(189 days)
The AUTO DISABLE SYRINGE is intended for use in the suction of vaccine for medical purposes. Additionally , after injection to the body, the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.
The AUTO DISABLE SYRINGE is designed for the hypodermic injection of the intended micro scale solution. It has the automatic function in the structure of the syringe which after injection of an intended fixed dose locks the syringe to prevent re-use of the syringe. It can be widely used for injection of vaccine for the immunization.
The syringe consists of a calibrated hollow barrel, a movable plunger, a rubber stopper (piston) assembled at end of the plunger, and a steel clip installed between the barrel and the plunger that functions to prevent re-use of the syringe.
At the end of the barrel, a fixed an unmovable needle is installed, and a needle cap covers the needle. The zero line and nominal capacity line are printed outside of barrel. The main materials are PP, latex free (polyisoprene rubber) and stainless steel.
This document describes the regulatory approval for an "Auto Disable Syringe" (K210464). The acceptance criteria are essentially the compliance with various international standards, and the "study" that proves the device meets these criteria is a series of non-clinical, functional performance, sterility, shelf-life, and biocompatibility tests.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Functional Performance (ISO 7864:2016) | In conformance with ISO 7864:2016 for: |
| - Fragmentation test | Passed |
| - Determination of flow rate | Passed |
| - Lubricant: Penetration force and drag force | Passed |
| - Bonding strength | Passed |
| Functional Performance (ISO 7886-3 & ISO 7886-1) | In conformance with ISO 7886-3 and ISO 7886-1 for: |
| - Limits for acidity and alkalinity | Passed |
| - Limits for extractable metals | Passed |
| - Lubricant: Penetration force and drag force | Passed |
| - Tolerance on nominal capacity | Passed |
| - Graduated scale | Passed |
| - Barrel- dimensions and flanges | Passed |
| - Plunger stopper and assembly - fitness of stopper /plunger in barrel | Passed |
| - Integrated needle | Passed |
| - Sharps protection features | Passed (Implicit by "Auto-disable syringe feature" and compliance with standards covering this) |
| - Dead space | Passed |
| - Freedom from air and liquid leakage | Passed |
| - Auto-disable syringe feature | Passed (device description states "the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.") |
| Functional Performance (ISO9626) | In conformance with ISO9626 for: |
| - Limits for acidity and alkalinity | Passed |
| - Designated metric size | Passed |
| - Stiffness | Passed |
| - Resistance to breakage | Passed |
| - Resistance to corrosion | Passed |
| Sterility, Shipping and Shelf-Life (ISO11135:2014, ISO11607-1:2019, ISO11607:2019, ISO10993-7:2008, ASTM D4169-16, ASTM F88/F88-15, ASTM F1886-16, ASTM F1929-15, ASTM F1980-16) | Validated/Conducted: |
| - EO sterilization validation | Conducted in accordance with ISO11135:2014, result 10-6 sterility assurance level. |
| - Sterilant residuals | Evaluated per ISO10993-7:2008. Average daily dose to patient of EO ) |
2. 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 explicitly state the specific sample sizes for each test mentioned (e.g., how many syringes were tested for flow rate, or how many were used in biocompatibility studies). It broadly states that the "AUTO DISABLE SYRINGE described in this summary were tested".
Regarding data provenance:
- Country of Origin: The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. from Tianchang, Anhui, China. It is highly probable that the non-clinical testing was performed in China or by labs commissioned by the Chinese manufacturer.
- Retrospective or Prospective: The testing described (functional performance, sterility, shelf-life, biocompatibility) is typically prospective and conducted specifically for regulatory submission to demonstrate compliance with standards and safety/effectiveness of the device.
3. 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 is a medical device (syringe), not an AI/diagnostic imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) does not apply. The "ground truth" for this device's performance is established by objective measurements against recognized international standards through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device's performance is determined by objective physical, chemical, and biological tests against established standards, not by human interpretation that would require adjudication.
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
Not applicable. This is a physical medical device (syringe), not a diagnostic imaging device utilizing AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (syringe), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by objective measurements and pass/fail criteria defined by recognized international standards (e.g., ISO, ASTM, USP). For example:
- Functional performance: Measurements of flow rate, penetration force, bonding strength, tolerance on nominal capacity, etc., against predefined limits in standards like ISO 7864, ISO 7886, ISO 9626.
- Sterility: Demonstrated sterile assurance level (SAL) of 10-6 per ISO 11135.
- Biocompatibility: Absence of cytotoxic, sensitizing, irritating, systemic toxic, pyrogenic, or hemocompatible effects as determined by tests outlined in ISO 10993 series.
- Shelf-life: Maintenance of package integrity and device functionality over a specified period (5 years) as per ASTM F1980.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for 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).