(63 days)
Sterile Syringes for Single Use are sterile, single-use, disposal, without needle and manually operated syringes intended to use with a 6% conical fitting device for injection of drug into the body. The syringes are intended for use immediately after filling and are not intended to contain the fluid/medication for extended periods of time.
KDL Sterile Syringes for Single Use are composed of barrel, plunger, and a moveable piston. The plunger does not contact any part of the fluid path, rather the plunger which attaches to the piston and the barrel are fluid path components. Materials of construction for the components have been shown to meet the applicable requirements of ISO 10993-1. Additionally, there is a small amount of lubricant for moving the plunger smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals. The Sterile Syringes for Single Use have different specifications, include 1ml, 3ml, 10ml, 20ml and 30ml.
The provided text is a 510(k) summary for the "Sterile Syringes for Single Use". This document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes compliance with recognized international standards (ISO and ASTM) and specific tests conducted. The "Performance" column in the table below represents the device's conformance to these standards and the completion of the described tests.
| Acceptance Criteria (as implied by standards and tests conducted) | Reported Device Performance (Conformance/Results) |
|---|---|
| Conformance to ISO 7886-1:2017 (Sterile hypodermic syringes for manual use) | Confirmed conformance to ISO 7886-1:2017 |
| Conformance to ISO 80369-7:2016 (Small-bore connectors for intravascular/hypodermic applications) | Confirmed conformance to ISO 80369-7:2016 |
| Biocompatibility (ISO 10993-1 and FDA Guidance) | Conformance demonstrated for: |
| - Cytotoxicity | Tested and conformed |
| - Sensitization | Tested and conformed |
| - Irritation | Tested and conformed |
| - Acute Systemic Toxicity | Tested and conformed |
| - Material-Mediated Pyrogenicity | Tested and conformed |
| - Hemolysis | Tested and conformed |
| Particulate Testing (USP ) | Tested and conformed |
| Sterilization (ISO 11135) | Evaluated for sterility using ISO 11135 |
| Packaging Integrity (ASTM F88/F88M-15 & ASTM F1929-15) | Tested using ASTM F88/F88M-15 and ASTM F1929-15 (Seal Strength, Dye Penetration) |
| Simulated Shipping (ISTA 3A:2018) | Tested using ISTA 3A:2018 |
| Shelf-life (5 years) | Validated using ASTM F1980-16 for 5 years |
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 specify the sample sizes used for any of the performance tests. It only states that the device was "tested" and "evaluated."
Regarding data provenance: The testing appears to be conducted by the manufacturer, Shanghai Kindly Enterprise Development Group Co., Ltd. within China, or by a testing facility on their behalf. The studies are prospective as they are conducted specifically to support this regulatory submission for the proposed device (non-clinical testing).
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 section is not applicable to this device and the type of studies conducted. The device is a sterile syringe, and the studies are primarily non-clinical performance and biocompatibility tests against established international standards. "Ground truth" in the context of expert consensus (like in AI/medical imaging studies) is not relevant here. The "ground truth" is defined by the technical specifications and performance requirements of the ISO and ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers interpreting results, especially in complex diagnostic scenarios or AI performance evaluation. The studies for this device are non-clinical, laboratory-based performance tests against 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 is not applicable. The device is a disposable, manually operated syringe, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted or warranted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (syringe), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on established international standards and validated testing methodologies described within those standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series, USP , ISO 11135, ASTM F88/F88M-15, ASTM F1929-15, ISTA 3A:2018, ASTM F1980-16). These standards define acceptable performance limits and test procedures.
8. The sample size for the training set
This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or deep learning algorithms.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 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).