(330 days)
This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through a surgically implanted vascular port. Secondly, it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needle stick injuries.
The Nipro SafeTouch Huber Infusion Set is a standard non-coring Huber type needle and administration set with an integrated safety mechanism to prevent accidental needle sticks. The device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The basic structure of the device consists of a needle tube, wing unit, needle hub, flexible tubing and luer connector. This device is also available with a clamp, Y-mixing tube and a joint tube. The needle is bent at a 90° angle and is available in gauges 19, 20, 22 and 24 and in lengths of ½" - 1 ½". The device is supplied in three basic configurations: 1. Type A: Y-site with rubber button, 2. Type B: Without Y-site, 3. Type C: Y-site with luer lock.
The NIPRO SafeTouch Huber Infusion Set successfully met the requirements for various international and national standards, as well as specific performance tests. The device demonstrates substantial equivalence to its predicate device (NIPRO SafeTouch Huber Infusion Set, K081210) based on physical properties, materials, configurations, and intended use.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Safety mechanism activation force | ≤ 8.4 N | Successfully met the requirement |
| 2. Safety mechanism activation breakage force | ≥ 25.2 N | Successfully met the requirement |
| 3. Safety mechanism deactivation force | Needle breaks before deactivation | Successfully met the requirement |
| 4. Flow rate | 19G: 41-52 ml/min | |
| 20G: 24-38 ml/min | ||
| 22G: 10-15 ml/min | ||
| 24G: 4-6 ml/min | ||
| Predicate Device 20G | Successfully met the requirement (implied, as stated "met or exceeded") | |
| 5. Air leakage - pressure endurance | Must show no signs of air leakage | |
| 50 [kPa] for 15 seconds. | Successfully met the requirement | |
| 6. Set Leakage - Endurance test | With y-site: 1.8MPa Without y-site: | |
| 3.7MPa | Successfully met the requirement | |
| 7. Wrapping paper leakage | Must not leak under the condition of | |
| 1.1[kPa] for 10 seconds. | Successfully met the requirement | |
| 8. Cannula/Hub adhesive strength measurement | 19G: ≥ 69 N | |
| 20G: ≥ 54 N | ||
| 22G: ≥ 34 N | ||
| 24G: ≥ 22 N | Successfully met the requirement | |
| 9. Popping needle tip inspection | No sound of puncture popping noise. | Successfully met the requirement |
| 10. Tensile Adhesive strength (Hub/tube, Y connector/tube, Connecting tube/connector) | Must withstand a static tensile force | |
| of 15[N] for 15 seconds. | Successfully met the requirement | |
| 11. Test for particulate matter | Contamination Index $I = Na - Nb$ 9 | Successfully met the requirement |
| 12. Injection Site (rubber button) | Must show no signs of air leakage | |
| 50 [kPa] for 15 seconds. | Successfully met the requirement | |
| 13. Transportation Testing | Withstand distribution environment | Successfully met the requirement |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific performance test. It broadly states that "Testing of the NIPRO SafeTouch Huber Needle Infusion Set was completed in conformance with the following standards" and then "In addition, it met or exceeded the acceptance criteria for the following performance tests." Without specific sample numbers for each test, it's impossible to provide these details.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer to demonstrate compliance with standards and performance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing described is for a medical device (Huber Infusion Set), which involves physical and mechanical performance tests, sterility, and biocompatibility, not diagnostic or interpretive tasks that would require human expert adjudication for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. As mentioned above, the tests are objective mechanical, physical, and biological evaluations, not requiring human 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 information is not applicable and not provided. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data, often with AI assistance. This device is a physical infusion set, not an AI-enabled diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests outlined (like flow rate, adhesive strength, leakage, etc.) is established by the specifications defined in the referenced international and national standards (e.g., ISO 8536-4, ISO 10555-3, ISO 7864, USP 31) and the specific acceptance criteria developed by the manufacturer. These are objective, measurable parameters rather than subjective expert consensus or pathology. For example, for "Safety mechanism activation force," the ground truth is simply the measured force in Newtons relative to the acceptance criterion of "≤ 8.4 N." Similarly, for "Flow rate," the ground truth is the measured flow rate in ml/min compared to the specified range for each gauge.
8. The sample size for the training set:
This information is not applicable and not provided. This device is a physical medical device that undergoes performance testing and compliance to standards, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided, for the same reasons as in point 8.
§ 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.