufacturer is also in China. The data is prospective as it involves tests conducted on the newly manufactured U&U Intravascular Administration Set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as this study is not evaluating a diagnostic algorithm or a clinical scenario requiring expert interpretation to establish "ground truth." The "ground truth" here is objective physical and chemical properties measured against established engineering standards and specifications.
4. Adjudication method for the test set:
This is not applicable for the same reason as point 3. The testing involves objective measurements rather than subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This document is for a physical medical device (intravascular administration set), not an AI-powered diagnostic tool, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as there is no algorithm or AI component in this medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by objective engineering standards and specifications, specifically those outlined in ISO 8536-4 (Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed), as well as general expectations for such devices (e.g., "No Leakage," "Normal" principle of operation). The predicate device's characteristics also serve as a benchmark for substantial equivalence.
8. The sample size for the training set:
This is not applicable as this is a physical medical device and does not involve machine learning algorithms requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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