(69 days)
The Inviro Snap Safety Insulin Syringes are intended for the subcutaneous injection of insulins. In addition, the Inviro Snap Safety Syringe is designed to aid in the prevention of needle stick injuries.
The Inviro Snap Safety Insulin Syringe is a 1 cc retractable type antineedlestick syringe. The syringe has a 100 unit scale in 1 unit increments. The Inviro Snap Safety Insulin Syringe is sterilized by gamma irradiation and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements. After use, with the plunger fully compressed, a 180 degree rotation of the plunger couples the Adapter/Needle to the end of the plunger. After this coupling occurs withdrawal of the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container.
The Inviro Snap Safety Insulin Syringe is a medical device intended for the subcutaneous injection of insulins and designed to prevent needle stick injuries. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with human readers or large-scale outcome data. Therefore, many of the requested elements (like MRMC studies, effect sizes of AI assistance, sample sizes for training sets with detailed ground truth establishment, expert qualifications for ground truth) are not applicable or detailed in this type of submission for this device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted, but it does not explicitly state numerical acceptance criteria for each test. It simply states that the "Inviro Snap Safety Insulin Syringe met all requirements." Without specific thresholds for "force to assemble/disassemble," "pressure leakage," "plunger action force," or "accuracy," a quantitative comparison in a table is not possible. However, the tests performed and the general conclusion are listed below:
| Acceptance Criteria (Implicitly Met) | Reported Device Performance |
|---|---|
| Biocompatibility Requirements: | |
| Cytotoxicity | Met all requirements |
| Intracutaneous Reactivity | Met all requirements |
| Maximization Sensitization Study | Met all requirements |
| In Vitro Hemolysis Study | Met all requirements |
| USP and ISO Systemic Toxicity Studies | Met all requirements |
| USP Prorogen Study | Met all requirements |
| Component Interface Tests: | |
| Force to assemble/disassemble cap | Met all requirements |
| Force to separate Adapter from Cannula | Met all requirements |
| Force to Snap off Plunger | Met all requirements |
| Cannula Bending Test | Met all requirements |
| Force required to press out Adapter from Barrel | Met all requirements |
| Syringe Assembly Tests: | |
| Freedom from air and liquid leakage past seals | Met all requirements |
| Pressure Leakage Test | Met all requirements |
| Plunger Action Force | Met all requirements |
| Accuracy | Met all requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each performance test performed. It generally refers to "Prior to testing, First Article Inspections were conducted on all components" and "The Inviro Snap Safety Syringe assembly was tested per the requirements of the ISO-FDA Modified Matrix, FDA/ODE General Program Memorandum - # G95-1 and ANSI/AAMI/ISO 10993-1:1997."
The data provenance is from Inviro Medical, based in Vancouver, BC, Canada. The testing appears to be retrospective in the sense that it was conducted on manufactured devices before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided as the device tests are engineering and biocompatibility tests, not diagnostic or interpretive tasks requiring human expert consensus for a "ground truth" in the traditional sense of medical image analysis or clinical data. The "ground truth" for these tests would be objective measurements against established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set:
This is not applicable as the tests are objective engineering and biocompatibility measurements, not subjective human interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical data (e.g., images) and the AI's impact on their performance is evaluated. The Inviro Snap Safety Insulin Syringe is a physical medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The "standalone" performance in this context refers to the device's own performance against engineering and biocompatibility standards, which was done. The listed tests (biocompatibility, component interface, and syringe assembly tests) are all evaluations of the device itself, independent of human interaction beyond normal use.
7. The Type of Ground Truth Used:
The ground truth used for the performance tests was based on established engineering standards, biocompatibility protocols (e.g., ISO, USP), and regulatory guidelines (FDA G95-1). This is a form of objective, quantitative measurement against predefined criteria.
8. The Sample Size for the Training Set:
This information is not applicable as this device is a physical medical product, not a software algorithm that undergoes machine learning training. There is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).