(9 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 intend to inject fluids into or withdraw fluids from the body.
The proposed devices include: a standard piston syringes consisting of the proposed syringes consist of three components: (1) barrel, (2) piston and (3) plunger rod, and a needle consists of (1) needle tube, (2) needle hub and (3) needle sheath. They would be available in three different configurations respectively as follows:
Configuration 1 Syringes with Needle
Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users.
Configuration 2 Syringes without Needle
Proposed syringes will be provided without a needle. The combination of sizes are various upon the It could be used together with any other U.S. legally marketed request of the users. a) hypodermic needle with luer slip female connector complied with ISO594-1:1988 or 'iver lock female connector complied with ISO 594-2:1996.
Configuration 3 Needles
Proposed needles will be provided alone, which could be used together with any other U.S. legally marketed syringes with luer slip male connector complied with ISO594-1:1988 or luer lock male connector complied with ISO 594-2:1996 to complete its intended use.
This document describes the safety and effectiveness of the proposed device, "Syringes, With or without Needles" and "Needles", as substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly states that the acceptance criterion is compliance with specific international standards. The reported device performance is that the proposed device met all design specifications and complied with these standards.
| Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| ISO 7886-1:1993 (Sterile hypodermic syringes for single use Part 1: Syringes for manual use) | Adherence to all specifications for sterile hypodermic syringes for manual use. | Met all design specifications and complied with the standard. |
| ISO 7864:1993 (Sterile hypodermic needles for single use) | Adherence to all specifications for sterile hypodermic needles for single use. | Met all design specifications and complied with the standard. |
| ISO 9626:1991, AMENDMENT 1 2001 (Stainless steel needle tubing for the manufacture of medical devices) | Adherence to all specifications for stainless steel needle tubing. | Met all design specifications and complied with the standard. |
| ISO 594-1:1986 (Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements) | Adherence to all general requirements for Luer taper conical fittings. | Met all design specifications and complied with the standard. |
| ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Adherence to all specifications for Luer lock fittings. | Met all design specifications and complied with the standard. |
| Sterilization | Achieve a Sterility Assurance Level (SAL) equivalent to the predicate device. | Sterilization was performed to demonstrate that the SAL of the proposed device was the same as that of the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Bench tests" being conducted. However, it does not specify the sample size used for these tests. The provenance of the data is not explicitly stated in terms of country of origin but implies the tests were conducted by the manufacturer, Jiangyin Caina Technology Co., Ltd. in China, or by a contract lab working for them. The nature of "Bench tests" typically suggests prospective testing to verify design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in this context. The "ground truth" for medical devices like syringes and needles is established by adherence to recognized international performance standards (e.g., ISO standards) and regulatory requirements, not by expert consensus on specific cases. The tests are objective measurements against predefined specifications.
4. Adjudication Method for the Test Set:
This information is not applicable. As the tests are objective measurements against standards, there is no need for an adjudication method by human experts. The results are either compliant or non-compliant with the specified criteria.
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 (syringes and needles) is a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human improvement with AI is irrelevant.
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 instrument, not an algorithm. Standalone performance refers to AI software.
7. The Type of Ground Truth Used:
The "ground truth" used for this device is based on established international performance standards and design specifications (e.g., ISO standards for dimensions, material properties, sterility, fluid tightness, etc.). These standards define the expected objective performance for such devices.
8. The Sample Size for the Training Set:
This information is not applicable. The development and testing of a physical medical device like a syringe or needle do not typically involve a "training set" in the context of machine learning or AI. Performance is evaluated against established engineering specifications and standards.
9. How the Ground Truth for the Training Set Was Established:
This information 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).