(225 days)
The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The Sterile Syringes for Single Use with/without Needle are three-piece, sterile, single use hypodermic syringes with a 6% (Luer) male connector/lock fitting in various sizes. Each syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
The provided document is an FDA 510(k) clearance letter and associated summary for a medical device (Sterile syringes for single use with/without needle). This document describes the device, its intended use, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.
However, the document does not describe a study involving an AI/algorithm-driven device with human-in-the-loop performance, nor does it detail acceptance criteria and performance for such a device in the way requested by your prompt. The device cleared is a manual medical device (syringes), not an AI-powered diagnostic or therapeutic tool.
Therefore, many of the requested details regarding AI acceptance criteria, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.
Below is a breakdown of the relevant information found in the document, framed as closely as possible to your prompt's structure, along with clear statements about what information is not available given the nature of the cleared device:
Analysis of Acceptance Criteria and Study for the Sterile Syringes for Single Use with/without Needle
The acceptance criteria and study detailed in the provided FDA 510(k) summary pertain to the physical, chemical, and biological performance of a manual medical device (sterile syringes), not an AI-powered system. As such, information regarding AI-specific criteria, human reader improvement with AI assistance, or expert consensus on AI outputs is not present.
The study proves the device meets the acceptance criteria through demonstrating substantial equivalence to a legally marketed predicate device, primarily by showing compliance with recognized international and national standards for syrings and needles.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are generally established by compliance with a comprehensive set of recognized industry standards. The reported device performance is that it "meets the requirements" or "complies with" these standards.
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 (overall) | The evaluation of the testing items meets the requirements. |
| Cytotoxicity (ISO 10993-5:2009) | Meets requirements | |
| Skin sensitization (ISO 10993-10:2010) | Meets requirements | |
| Hemolysis (ISO 10993-4:2017) | Meets requirements | |
| Intracutaneous reactivity (ISO 10993-10:2010) | Meets requirements | |
| Acute systemic toxicity (ISO 10993-11:2017) | Meets requirements | |
| Pyrogenicity (ISO 10993-11:2017) | Meets requirements (also "Non-pyrogenic" in comparison table) | |
| Particulate (USP ) | Meets requirements | |
| Sterilization & Shelf-Life | ISO 11135 (Sterilization) | Validated; thereby determined routine control and monitoring parameters. |
| Shelf Life Evaluation (e.g., physical, chemical, biological, sterility, seal strength, leakage) | 3 years shelf life determined based on stability studies (including accelerated aging). Tests performed: EO residue (ISO 10993-7), ECH residue (ISO 10993-7), Packaging Standards (ISO 11607, ASTM F1980, ASTM D4169, ASTM F88/F88M, ASTM F1140/F1140M, ASTM F1929, ASTM F2096), Microbial Barrier (DIN 58953-6). | |
| Performance Testing (Syringe) | ISO 7886-1:2017 (general) | Complies with the standard. |
| Cleanliness (Cl 6.1) | Complies | |
| Acidity/Alkalinity Limits (Cl 6.2) | Complies | |
| Extractable metals Limits (Cl 6.3) | Complies | |
| Lubricant (Cl 7) | Complies | |
| Graduated capacity tolerance (Cl 8) | Complies | |
| Scale, Numbering, Length, Position (Cl 9.1-9.4) | Complies | |
| Dimensions, Barrel flanges (Cl 10.1-10.2) | Complies | |
| Design (Cl 11.1) | Complies | |
| Conical fitting (Cl 12.1, ISO 80369-7) | Complies | |
| Nozzle position/lumen (Cl 12.2-12.3) | Complies | |
| Dead Space (Cl 13.1) | Complies | |
| Freedom from air/liquid leakage past plunger stopper (Cl 13.2) | Complies | |
| Force to operate piston (Cl 13.3) | Complies | |
| Fit of plunger stopper/plunger (Cl 13.4) | Complies | |
| Performance Testing (Needle) | ISO 7864:2016 (general) | Complies with the standard. |
| Cleanliness (Cl 4.3) | Complies | |
| Acidity/Alkalinity Limits (Cl 4.4) | Complies | |
| Extractable metals Limits (Cl 4.5) | Complies | |
| Tubular needle designation (Cl 4.6) | Complies | |
| Color coding (Cl 4.7) | Complies (Color-coded per ISO 6009) | |
| Needle hub (Cl 4.8, ISO 80369-7, ISO 6009) | Complies | |
| Needle cap (Cl 4.9) | Complies | |
| Needle tube (length, defects, lubricant) (Cl 4.10) | Complies | |
| Needle Point (Cl 4.11) | Complies | |
| Bond between Tube and Hub (Cl 4.12) | Complies | |
| Patency of Lumen (Cl 4.13) | Complies | |
| Performance Testing (Luer Connectors) | ISO 80369-7:2016 (now 2021) (general) | Complies with the standard. |
| Dimensional requirements (Cl 5) | Complies | |
| Fluid leakage (Cl 6.1.3) | Complies | |
| Sub-atmospheric pressure air leakage (Cl 6.2) | Complies | |
| Stress cracking (Cl 6.3) | Complies | |
| Resistance to separation (axial/unscrewing) (Cl 6.4-6.5) | Complies | |
| Resistance to overriding (Cl 6.6) | Complies | |
| Performance Testing (Needle Tube - Materials) | ISO 9626:2016 (general) | Complies with the standard. |
| Surface finish, visual appearance (Cl 5.2) | Complies | |
| Cleanliness (Cl 5.3) | Complies | |
| Acidity/Alkalinity Limits (Cl 5.4) | Complies | |
| Size designation (Cl 5.5) | Complies | |
| Dimensions (Cl 5.6) | Complies | |
| Stiffness (Cl 5.8) | Complies | |
| Resistance to breakage (Cl 5.9) | Complies | |
| Resistance to corrosion (Cl 5.10) | Complies | |
| Labeling | 21 CFR Part 801 | Meets the requirements. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for each test mentioned (e.g., how many syringes were tested for each performance criterion). It generally states that "The Sterile Syringes for Single Use with/without Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body."
- Data Provenance: The testing was conducted by or on behalf of the manufacturer, Zhejiang Kangkang Medical-Devices CO., Ltd., based in China. The data would therefore originate from China and pertain to laboratory testing of the manufactured device. The studies described are prospective laboratory tests performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the evaluation is based on compliance with harmonized standards for physical and chemical properties of a device, not on clinical interpretation or ground truth established by medical experts for diagnostic accuracy. The "ground truth" here is the pass/fail result against established standard specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical trials involving human interpretation of medical images or data, not for laboratory compliance testing of a physical medical device. The "adjudication" is the assessment of compliance with the specified test methods and criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists, pathologists). The device under review is a manual syringe, which does not involve human readers in this context or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This concept is completely irrelevant to a manual medical device like a syringe.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by the specified physical, chemical, and biological requirements and test methods outlined in the referenced international and national standards (e.g., ISO 7886-1, ISO 10993, USP , etc.). For instance, for sterility, the ground truth is achieving a Sterility Assurance Level (SAL) of $10^{-6}$. For dimensions, the ground truth is meeting the specified dimensional tolerances. This is entirely lab-based and objective measurement.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device (syringe), not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above. There is no AI training set.
§ 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).