(174 days)
The 3S Safety Insulin Syringe a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The 3S Safety Insulin Syringe is an integrated needle and piston syringe with an innovative antineedle-stick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques are required to use the safety mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn, snapped off and used syringe is discarded into a sharps container per regulatory provision.
The 3S safety syringe with/without Needle will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G )
The provided text describes a 510(k) premarket notification for the "3S Safety Insulin Syringe." The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data for a novel device or AI algorithm.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided in the format requested. The document does not describe a performance study with specific acceptance criteria, sample sizes, expert ground truth, adjudication methods, or AI comparative effectiveness.
However, I can extract the information related to the device's characteristics and the basis for its substantial equivalence, as presented in the document.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of acceptance criteria for a performance study. Instead, it presents a Safety Syringe Comparison Table showing the characteristics of the submitted device against a predicate device to demonstrate substantial equivalence. The "performance" aspect is generally referred to as "Conforms to ISO7864 ISO8537" and "Conforms to ISO10993" for biocompatibility. These are general standards, not specific acceptance criteria for a performance study in the context of device function or efficacy.
| Element of Comparison | Submission Device (3S Safety Insulin Syringe) | Predicate Device (InsoSAFE BakSNAP Retractable Insulin Safety Syringe) |
|---|---|---|
| Intended Use | A sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. | A sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. |
| Principle of Operation | Normal | Normal |
| Syringe Capacity | Various Sizes | Various Sizes |
| Nozzle Type | N.A | N.A |
| Lubricant for Barrel | Silicone Oil | Silicone Oil |
| Barrel Transparency | Transparent and Clear | Transparent and Clear |
| Gradations Legibility | Legible | Legible |
| Barrel Material | PP | PP |
| Plunger Material | PP | PP |
| Piston Material | TPE | TPE |
| Needle Hub Material | PP | PP |
| Needle Material | Stainless Steel | Stainless Steel |
| Needle Sheath Material | PP | PP |
| Needle Gauge and Length | Various Sizes | Various Sizes |
| Lubricant for Needle | Silicone Oil | Silicone Oil |
| Sharps Injury Prevention Method | Manual Retractable | Manual Retractable |
| Performances Status | Conforms to ISO7864 ISO8537 | Conforms to ISO7864 ISO8537 |
| Biocompatibility Status | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling Status | Meet the requirements of 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document.
- Data Provenance: Not specified in the document. The document refers to a comparison to a predicate device and conformance to ISO standards, but no details of original test data are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This document pertains to a medical device (syringe), not an AI/imaging diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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 is not an AI/imaging diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not specified. The assessment relies on conformity to established international standards (ISO7864, ISO8537 for performance; ISO10993 for biocompatibility) and comparison of physical/material characteristics with a predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the Study/Basis for Acceptance (as per the document):
The "study" in this context is a substantial equivalence determination based on a comparison between the 3S Safety Insulin Syringe and a legally marketed predicate device (InsoSAFE BakSNAP Retractable Insulin Safety Syringe, K050131).
The core of the "proof" is the "Safety Syringe Comparison Table" in Section 6, which argues that the "materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent."
The performance aspects are addressed by stating that the device "Conforms to ISO7864 ISO8537" (likely for sterile hypodermic syringes and needles) and "Conforms to ISO10993" (for biological evaluation of medical devices). This implies that standard tests dictated by these ISO norms were conducted and passed, but the specifics of those tests, their acceptance criteria, and specific data are not detailed in this 510(k) summary.
§ 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).