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K Number
K210229
Device Name
Sterile Auto-Disable Syringes with/without Needle for Single Use
Manufacturer
Zhejiang Kangkang Medical-Devices CO., Ltd.
Date Cleared
2022-02-15

(383 days)

Product Code
MEG,FMF,FMI
Regulation Number
880.5860
Type
Traditional
Panel
HO
Reference & Predicate Devices
K143497
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

Device Description

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Sterile Auto-Disable Syringes with/without Needle for Single Use). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, the document does not contain the specific details about acceptance criteria and the comprehensive study results to prove that the device meets those criteria, as requested in your prompt regarding a typical device performance study.

The prompt asks for details like:

  1. A table of acceptance criteria and the reported device performance: This is not provided in a summarized table format for specific performance metrics.
  2. Sample sizes used for the test set and the data provenance: Not specified for each test.
  3. Number of experts used to establish the ground truth... and their qualifications: Not applicable as this is a physical medical device, not an AI/diagnostic software.
  4. Adjudication method: Not applicable.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
  6. Standalone performance: The document describes performance testing for the device itself (standalone in a physical sense), but not algorithm standalone performance.
  7. Type of ground truth used: For physical device testing, ground truth refers to established standard measurements and specifications (e.g., ISO standards).
  8. Sample size for the training set: Not applicable (not an AI/ML device).
  9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding performance and testing:

The Section "VII Performance Testing" lists the types of tests conducted:

  • Biocompatibility testing:
    • Classification: Externally Communicating Device, Blood Path Indirect, Limited Contact (.
    • Acceptance Criteria/Reported Performance: It states "Conforms to ISO 10993" and "Non-pyrogenic" but does not provide specific numerical outcomes or detailed acceptance criteria for each sub-test.
  • Sterilization, Shipping and shelf-life:
    • Tests conducted: EO sterilization validation per ISO11135:2014, Pyrogen testing per USP , EO residuals per ISO 10993-7, Simulated shipping per ASTM D4169, Sterile Barrier Package testing (Seal Strength ASTM F88/F88M-2015, Bubble leak testing ASTM D3078-02(2013), Dye Penetration ASTM F1929-2015).
    • Acceptance Criteria/Reported Performance: "Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16." It implies compliance with these standards, but doesn't offer specific data points or "acceptance criteria met" statements for each.
  • Performance testing:
    • Tests conducted according to: ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2016, ISO 7886-4:2018, ISO 7886-1:2017.
    • Acceptance Criteria/Reported Performance: The comparison table (Table 5-1) under "Performance specifications" states: "Complies with ISO 7864, ISO 7886-1, ISO 7886-4." This indicates the device passed these standards, which inherently include acceptance criteria for parameters like syringe dimensions, fluid leakage, plunger force, auto-disable features, etc. However, the exact specific criteria and the numerical results are not detailed in this summary.

In summary, based only on the provided text, I cannot construct the detailed table and answer all points of your prompt because the 510(k) summary provides a high-level overview of the types of tests performed and the standards met, rather than detailed acceptance criteria and specific reported performance metrics for each test. The document confirms that testing was done to demonstrate compliance with relevant international standards, which is typical for a 510(k) submission showing substantial equivalence for a physical device.

§ 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).