(21 days)
The Injex 30 Injector System is designed to deliver various medicines and vaccines by means of a narrow, high velocity jet of fluid which penetrates the surface of the skin and delivers the medicine or vaccine to the body.
Equidyne Systems Injex 30 Injector System is a means of administering subcutaneous medications without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the medication in the subcutaneous tissue. The process takes place in a fraction of a second. Needle free injection is useful in a wide range of drug therapy including immunization vaccines, hormones and local anesthetics, as well as the administration of insulin to the diabetic population, where individuals may need a number of injections per day.
The Injex 30 Injector system consists of four main components;
- Injector A small re-usable hand held Injector,
- Reset Box A compact re-usable Reset Box used to reset and store the Injex 30 Injector,
- Ampule A disposable, sterile 0.3 ml Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Ampule is loaded into the Iniex 30 Iniector, the dose is injected into the individual by releasing the Safety and pressing the trigger.
- Vial Adapter A disposable, sterile Vial Adapter facilitates the transfer of the medication from the medicine bottle or vial to the Ampule.
The Injex 30 Injector can deliver variable doses of fluid medication from 0.05 ml to 0.30 ml.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Injex 30 Needle Free Injection System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner for the Injex 30's primary function of medication delivery compared to a predicate. Instead, it describes a comparative study aiming for "substantial equivalence." The "acceptance criteria" are implied by the conclusion of this equivalency testing.
| Acceptance Criteria (Implied) | Reported Device Performance & Conclusion |
|---|---|
| Biocompatibility: Device materials are non-toxic. | Cytotoxicity: Non-toxic (Agarose Overlay test). |
| Biocompatibility: Device materials are non-irritating. | Irritation/Sensitization: Non-irritating (Primary Skin Irritation test in rabbits). |
| Equivalency (Injection Performance): Flow and dispersion of injected fluid is substantially equivalent to the predicate device (Hypex Jet Injector). | Equivalency Tests: "The results of testing showed that the flow and dispersion of the injected fluid from the Injex 30 Injector System was substantially equivalent to that of the predicate device." (Performed using colored water in a chicken breast model at various volumes: 0.05, 0.10, 0.15, 0.20, 0.25, and 0.30 ml). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "equivalency tests" involved injecting colored water into chicken breasts. The term "chicken breast" was used as a human subcutaneous tissue model.
- Sample Size: The document does not specify the number of chicken breasts used, or how many injections were performed at each volume.
- Data Provenance: The study was conducted by Equidyne Systems Inc. It is a prospective study, specifically designed to demonstrate equivalence for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- No external experts are mentioned for establishing ground truth regarding the injection performance.
- The comparison was performed internally by Equidyne Systems Inc., with "The injection sites were then dissected and the flow and dispersion of the colored water was examined and compared" to the predicate device. The qualifications of the individuals performing this comparison are not stated.
4. Adjudication Method for the Test Set
- None described. The comparison appears to have been a direct observation and qualitative assessment by the company, not involving a formal adjudication process or multiple independent reviewers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This study solely focused on the physical characteristics of the injection performed by the device, not on human reader interpretation or clinical outcomes with and without AI assistance. The device is a physical delivery system, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
- Yes, a standalone study was done. The "equivalency tests" were conducted on the device itself (Injex 30 Injector System) in a model (chicken breast) to assess its performance in delivering fluid compared to a predicate device, independent of human interaction beyond the operation of the device during the test. There is no AI involved, so the concept of "human-in-the-loop" is not applicable here.
7. Type of Ground Truth Used
- For Biocompatibility: Laboratory test results (non-toxic, non-irritating) are the ground truth.
- For Equivalency (Injection Performance): The "ground truth" was a direct comparison to the predicate device's performance in the same chicken breast model. The predicate's fluid flow and dispersion characteristics served as the benchmark for "substantial equivalence." This is a comparative engineering/performance assessment, not a clinical ground truth like pathology or patient outcomes.
8. Sample Size for the Training Set
- Not applicable. The Injex 30 is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, this question is irrelevant to the Injex 30.
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).