Search Results

It is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes. The safety shield is intended to reduce the risk of sharp injuries.

Verifine Mechanical Safety Insulin Syringe is a sterile device consisting of a calibrated barrel with plunger intended to be used to administer an injection of insulin to a patient subcutaneously. It includes an attached needle with a safety mechanism, i.e, after the injection, the protective shield will permanently be locked in place by pushing forward till click, providing protection against needle sticks and rendering the device unusable.

This document is a 510(k) summary for the Verifine Mechanical Safety Insulin Syringe. It outlines the device's characteristics, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's the information extracted and structured as requested:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document refers to various ISO and ASTM standards, implying that compliance with these standards serves as the acceptance criteria for different aspects of the device's performance. The "reported device performance" is generally stated as "Complied" or "met the USP acceptance criteria," indicating successful adherence to these standards.

2. Sample Sizes Used for the Test Set and the Data Provenance:

The document does not specify exact sample sizes for each test set. It mentions "bench testing" and "simulated clinical use testing," but specific numbers of devices tested are not provided. The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not provided in the document. The tests performed are primarily bench testing against established engineering and biocompatibility standards, rather than tests requiring expert human interpretation for "ground truth."

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The tests described are objective measurements against defined standards, not subjective assessments requiring adjudication by multiple experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not conducted or described in this 510(k) summary. The device is a physical medical instrument (insulin syringe) and the evaluation focuses on its physical and biological performance characteristics, not on diagnostic accuracy requiring human reader interpretation with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a mechanical insulin syringe, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the tests performed is based on established international and national standards (e.g., ISO, ASTM, USP) for medical device performance, biocompatibility, sterility, and packaging. For example, "No cytotoxicity" is the ground truth for the cytotoxicity test if the criteria of ISO 10993-5 are met.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical insulin syringe, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, this device does not involve a training set.

Ask a specific question about this device