(197 days)
Sterile Syringe with Safety needle for Single Use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Sterile Syringe for Single Use is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Safety Needle for Single Use is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Sterile Syringe with Safety needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.
The Sterile Syringe for Single Use is intended for manual and single use only, which consists of piston, barrel and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock, which is intended to be connected with a hypodermic needle.
Sterile Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, retractable cartridge, jointing medium and needle hub. The proposed device is available in variety of needle gauge and needle length. According to the needle length, the safety mechanism is available in 2-part cartridge (outer retractable cartridge and inner retractable cartridge) and 3-part cartridge (outer retractable cartridge, middle retractable cartridge and inner retractable cartridge). The proposed device is compatible for use with a luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The provided text describes a submission for K192679 (Sterile Syringe with Safety Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use) to the FDA, asserting substantial equivalence to predicate device K170651.
The document discusses acceptance criteria for various tests and confirms that the proposed device met these criteria through non-clinical testing and a simulated clinical study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Category | Specific Test / Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical, Mechanical, Chemical | Clause 5 of ISO 7886-1:2017 | General requirements | Conforms with requirements of related standards. |
| Clause 6 of ISO 7886-1:2017 | Extraneous matter | Conforms with requirements of related standards. | |
| Clause 7 of ISO 7886-1:2017 | Lubricant | Conforms with requirements of related standards. | |
| Clause 8 of ISO 7886-1:2017 | Tolerance on graduated capacity (Syringe) | Met the requirements of ISO 7886-1. | |
| Clause 9 of ISO 7886-1:2017 | Graduated scale | Conforms with requirements of related standards. | |
| Clause 10 of ISO 7886-1:2017 | Barrel | Conforms with requirements of related standards. | |
| Clause 11 of ISO 7886-1:2017 | Piston/plunger assembly | Conforms with requirements of related standards. | |
| Clause 12 of ISO 7886-1:2017 | Nozzle | Conforms with requirements of related standards. | |
| Clause 13 of ISO 7886-1:2017 | Performance (Syringe) | Met the requirements of ISO 7886-1. | |
| Clause 4.3 of ISO 7864:2016 | Cleanliness (Needle) | Complies with ISO 7864. | |
| Clause 4.4 of ISO 7864:2016 | Limits for acidity or alkalinity (Needle) | Complies with ISO 7864. | |
| Clause 4.5 of ISO 7864:2016 | Limits for extractable metals (Needle) | Complies with ISO 7864. | |
| Clause 4.6 of ISO 7864:2016 | Size designation (Needle) | Complies with ISO 7864. | |
| Clause 4.7 of ISO 7864:2016 | Colour coding (Needle) | Complies with ISO 7864. | |
| Clause 4.8 of ISO 7864:2016 | Needle hub | Complies with ISO 7864. | |
| Clause 4.9 of ISO 7864:2016 | Needle Cap | Complies with ISO 7864. | |
| Clause 4.10 of ISO 7864:2016 | Needle tube | Complies with ISO 7864. | |
| Clause 4.11 of ISO 7864:2016 | Needle point | Complies with ISO 7864. | |
| Clause 4.12 of ISO 7864:2016 | Bond between hub and needle tube | Complies with ISO 7864. | |
| Clause 4.13 of ISO 7864:2016 | Patency of lumen | Complies with ISO 7864. | |
| Clause 5.2 of ISO 9626:2016 | Surface finish and appearance | Complies with ISO 9626. | |
| Clause 5.3 of ISO 9626:2016 | Cleanliness | Complies with ISO 9626. | |
| Clause 5.4 of ISO 9626:2016 | Limits for acidity and alkalinity | Complies with ISO 9626. | |
| Clause 5.5 of ISO 9626:2016 | Size designation | Complies with ISO 9626. | |
| Clause 5.6 of ISO 9626:2016 | Dimensions | Complies with ISO 9626. | |
| Clause 5.8 of ISO 9626:2016 | Stiffness | Complies with ISO 9626. | |
| Clause 5.9 of ISO 9626:2016 | Resistance to breakage | Complies with ISO 9626. | |
| Clause 5.10 of ISO 9626:2016 | Resistance to corrosion | Complies with ISO 9626. | |
| Sterile Barrier Packaging | ASTM F1886/F1886M-16 | Visual inspection | Maintain its integrity. |
| ASTM F88/F88-15 | Seal strength | Maintain its integrity. | |
| ASTM F1929-15 | Dye penetration test | Maintain its integrity. | |
| Sterilization and Shelf Life | ISO 10993-7:2008 | EO residue limit | Did not exceed the limit. |
| ISO 10993-7:2008 | ECH residue limit | Did not exceed the limit. | |
| USP 38-NF 33 | Bacteria Endotoxin Limit (20EU/device) | Did not exceed 20EU/device. | |
| Physical, Mechanical, Chemical, Package Test on aging samples | Maintain its performance during the claimed shelf life. | Maintained its performance during the claimed shelf life. | |
| Biocompatibility | ISO 10993-1 series (Tests for blood path, indirect, |
§ 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).