(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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
November 27, 2023
OcuJect, LLC % Heidi Busz Senior Regulatory Consultant Namsa 400 Highway 169 South Suite 500 Minneapolis, Minnesota 55426
Re: K233343
Trade/Device Name: SteriCap Safety Needle; VitreJect Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 29, 2023 Received: September 29, 2023
Dear Heidi Busz:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233343
Device Name SteriCap Safety Needle; VitreJect Safety Needle
Indications for Use (Describe)
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 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 Vitrelect Safety Needle is indicated for intravitreal use.
The VitreJect Safety Needle has an integrated passive 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for OcuJect LLC. The logo consists of three hexagons on the left side, with the top hexagon being white, the middle hexagon being dark blue, and the bottom hexagon being light blue. To the right of the hexagons is the company name "OcuJect LLC" in blue font, with the word "OcuJect" being larger than "LLC". Below the company name is the text "ADVANCED DRUG DELIVERY" in a smaller blue font.
K233343 510(k) Summary
I. SUBMITTER
OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660 Phone: (949) 721-6716 Email: llerner@ocuject.com Primary Contact: Leonid Lerner, MD, PhD Date prepared: October 16, 2023
II. DEVICE
| Device Name: | SteriCap® Safety Needle and VitreJect® Safety Needle |
|---|---|
| Common/Usual Name: | Hypodermic needle with safety system |
| Classification Name: | Needle, Hypodermic, Single Lumen (21 CFR 880.5570) |
| Regulatory Class: | II |
| Product Code: | FMI |
III. PREDICATE DEVICE
SteriCap® Mini Needle, K212805 | VitreJect® Needle, K230959
The predicate devices have not been subject to design-related recall.
DEVICE DESCRIPTION IV.
SteriCap Safety Needle
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.
VitreJect Safety Needle
The Vitrelect 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
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Image /page/4/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three interconnected hexagons in different shades of blue on the left side. To the right of the hexagons, the company name "OcuJect" is written in a stylized, italicized blue font, with "LLC" in smaller letters. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif blue font.
use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Safety Needle is suitable for ophthalmic use.
INTENDED USE / INDICATIONS FOR USE V.
SteriCap Safety Needle
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.
VitreJect Safety Needle
The Vitrelect 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of the SteriCap Safety Needle and VitreJect Safety Needle are substantially equivalent to the predicate devices. The intended use of the subject devices is identical to the predicate devices.
| Intended Use | Indications for Use | Discussion | AssociatedTestingStandard | |
|---|---|---|---|---|
| SubjectDeviceSteriCapSafetyNeedle | Intended toinject fluidsinto, orwithdrawfluids from,the body. | The SteriCap Safety Needle is intendedfor use with a luer-tip syringe for theadministration of drugs.The SteriCap Safety Needle has anintegrated passive needle shield thatcovers the needle prior to use andautomatically activates to cover theneedle immediately after use. A lockmechanism can be manually activatedto lock/unlock the needle shield. Thelocked needle shield minimizes risk ofaccidental needle stick. | Identical intended usesupported byreferencedperformance andbiocompatibilitytesting.Equivalent indicationsfor use. The existingintegrated mechanismof the predicateSteriCap Mini Needle | ISO 7864,InternalStandards,ISO 23908,ISO 80369-7,ISO 10993,USP <788> |
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Image /page/5/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three interlocking hexagons in white and blue on the left side. To the right of the hexagons is the company name, "OcuJect LLC," in a blue sans-serif font, with the "LLC" in a smaller font size. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a similar blue font.
