(279 days)
The InviroLink and InviroLink w/EZ Wings Plastic Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.
The InviroLink/InviroTip Plastic Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites.
The family of InviroLink Plastic Cannulas are 18 gauge equivalent plastic cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. Following is a list of the InviroLink Plastic Cannulas:
- InviroLink, Model # 130001
- InviroLink with EZ wings, Model # 130501
The InviroLink Plastic Cannulas are used in conjunction with a syringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.
This looks like a 510(k) summary for a medical device called InviroLink/InviroLink w/EZ Wings Plastic Cannula.
The summary does not contain information about an AI/ML device, therefore, the following information is not available:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
However, it does provide acceptance criteria and a summary of the nonclinical and clinical tests performed.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Product/Performance Requirements) | Reported Device Performance |
|---|---|
| Visual Inspection: | |
| - Smooth surface | Met requirement |
| - Without oil contamination | Met requirement |
| - Without extraneous matter | Met requirement |
| - Without other defects | Met requirement |
| - Invisible lubricant on cannula | Met requirement |
| - Free of flash and burrs | Met requirement |
| Color: | |
| - Color of each cannula and cap meets product requirement | Met requirement |
| Dimensional: | |
| - All components met dimensional requirements | Met requirement |
| Functional: | |
| - Cap Pull off Force | Met requirement |
| - InviroLink/Syringe interface | Met requirement |
| - Penetration | Met requirement |
| - Bending | Met requirement |
| - Tip breaking Forces | Met requirement |
| - Flow rate | Met requirement |
| Interface: | |
| - Secure interface between InviroLink and medicine vial stopper | Able to withstand 330 kPa for 30 seconds without leakage |
| - Secure interface between InviroLink and syringe luer lock fitting | Able to withstand 330 kPa for 30 seconds without leakage |
2. Study that Proves the Device Meets the Acceptance Criteria:
The document states: "The InviroLink/InviroLink w/EZ Wings Plastic Cannulas met the following product/performance requirements: A visual inspection of the device showed that the surface of the device was smooth and without oil contamination or extraneous matter or other defects. The lubricant on the cannula was invisible and the device was free of flash and burrs."
The study described is a series of nonclinical performance tests conducted by Inviro Medical. The details provided are a direct summary of the outcomes of these tests, confirming that the device achieved the established product/functional requirements. There is no specific study name or reference provided beyond this summary.
Breakdown of the Nonclinical Tests:
- Visual Inspection: This involved physical examination to ensure the device's surface quality (smoothness, absence of contaminants, defects, flash, burrs) and the visibility of lubricant.
- Color Check: Verification that the cannula and cap colors conformed to product specifications.
- Dimensional Testing: Measurement of all components of the InviroLink and InviroLink w/EZ Wings to ensure they met the specified dimensional requirements outlined in the part/assembly drawings.
- Functional Testing: This encompassed several specific tests:
- Cap Pull off Force: Measuring the force required to remove the cap.
- InviroLink/Syringe interface: Assessing the integrity and fit of the connection to the syringe.
- Penetration: Evaluating the ease and effectiveness of penetrating rubber-stoppered vials or septums.
- Bending: Testing the device's resistance to bending.
- Tip breaking Forces: Determining the force at which the tip would break.
- Flow rate: Measuring the rate at which fluids can be dispensed through the cannula.
- Interface Testing: This focused on the security and integrity of the critical connections:
- Medicine Vial Stopper Interface: Testing the seal between the cannula and a medicine vial stopper.
- Syringe Luer Lock Fitting Interface: Testing the seal between the cannula and the syringe luer lock.
- Both interfaces were tested to withstand 330 kPa of pressure for 30 seconds without leakage.
The document presents the outcomes of these tests as conclusive proof that the device met all listed product/performance requirements. There's no mention of a traditional "study" in the sense of a published clinical trial or a detailed methodology report beyond this summary of successful outcomes.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).