(26 days)
The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically 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 patient authorized by their physicians to self inject at home.
The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically 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.
This submission (K051985) is for a "label-only" modification to an already marketed device, the BioValve Mini-Ject Needlefree Injection System. As such, the submission explicitly states that no performance data was required or provided to demonstrate the device meets acceptance criteria because the technological characteristics and the device itself remained unchanged.
Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this specific 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable. This submission focuses on updating the Instructions for Use (labeling) for an already marketed device. The text explicitly states: "No change was made to the Mini-Ject device and therefore no physical testing was required to confirm the injectors meet their specifications." This indicates that previous acceptance criteria were met by the device itself, but those criteria and performance data are not part of this submission.
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 new performance testing was conducted for this label-only modification.
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. No new performance testing was conducted for this label-only modification, so no ground truth establishment for a test set was required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance testing was conducted for this label-only modification.
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 device is a needle-free injection system, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical injection system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new performance testing was conducted for this label-only modification.
8. The sample size for the training set
- Not applicable. This device is a mechanical injection system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a mechanical injection system, not a machine learning model.
Summary of the 510(k) Submission (K051985):
This 510(k) submission sought to update the Instructions for Use (IFU) for the BioValve Mini-Ject Needlefree Injection System. The device itself (including its technological characteristics) remained unchanged from the previously cleared version (K021969). Therefore, the manufacturer stated, and the FDA determined, that no new performance data or testing was required to demonstrate substantial equivalence for this specific submission, as it was solely a labeling modification. The substantial equivalence was based on the device being identical to the legally marketed predicate device, with only the instructions for use being updated to clarify and simplify warnings, precautions, and contraindications.
§ 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).