(16 days)
The Inviro Snap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the Inviro Snap Safety Syringe is designed to aid in the prevention of needle stick injuries.
The Inviro Snap Safety Syringe is a retractable type anti-needlestick syringe. The Inviro Snap Safety 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 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 After this coupling occurs withdrawal of the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel.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 provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Inviro Snap Safety Syringe.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with numerical targets for each test. Instead, it describes general requirements and states that the device "met all accuracy requirements," "met all of the biocompatibility requirements," and that "any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness."
However, we can infer some criteria and reported performance from the descriptions of the tests:
| Acceptance Criteria/Test | Performance Statement in Document |
|---|---|
| Biocompatibility | * "The Inviro Snap Safety Syringe met all of the biocompatibility requirements." |
| - Cytotoxicity | * (Part of "all biocompatibility requirements") |
| - Intracutaneous Reactivity | * (Part of "all biocompatibility requirements") |
| - Maximization Sensitization Study | * (Part of "all biocompatibility requirements") |
| - In Vitro Hemolysis Study | * (Part of "all biocompatibility requirements") |
| - USP/ISO Systemic Toxicity Studies | * (Part of "all biocompatibility requirements") |
| - USP Pyrogen Study | * (Part of "all biocompatibility requirements") |
| Scale Accuracy | * "The scale met all accuracy requirements." |
| Force to separate Adapter from Cannula | * "The ISO Standard requires a minimum of 4,9 lbs of force to separate the cannula from the adaptor." |
| * "The average force along with the standard deviation was determined for separating the cannula from the adapter." | |
| Freedom from air and liquid leakage past seals | * "Medication leakage can occur around the plunger seal or around the needle holder. This test involves blocking the needle lumen and forcing the plunger handle forward. Pressure is increased incrementally and held for several seconds at each increment. The pressure at which leakage occurs and the location of the leak is recorded." |
| * Implicit acceptance: No leakage at required pressures. | |
| Pressure Leakage Test (internal pressure) | * "In this test series, the system was submerged in liquid and an internal pressure of 43.5 and 400 PSI was applied. Any leakage past the seals was recorded." |
| * Implicit acceptance: No leakage at required pressures. | |
| Plunger Action Force | * "This test measures the force to initiate plunger action as well as the maximum and minimum forces required to move the plunger within the Barrel." |
| * Implicit acceptance: Plunger action within acceptable force range for usability. | |
| Force to Assemble/Disassemble Cap | * "The average force along with the standard deviation is determined to assemble and disassemble the Cap from the Barrel. A good seal between the cap and barrel will reduce the chance that the cap will fall off and expose the needle." |
| * Implicit acceptance: Force within a range that ensures a good seal and ease of use. | |
| Force to Snap off Plunger | * "A torque gauge is used to snap off the plunger from the syringe. This test will verify that the plunger is not too difficult to snap off." |
| * Implicit acceptance: Plunger snaps off within an acceptable force range for safe disposal. | |
| Cannula Bending Test | * "To verify the cannula can withstand the forces required to penetrate a medicine bottle septum." |
| * Implicit acceptance: Cannula withstands forces without bending inappropriately. | |
| Force required to press out Adapter from Barrel | * "This test determines the force required to push/press out the adaptor from the barrel. This test will assure that the adaptor is not pushed out during an injection." |
| * Implicit acceptance: Adapter remains in place during injection. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size for any of the individual verification (test set) tests. It mentions "all components" for First Article Inspections and material verification but doesn't quantify the number of devices or components tested for the performance evaluations.
- Data Provenance: The studies are described as nonclinical (biocompatibility, mechanical testing) and were conducted within the context of the device manufacturer and its testing processes. The country of origin for the data is not specified beyond the submitter's address being in Vancouver, BC, Canada, implying the studies were performed or overseen by entities associated with Inviro Medical. The studies appear to be prospective as they were conducted specifically for the purpose of validating this device model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable: For a device like a syringe, "ground truth" in the sense of expert medical diagnosis or interpretation (e.g., as in an AI imaging study) is not applicable. The evaluations are based on objective physical and chemical tests, and compliance with established standards (ISO, AAMI, FDA G95-1).
4. Adjudication Method for the Test Set
- Not Applicable: As the tests are objective, physical, and chemical measurements against predefined criteria/standards, an adjudication method for conflicting expert opinions is not relevant. The results are binary (pass/fail) based on measurement outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) with and without AI assistance. The Inviro Snap Safety Syringe is a mechanical medical device, not a diagnostic tool, so such a study would not be relevant.
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone study was done, but not for an algorithm in the typical AI sense. All the described tests (biocompatibility, scale accuracy, mechanical tests like force to separate cannula, leakage tests, plunger action force, etc.) evaluate the device's inherent physical and chemical properties and performance without human intervention during the test itself. This is akin to standalone performance for a mechanical device. There is no "algorithm" to be evaluated independently of human interaction in this context; the device itself is the "algorithm" in how it functions mechanically.
7. Type of Ground Truth Used for the Test Set
- Objective Standards and Measurements: The ground truth for the device's performance is established by:
- International Standards: ISO 7864:1993(E), ISO 7886-1:1993(E), ANSI/AAMI/ISO 10993-1:1997.
- Regulatory Guidance: FDA G95-1 (General Program Memorandum).
- Material Specifications: Verification tests on components and materials.
- Engineering Specifications: Designed tolerances and performance characteristics (e.g., "minimum of 4.9 lbs of force to separate the cannula").
- Physical Measurements: Data collected from weighing, force gauges, pressure transducers, etc.
8. Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms. The Inviro Snap Safety Syringe is a manufactured medical device, not an AI model. Its design and manufacturing processes are based on engineering principles and established standards, rather than statistical learning from data in a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for an AI/machine learning model, the concept of establishing ground truth for it does not apply. The device's design is based on established engineering principles, material science, and regulatory requirements, not learned from a "ground truth" dataset.
§ 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).