| PredicateDeviceSteriCapMiniNeedle(K212805) | Intended toinject fluidsinto, orwithdrawfluids from,the body. | The SteriCap Mini Needle is intendedfor use with a luer-tip syringe for theadministration of drugs. | is not indicated assharps injuryprevention feature. | |
|---|---|---|---|---|
| Subject | VitreJect Safety Needle | |||
| DeviceVitreJectSafetyNeedle | Intended toinject fluidsinto, orwithdrawfluids from,the body. | The VitreJect Safety Needle isintended for use with a luer-tip syringefor the administration of drugs.The VitreJect Safety Needle has anintegrated passive needle shield thatcovers the needle prior to use andautomatically activates to cover theneedle immediately after use. A lockmechanism can be manually activatedto lock/unlock the needle shield. Thelocked needle shield minimizes risk ofaccidental needle stick. | Identical intended usesupported byreferencedperformance andbiocompatibilitytesting.Equivalent indicationsfor use. The existingintegrated mechanismof the predicateVitreJect Needle is notindicated as sharpsinjury preventionfeature. | ISO 7864,InternalStandards,ISO 23908,ISO 80369-7,ISO 10993,USP <788>,USP <789> |
| PredicateDeviceVitreJectNeedle(K230959) | Intended toinject fluidsinto, orwithdrawfluids from,the body. | The VitreJect Needle is intended foruse with a luer-tip syringe for theadministration of drugs. The VitreJectNeedle is indicated for intravitreal use. | indicated as sharpsinjury preventionfeature. |
The SteriCap Safety Needle has identical technological characteristics when compared to predicate SteriCap Mini Needle. These devices have identical design, material, manufacturing process, sterilization method, operation method, and packaging configuration; however, the SteriCap Mini Needle does not indicate the integrated sliding needle cap and locking mechanism as a safety feature.
The VitreJect Safety Needle has identical technological characteristics when compared to predicate VitreJect Needle. These devices have identical design, material, manufacturing process, sterilization method, operation method, and packaging configuration; however, the VitreJect Needle does not indicate the integrated sliding needle cap and locking mechanism as a safety feature.
Comparisons of the technological characteristics between the subject and predicate devices are illustrated in the tables below:
| SteriCap Safety Needle | |||||
|---|---|---|---|---|---|
| Characteristic | Subject DeviceSteriCap SafetyNeedle | PredicateDeviceSteriCap MiniNeedle(K212805) | Discussion | AssociatedTestingStandard | |
| Applicant | OcuJect, LLC | Identical | |||
| Proprietary Name | SteriCap | Identical | |||
| SteriCap Safety Needle | |||||
| Characteristic | Subject DeviceSteriCap SafetyNeedle | PredicateDeviceSteriCap MiniNeedle(K212805) | Discussion | AssociatedTestingStandard | |
| Device | Needle,Hypodermic,Single Lumen | Identical | |||
| Regulation Number | 21 CFR 880.5570 | Identical | |||
| Product Code | FMI | Identical | |||
| Device Class | II | Identical | |||
| Regulation MedicalSpecialty | General Hospital | Identical | |||
| Intended Users and | Clinicians in aclinical setting. | Identical | |||
| Principle ofOperation | Connects to a luertype syringe toserve as a conduitfor the movementof fluid. | Identical | ISO 7864,ISO 9626,ISO 80369-7 | ||
| Device Components | Needle Assembly:needle, needle hub,spring-loadedneedle cap)Designed to fitstandard 6% luerfittings | Identical | ISO 10993-1,ISO 10993-5, ISO10993-7,ISO 10993-10,ISO 10993- | ||
| Material | Needle | Stainless steel | Identical | 11,ISO 10993- | |
| Needlehub | Polypropylene | Identical | 12,ISO 7864, | ||
