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510(k) Data Aggregation

    K Number
    K021993
    Device Name
    SHANCHUAN SYRINGE
    Manufacturer
    SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.
    Date Cleared
    2003-06-03

    (350 days)

    Product Code
    FMF,FMI
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K980181,K941657
    Why did this record match?
    Device Name :

    SHANCHUAN SYRINGE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.

    The SHANCHUAN Insulin Syringe is design for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange.

    The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.

    Device Description

    The SHANCHUAN 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 nozzle for fitting the hub of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

    The Hypodermic Single Lumen Needle is a device intended to inject below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a hub designed syringe or an intravascular administration set.

    The Insulin Syringe is a piston syringe, typically sterile, single-use with a needle, used for subcutaneous injection of insulin.

    AI/ML Overview

    The provided text describes a 510(k) submission for the SHANCHUAN Syringe, claiming substantial equivalence to predicate devices (Terumo Disposable Hypodermic Syringe and BD Insulin Syringe). It is primarily a comparison against existing devices, rather than a study with specific acceptance criteria and detailed performance metrics to "prove" the device meets them as would be seen in a clinical trial for a novel AI device.

    Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable or are not explicitly stated in this type of regulatory submission for a medical device like a syringe. The submission focuses on demonstrating that the new device is as safe and effective as previously cleared devices.

    Here's an attempt to populate the table and answer the questions based on the provided text, highlighting where information is not available:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryAcceptance Criteria (from text)Reported Device Performance (from text)
    Piston Syringe
    1. Intended UsesIntended to be used for injecting fluids or withdrawing fluids from the body.SHANCHUAN Piston Syringe is intended to be used for injecting fluids or withdrawing fluids from the body (substantially equivalent to predicate).
    2. LabelingIncludes identity (type, size, needle gauge/length) and quantity; prescription statement according to 801.109(b)(1) (except insulin syringes).SHANCHUAN Piston Syringe labeling includes identity (type, size, needle gauge/length) and quantity; prescription statement according to 801.109(b)(1) (substantially equivalent to predicate).
    3. Design and MaterialsComprised of barrel, plunger, gasket, needle. Materials are medical polypropylene (barrel, plunger, hub), rubber (gasket - no emulsion/natural rubber), X2C,N;18-9 stainless steel (needle), medical silicon oil (lubricant).SHANCHUAN Piston Syringe design (barrel, plunger, gasket, needle) and materials (medical polypropylene, rubber gasket, stainless steel needle, medical silicon oil lubricant) are basically the same as the predicate (substantially equivalent).
    4. SpecificationsPhysical specifications are basically the same, mechanical and biological according to the same international standard.SHANCHUAN Piston Syringe physical specifications are basically the same as the predicate (difference in syringe sizes and needle length noted, but not raising new safety/effectiveness issues). Mechanical and Biological specifications are according to the same international standard (substantially equivalent).
    5. Performance (Bench)Performs equivalently to predicate devices and is effective when used as intended.The bench test results demonstrate that the SHANCHUAN Piston Syringe performs equivalent to the predicate devices and is effective when used as intended.
    6. Performance (Clinical)Has been used in clinic for many years, ensuring effectiveness. (This is a statement about the predicate, implying the new device is equivalent)."Both of them have been used in clinic for many years, which ensure the effectiveness of the SHANCHUAN Piston Syringe." (This refers to predicate devices, and by substantial equivalence, implies the SHANCHUAN Piston Syringe meets this criterion through its equivalence to existing clinically used devices).
    Insulin Syringe
    1. Intended UsesIntended for the subcutaneous injection of insulin.SHANCHUAN Insulin Syringe is intended for the subcutaneous injection of insulin (substantially equivalent to predicate).
    2. LabelingIncludes identity (type, needle gauge/length) and quantity; "For use with U-100 insulin only" and graduations printed on barrel according to 801.403.SHANCHUAN Insulin Syringe labeling includes identity (type, needle gauge/length) and quantity; includes "For use with U-100 insulin only" and graduations printed on barrel (substantially equivalent to predicate).
    3. Design and MaterialsComprised of barrel, plunger, gasket, needle. Materials are basically the same as predicate (difference noted in gasket and lubricant).SHANCHUAN Insulin Syringe design (barrel, plunger, gasket, needle) and materials are basically the same as the predicate (difference in gasket and lubricant noted, but not raising new safety/effectiveness issues).
    4. SpecificationsPhysical specifications are basically the same, mechanical and biological according to the same international standard.SHANCHUAN Insulin Syringe physical specifications are basically the same as predicate (differences in syringe sizes, needle gauge sizes, and needle length noted, but not raising new safety/effectiveness issues). Mechanical and Biological specifications are according to the same international standard (substantially equivalent).
    5. Performance (Bench)Performs equivalently to predicate devices and is effective when used as intended.The bench test results demonstrate that the SHANCHUAN Insulin Syringe performs equivalently to the predicate devices and is effective when used as intended.
    6. Performance (Clinical)Has been used in clinic for many years, ensuring safety and effectiveness. (This is a statement about the predicate, implying the new device is equivalent)."Both of them have been used in clinic for many years, which ensure the safety and effectiveness of the SHANCHUAN Insulin Syringe." (This refers to predicate devices, and by substantial equivalence, implies the SHANCHUAN Insulin Syringe meets this criterion through its equivalence to existing clinically used devices).
    General Safety & Effectiveness (both devices)No new issues of safety or effectiveness should be raised by differences compared to predicate devices. The device should be sterile, non-toxic, non-pyrogen, and single use, disposable."Any noted differences between the two devices do not raise new issues of the safety and effectiveness." (Repeated for both piston and insulin syringes). "All the results demonstrate that the SHANCHUAN Piston Syringe performs equivalently to the predicate devices and is safe and effective when used as intended." (Similar statement for Insulin Syringe). The syringe fluid path is stated to be sterile, non-toxic, non-pyrogen, and single use, disposable.

