(175 days)
The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.
The provided text describes the regulatory clearance (510(k)) for the "Sterile Hypodermic Syringes for Single Use with Safety Needles" by Sichuan Prius Biotechnology Co., Ltd. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report for AI-powered medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or present in this given text.
However, I can extract the acceptance criteria and performance data for the non-clinical functional and safety aspects of the device, as well as general information about testing methodologies.
1. Table of acceptance criteria and the reported device performance:
| Test / Performance Characteristic | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Syringe Performance | ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use- Part 1: Syringes for manual use | Demonstrated that the syringe meets the requirements of ISO 7886. |
| Luer Connector Performance | ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | Demonstrated that the luer connector meets the requirements of ISO 80369-7. Also tested with ISO 80369-20:2015 (Common test methods). |
| Needle Performance | ISO 7864: 2016, Sterile Hypodermic Needles for Single Use. | Demonstrated that the needle meets the requirements of ISO 7864. |
| Needle Tubing Performance | ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices | Demonstrated that the needle meets the requirements of ISO 9626. |
| Safety Mechanism | FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 | Demonstrated that the proposed device met the pre-established criteria (for simulated clinical study) and the acceptance criteria (for safety feature test). |
| Biocompatibility | ISO10993-1 (classification: Externally Communicating Device, Blood Path Indirect, Limited Contact ( Particulate Matter in Injections | Met the USP acceptance criteria. |
| Sterility (SAL) | ISO 11135:2014 | Achieved a sterility assurance level (SAL) of 10-6. |
| EO and ECH Residuals | ISO 10993-7:2008 | Below the limits specified in ISO 10993-7. |
| Bacterial Endotoxin Levels | USP | Below the level of 20 EU/device. |
| Shelf-life | ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Both baseline and accelerated shelf life testing were conducted, demonstrating the device will perform as intended to support the proposed 5-year shelf-life. |
| Sterile Barrier Packaging | Visual Inspection ASTM F1886 / F1886M-16, Seal Strength ASTM F88/F88-15, Dye penetration ASTM F1929-15 | Performed on the proposed device (results implicitly met standards). |
| Simulated Transportation | ASTM D4169-16 | Performed on final, packaged, and sterile device (results implicitly met standards). |
The following questions are not applicable as the document describes a traditional medical device (syringes with safety needles) and not an AI/ML-powered device:
- Sample size used for the test set and the data provenance: Not applicable. The testing described is for physical characteristics and biological safety, not a "test set" in the AI/ML context.
- 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): Not applicable. This refers to expert review for AI/ML model training/validation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI context. For physical device testing, "ground truth" is established by the specified ISO/ASTM standards and their associated test methods for measuring properties (e.g., strength, sterility, dimensions).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).