(301 days)
The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
The Insulin Syringe with Safety Retractable is a sterile, single use 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.
(1) Insulin Syringe
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).
(2) Insulin Syringe with Safety Retractable
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube, safety shield and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).
1. Acceptance Criteria and Reported Device Performance:
The document outlines the acceptance criteria by stating that the device "conforms with the requirements of ISO 7864 and ISO 8537" for performance, safety, and effectiveness, and "conforms to the requirement of ISO 10993 series Standards" for biocompatibility.
For the "Insulin Syringe with Safety Retractable," additional performance criteria specifically related to the safety feature are provided:
| Acceptance Criteria (Safety Feature) | Reported Device Performance |
|---|---|
| In-Safe mode force: not be more than 5N | Test value: 3.45-4.45N |
| Resist force: 60s with 20N weights, and the protective device shall not be opened. | Test value: >20N/60s |
For the general Insulin Syringe and Insulin Syringe with Safety Retractable, the following criteria are implicitly met by conformance to the cited ISO standards. The "Reported Device Performance" column indicates that the device did conform to these standards.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Biocompatibility: No cytotoxicity, no irritation to skin, no significant evidence of sterilization, no systemic toxicity, no hemolysis, no pyrogen (based on ISO 10993 series) | Conforms to ISO 10993 series Standards |
| Performance, Safety & Effectiveness (general syringe functionality): Cleanliness, limits for acidity or alkalinity, limits for extractable metals, needle cap, tolerances on length, freedom from defects, lubricant, needle point, bond between hub and needle tube, patency of lumen, sharps injury protection (based on ISO 7864) | Conforms with ISO 7864 |
| Performance, Safety & Effectiveness (insulin syringe specific): Color coding, limits for acidity or alkalinity, limits for extractable metals, lubrication of syringes, lubrication of needle tube, barrel and plunger stopper, finger grips, fit of plunger stopper in barrel, position of nozzle on end of barrel, needle tubing for specific syringe types, bond between hub and needle tube, dead space, freedom from leakage at needle, freedom from leakage past plunger stopper (based on ISO 8537) | Conforms with ISO 8537 |
| Stainless Steel Needle Tubing: Dimensions, Stiffness, Resistance to breakage, Resistance to corrosion (based on ISO 9626) | Conforms with ISO 9626 |
| Particulate matter testing | Performed per USP , Method 1 |
| ETO residuals | Performed per ISO 10993-7:2008 |
| Packaging and Shelf life testing | Performed per ASTM D4169-16, ASTM F1929-15:1998 ASTM F88:2009 |
| Risk Management Report | Available (implied conformance) |
| Sharps Injury Protection | Performed per ISO 23908 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the non-clinical tests. It refers to standards like ISO 7864, ISO 8537, ISO 10993, ISO 9626, USP , ASTM D4169, ASTM F1929, ASTM F88, and ISO 23908. These standards likely define the minimum sample sizes for relevant tests. The data provenance is implied to be from testing conducted by Jiangsu Micsafe Medical Technology Co., Ltd in China, as it is the submitting company. The studies are prospective in nature, as they involve testing the device to ensure it meets established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish a "ground truth" in the context of clinical or diagnostic studies. The evaluation is focused on demonstrating conformance to established international and national standards for medical devices. Therefore, the "ground truth" is defined by the technical specifications and performance requirements outlined in these standards. The experts involved would be the engineers, scientists, and technicians conducting the tests and interpreting the results in accordance with these standards. Their qualifications would align with the specific tests performed (e.g., biocompatibility specialists, mechanical testing engineers).
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective measurements against predefined criteria in recognized standards, not subjective interpretations requiring adjudication.
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 a medical device (insulin syringe) that does not involve "readers" or Artificial Intelligence (AI) for diagnostic or interpretive tasks. The studies are related to the physical performance, safety, and biocompatibility of the syringe itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used:
The ground truth used for these studies is defined by the established technical specifications and performance requirements detailed in the referenced international (ISO) and national (ANSI AAMI, ASTM, USP) standards. These standards set the benchmarks for characteristics like biocompatibility, sterility, physical dimensions, material properties, and safety features.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of a physical medical device undergoing performance and safety testing. This document describes the testing of a finished product against established standards, not the training of a machine learning model.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device submission.
§ 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).