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K Number
K211728
Device Name
Sterile hypodermic syringes for single use
Manufacturer
Jiangsu Kangyou Medical Instrument Co., Ltd.
Date Cleared
2021-10-05

(123 days)

Product Code
FMF
Regulation Number
880.5860
Type
Traditional
Panel
HO
Reference & Predicate Devices
K163161
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sterile hypodermic syringes for single use are intended to inject fluids into or withdraw fluids from the body.

Device Description

The Sterile hypodermic syringes for single use are intended for manual and single use only to aspirate and inject of fluids for medical purpose, and consist of syringe (barrel, plunger, piston) and hypodermic needle (needle tube, hub, needle cap). The proposed device is available in a variety of syringe and needle sizes.

AI/ML Overview

The provided text describes the 510(k) summary for "Sterile hypodermic syringes for single use" and does not contain information about an AI/ML powered medical device. Therefore, it's not possible to extract information related to acceptance criteria or studies performed for such a device.

The document focuses on demonstrating the substantial equivalence of the subject device (syringes) to a predicate device based on material, design, performance, and compliance with established standards (ISO, ASTM, USP).

Specifically, the provided information does not include:

  • A table of acceptance criteria and reported device performance for an AI/ML device.
  • Sample size for a test set or data provenance for an AI/ML device.
  • Number of experts or their qualifications for establishing ground truth for an AI/ML device.
  • Adjudication methods for an AI/ML device.
  • Multi-reader multi-case (MRMC) comparative effectiveness study or effect size for AI assistance.
  • Standalone performance for an AI/ML algorithm.
  • Type of ground truth used for an AI/ML device study.
  • Sample size for a training set for an AI/ML device.
  • How ground truth for the training set was established for an AI/ML device.

The 'Performance data' section lists various tests performed on the syringes, such as biocompatibility, sterilization, shelf-life, and physical performance tests according to ISO and ASTM standards. These are standard tests for physical medical devices to ensure their safety and effectiveness.

§ 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).