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The Clip'n'Ject Reconstitution System is a single use device intended to transfer diluent into a vial containing a lyophilized drug, mix the diluent and the lyophilized drug, and transfer the reconstituted drug into a standard syringe. The Clip'n'Ject Reconstitution System may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physician to administer injections of prescribed medication.

Clip'n'Ject Reconstitution System is a single use device intended to transfer, mix and inject lyophilized drugs contained in vials. The Clip'n'Ject Reconstitution System shown in Figure 1 is comprised of a sliding joint and connector and is compatible with a BD Readyfill or comparable syringe(s). The syringe and needle would be legally authorized through its own clearance or customer NDA and is not intended to be cleared as part of this premarket notification. The needle is attached to the syringe by means of a standard luer connection. The sliding joint is placed onto a portion of the syringe. The syringe with the sliding joint and needle is inserted into the connector. The user attaches the Clip'n'Ject Reconstitution System to a vial by inserting the vial into the connector. The system is then activated by pressing down on the syringe. This advances the needle into the vial through the vial stopper. The user then attaches the plunger rod to the syringe. The contents of the syringe are then transferred into the vial. Mixing of the syringe contents and vial contents then occurs. After this is complete, the mixture is then drawn back into the syringe. The syringe with needle attached is then removed from the connector and sliding joint. The syringe can then be used for administration. This system is disposable and for single use only.

The provided text describes the "Clip'n'Ject Reconstitution System" and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving device performance against such criteria in the detail requested by the prompt.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a detailed performance study with acceptance criteria.

However, I can extract the information that is present concerning performance, testing, and regulatory compliance.

Here's a breakdown of what is available in the provided text:

Summary of Performance and Compliance Information from the Document:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria table or quantitative performance data (e.g., sensitivity, specificity, accuracy, error rates) is provided for the Clip'n'Ject Reconstitution System itself. The document states "A six (6) point comparison of technological characteristics... The devices were found to be substantially equivalent," indicating a qualitative comparison rather than a quantitative performance study with thresholds.

The document does list compliance with recognized consensus standards:

• ANSI/AAMI/ISO 11135-1995: Guideline for Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
• AAMI TIR 10:2000: Process Development and Performance Qualification for Ethylene Oxide Sterilization - Microbiological Aspects
• AAMI/ANSI/ISO: 10993-7:1995 ® 2001: Biological Evaluation of Medical Devices part 7: Ethylene Oxide Sterilization Residuals

However, these are standards for sterilization and biocompatibility, not for the functional performance (e.g., drug transfer efficiency, leak rates, mixing effectiveness) of the reconstitution system itself as would be presented in a performance study with defined acceptance criteria.

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 performance study directly evaluating the Clip'n'Ject system against specific acceptance criteria is detailed. The comparison was for "technological characteristics."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment is described for a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.

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 medical device for drug reconstitution, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described. The "Summary of Technological Characteristics" mentions a six-point comparison. For substantial equivalence, the "ground truth" implicitly refers to the characteristics and performance capabilities of the predicate devices.

8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.

In summary, the provided document is a regulatory submission for substantial equivalence (510(k)) and not a detailed clinical or performance study with defined acceptance criteria and results for the device's functional attributes. It focuses on comparing technological characteristics and compliance with general standards rather than specific performance metrics.

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