| Lubricant | Silicone | Identical | ISO 9626, | ||
| Spring | Stainless steel | Identical | ISO 6009, | ||
| Adhesive | Polyacrylate | Identical | ISO 80369- | ||
| Needlecap | Polypropylene | Identical | 7,InternalStandards,ISO 23908 | ||
| Needle Length(Exposed) | 4 mm, 5.5 mm, 6mm | Identical | ISO 7864,ISO 9626 | ||
| Needle Length(Total) | 19.5 mm, 20 mm,21.5 mm | Identical | |||
| Needle Tip | Lancet Bevel | Identical | |||
| Needle Taper | None | Identical | |||
| Wall Type | Std | Identical | |||
| Needle Gauge | 30G,31G,33G | 23G,25G,27G,29G,30G,31G,32G,33G | Differences in configuration /size offering do not raise new ordifferent questions of safety or | ISO 7864,ISO 9626,ISO 6009 | |
| Configurations | 31G x 4 mm33G x 4 mm | 31G x 4 mm33G x 4 mm | effectiveness. All claimconformance to standards. | ||
| SteriCap Safety Needle | |||||
| Characteristic | Subject DeviceSteriCap SafetyNeedle | PredicateDeviceSteriCap MiniNeedle(K212805) | Discussion | AssociatedTestingStandard | |
| 30G x 5.5 mm31G x 5.5 mm33G x 5.5 mm30G x 6 mm31G x 6 mm33G x 6 mm | 23G x 5.5 mm25G x 5.5 mm27G x 5.5 mm29G x 5.5 mm30G x 5.5 mm32G x 5.5 mm33G x 5.5 mm30G x 6 mm31G x 6 mm33G x 6 mm | ||||
| Connection | Luer-slipLuer-lock | Identical | ISO 7864,ISO 80369-7 | ||
| Needle ColorCoding | Conforms to ISO6009 | Identical | ISO 6009 | ||
| Sterilization andShelf Life | Provided Sterile,Single-Use100 individualblister packeddevices packagedinto shelf cartonSterilizationMethod: EOSAL: 10-6Shelf Life: 5 years | Identical | AAMITIR28,ISO 11135,ISO 10993-7,USP <85>,USP <161>,ANSI/AAMIST72,ASTMF1980-16,ISO 7864,ISO 9626,ISO 80369-7,ISO 11607-1,ASTMF88/F88-15,ASTMD4169-16 | ||
| Biocompatibility perISO 10993-1;categorization asexternallycommunicatingdevice with limited(<24 hours) directtissue and indirectblood path contact | Non-cytotoxic | Identical | ISO 10993-5 | ||
| Non-sensitizer | Identical | ISO 10993-10 | |||
| Non-irritant,IntracutaneousReactivity | Identical | ISO 10993-10 | |||
| Non-pyrogenic | Identical | ISO 10993-11,USP <151> | |||
| Non-toxic | Identical | ISO 10993-11 | |||
| SteriCap Safety Needle | |||||
| Characteristic | Subject DeviceSteriCap SafetyNeedle | PredicateDeviceSteriCap MiniNeedle(K212805) | Discussion | AssociatedTestingStandard | |
| Performance Data | Needleperformance meetsdesignspecification andconforms tostandard. | Identical | ISO 7864,ISO 9626 | ||
| Luer connectionperformance meetsdesignspecification andconforms tostandard. | Identical | ISO 80369-7 | |||
| Particulates meetdesignspecification andconforms tostandard. | Identical | USP <788> | |||
| Sharps InjuryPrevention Featureperformance meetsdesignspecification andconforms tostandard. | N/AThe existingintegratedmechanism isnot indicated assharps injurypreventionfeature | Passed bench testing for sharpsinjury prevention featureactivation, access in the safemode, and destructive force, anddemonstrate 0% injury rate. | InternalStandards,ISO 23908 |
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Image /page/6/Picture/0 description: The image contains the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three hexagons in different shades of blue on the left side. The company name "OcuJect" is written in a stylized blue font, with "LLC" in smaller letters to the right. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three hexagons in different shades of blue on the left side. To the right of the hexagons is the company name, "OcuJect," in a bold, sans-serif font, with "LLC" in a smaller font size. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a smaller, sans-serif font.
