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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.

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Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Single use Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions.

The device has three model with the following:
(1) Single use Needle (108 model codes including Sofjec-16-13)
Single use Needle consist of Cap, Needle and Hub and 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.
(2) Single use Syringe with Needle (1734 model codes including HJ-1-16G-13)
Single use Syringe with Needle consist of Syringe, Cap, Needle and Hub and 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 are two type of Luer Slip and Luer Lock. These device are injecting the medicine with syringes. This device is finished biocompatibility test and performance test for safety.
(3) Membrane Filter Syringe (16 model codes including HJM-18-1)
This devices are consists of membrane filter needle and syringe. Membrane filter needle is attached 0.5nm filtration membrane (Acrylic copolymer material). Syringe is two type. (Luer slip type and Luer lock type) This device is Filtering with syringes and injection device is finished biocompatibility test and performance test for safety.

This document is a 510(k) premarket notification for medical devices (syringes and needles), which primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain the kind of acceptance criteria and performance study details typically found for novel AI/ML medical devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement in ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not present in this document.

This document details the following aspects relevant to the device clearance:

1. Acceptance Criteria and Device Performance:

• The document does not specify quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML device.
• Instead, the "acceptance criteria" are compliance with established international standards for medical devices of this type. The "reported device performance" is the statement that the device "Complied with" these standards.

2. Sample Size and Data Provenance:

• This document does not refer to "test sets" or "training sets" in the context of AI/ML models. The performance assessment is based on physical and chemical testing of the devices themselves, performed according to the listed ISO and USP standards.
• The data provenance is from the manufacturer's internal testing as part of their regulatory submission for a physical medical device (needles and syringes), not AI/ML data. The manufacturer is Hwajin Medical Co., Ltd. from South Korea. The studies are non-clinical (laboratory/bench testing) and not specifically "retrospective" or "prospective" in the same sense as clinical trials or AI/ML data collection.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. Ground truth, in this context, refers to the established standards and test methods for physical properties and biocompatibility of medical devices. There are no "experts establishing ground truth" in the sense of image annotation or clinical diagnosis for an AI/ML model. The "experts" would be the scientists and engineers who developed and performed the standard tests to verify compliance.

4. Adjudication Method:

• Not applicable. There is no human interpretation or adjudication process described as it would be for an AI/ML diagnostic output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC study was done, as this is a submission for a physical medical device (syringe/needle), not an AI/ML diagnostic aid. Therefore, there is no effect size of human readers improving with AI assistance.

6. Standalone Performance:

• Not applicable. This is a physical device, so the concept of "algorithm only without human-in-the-loop performance" does not apply. The device's "standalone" performance is its ability to meet the defined ISO and USP standards.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance is compliance with internationally recognized medical device performance standards (ISO, USP, ASTM, EN), and biocompatibility testing results. It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set." The product development and manufacturing processes conform to quality system regulations.

9. How the Ground Truth for the Training Set was Established:

• Not applicable for the same reason as above.

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