(267 days)
The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged, and as part of a sterile kit.
The Plastic LOR syringe is a piston syringe of three pieces. It consists of barrel, plunger and piston. The barrel is available with Luer slip, NRFit lock, NRFit Slip male connector. The Plastic LOR syringe is provided in combinations of four connectors and four syringe capacities (5ml, 7ml, 10ml, 20ml). The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile will be supplied to Anesthetic Conduction Kit manufacturers to be sterile and packaged into kit. The Plastic LOR syringe is a single use device which will be supplied as sterile individually packaged and the non-sterile bulk packed. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the s helf life of five years.
This document is a 510(k) Summary for a Plastic LOR Syringe. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from various ISO and ASTM standards for syringes, neuraxial, and Luer connectors, as well as biocompatibility and sterilization standards. The reported device performance indicates compliance with these standards.
| Acceptance Criteria Category | Specific Standard/Clause | Reported Device Performance |
|---|---|---|
| Physical/Mechanical | Clause 5 of ISO 7886-1:2017 (General requirements) | Conforms to requirements |
| Clause 6 of ISO 7886-1:2017 (Extraneous matter) | Conforms to requirements | |
| Clause 7 of ISO 7886-1:2017 (Lubricant) | Conforms to requirements | |
| Clause 8 of ISO 7886-1:2017 (Tolerance on graduated capacity) | Conforms to requirements | |
| Clause 9 of ISO 7886-1:2017 (Graduated scale) | Conforms to requirements | |
| Clause 10 of ISO 7886-1:2017 (Barrel) | Conforms to requirements | |
| Clause 11 of ISO 7886-1:2017 (Piston stopper/plunger assembly) | Conforms to requirements | |
| Clause 12 of ISO 7886-1:2017 (Nozzle) | Conforms to requirements | |
| Clause 13 of ISO 7886-1:2017 (Performance) | Conforms to requirements | |
| Neuraxial Small-Bore Connector | Clause 5 of ISO 80369-6:2016 (Dimensional requirements) | Conforms to requirements |
| Clause 6.1 of ISO 80369-6:2016 (Fluid leakage) | Conforms to requirements | |
| Clause 6.2 of ISO 80369-6:2016 (Sub-atmospheric pressure air leakage) | Conforms to requirements | |
| Clause 6.3 of ISO 80369-6:2016 (Stress cracking) | Conforms to requirements | |
| Clause 6.4 of ISO 80369-6:2016 (Resistance to separation from axial load) | Conforms to requirements | |
| Clause 6.5 of ISO 80369-6:2016 (Resistance to separation from unscrewing) | Conforms to requirements | |
| Clause 6.6 of ISO 80369-6:2016 (Resistance to overriding) | Conforms to requirements | |
| Luer Connector | Clause 5 of ISO 80369-7:2016 (Dimensional requirements) | Conforms to requirements |
| Clause 6.1 of ISO 80369-7:2016 (Fluid leakage) | Conforms to requirements | |
| Clause 6.2 of ISO 80369-7:2016 (Sub-atmospheric pressure air leakage) | Conforms to requirements | |
| Clause 6.3 of ISO 80369-7:2016 (Stress cracking) | Conforms to requirements | |
| Clause 6.4 of ISO 80369-7:2016 (Resistance to separation from axial load) | Conforms to requirements | |
| Clause 6.5 of ISO 80369-7:2016 (Resistance to separation from unscrewing) | Conforms to requirements | |
| Clause 6.6 of ISO 80369-7:2016 (Resistance to overriding) | Conforms to requirements | |
| Sterile Barrier Packaging | ASTM F1886/F1886M-16 (Visual inspection) | Maintained integrity |
| ASTM F88/F88-15 (Seal strength) | Maintained integrity | |
| ASTM F1929-15 (Dye penetration test) | Maintained integrity | |
| Sterilization & Shelf Life | ISO 10993-7:2008 (EO residue) | EO ECH residue did not exceed the limit |
| USP 39-NF 34 (Bacteria Endotoxin Limit) | Endotoxin limit did not exceed 2.15 EU/device | |
| Shelf Life Evaluation (Physical, Mechanical, Chemical, Package Tests on aging samples) | Maintained performance during claimed shelf life (5 years) | |
| Biocompatibility | (Implicitly based on ISO 10993 for indirect contact, |
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).