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510(k) Data Aggregation
(182 days)
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.
| Performance Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Needle Tubing (Stainless Steel) | ISO 9626:2016 | Bench testing performed verifies performance |
| Sterile Hypodermic Needles | ISO 7864:2016 | Bench testing performed verifies performance |
| Sterile Single-Use Syringes for Insulin | ISO 8537:2016 | Bench testing performed verifies performance |
| Sharps Injury Protection | ISO 23908:2011 | Bench testing performed verifies performance |
| Sharps Injury Prevention Features | FDA guidance, Medical Devices with Sharps Injury Prevention Features | Simulated clinical use testing conducted |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 | No cytotoxicity |
| Biocompatibility (Skin Irritation) | ISO 10993-10:2010 | No evidence of skin irritation |
| Biocompatibility (Skin Sensitization) | ISO 10993-10:2010 | No evidence of sensitization |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11:2006 | No systemic toxicity |
| Biocompatibility (Subacute Systemic Toxicity) | ISO 10993-11:2017 | No systemic toxicity |
| Biocompatibility (Hemocompatibility) | ISO 10993-4:2017 | No evidence of hemolysis |
| Biocompatibility (Pyrogen) | USP42-NF37 | Non pyrogenic |
| Particulate Matter | USP | Met the USP acceptance criteria |
| Sterilization (Ethylene Oxide) | ISO 11135:2014 | Complied with standard |
| Package Integrity | ASTM D4169-16 | All packaging deemed acceptable for protection of product and sterility maintenance |
| Seal Strength | ASTM F88/F88-15 | Performed |
| Dye Penetration | ASTM F1929-15 | Performed |
| Sterility Test | USP38-NF33 C71 | Performed |
| Shelf Life | ASTM F1980-16 | 5 years validated |
| Hub/Needle bond strength (≥0.33mm) | Implicit: Minimum shearing strength 22N | Implied compliance via "Same" to predicate |
| Hub/Needle bond strength ( |
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