(63 days)
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body. Needles are intended to be used with a legally marketed syringe intended to inject fluids into or withdraw fluids from the body.
The proposed devices contain syringes and needles with various models. All the models for syringes and needles follow same design principle respectively; the differences are the size of the devices. The proposed devices are intended to inject fluids into or withdraw fluids from the body. The proposed devices would be available in two different configurations: Syringe with needle and Syringe without needle. Proposed devices are provided radiation (Co60) sterilized with a hard pack package which could maintain the sterility of the devices for five years. They are for single use only.
This document is a 510(k) Pre-market Notification for a medical device (syringes and needles). The purpose of this type of submission is to demonstrate that the new device is "substantially equivalent" to a predicate device already on the market. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence, primarily by conforming to recognized standards and showing comparable performance to the predicate device.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are the international standards the device aims to comply with, and the reported performance is the confirmation that the device does comply with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | Complied with standard |
| ISO 7864:1993 Sterile hypodermic needles for single use | Complied with standard |
| ISO 9626:1991, AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices | Complied with standard |
| ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements | Complied with standard |
| ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings | Complied with standard |
| ISO 11137-2:2012, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose | Complied with standard (for radiation sterilization) |
| ISO 10993:5 Standard (Biocompatibility - Cytotoxicity) | Complied with standard |
| ISO 10993:10 Standard (Biocompatibility - Irritation and Sensitization) | Complied with standard |
Note: The document only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device, [and] The test results demonstrated that the proposed device complies with the following standards." It does not provide specific numerical performance metrics for the device against each standard's criteria, but rather a blanket statement of compliance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "non clinical tests" but does not detail the number of units tested for each standard.
- Data Provenance: The manufacturing company is Jiangyin Caina Technology Co., Ltd. in Jiangsu, China, and the submission correspondent is also based in Shanghai, China. The testing was conducted by the manufacturer, or a facility contracted by them. The data is retrospective in the sense that the tests were performed on finished products.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and submission. This document pertains to the regulatory clearance of basic medical devices (syringes and needles) based on engineering performance and biocompatibility standards, not on expert interpretation of complex diagnostic data. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this product.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data (e.g., medical images) and their decisions need to be reconciled to establish a ground truth. For this submission, the "ground truth" is defined by compliance with established international performance and safety standards, as measured by objective tests.
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 section is not applicable. This submission is for a physical medical product (syringes and needles), not an AI-powered diagnostic device or software. Therefore, there are no human readers or AI assistance involved in its intended use or evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. As mentioned above, this is not an AI algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" for this device's validation is compliance with established performance and safety standards (ISO standards) for sterile hypodermic syringes, needles, and their components, as well as biocompatibility standards. The standards themselves define the acceptable parameters for mechanical performance, material properties, sterility, and safety.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of a physical medical device like a syringe and needle. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as point 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).