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The Cystoject Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.

The Cystoject Syringe Lever is a reusable device that is intended for use in the delivery of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of the physician. The Cystoject Syringe Lever body contains a housing for holding a standard syringe and a lever that pushes the syringe's plunger when the user rotates its knob. A clutch mechanism allows the user to quickly move the lever to the syringe plunger's position. The Cystoject Syringe Lever does not require an energy source, does not utilize electrical components, and does not utilize software or hardware. The Cystoject Syringe Lever does not come into direct or indirect contact with the patient nor with fluids intended for instillation. The Cystoject Syringe Lever is provided non-sterile as a reusable, reprocessable device to be cleaned and sterilized or high-level disinfected before each use. The Cystoject Syringe Lever indicated for use with a 30 mL syringe.

The provided text describes a 510(k) premarket notification for the "Cystoject Syringe Lever." This is a device for administering sterile materials, not an AI/ML powered device, therefore the typical acceptance criteria and study information for AI/ML devices, such as performance metrics, sample sizes for test and training sets, expert qualifications, and MRMC studies, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Uroject12 Syringe Lever) based on intended use, technological characteristics, and non-clinical performance tests.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document states that "The results of the validation testing demonstrate that the Cystoject Syringe Lever met all predetermined acceptance criteria." However, the specific acceptance criteria and detailed performance results are not publicly available in this FDA letter/summary. The performed tests were:

2. Sample size used for the test set and the data provenance:

Not applicable. The described tests are non-clinical (validation testing of the physical device), not an evaluation of diagnostic accuracy using a test set of medical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not an AI/ML device that requires expert-established ground truth for a test set.

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.

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. The "ground truth" for a mechanical device's performance would be engineering specifications and functional requirements.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that utilizes a training set.

9. How the ground truth for the training set was established:

Not applicable.

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