SteriCap Safety Needle; VitreJect Safety Needle

K233343 · Ocuject, LLC · FMI · Nov 27, 2023 · General Hospital

Device Facts

• Record ID: K233343
• Device Name: SteriCap Safety Needle; VitreJect Safety Needle
• Applicant: Ocuject, LLC
• Product Code: FMI · General Hospital
• Decision Date: Nov 27, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Single lumen hypodermic needles with integrated passive safety shield; designed for fluid injection/aspiration. Input: manual attachment to luer-tip syringe. Operation: spring-actuated sliding cap moves along needle hub axis; automatically covers needle tip post-use; manual lock/unlock mechanism provided. Output: drug delivery to patient. Used by healthcare professionals in clinical settings. Benefits: minimizes risk of accidental needle stick injuries via integrated safety feature. Sterilized by ethylene oxide.

Clinical Evidence

Bench testing only. Testing included dimensional/physical verification, bond/material strength, needle quality, color coding, luer connector performance, particulate testing (USP <788>/<789>), sharps injury prevention feature performance (ISO 23908), biocompatibility (ISO 10993-1), and sterility/shelf-life validation (ASTM F1980-16, ASTM F88/F88M-15).

Technological Characteristics

Materials: stainless steel (needle, spring), polypropylene (hub, cap), silicone (lubricant), polyacrylate (adhesive). Design: single lumen, lancet bevel, luer-slip/luer-lock connection. Dimensions: 4-6mm exposed length. Connectivity: none. Sterilization: ethylene oxide (SAL 10^-6). Standards: ISO 7864, ISO 9626, ISO 80369-7, ISO 6009, ISO 23908, ISO 10993 series.

Indications for Use

Indicated for clinicians in a clinical setting for the administration of drugs using a luer-tip syringe. The VitreJect Safety Needle is specifically indicated for intravitreal use. No specific patient population age or gender restrictions are noted.

Regulatory Classification

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.

Predicate Devices

• SteriCap Mini Needle (K212805)
• VitreJect Needle (K230959)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Email: [e-mail] 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 | Associated<br>Testing<br>Standard |
|---------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Subject<br>Device<br>SteriCap<br>Safety<br>Needle | Intended to<br>inject fluids<br>into, or<br>withdraw<br>fluids from,<br>the body. | The SteriCap Safety Needle is intended<br>for use with a luer-tip syringe for the<br>administration of drugs.<br><br>The SteriCap Safety Needle has an<br>integrated passive needle shield that<br>covers the needle prior to use and<br>automatically activates to cover the<br>needle immediately after use. A lock<br>mechanism can be manually activated<br>to lock/unlock the needle shield. The<br>locked needle shield minimizes risk of<br>accidental needle stick. | Identical intended use<br>supported by<br>referenced<br>performance and<br>biocompatibility<br>testing.<br><br>Equivalent indications<br>for use. The existing<br>integrated mechanism<br>of the predicate<br>SteriCap Mini Needle | ISO 7864,<br>Internal<br>Standards,<br>ISO 23908,<br>ISO 80369-7,<br>ISO 10993,<br>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.

