Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
Hypodermic Safety Needle: The Hypodermic Safety Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The device is used for subcutaneous injection, intravenous injection of blood and preparation of liquid medicine. The needle tube will be pushed into safety cap after use. It is designed to aid in the prevention of needle stick injuries. This device is a single use device, which is delievered sterile. The device is a disposable anti-needle stick syringe made of the following components: Needle cap, Needle tube, Safety shield, Needle hub, Barrel, Plunger, Plunger stopper.
The provided document describes the acceptance criteria and the studies conducted for the Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.'s Hypodermic Safety Needle and Hypodermic Safety Needle with Syringe.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The document states that "All of the pre-determined acceptance criteria were met" for each of the performance tests, biocompatibility tests, and sterility information tests. Specific numerical acceptance criteria are generally not explicitly detailed in this type of summary report but are implied by adherence to the referenced standards.
| Type of Test | Acceptance Criteria (Implied by standard adherence) | Reported Device Performance |
|---|---|---|
| Performance Testing | Met requirements of referenced ISO standards | All pre-determined acceptance criteria were met. |
| ISO 9626: 2016-08-01 | (Stainless steel needle tubing requirements) | Met. |
| ISO 7864: 2016-08-01 | (Sterile hypodermic needles requirements) | Met. |
| ISO 594-1:1986-06-15 | (Luer taper fittings - General requirements) | Met. |
| ISO 594-2: 1998-09-01 | (Luer taper fittings - Lock fittings) | Met. |
| ISO 23908: 2011-06-11 | (Sharps injury protection requirements) | No failures of the safety feature were demonstrated. |
| ISO 7886-1: 2017-05 | (Sterile hypodermic syringes requirements) | Met. |
| ISO 6009: 2016-08-01 | (Needle color coding requirements) | Met. |
| Simulated Clinical Study | No failures of the safety feature | No failures of the safety feature of the Hypodermic Safety Needle with Syringe. All pre-determined acceptance criteria were met. |
| Biocompatibility Testing | Met requirements of referenced ISO/ASTM standards | All pre-determined acceptance criteria were met. |
| In Vitro Cytotoxicity | (ISO10993-5: 2009) | Met. |
| Skin Sensitization | (ISO10993-10: 2010) | Met. |
| Intracutaneous Reactivity Test | (ISO10993-10: 2010) | Met. |
| Acute Systemic Toxicity | (ISO10993-11; 2006) | Met. |
| Coagulation test | (ISO10993-4: 2002 Amd1:2006(E)) | Met. |
| Complement activity Test | (ISO10993-4: 2002 Amd1:2006(E)) | Met. |
| Hemolytic Properties Test | (ASTM F756-13) | Met. |
| Pyrogen Test | (ISO 10993-11:2006) | Met. |
| Subacute/Subchronic Toxicity Testing | (Implied by ISO10993-1 and ISO10993-11) | Met. |
| USP 788 Particulate Matter | (USP 788 standard) | Met. |
| Sterility Information | Met requirements of referenced ISO/ANSI/AAMI standards | All pre-determined acceptance criteria were met. |
| Package and Shelf Life | Met requirements of referenced ISO/ASTM standards to support 5-year shelf life | The test result supports the 5 years shelf life claim. All pre-determined acceptance criteria were met. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test set. It mentions a "simulated clinical study" but does not provide details on the number of devices tested.
The data provenance is implied to be from internal testing conducted by the manufacturer, Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., likely in China (Anhui Province China is listed as the manufacturer's location). The studies are retrospective as they were conducted to support a premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document describes bench testing, simulated clinical studies, biocompatibility, sterility, and packaging tests, which typically rely on standardized methods and laboratory results rather than expert consensus on ground truth in the way a clinical imaging study might.
4. Adjudication method for the test set
This information is not applicable and is not provided. The testing described does not involve expert adjudication or interpretation for ground truth.
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 is not applicable to the device described. The device is a medical hardware product (safety needle/syringe), not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the device described as it is not an algorithm or AI product. The "simulated clinical study" refers to testing the physical safety feature of the needle/syringe.
7. The type of ground truth used
For the performance testing, biocompatibility, sterility, and package/shelf life, the "ground truth" is defined by adherence to specific international and national standards (ISO, ASTM, USP, AAMI, ANSI). For example, for sharps injury prevention, the ground truth is whether the safety feature prevents accidental needle sticks as per ISO 23908 requirements. For biocompatibility, the ground truth is that the materials do not elicit adverse biological responses as per ISO 10993.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML algorithm.
§ 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).