(179 days)
Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw from body.
Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw from body. The filter operates when injecting the human body to remove foreign substances from the drug solutions.
Single use Syringe with or without Needle consist of Syringe, Cap, Needle and Hub and Blister paper. Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization, and the syringes of Luer Slip and Luer Lock.
These devices are injecting the medicine with syringes. Biocompatibility testing and performance testing has been completed to support the substantial equivalence of the device.
This document describes a Special 510(k) submission for modifications to the "Sofjec Single use Syringe with or without Needle." The submission primarily addresses the addition of a new 60mL syringe volume and the inclusion of "without needle" options for existing syringe models.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on compliance with harmonized international standards for sterile hypodermic syringes and needles. The document does not provide a specific table of numerical acceptance criteria with corresponding performance data. Instead, it states that the device "Complied with ISO 7886-1, ISO 7864, ISO 9626."
- ISO 7886-1: Sterile hypodermic syringes for single use — Part 1: Syringes for manual use. This standard details requirements for material, design, performance, and packaging. Key performance aspects typically include:
- Absence of air and liquid leakage past the plunger during aspiration and injection.
- Dimensional accuracy (e.g., barrel capacity, graduations).
- Smoothness of plunger movement.
- Resistance to breakage.
- Sterility.
- ISO 7864: Sterile hypodermic needles for single use. This standard specifies requirements for sterile hypodermic needles. Key performance aspects typically include:
- Needle dimensions (e.g., gauge, length).
- Integrity of the bond between needle and hub.
- Resistance to breakage and corrosion.
- Patency.
- Sterility.
- ISO 9626: Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods. This standard specifies requirements for the tubing used to make hypodermic needles.
The reported device performance, in summary, is that the modified devices complied with these standards. This implies that the devices met all specified requirements within these standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for performance testing. It states that "Successful performance testing has been completed using FDA recognized standards." The data provenance is implied to be from the manufacturer, HLB Life Science Co., Ltd., located in the Republic of Korea. The testing conducted is for a "Special 510(k) Premarket Notification" for device modification, which typically involves prospective testing of the modified device to ensure it meets established safety and performance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a submission for medical devices (syringes and needles), not an AI/Software as a Medical Device (SaMD). The "ground truth" here is defined by compliance with established international standards for physical device performance and sterility. The evaluation is done through laboratory testing, not expert interpretation of data like in image analysis.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/SaMD submission, there is no expert adjudication process for ground truth establishment. Performance is determined by objective laboratory tests against pre-defined criteria in the ISO standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/SaMD product.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI/SaMD product.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by compliance with recognized international consensus standards (ISO 7886-1, ISO 7864, ISO 9626). This means the device's physical and functional properties were tested against the objective specifications outlined in these standards.
8. Sample Size for the Training Set
Not applicable. This is not an AI/SaMD product; therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, the concept of establishing ground truth for it does not apply.
§ 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).