(257 days)
Sterile single-use syringe with needle is intended to inject fluids into or withdraw fluids from the body.
The subject device is for single use only, which is comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consist of needle hub, needle cap. The proposed devices shall be operated manually, and are not intended for use with syringe pumps. The proposed devices are available in a variety combination of needle size and syringe volume.
This submission is for a medical device (Disposable Syringe with Needle) and does not involve AI or algorithms, nor does it present any studies that would involve human readers or experts to establish ground truth from a test set. Therefore, questions relating to AI performance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance are not applicable.
The document describes the device's acceptance criteria in terms of performance testing against established international standards for syringes, needles, Luer connectors, sterile barrier packaging, sterilization, shelf life, and biocompatibility.
Here's a breakdown of the requested information based on the provided text, focusing on the relevant parts for a medical device:
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Table of acceptance criteria and reported device performance:
Test Item Standard Reported Device Performance Syringe Performance ISO 7886-1: 2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use Complies with the standard Needle Performance ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods Complies with the standard Needle Performance ISO 7864: 2016 Sterile hypodermic needles for single use - Requirements and test methods Complies with the standard Luer Connector Performance ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications Complies with the standard Seal Strength ASTM F88/F88M-2015 Complies with the standard Detecting Seal Leaks ASTM F1929-2015 Complies with the standard Determining Seal Integrity ASTM F1886/F1886M-2016 Complies with the standard EO Residue ISO 10993-7:2008 Complies with the standard ECH Residue ISO 10993-7:2008 Complies with the standard Bacteria Endotoxin Limit USP 36-NF 31 Complies with the standard Shelf Life Evaluation Physical, Mechanical, Chemical, Package and Sterility Tests performed on aging samples to verify the shelf life Verified shelf life of 3 years Hub Color Compliance ISO 6009:2016 (for different needle gauges) Complies with the standard (hub is made of pigmented material) Cytotoxicity Test ISO 10993-5:2009 Complies with the standard Skin Sensitization Test ISO 10993-10:2010 Complies with the standard Intracutaneous Reactivity Test ISO 10993-10:2010 Complies with the standard Acute Systemic Toxicity Test ISO 10993-11:2017 Complies with the standard Pyrogen Test ISO 10993-11:2017 Complies with the standard Hemolysis Test ISO 10993-4:2017 Complies with the standard Particulate USP Complies with the standard Sterilization (SAL) ISO 11135 (Sterilization of health-care products for ethylene oxide - requirements for the development, validation and routine control of a sterilization process) SAL of 10⁻⁶ -
Sample size used for the test set and the data provenance: Not applicable. The testing described involves physical, chemical, mechanical, and biological evaluations of device components and finished products, not a "test set" in the context of an AI/algorithm study. The document does not specify exact sample sizes for each test but refers to compliance with the methodology outlined in the cited standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a medical device and not an AI/algorithm study requiring expert review for ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by its adherence to the technical specifications and performance requirements outlined in published international and national standards (e.g., ISO, ASTM, USP). This involves objective measurements and assessments defined within these standards.
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The sample size for the training set: Not applicable, as this is a medical device and does not involve AI/machine learning training sets.
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How the ground truth for the training set was established: Not applicable.
§ 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).