(185 days)
Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is (not) included. lt is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
This document describes the acceptance criteria and study proving the device meets those criteria for the Shina Syringe and Shina Safety Syringe.
The listed information primarily focuses on bench testing for mechanical, physical, and biocompatibility properties, rather than effectiveness studies involving human subjects or AI-assisted diagnoses. Therefore, several requested sections, particularly those related to clinical studies, human readers, ground truth establishment for training sets, and effect sizes of AI assistance, are not applicable based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is demonstrated by compliance with various ISO standards and USP . The document does not explicitly present specific numerical results for each test item but states that the tests demonstrated that the device performs in a substantially equivalent manner to the predicate device and meets the requirements.
Syringe
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Appearance and Structure | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Graduated capacity | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Scale | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Barrel | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Plunger stopper / Plunger assembly | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Nozzle | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Dead Space | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Meets ISO 7886-1 standard |
| Freedom from liquid leakage past plunger stopper | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Freedom from air leakage past plunger stopper | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Force to operate the piston | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Fit of plunger stopper / plunger in barrel | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Demonstrated substantial equivalence |
| Amount of Silicon Oil | 0.25mg or less per square centimeter of inner area | Demonstrated substantial equivalence |
| EO Gas residuals | ISO 10993-7:2008 Ethylene oxide sterilization residuals | Reported Compliance |
| Sterility test | EO, ECH residuals | Reported Compliance |
Needle
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Cleanliness | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Size designation | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Colour coding | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Needle hub | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Needle tube (Tolerances on length) | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Freedom from defects | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Lubricant | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Needle point | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Bond between hub and needle tube | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Patency of lumen | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods | Demonstrated substantial equivalence |
| Sharps injury protection | ISO 23908:2011 Sharps injury protection | Reported Compliance |
| Materials | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Surface finish and visual appearance | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Cleanliness | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Limits for acidity and alkalinity | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Size designation | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Dimension | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Stiffness | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Resistance to breakage | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
| Resistance to corrosion | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | Demonstrated substantial equivalence |
Syringe with needle (Model : WNLS0125)
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Extraction : pH | Difference of pH $\leq$ 1.0 | Reported Compliance |
| Extraction : Potassium permanganate reducing substances | Difference of the consumption $\leq$ 2.0 mL | Reported Compliance |
| Extraction: Residue on evaporation | Amount of residue $\leq$ 1.0 mg | Reported Compliance |
| Extraction: Pb, Fe, Sn, Zn | Total content of heavy metals $\leq$ 5.0 mg/L | Reported Compliance |
| Extraction: Cd | Content of Cd $\leq$ 0.1 mg/L | Reported Compliance |
Syringe with needle (Particulate test for various models including WNLG0123, WNLS0123, WNSG0125, WNLS0125, WNLG0323, WNLS0323, WNSG0325, WNLS0325, WNLG0523, WNLS0523, WNSG0525, WNLS0525, WNLG1023, WNLS1023, WNSG1025, WNLS1025)
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Particulate test report | USP Method 1. Light obscuration method | Reported Compliance |
Safety test
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Simulated Clinical Use | ISO 23908:2011 Sharps injury protection | Reported Compliance |
Biocompatibility (for 25G Model, 23G Model, and Syringe Model SSN2301)
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 | Reported Compliance |
| Acute systemic toxicity test | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11 | Reported Compliance |
| Pyrogen test | ISO 10993-11:2017 Test for systemic toxicity, pyrogen test USP | Reported Compliance |
| Sensitization test | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10 | Reported Compliance |
| Hemolytic test | ISO 10993-4:2017, ASTM F756-17 | Reported Compliance |
| Intracutaneous reactivity test | ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 | Reported Compliance |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for each bench test conducted. The provenance of the data is that these are bench tests conducted by the manufacturer, Shina Med Corporation, in the Republic of Korea. The studies are by nature retrospective in the context of device development, where the device is manufactured and then tested to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The ground truth for these types of mechanical, physical, and biocompatibility tests is established by published international standards (ISO, USP, ASTM), not by expert consensus in diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple experts. The reported studies are bench tests against defined international standards.
5. 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
This section is not applicable. No MRMC comparative effectiveness study was performed or discussed, as the device is a syringe and needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical device (syringe and needle) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for these tests are established international and national standards for medical devices, specifically:
- ISO 7886-1: Sterile hypodermic syringes for single use
- ISO 7864: Sterile hypodermic needles for single use
- ISO 9626: Stainless steel needle tubing
- USP : Particulate Matter in Injections
- ISO 23908: Sharps injury protection
- ISO 10993 series for Biological evaluation of medical devices (Parts 4, 5, 7, 10, 11, 23)
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
8. The sample size for the training set
This section is not applicable. As this is a physical medical device submission focusing on bench testing, there is no AI model or "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as section 8.
§ 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).