(205 days)
The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This non electrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patients authorized by their physicians to self inject at home.
The Mini-Ject is a sterile, single use medical device. The Mini-Ject delivers 0.5ml subcutaneously. The device consists of an injector and a luer adapter to provide a means of filling the device using a standard slip lock syringe. The device is powered by a proprietary charge system wholly contained in the distal portion of the device.
The provide submission does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a typical diagnostic or AI/ML device submission would. This 510(k) submission is for a physical medical device—a needle-free injection system—and its approval is based on demonstrating substantial equivalence to a predicate device rather than performance against a set of predefined acceptance metrics for accuracy, sensitivity, or specificity.
Instead, the submission focuses on:
- Device Description: Detailing the components and function of the "Mini-Ject Needlefree Injection System."
- Substantial Equivalence: Comparing the proposed device to a legally marketed predicate device (Biojector 2000) based on intended use, system configuration, materials, packaging, sterility, shelf life, and fill adapter. The goal is to show that the new device is as safe and effective as the predicate.
- Intended Use Statement: Clearly defining the purpose and user population for the device.
Based on the information provided, here's how to address your questions in the context of this device type:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) are provided for this needle-free injection system in the document. The regulatory pathway here is demonstrating "substantial equivalence," not meeting quantitative performance targets in the same sense as an AI/ML or diagnostic device.
The "performance" is implicitly demonstrated through the comparison table, showing that:
| Feature | Predicate Device (Biojector 2000) Performance | Proposed Device: Mini-Ject Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Intended Use | Needlefree subcutaneous and intramuscular injection system | Needlefree subcutaneous injection system (0.5ml only) | Safe and effective delivery of medication subcutaneously. |
| Materials - Fluid Contact | Polycarbonate, Silicone, Polystyrene | Polycarbonate, Silicone, ABS, UHMWPE | Biocompatible and suitable for fluid contact. |
| Packaging | Tyvek/Film Pouch | Same | Maintains sterility and device integrity. |
| Sterility | Ethylene Oxide (ETO) Sterilized | Same | Sterile. |
| Shelf Life | 3 years | 3 years | Stable efficacy and sterility over the declared shelf life. |
| Fluid Delivery | Multiple orifices for achieving subcutaneous or intramuscular injections in various injection volumes | Set orifice size and energy source designed to achieve 0.5 ml subcutaneous injections only (fully disposable) | Delivers specified 0.5 ml subcutaneously with appropriate force for skin penetration and drug dispersion. |
The main "study" proving the device meets the (implicit) acceptance criteria is the comparison to the predicate device, asserting that its fundamental technology, materials, and intended function are comparable, and any differences (like being fully disposable and fixed volume/route) do not raise new questions of safety or effectiveness.
Regarding your other questions, they are largely not applicable to this type of 510(k) submission for a physical, non-AI medical device:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the context of diagnostic performance or AI model evaluation is mentioned. Device testing would have been conducted for aspects like sterility, material compatibility, dose delivery accuracy, and shelf life, but details on sample sizes for such engineering/bench tests are not provided in this summary document.
3. 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)
Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is a physical injection device, not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to successful fluid delivery, sterility, and material safety, which are confirmed through engineering tests and material specifications, not clinical outcomes or expert consensus on a diagnostic interpretation.
8. The sample size for the training set
Not applicable. This device does not have a "training set" as it's not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable.
§ 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).