(59 days)
The SteriCap Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.
The VitreJect Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect Safety Needle is indicated for intravitreal use.
The VitreJect Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.
The SteriCap Safety Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen hypodermic needle intended for use with a luer-tip syringe. The SteriCap Safety Needle has a spring-actuated, non-removable sliding cap that moves along the axis of the needle hub during clinical use and automatically re-covers the needle tip after use. The needle cap can be manually locked/unlocked. The SteriCap Safety Needle is intended for manual use by health care professionals for administration of drugs. The SteriCap Safety Needle is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas.
The VitreJect Safety Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen hypodermic needle intended for use with a luer-tip syringe. The VitreJect Safety Needle has a spring-actuated, non-removable sliding cap that moves along the axis of the needle hub during clinical use and automatically re-covers the needle tip after use. The needle cap can be manually locked/unlocked. The VitreJect Safety Needle is intended for manual use by health care professionals for administration of drugs. The VitreJect Safety Needle is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Safety Needle is suitable for ophthalmic use.
This document details the acceptance criteria and supporting studies for the OcuJect SteriCap Safety Needle and VitreJect Safety Needle.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the OcuJect SteriCap Safety Needle and VitreJect Safety Needle are based on conformance to recognized international and internal standards, and performance against these standards. The subject devices are described as having "identical" characteristics where they match the predicate devices, and "meet design specification and conforms to standard" or "Passed bench testing for sharps injury prevention feature activation, access in the safe mode, and destructive force, and demonstrate 0% injury rate" for performance features.
| Characteristic | Acceptance Criteria (Standard / Description) | Reported Device Performance |
|---|---|---|
| Intended Use | Inject fluids into, or withdraw fluids from, the body. | Identical to predicate devices. |
| Indications for Use | Administration of drugs. For VitreJect, also intravitreal use. Integrated passive needle shield covers needle prior to use, automatically activates post-use. Manual lock mechanism for needle shield. Locked shield minimizes accidental needle stick. | Equivalent indications for use. Subject devices specifically indicate sharps injury prevention feature. |
| Material | Stainless steel (needle, spring), Polypropylene (needle hub, needle cap), Silicone (lubricant), Polyacrylate (adhesive). | Identical to predicate devices. |
| Dimensional & Physical Properties | Conformance to ISO 7864, ISO 80369-7. | Meets design specification and conforms to standard. |
| Bond & Material Strength | Conformance to ISO 7864, ISO 80369-7. | Meets design specification and conforms to standard. |
| Needle Quality | Conformance to ISO 9626, ISO 7864. | Meets design specification and conforms to standard. |
| Color Coding | Conformance to ISO 6009, ISO 7864. | Conforms to ISO 6009. |
| Luer Connector | Conformance to ISO 80369-7. | Meets design specification and conforms to standard. |
| Particulate Testing | Conformance to USP (SteriCap) / USP , USP (VitreJect). | Meets design specification and conforms to standard. |
| Sharps Injury Prevention Feature | Conformance to International Standards, ISO 23908. | Passed bench testing for activation, access in safe mode, destructive force, and demonstrate 0% injury rate. |
| Biocompatibility | Non-cytotoxic, non-sensitizer, non-irritant (intracutaneous, ocular, intravitreal, intraocular), non-pyrogenic, non-toxic, non-hemolytic (for VitreJect). Categorization as externally communicating device with limited (, USP , ISO 23908, ISO 10993 series, ISO 11135, ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, ASTM F88/F88M-15, AAMI TIR28, ANSI/AAMI ST72. |
- Internal Standards: The document refers to "Internal Standards" for certain performance aspects, particularly for the Sharps Injury Prevention Feature.
- Bench Testing Results: Demonstrating specific quantifiable performance metrics such as "0% injury rate" for the sharps injury prevention feature.
- Post-market data: Mentioned as recording a "0% injury rate" for the predicate devices.
8. Sample Size for the Training Set
This question is not applicable. The device is a physical medical instrument, not a machine learning model, and therefore does not involve a training set in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for a physical medical device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).