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The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

1 ml Sterile Hypodermic Syringe is 3-piece design. These 3 pieces are piston, plunger and barrel. The piston is made from isoprene rubber. Barrel is made from polypropylene. Plunger is made from polypropylene and polyethylene combination. Needle is made from stainless steel 304 grade and hub of needle is made from polypropylene. There are with or without needle configurations within this Special 510k submission. There are luer and luer-lock configurations within this special 510k submission. This special 510k submission only covers the 1ml syringe but several needle dimensions including 21Gx5/8", 23Gx1", and 25Gx1". The barrel marking scale interval is 0.1 ml and legible for all configurations covered by this Special 510k submission. Luer and Luer-lock have a 6% conical design. The barrel is transparent. The length (without needle), outside diameter are 99.30/100.2mm, 6.9/6.75 and 4.70/4.70, respectively for luer and luer-lock configurations. Intended users are medical professionals and trained caregivers. It is prescription use only.

It is EtO sterile and a single use device. Packaging combination is maintained from a transparent sterilization film and Tyvek paper appropriate to EtO sterilization.

The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient.

The products covered in this special 510k are in compliance with ISO 10993-1 and ISO 7886-1.

This is a 510(k) premarket notification for a medical device (Sterile Hypodermic Syringe for Single Use) and not a study on an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design for AI/ML, expert adjudication, MRMC studies, standalone performance, ground truth establishment, and training set details are not applicable as they relate to AI/ML device evaluations.

The document indicates that the device's performance was evaluated against recognized international standards. It states that the device complies with:

• ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
• ISO 7864: Sterile hypodermic needles for single use — Requirements and test methods
• ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
• ISO 10993-4: Biological Evaluation of Medical Devices — Part 4: Selection of Tests for Interactions with Blood
• ISO 10993-5: Biological Evaluation of Medical Devices — Part 5: Tests for In Vitro Cytotoxicity
• ISO 10993-10: Biological Evaluation of Medical Devices — Part 10: Tests for Irritation and Skin Sensitization
• ISO 10993-11: Biological Evaluation of Medical Devices — Part 11: Tests for Systemic Toxicity

The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K201284) by adding a new size (1ml syringe). The conclusion states that the differences do not raise new questions of safety or effectiveness because the modified devices were tested in accordance with ISO 7886-1.

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The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The sterile insulin syringe for single use with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile insulin syringe for single use with the calibration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock consists of a Piston, Plunger, and Barrel. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in various lengths, diameters, tip types, needle tip configurations, nozzle types, barrel marking specs, volumes, sizes, and needle lengths. Materials include Isoprene Rubber, PP, PE, and SUS304.
The Sterile Insulin Syringe for Single use, with needle consists of a Needle Cap, Needle, Piston, Plunger, Barrel, and End Cap. It is EO Sterilized and intended for Prescription use by patients. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in 0.3ml, 0.5ml, and 1ml volumes with fixed needles of 8mm and 13mm lengths. Materials include Isoprene Rubber, PP, PE, and SUS304.
The Sterile Hypodermic needle for Single use consists of a Protective cap, Needle, Adhesives, and Needle hub. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and for Manual Use Only. It comes in various sizes and needle lengths. Materials include PP, Epoxy resin, and SUS304.

This document is a 510(k) summary for hypodermic syringes, insulin syringes, and hypodermic needles. It describes the devices, their indications for use, and a comparison to a predicate device (K190002). The document primarily focuses on demonstrating substantial equivalence to the predicate device through comparisons of technological characteristics and compliance with recognized performance standards. It certifies that the devices meet various ISO standards and biological evaluation requirements.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a "table of acceptance criteria and reported device performance" as you might expect for a diagnostic AI device with metrics like sensitivity, specificity, or AUC. Instead, for these medical devices (syringes and needles), acceptance criteria are met through compliance with established international standards for design, performance, and biocompatibility. The reported device performance is stated as "Complied with" these standards.

Here's how we can infer the acceptance criteria and reported performance from the text:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify sample sizes for test sets in the traditional sense of a clinical trial or algorithm evaluation. The testing referenced refers to compliance with ISO standards, which typically involve specific sampling plans and test methods for manufacturing quality control and performance validation.

• Test Set Sample Size: Not explicitly stated as individual numbers for device testing. Compliance with ISO standards implies that appropriate sample sizes were used according to those standards for each specific test (e.g., performance, biocompatibility).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are "performance testing" and "biocompatibility studies" conducted to demonstrate compliance with international standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic medical devices or AI algorithms. For syringes and needles, the "ground truth" is defined by the technical specifications and performance requirements outlined in the ISO standards themselves, verified through physical and chemical testing.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1) are used to resolve disagreements among multiple human readers in the context of diagnostic evaluations, typically for AI or imaging studies. For the direct performance testing of syringes and needles against standards, there isn't a "ground truth" established by human readers that requires adjudication.

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

This information is not applicable. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. This submission is for physical medical devices (syringes and needles), not a diagnostic AI system, so such a study would not be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable. This refers to the performance of a software algorithm or AI model without human intervention. The devices being reviewed are physical medical instruments (syringes and needles), not software or AI.

7. Type of Ground Truth Used:

The "ground truth" in this context is adherence to the technical specifications and safety/performance parameters defined by internationally recognized standards (e.g., ISO 7886-1 for syringes, ISO 7864/9626 for needles, ISO 8537 for insulin syringes, and ISO 10993 series for biocompatibility). This is established through objective technical measurements and laboratory test results that demonstrate the device meets these pre-defined (standardized) criteria. It is not expert consensus, pathology, or outcomes data in the sense of diagnostic device validation.

8. Sample Size for the Training Set:

This information is not applicable. A "training set" is used for machine learning or AI model development. These devices are physical medical products, not AI systems, so there is no training set in this context.

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

This information is not applicable for the reasons stated in point 8.

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