| Predicate<br>Device<br>SteriCap<br>Mini<br>Needle<br>(K212805) | Intended to<br>inject fluids<br>into, or<br>withdraw<br>fluids from,<br>the body. | The SteriCap Mini Needle is intended<br>for use with a luer-tip syringe for the<br>administration of drugs. | is not indicated as<br>sharps injury<br>prevention feature. | |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Subject | VitreJect Safety Needle | | | |
| Device<br>VitreJect<br>Safety<br>Needle | Intended to<br>inject fluids<br>into, or<br>withdraw<br>fluids from,<br>the body. | The VitreJect Safety Needle is<br>intended for use with a luer-tip syringe<br>for the administration of drugs.<br>The VitreJect Safety Needle has an<br>integrated passive needle shield that<br>covers the needle prior to use and<br>automatically activates to cover the<br>needle immediately after use. A lock<br>mechanism can be manually activated<br>to lock/unlock the needle shield. The<br>locked needle shield minimizes risk of<br>accidental needle stick. | Identical intended use<br>supported by<br>referenced<br>performance and<br>biocompatibility<br>testing.<br>Equivalent indications<br>for use. The existing<br>integrated mechanism<br>of the predicate<br>VitreJect Needle is not<br>indicated as sharps<br>injury prevention<br>feature. | ISO 7864,<br>Internal<br>Standards,<br>ISO 23908,<br>ISO 80369-7,<br>ISO 10993,<br>USP <788>,<br>USP <789> |
| Predicate<br>Device<br>VitreJect<br>Needle<br>(K230959) | Intended to<br>inject fluids<br>into, or<br>withdraw<br>fluids from,<br>the body. | The VitreJect Needle is intended for<br>use with a luer-tip syringe for the<br>administration of drugs. The VitreJect<br>Needle is indicated for intravitreal use. | indicated as sharps<br>injury prevention<br>feature. | |

