(178 days)
The Sterile Safety Syringe with Needle for Single Use 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 Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for 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 Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.
The Sterile Safety Syringe with Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Safety Hypodermic Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. The Sterile Auto-Disable Syringe with Needle for Single Use is available in various capacities of syringes.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
The provided text describes a 510(k) summary for Sterile Safety Syringes and Needles. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a multi-reader multi-case (MRMC) study.
Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment for AI/ML device validation are not present in this document, as this is a traditional medical device submission.
However, I can extract information related to the non-clinical performance tests that serve as acceptance criteria for this type of device and how the device proved it met them.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this non-AI/ML device are primarily based on compliance with established international standards and demonstration of substantial equivalence to predicate devices through various non-clinical tests. The reported device performance is presented as meeting these standards and showing similar performance to predicates.
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Sterile Safety Syringe with Needle for Single Use | Complied with |
| ISO 7886-1: 2017 (Sterile hypodermic syringes for manual use) | Complied with |
| ISO 9626: 2016 (Stainless steel needle tubing) | Complied with |
| ISO 80369-7: 2016 (Small-bore connectors) | Complied with |
| Sterile Safety Hypodermic Needle for Single Use | Complied with |
| ISO 7864: 2016 (Sterile hypodermic needles) | Complied with |
| ISO 9626: 2016 (Stainless steel needle tubing) | Complied with |
| Sterile Auto-Disable Syringe with Needle for Single Use | Complied with |
| ISO 7886-3: 2020 (Auto-disabled syringes for fixed-dose immunization) | Complied with |
| Sterile Barrier Packaging Tests | Results Met Criteria |
| Visual inspection (ASTM F1886/F1886M-16) | Integrity maintained |
| Seal strength (ASTM F88/F88-15) | Integrity maintained |
| Dye penetration test (ASTM F1929-15) | Integrity maintained |
| Sterilization and Shelf Life Tests | Results Met Criteria |
| EO residue (ISO 10993-7:2008) | Did not exceed limit |
| ECH residue (ISO 10993-7:2008) | Did not exceed limit |
| Bacteria Endotoxin Limit (USP) | Did not exceed 20 EU/device |
| Shelf Life Evaluation (Physical, Mechanical, Chemical, Package Tests on aging samples) | Device maintained performance during claimed shelf life (3 years) |
| Biocompatibility Tests | Results Showed No Negative Impacts |
| Cytotoxicity | No cytotoxicity |
| Sensitization | No skin sensitization |
| Intracutaneous (Irritation) | No intracutaneous reactivity |
| Acute Systemic Toxicity | No systemic toxicity |
| Hemolysis | No Hemolysis |
| Pyrogen | No Pyrogen |
| Particulate testing | (Presence of particulars not explicitly stated as an acceptance criterion in table, but noted as evaluated) |
| Simulated Clinical Study | The proposed device met the pre-established criteria according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism. |
| Safety Feature Test (Comparison to Predicate) | Test data of the proposed device is "very close" to the test data of the predicate device. |
| Simulated Distribution (ASTM D4169-16) | Packing can protect the proposed device from damage during storage and distribution environments. |
Additional Details (Based on available information and the nature of this submission):
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Sample sizes used for the test set and the data provenance:
- The document does not specify exact sample sizes for each non-clinical test performed (e.g., how many syringes were tested for each performance characteristic, or how many samples for biocompatibility).
- The data provenance is implied to be from non-clinical testing conducted by the manufacturer, Shandong Weigao Group Medical Polymer Co., Ltd. (China). These are laboratory tests, not human data. The document does not specify if the tests were performed retrospectively or prospectively relative to the submission date, but typical device testing for 510(k) is performed as part of the development and validation process.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a submission for a traditional medical device (syringes and needles), not an AI/ML device that requires human expert review to establish "ground truth" for interpretive tasks (like image classification). The "ground truth" for this device's performance is established by objective measurements and compliance with international standards in laboratory settings.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept applies to human reader studies often conducted for AI/ML devices where there might be disagreement among readers. For physical device testing, adjudication methods generally involve standardized measurement protocols and calibration, not expert consensus.
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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:
- No. This is not an AI/ML device, so an MRMC study is not applicable or mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is not an AI/ML device. The "standalone" performance here refers to the device itself meeting the defined physical and performance criteria.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on objective, measurable criteria as defined by international standards (e.g., ISO, ASTM). For example:
- Needle sharpness and bend resistance are measured via mechanical tests.
- Syringe flow rates and accuracy are measured via fluid dynamics tests.
- Biocompatibility is assessed through standardized biological assays.
- Sterility is validated through microbiological testing (SAL).
- Safety mechanism effectiveness is assessed via simulated use tests following FDA guidance and ISO standards.
- The "ground truth" for this device's performance is based on objective, measurable criteria as defined by international standards (e.g., ISO, ASTM). For example:
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The sample size for the training set:
- N/A. This is a manufactured physical device, not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- N/A. 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).