    Study Details for Acceptance Criteria

    The provided text is a 510(k) Summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing a detailed report of a formal study with specific acceptance criteria and performance results in the context of, for example, an AI/imaging device. For a syringe, "performance" is assessed through bench testing and comparison to established device standards and predicate devices' proven clinical use.

    Therefore, for most of the detailed questions regarding study design, sample sizes, ground truth, and expert involvement (which are typical for AI/diagnostic device studies), the information is not applicable or not provided in this type of submission.

    1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

      • Not provided. The document refers to "bench test results" but does not specify sample sizes for these tests. Data provenance is not mentioned.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

      • Not applicable/Not provided. For a mechanical device like a syringe, "ground truth" is typically established through adherence to engineering specifications and international standards, and comparison to predicate devices, rather than expert interpretation of a test set in the way it would be for a diagnostic AI.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • Not applicable/None specified. This is a concept related to human-expert review of diagnostic outcomes, not applicable to the bench testing of a syringe.

    4. 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:

      • No, not done. This type of study is specifically for diagnostic AI tools that assist human interpreters. A syringe is a mechanical medical device with no interpretation component.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This refers to AI algorithm performance. A syringe is a manually operated device. The "performance" is its physical characteristics and functionality.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • For a syringe, "ground truth" is likely defined by adherence to specified engineering standards (e.g., ISO standards) for physical dimensions, material properties, sterility, force required for plunger movement, leakage, etc. The document states: "Both of the Mechanical and Biological are according to the same international standard." It also heavily relies on comparison/equivalence to predicate devices that are already considered safe and effective, rather than a novel "ground truth" derived from clinical outcomes or expert consensus on new data.

    7. The sample size for the training set:

      • Not applicable/Not provided. "Training set" is a concept for machine learning or AI models. This device is a physical product, not an AI.

    8. How the ground truth for the training set was established:

      • Not applicable. As above, this is for AI models.
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