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510(k) Data Aggregation
(90 days)
The HWJECT Auto-Disable Syringe is intended for aspiration of fluids. Additionally, it features autodisable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.
The auto-disable syringe is intended for aspiration and injection of fluids. The subject device is composed of needle cap, barrel, plunger, clip, plunger stopper, and needle tube. The clip cooperates with plunger and barrel to complete self-destruction of the device. It is nonpyrogenic and intended for single use. The auto-disable feature (no sharp injury) involves a design where the syringe automatically becomes inoperable by locking the plunger with the clip after injection to prevent syringe reuse. The capacity of the auto-disable syringe is available in 0.05 mL, 0.1 mL, 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube ranges from 22G to 27G. The needle length ranges from 10 mm to 38 mm.
This document is a 510(k) premarket notification for a medical device called the "HWJECT Auto-disable syringe." The FDA's review concludes that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence to an existing device, rather than proving a novel device's safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).
Therefore, the study conducted is primarily non-clinical performance testing and biocompatibility testing, aiming to show that the new device performs comparably to the predicate device and meets established safety standards. There is no information about AI/ML models or human reader studies in this document. The term "acceptance criteria" here refers to the performance standards and regulatory requirements the device must meet to demonstrate substantial equivalence, not statistical measures for an AI model's performance.
Here's an analysis based on the provided text, while explicitly noting that the request for information on AI/ML-specific criteria (like MRMC studies, expert adjudication for ground truth of an AI model, and training/test set sample sizes for AI) is not applicable to this document as it does not describe an AI/ML medical device.
Acceptance Criteria and Device Performance for HWJECT Auto-disable syringe
The acceptance criteria for this device are largely defined by adherence to recognized international and national standards for medical devices, particularly those for hypodermic syringes and needles. The "study" refers to a series of non-clinical tests performed to demonstrate compliance with these standards and substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard Compliance/Requirement) | Reported Device Performance |
|---|---|---|
| Performance Testing | ||
| ISO 7886-3:2020 (Sterile Hypodermic Syringes for Single Use Part 3: Auto-disabled syringes for fixed-dose immunization) | - Limits for acidity or alkalinity- Limits for extractable metals- Lubricant- Tolerance on nominal capacity- Graduated scale- Barrel- Design- Fit of the plunger stopper/plunger in the barrel- Fiducial line- Dead space- Freedom from air and liquid leakage- Auto-disable syringe feature | Performance testing results met the requirements of the standard, demonstrating substantial equivalence to the predicate device. Specific numerical results are not provided in this summary, but the conclusion is conformance. For the auto-disable feature, "Activation force: 2-4 N," and "Auto-disabled, prevents syringe re-use" are explicitly stated as characteristics matching the predicate device. |
| ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods) | - Stiffness- Resistance to breakage- Resistance to corrosion- Needle O.D.- Needle inner diameter | Performance testing results met the requirements of the standard. For the 22G needle gauge (a difference from the predicate), specific testing was conducted to verify that this difference does not raise new questions of safety and effectiveness, and it was found to be "in accordance with ISO 9626." |
| ISO 7864:2016 (Sterile hypodermic needles for single use-Requirements and test methods) | - Needle point- Bond between hub and needle tube- Patency of lumen- Cleanliness- Needle length- Testing for measuring the penetration force and drag force for needles | Performance testing results met the requirements of the standard. For needle bonding strength, a range of "62-100 N" is reported, conforming to ISO 7864:2016 requirements. For differences in needle length (extra specifications compared to predicate), non-clinical performance testing validated that these do not raise new safety/effectiveness questions. |
| USP <788> (Particulate matter in injections) | USP acceptance criteria for particulate matter. | Particulate testing results met the USP acceptance criteria. |
| Biocompatibility Testing | Compliance with ISO 10993-1 for an Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours), addressing: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity. | The proposed device was tested in compliance with ISO 10993-1, covering all listed parameters. The implication is that the tests passed, allowing the substantial equivalence determination. |
| Sterility | Achievement of 10^-6^ Sterility Assurance Level (SAL), per ISO 11135:2014 (ethylene oxide sterilization) | Sterilization process confirmed the device reached 10^-6^ SAL, and performance/packaging post-sterilization aligned with expectations. |
| Shelf Life | Maintain complete sterile state within the five-year labeling period (evaluated under accelerated aging per ASTM F1980). | Shelf-life validation study conducted showing conformance for a five-year period. |
| Package Integrity | Compliance with ASTM D4169-22 for simulated shipping conditions, ASTM D3078-02 (Vacuum Leak Test), ASTM F1929-15 (Dye Penetration Test), DIN 58953-6:2016 (Microbial Barrier Properties Test), ASTM F88/F88M-21 (Seal Strength Test). | Testing was conducted. "All packaging was deemed acceptable for the protection of product and sterility maintenance." |
| Simulated Clinical Use Testing | Compliance with FDA Guidance for industry and FDA Stuff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005. | Simulated clinical use testing of the proposed device has been conducted in compliance with the guidance. This likely means the auto-disable mechanism functioned as intended in simulated use. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. These details are typically found in the full test reports referenced by the summary. Standard practices for medical device testing often involve statistical sampling plans (e.g., AQL levels for lot acceptance) rather than a fixed "test set" in the AI sense.
- Data Provenance: The manufacturer, Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., is located in China. The testing was conducted in conformance with internationally recognized standards (ISO, ASTM, USP, DIN) and FDA guidance. The data is prospective, generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable as the document does not describe a study involving human experts establishing ground truth for an AI/ML model for diagnostic or predictive purposes. The "ground truth" here is the adherence to engineering and material science standards (e.g., a needle's bond strength, a syringe's sterility, the function of the auto-disable feature), verified through objective testing methods.
4. Adjudication Method for the Test Set
- This is not applicable. There is no "adjudication" (in the sense of expert consensus on complex data interpretations) because the tests are governed by clear, objective, and measurable parameters defined by international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is a clinical study design used to evaluate the diagnostic accuracy of a radiology AI/ML device, often comparing human readers with and without AI assistance. This document is for an auto-disable syringe, which is a mechanical medical device, not an AI/ML diagnostic software. Therefore, such a study was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. There is no AI algorithm being evaluated. The device's performance is inherently "standalone" in that its mechanical functions (auto-disable, fluid aspiration/injection) are tested directly.
7. The Type of Ground Truth Used
- For this type of device, the "ground truth" is defined by:
- Engineering and Performance Specifications: As set forth in standards like ISO 7886-3, ISO 9626, ISO 7864, which define acceptable parameters for physical and functional properties (e.g., specific ranges for "Activation force," limits for "extractable metals," "freedom from liquid leakage").
- Material Science Properties: Adherence to material specifications (e.g., "stainless steel" for needle/clip, "PP" for barrel/plunger).
- Sterility Assurance: Demonstrated through documented sterilization processes and testing to achieve a specific SAL.
- Biocompatibility: Demonstrated through specific tests (cytotoxicity, sensitization, etc.) as per ISO 10993.
- Functional Success: The auto-disable feature either successfully locks the plunger after injection or it does not.
8. The Sample Size for the Training Set
- This is not applicable. This device is not an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- This is not applicable. There is no AI/ML model or corresponding training data/ground truth in this submission.
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