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Image /page/8/Picture/0 description: The image shows the logo for OcuJect, LLC, a company specializing in advanced drug delivery. The logo features three interconnected hexagons in varying shades of blue on the left side. To the right of the hexagons is the company name, "OcuJect," in a bold, sans-serif font, with "LLC" in a smaller font size. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a smaller, sans-serif font.
| VitreJect Safety Needle | ||||
|---|---|---|---|---|
| Characteristic | Subject DeviceVitreJect SafetyNeedle | PredicateDeviceVitreJectNeedle(K230959) | Discussion | AssociatedTestingStandard |
| Applicant | OcuJect, LLC | Identical | ||
| Proprietary Name | VitreJect | Identical | ||
| Device | Needle,Hypodermic,Single Lumen | Identical | ||
| Regulation Number | 21 CFR 880.5570 | Identical | ||
| Product Code | FMI | Identical | ||
| Device Class | II | Identical | ||
| Regulation MedicalSpecialty | General Hospital | Identical | ||
| Intended Users andEnvironment | Clinicians in aclinical setting. | Identical | ||
| VitreJect Safety Needle | ||||
| Characteristic | Subject DeviceVitreJect SafetyNeedle | PredicateDeviceVitreJectNeedle(K230959) | Discussion | AssociatedTestingStandard |
| Principle ofOperation | Connects to a luertype syringe toserve as a conduitfor the movementof fluid. | Identical | ISO 7864,ISO 9626,ISO 80369-7 | |
| Device Components | Needle Assembly:needle, needle hub,spring-loadedneedle cap)Designed to fitstandard 6% luerfittings | Identical | ISO 10993-1,ISO 10993-5, ISO10993-7,ISO 10993-10, ISO 10993- | |
| Material | NeedleStainless steel | Identical | 11,ISO 10993- | |
| NeedlehubPolypropylene | Identical | 12,ISO 10993- | ||
| LubricantSilicone | Identical | 23, USP | ||
| SpringStainless steel | Identical | <151>, ISO10993-4, | ||
| AdhesivePolyacrylate | Identical | ASTM F756 | ||
| NeedlecapPolypropylene | Identical | ISO 7864,ISO 9626,ISO 6009,ISO 80369-7,InternalStandards,ISO 23908 | ||
| Needle Length(Exposed) | 4 mm, 5.5 mm, 6mm | Identical | ISO 7864,ISO 9626 | |
| Needle Length(Total) | 19.5 mm, 20 mm,21.5 mm | Identical | ||
| Needle Tip | Lancet Bevel | Identical | ||
| Needle Taper | None | Identical | ||
| Wall Type | Std | Identical | ||
| Needle Gauge | 30G, 31G, 33G | Identical | ISO 7864,ISO 9626,ISO 6009 | |
| Configurations | 31G x 4 mm33G x 4 mm30G x 5.5 mm31G x 5.5 mm33G x 5.5 mm30G x 6 mm | Identical | ISO 7864,ISO 9626,ISO 6009 | |
| VitreJect Safety Needle | ||||
| Characteristic | Subject DeviceVitreJect SafetyNeedle | PredicateDeviceVitreJectNeedle(K230959) | Discussion | AssociatedTestingStandard |
| 33G x 6 mm | ||||
| Connection | Luer-slipLuer-lock | Identical | ISO 7864,ISO 80369-7 | |
| Needle ColorCoding | Conforms to ISO6009 | Identical | ISO 6009 | |
| Sterilization andShelf Life | Provided Sterile,Single-Use100 individualblister packeddevices packagedinto shelf cartonSterilizationMethod: EOSAL: 10-6Shelf Life: 5 years | Identical | AAMITIR28,ISO 11135,ISO 10993-7,USP <85>,USP <161>,ANSI/AAMIST72,ASTMF1980-16,ISO 7864,ISO 9626,ISO 80369-7,ISO 11607-1,ASTMF88/F88-15,ASTMD4169-16 | |
| Biocompatibility perISO 10993-1;categorization asexternallycommunicatingdevice with limited(<24 hours) directtissue and indirectblood path contact | Non-cytotoxicNon-sensitizer | IdenticalIdentical | ISO 10993-5ISO 10993-10 | |
| Non-irritant,IntracutaneousReactivity | Identical | ISO 10993-10 | ||
| Non-pyrogenic | Identical | ISO 10993-11,USP <151> | ||
| Non-toxic | Identical | ISO 10993-11 | ||
| Non-hemolytic | Identical | ISO 10993-4, ASTMF756 | ||
| Non-irritant,Ocular | Identical | ISO 10993-10 | ||
| Non-irritant,IntravitrealInjection | Identical | ISO 13485 | ||
| Characteristic | Subject DeviceVitreJect SafetyNeedle | PredicateDeviceVitreJectNeedle(K230959) | Discussion | AssociatedTestingStandard |
| Non-irritant,Intraocular | Identical | ISO 13485 | ||
| Performance Data | Needleperformance meetsdesign specificationand conforms tostandard. | Identical | ISO 7864,ISO 9626 | |
