(325 days)
Insulin syringes are intended for subcutaneous injection of U-100 insulin
The insulin syringe consists of needle cap, barrel, plunger stopper, needle tube and plunger cap. It is sterile disposable, non-pyrogenic, easy to use and meets all of the required standards. The plunger cap is optional. The single insulin syringe in unit package lacks the plunger cap compared with the product in the multi-unit package. The needle cap is used to protect physical protection of the needle prior to use. The needle tube penetrates the patient's skin to inject fluid into the body. The plunger stopper is the sealing assembly that encloses mandrel component and is used to inject fluid into the body. The barrel is a tube-like and cylindrical structure that holds insulin before the injection. The plunger is the rod pushed down or up depending on clinical use. The plunger cap is used to protect plunger before use. The capacity of the insulin device is 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube is 26G, 27G, 28G, 29G, 30G, 31G, 32G and 33G. The needle length is 5 mm, 6 mm, 8 mm and 10 mm.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for an Insulin Syringe (K230061).
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A table of acceptance criteria and the reported device performance
The document lists the following performance tests and states that the proposed device was tested and demonstrated to be in conformance with the specified FDA recognized standards, and that the performance testing results met the standards' requirements to demonstrate the device's safety and effectiveness. No specific numerical performance values are provided, only conformance to standards.
Acceptance Criteria (Standard) Reported Device Performance ISO 8537-2016: Sterile single-use syringes, with or without needle, for insulin Conforms to requirements for: Limits for acidity or alkalinity, Limits for extractable metals, Tolerance on the graduated capacity, Graduation lines, Numbering of scale, Scale interval units, Overall length of scale, Barrel and plunger stopper, Finger grips, Fit of plunger stopper in barrel, Dead space, Freedom from leakage past plunger stopper, Bond between hub and needle tube, Needle cap. ISO 7886:1-2017: Sterile hypodermic syringes for single use – Part 1: Syringes for manual use Conforms to requirements for Lubricant of syringe. ISO 9626-2016: Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods Conforms to requirements for: Stiffness, Resistance to Breakage, Resistance to Corrosion, Needle O.D., Needle inner diameter. ISO 7864-2016: Sterile hypodermic needles for single use - Requirements and test methods Conforms to requirements for: Needle point, Patency of lumen, Cleanliness, Needle length, Lubricant of needle tube, Penetration force and drag force for needles. ISO 10993-1 (Biocompatibility) Conforms to requirements for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogen, Subacute/Subchronic Toxicity, Genotoxicity. (For Externally Communicating Device, Blood Path Indirect, prolonged Contact (>24hrs to 30 days)). USP and USP (Particulate testing) Met USP acceptance criteria. ISO 11135 (Sterilization) Sterilization process validated, EO and ECH residual does not exceed limit according to ISO 10993-7. ASTM F1980-16 (Shelf-Life) Verified claimed shelf-life of 5 years under accelerated aging conditions. ASTM D4169-16 (Package integrity - shipping) All packaging deemed acceptable for protection of product and sterility maintenance. ASTM D3078-02 (Vacuum Leak Test) Conforms to requirements. ASTM F 1929-15 (Dye Penetration Test) Conforms to requirements. DIN 58953-6: 2016 (Microbial Barrier Properties Test) Conforms to requirements. ASTM F88/F88M-21 (Seal Strength Test) Conforms to requirements. FDA Guidance for Medical Devices with Sharps Injury Prevention Features, August 9, 2005 (Simulated Clinical Use Testing) Conducted and demonstrated conformance. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each test. For instance, for biocompatibility, it states testing was done in compliance with ISO 10993-1, but not the number of samples. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, but the manufacturer is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in China.
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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)
This information is not applicable and therefore not provided in the document. The device is a physical medical device (insulin syringe), not an AI/software device that requires expert adjudication for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document, as it pertains to AI/software device assessments.
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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 MRMC study was done, as this is a physical medical device (insulin syringe) and not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is conformance to established international and FDA-recognized standards for sterile single-use syringes and needles, verified through various physical, chemical, and biological tests. This includes mechanical properties, material safety, sterility, packaging integrity, and simulated use. There is no "ground truth" derived from expert consensus or pathology in the context of an AI/software device.
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The sample size for the training set
Not applicable, as this is a physical medical device, not an AI/software device that requires a training set.
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How the ground truth for the training set was established
Not applicable, as this is a physical medical 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).