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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

• 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 (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 (

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