| Luer connectionperformance meetsdesign specificationand conforms tostandard. | Identical | ISO 80369-7 | ||
| Particulates meetdesign specificationand conforms tostandard. | Identical | USP <788>USP <789> | ||
| Sharps InjuryPrevention Featureperformance meetsdesign specificationand conforms tostandard. | N/AThe existingintegratedmechanism isnot indicated assharps injurypreventionfeature. | Passed bench testing for sharpsinjury prevention featureactivation, access in the safemode, and destructive force, anddemonstrate 0% injury rate. | InternalStandards,ISO 23908 |
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Image /page/9/Picture/0 description: The image shows the logo for OcuJect, LLC, a company specializing in advanced drug delivery. The logo features three interconnected hexagons in varying shades of blue on the left side. To the right of the hexagons is the company name, "OcuJect," in a bold, sans-serif font, with "LLC" in a smaller font size. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a smaller, sans-serif font.
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Image /page/10/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three hexagons in different shades of blue on the left side. The company name "OcuJect" is written in a stylized blue font, with "LLC" in smaller letters to the right. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif font.
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Image /page/11/Picture/0 description: The image is a logo for OcuJect LLC, a company that specializes in advanced drug delivery. The logo features three hexagons in different shades of blue on the left side. The company name "OcuJect" is written in a stylized blue font, with "LLC" in smaller letters to the right. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif font.
VII. PERFORMANCE DATA
SteriCap Safety Needle
The following non-clinical testing was performed to confirm the safety and effectiveness of the SteriCap Safety Needle as compared to the predicate device. Performance testing was performed as per the design control system. The following tests were conducted:
- . Dimensional and Physical Properties Verification
- o ISO 7864, ISO 80369-7
- Bond and Material Strength Verification .
- o ISO 7864, ISO 80369-7
- Needle quality
- o ISO 9626, ISO 7864
- . Color coding
- o ISO 6009, ISO 7864
- . Luer connector
- o ISO 80369-7
- Particulate testing .
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Image /page/12/Picture/0 description: The image is the logo for OcuJect LLC, a company that specializes in advanced drug delivery. The logo features three hexagons in different shades of blue on the left side. The company name "OcuJect" is written in a stylized blue font, with the letters connected in a flowing manner. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif font.
- USP <788> O
- Sharps Injury Prevention Feature ●
- Internal Standards o
- ISO 23908 o
- Biocompatibility (ISO 10993-1) ●
SteriCap Safety Needle is categorized as an externally communicating device with limited (<24 hours) direct tissue and indirect blood path contact. The testing performed remains applicable to the SteriCap/VitreJect product family and demonstrates the subject device is biocompatible for its intended use.
- Sterility and Shelf Life ●
SteriCap Safety Needle is sterilized using ethylene oxide. The sterilization cycle was validated based on the principles of ISO 11135:2014. The residual levels meet the requirements of ISO 10993-7. LAL testing for each lot ensures the devices meet the acceptance criteria of 20 EU/device.
Shelf-life was validated using industry-standard accelerated aging technique (ASTM F1980-16) and assured functional performance of the device as well as packaging and sterile barrier integrity. The shelf-life validation included anticipated stress associated with transportation and handling, per ASTM D4169-16. Packaging integrity was validated using the bubble leak test method (ASTM F2096-11). The seal strength was verified per ASTM F88/F88M-15.
