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510(k) Data Aggregation
(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 <788> (SteriCap) / USP <788>, USP <789> (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 (<24 hours) direct tissue and indirect blood path contact, per ISO 10993-1, ISO 13485. | Meets requirements, applicable to product family, demonstrating biocompatibility for intended use. |
| Sterilization & Shelf Life | Sterilized by ethylene oxide (EO) with SAL: 10-6. Residual levels meet ISO 10993-7. LAL testing ≤ 0.2 EU/device. 5-year shelf life. Packaging integrity (ASTM F2096-11), seal strength (ASTM F88/F88M-15). Stress associated with transportation (ASTM D4169-16). | Validated as per ISO 11135:2014, ISO 10993-7, LAL testing, ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, ASTM F88/F88M-15. |
| Device Components | Needle, needle hub, spring-loaded needle cap, designed to fit standard 6% luer fittings. | Identical to predicate devices. |
| Needle Length (Exposed) | 4 mm, 5.5 mm, 6 mm. | Identical to predicate devices. |
| Needle Length (Total) | 19.5 mm, 20 mm, 21.5 mm. | Identical to predicate devices. |
| Needle Tip | Lancet Bevel. | Identical to predicate devices. |
| Needle Taper | None. | Identical to predicate devices. |
| Wall Type | Std. | Identical to predicate devices. |
| Needle Gauge | SteriCap: 30G, 31G, 33G. VitreJect: 30G, 31G, 33G. | SteriCap: Differences in configuration/size offering do not raise new questions of safety or effectiveness. VitreJect: Identical to predicate. |
| Connection | Luer-slip, Luer-lock. | Identical to predicate devices. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test. It broadly mentions "bench testing" and "performance testing" being performed. The data provenance is not explicitly stated in terms of country of origin. The studies appear to be retrospective in the sense that they are comparing the performance of the subject devices to established predicate devices and existing standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical studies. The testing relies on established engineering and medical device standards (ISO, USP, ASTM, AAMI) and internal company standards. The "ground truth" in this context is adherence to these predefined technical and performance specifications. Therefore, information regarding the number and qualifications of experts for ground truth establishment for a test set is not applicable here.
4. Adjudication Method for the Test Set
As the evaluation is primarily based on meeting predefined technical specifications and standards through laboratory testing, an adjudication method (such as 2+1 or 3+1 used in clinical assessments) is not relevant or described. The results are likely binary (pass/fail) against the specified criteria.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to predicate devices through technical and performance testing, rather than comparing human reader performance with and without AI assistance. This device is a physical hypodermic needle with a safety mechanism, not an AI-powered diagnostic tool.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable. The devices are physical medical instruments (hypodermic needles with safety features), not algorithms or software for which standalone performance (algorithm only) would be evaluated.
7. Type of Ground Truth Used
The "ground truth" used for evaluating the device is primarily:
- Conformance to International and National Standards: e.g., ISO 7864, ISO 803369-7, ISO 9626, ISO 6009, USP <788>, USP <789>, 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.
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