(450 days)
The TK Insulin Syringe with Safety Retractable Device is a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The TK Insulin Syringe is a sterile, single-use, disposable, insulin syringe intended for injection of U-100 insulin into the body.
The TK Insulin Syringe with/without Safety Retractable Device are similar devices except one has a safety feature and the other is a standard insulin syringe.
The TK Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharp's container.
The subject devices are sterile, single-use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
The provided text describes a 510(k) premarket notification for the "TK Insulin Syringe with/without Safety Retractable Device." The submission aims to demonstrate substantial equivalence to a predicate device, the "U&U Insulin Syringe with/without Safety Retractable Device."
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it relies on demonstrating conformance to established international and national standards. The implicit acceptance criteria are defined by these standards, and the reported performance is that the device "conforms" to them.
Here's a summary of the standards the device was tested against, which serve as the implicit acceptance criteria:
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| ISO 8537:2016 (Sterile single-use syringes, with or without needle, for insulin) | Conforms |
| ISO 7864:2016 (Sterile hypodermic needles for single use - Requirements and test method) | Conforms |
| ISO 9626:2016 (Stainless steel needle tubing for manufacture of medical device - Requirements and test method) | Conforms |
| ISO 23908:2011 (Sharps Injury Protection - Requirements and test methods - Sharps protection features) | Conforms |
| Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features | Conforms |
| ISO 10993 (Biocompatibility - various parts: 1, 4, 5, 7, 10, 11) | Conforms |
| USP (Particulate Matter for injection) | Conforms |
| 21 CFR Part 801 (Labeling requirements) | Meets requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the non-clinical tests performed on the subject device (e.g., number of syringes tested for performance standards, number of samples for biocompatibility).
The data provenance for these tests is that they were "performed on the subject device" by the manufacturer, Anhui Tiankang Medical Technology Co.,Ltd. The origin of the data would be associated with the manufacturing and testing facility in Tianchang City, Anhui, China. The studies are by nature prospective, as they involve testing the newly manufactured device against established criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. The "ground truth" for insulin syringes and needles is established by internationally recognized performance and safety standards (e.g., ISO, USP), not by expert consensus on individual test instances in the way one might evaluate an AI diagnostic tool. The compliance with these standards is objectively measurable through predefined test methods.
4. Adjudication method for the test set
This information is not applicable. Since the evaluation is based on conformance to objective standards with predefined test methods, there is no need for expert adjudication of results in the traditional sense of a clinical or image interpretation study. The interpretation of test results against the specified criteria of the standards would be straightforward.
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
This information is not applicable. The device is an insulin syringe, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device (an insulin syringe), not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance and safety is derived from established international and national standards for medical devices, specifically:
- Performance Standards: ISO 8537, ISO 7864, ISO 9626, ISO 23908.
- Biocompatibility Standards: ISO 10993 (various parts).
- Other Quality Standards: USP (Particulate Matter), 21 CFR Part 801 (Labeling).
8. The sample size for the training set
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by established engineering principles and prior knowledge from similar devices, but not by a data training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #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).