(74 days)
The primary indicated use for the 1cc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid.
The secondary indicated use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
The 1cc Insulin SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries. Other than scale graduation for use with U-100 strength insulin, the 1cc Insulin SafePro* Safety Syringe is essentially identical to the legally marketed 1cc SafePro* Safety Syringe in design and materials of construction.
The provided documentation describes the 1cc Insulin SafePro Safety Syringe and its substantial equivalence to predicate devices, rather than a study involving acceptance criteria and device performance in the context of an AI or diagnostic device.
Therefore, many of the requested fields cannot be filled, as the document is a 510(k) summary for a physical medical device, not a software or AI-driven diagnostic tool. The "performance" discussed relates to design and material equivalence, as well as the safety features of the syringe itself.
Here's an attempt to extract relevant information, with an emphasis on what cannot be answered given the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way a study for a diagnostic or AI device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily shown through the comparison matrix and claims of identical design and materials.
| Factor | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Primary Intended Use | Aspiration and infusion of insulin fluid | "Identical to ... SafePro Safety Syringe" (K022063) in design and materials, which is functionally equivalent. |
| Secondary Intended Use (Needlestick Protection) | Reduce risk of accidental needlestick injuries | Built-in safety feature; "Identical to ... SafePro Safety Syringe" (K022063) in safety features and characteristics. Claims to reduce risks of accidental needlesticks. |
| Material Safety/Biocompatibility | Meet established safety and biocompatibility standards | Materials identical to predicate devices (K012726, K022063) that were previously tested and found safe. |
| Functional & Performance Characteristics | Operate effectively and safely (e.g., manual actuation of safety mechanism, safety mechanism remains activated during disposal, integral part of device) | "Identical to ... SafePro Safety Syringe" (K022063) features and characteristics, which were previously verified and validated. |
| Substantial Equivalence to Predicate | Demonstrate equivalence in intended use, technology, materials | Claims "essentially equivalent" to B-D Conventional hypodermic and insulin syringe (K980580) and 1cc SafePro Safety Syringe (K022063) in design, materials, instructions for use, and product claims. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a test set of data for an AI or diagnostic device. The "testing" referred to is material testing and simulated use studies for a physical device, which were previously conducted on predicate devices. There is no mention of a "test set" in the context of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is described, as this is not an AI or diagnostic device. The "ground truth" for a physical device like this is typically established through adherence to engineering standards, material specifications, and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method described for an algorithm or diagnostic performance.
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. This document pertains to a physical medical device (syringe with a safety feature), not an AI or diagnostic device requiring human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is largely based on:
- Material compatibility and safety standards: Established through prior testing of identical materials in predicate devices (K012726, K022063).
- Functional performance standards: Demonstrated by the physical design and features being identical to previously cleared devices.
- Substantial Equivalence: Comparison to legally marketed predicate devices (K980580, K012726) that have already met regulatory requirements.
- Guidance documents: The comparison matrix was developed in accordance with the "Supplementary Guidance on the Content of Premarket Notification [510(K)] Submissions for Medical Device with Sharp Injury Prevention Features (March, 1995)".
8. The sample size for the training set
Not applicable. There is no training set for an AI or diagnostic algorithm described.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the context of this device.
§ 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).