VitreJect Safety Needle
The following non-clinical testing was performed to confirm the safety and effectiveness of the VitreJect Safety Needle as compared to the predicate device. Performance testing was performed as per the design control system. The following tests were conducted:
- Dimensional and Physical Properties Verification ●
- o ISO 7864, ISO 80369-7
- Bond and Material Strength Verification o ISO 7864, ISO 80369-7
- Needle quality
- o ISO 9626, ISO 7864
- Color coding ●
- o ISO 6009, ISO 7864
- Luer connector
- o ISO 80369-7
- Particulate testing
- o USP <788>, USP <789>
- Sharps Injury Prevention Feature
- Internal Standards o
- o ISO 23908
- Biocompatibility (ISO 10993-1) ● VitreJect Safety Needle is categorized as an externally communicating device with limited
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Image /page/13/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three overlapping hexagons in different shades of blue on the left side. To the right of the hexagons, the company name "OcuJect" is written in a stylized blue font, with "LLC" in smaller letters. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif blue font.
(<24 hours) direct tissue and indirect blood path contact. The testing performed remains applicable to the SteriCap/VitreJect product family and demonstrates the subject device is biocompatible for its intended use.
- Sterility and Shelf Life .
VitreJect Safety Needle is sterilized using ethylene oxide. The sterilization cycle was validated based on the principles of ISO 11135:2014. The residual levels meet the requirements of ISO 10993-7. LAL testing for each lot ensures the devices meet the acceptance criteria of ≤ 0.2 EU/device.
Shelf-life was validated using industry-standard accelerated aging technique (ASTM F1980-16) and assured functional performance of the device as well as packaging and sterile barrier integrity. The shelf-life validation included anticipated stress associated with transportation and handling, per ASTM D4169-16. Packaging integrity was validated using the bubble leak test method (ASTM F2096-11). The seal strength was verified per ASTM F88/F88M-15.
SUBSTANTIAL EQUIVALENCE VIII.
SteriCap/VitreJect Safety Needle
The SteriCap/VitreJect Safety Needle are substantially equivalent to the predicate devices when evaluating intended use and technological characteristics.
- The subject devices have the identical intended use as the predicate devices. ●
- The subject devices specifically indicate a sharps injury prevention feature while the ● predicate devices do not indicate the existing integrated sliding needle cap and locking mechanism as a safety feature.
- The subject devices and predicate devices are identical in device materials, dimensional specifications, connection type, sterilization, packaging configuration, etc.
- Performance testing according to internal standards and ISO 23908 demonstrate the subject ● devices, specifically the sharps injury prevention feature, are as safe and effective as the legally marketed predicate devices and do not raise new or different questions of safety and effectiveness compared to the predicate devices.
The performance test data and post-market data recording a 0% injury rate demonstrate that the SteriCap Safety Needle and VitreJect Safety Needle meet the established safety and performance characteristics of the device and demonstrate substantial equivalence to the predicate devices.
IX. CONCLUSIONS
The SteriCap Safety Needle and VitreJect Safety Needle meet the established safety and performance characteristics for a hypodermic injection needle with a safety/antistick system. Performance testing demonstrates the SteriCap Safety Needle and VitreJect Safety Needle are as safe and effective as the predicate devices and will perform as intended.
The SteriCap Safety Needle and VitreJect Safety Needle are biocompatible for their intended uses and demonstrate equivalent performance to their predicate devices. The SteriCap Safety Needle is
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Image /page/14/Picture/0 description: The image shows the logo for OcuJect LLC. The logo consists of three hexagons on the left side, with the top one being white, the middle one being dark blue, and the bottom one being light blue. To the right of the hexagons is the company name, "OcuJect LLC", in blue font, with the "LLC" being in a smaller font size. Below the company name is the text "ADVANCED DRUG DELIVERY" in a smaller, blue font.
substantially equivalent to predicate SteriCap Mini Needle cleared under K212805. The VitreJect Safety Needle is substantially equivalent to predicate VitreJect Needle cleared under K230959.
§ 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).