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 Device<br>SteriCap Safety<br>Needle | Predicate<br>Device<br>SteriCap Mini<br>Needle<br>(K212805) | Discussion | Associated<br>Testing<br>Standard | |
| Applicant | OcuJect, LLC | Identical | | | |
| Proprietary Name | SteriCap | Identical | | | |
| SteriCap Safety Needle | | | | | |
| Characteristic | | Subject Device<br>SteriCap Safety<br>Needle | Predicate<br>Device<br>SteriCap Mini<br>Needle<br>(K212805) | Discussion | Associated<br>Testing<br>Standard |
| Device | | Needle,<br>Hypodermic,<br>Single Lumen | Identical | | |
| Regulation Number | | 21 CFR 880.5570 | Identical | | |
| Product Code | | FMI | Identical | | |
| Device Class | | II | Identical | | |
| Regulation Medical<br>Specialty | | General Hospital | Identical | | |
| Intended Users and | | Clinicians in a<br>clinical setting. | Identical | | |
| Principle of<br>Operation | | Connects to a luer<br>type syringe to<br>serve as a conduit<br>for the movement<br>of fluid. | Identical | | ISO 7864,<br>ISO 9626,<br>ISO 80369-7 |
| Device Components | | Needle Assembly:<br>needle, needle hub,<br>spring-loaded<br>needle cap)<br>Designed to fit<br>standard 6% luer<br>fittings | Identical | | ISO 10993-<br>1,<br>ISO 10993-<br>5, ISO<br>10993-7,<br>ISO 10993-<br>10,<br>ISO 10993- |
| Material | Needle | Stainless steel | Identical | | 11,<br>ISO 10993- |
| | Needle<br>hub | Polypropylene | Identical | | 12,<br>ISO 7864, |
| | Lubricant | Silicone | Identical | | ISO 9626, |
| | Spring | Stainless steel | Identical | | ISO 6009, |
| | Adhesive | Polyacrylate | Identical | | ISO 80369- |
| | Needle<br>cap | Polypropylene | Identical | | 7,<br>Internal<br>Standards,<br>ISO 23908 |
| Needle Length<br>(Exposed) | | 4 mm, 5.5 mm, 6<br>mm | Identical | | ISO 7864,<br>ISO 9626 |
| Needle Length<br>(Total) | | 19.5 mm, 20 mm,<br>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,<br>29G,30G,31G,<br>32G,33G | Differences in configuration /<br>size offering do not raise new or<br>different questions of safety or | ISO 7864,<br>ISO 9626,<br>ISO 6009 |
| Configurations | | 31G x 4 mm<br>33G x 4 mm | 31G x 4 mm<br>33G x 4 mm | effectiveness. All claim<br>conformance to standards. | |
| SteriCap Safety Needle | | | | | |
| Characteristic | Subject Device<br>SteriCap Safety<br>Needle | Predicate<br>Device<br>SteriCap Mini<br>Needle<br>(K212805) | Discussion | Associated<br>Testing<br>Standard | |
| | 30G x 5.5 mm<br>31G x 5.5 mm<br>33G x 5.5 mm<br>30G x 6 mm<br>31G x 6 mm<br>33G x 6 mm | 23G x 5.5 mm<br>25G x 5.5 mm<br>27G x 5.5 mm<br>29G x 5.5 mm<br>30G x 5.5 mm<br>32G x 5.5 mm<br>33G x 5.5 mm<br>30G x 6 mm<br>31G x 6 mm<br>33G x 6 mm | | | |
| Connection | Luer-slip<br>Luer-lock | Identical | | ISO 7864,<br>ISO 80369-7 | |
| Needle Color<br>Coding | Conforms to ISO<br>6009 | Identical | | ISO 6009 | |
| Sterilization and<br>Shelf Life | Provided Sterile,<br>Single-Use<br>100 individual<br>blister packed<br>devices packaged<br>into shelf carton<br>Sterilization<br>Method: EO<br>SAL: 10-6<br>Shelf Life: 5 years | Identical | | AAMI<br>TIR28,<br>ISO 11135,<br>ISO 10993-<br>7,<br>USP <85>,<br>USP <161>,<br>ANSI/AAMI<br>ST72,<br>ASTM<br>F1980-16,<br>ISO 7864,<br>ISO 9626,<br>ISO 80369-<br>7,<br>ISO 11607-<br>1,<br>ASTM<br>F88/F88-15,<br>ASTM<br>D4169-16 | |
| Biocompatibility per<br>ISO 10993-1;<br>categorization as<br>externally<br>communicating<br>device with limited<br>(<24 hours) direct<br>tissue and indirect<br>blood path contact | Non-cytotoxic | Identical | | ISO 10993-5 | |
| | Non-sensitizer | Identical | | ISO 10993-<br>10 | |
| | Non-irritant,<br>Intracutaneous<br>Reactivity | Identical | | ISO 10993-<br>10 | |
| | Non-pyrogenic | Identical | | ISO 10993-<br>11,<br>USP <151> | |
| | Non-toxic | Identical | | ISO 10993-<br>11 | |
| SteriCap Safety Needle | | | | | |
| Characteristic | Subject Device<br>SteriCap Safety<br>Needle | Predicate<br>Device<br>SteriCap Mini<br>Needle<br>(K212805) | Discussion | Associated<br>Testing<br>Standard | |
| Performance Data | Needle<br>performance meets<br>design<br>specification and<br>conforms to<br>standard. | Identical | | ISO 7864,<br>ISO 9626 | |
| | Luer connection<br>performance meets<br>design<br>specification and<br>conforms to<br>standard. | Identical | | ISO 80369-7 | |
| | Particulates meet<br>design<br>specification and<br>conforms to<br>standard. | Identical | | USP <788> | |
| | Sharps Injury<br>Prevention Feature<br>performance meets<br>design<br>specification and<br>conforms to<br>standard. | N/A<br>The existing<br>integrated<br>mechanism is<br>not indicated as<br>sharps injury<br>prevention<br>feature | Passed bench testing for sharps<br>injury prevention feature<br>activation, access in the safe<br>mode, and destructive force, and<br>demonstrate 0% injury rate. | Internal<br>Standards,<br>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 Device<br>VitreJect Safety<br>Needle | Predicate<br>Device<br>VitreJect<br>Needle<br>(K230959) | Discussion | Associated<br>Testing<br>Standard |
| Applicant | OcuJect, LLC | Identical | | |
| Proprietary Name | VitreJect | Identical | | |
| Device | Needle,<br>Hypodermic,<br>Single Lumen | Identical | | |
| Regulation Number | 21 CFR 880.5570 | Identical | | |
| Product Code | FMI | Identical | | |
| Device Class | II | Identical | | |
| Regulation Medical<br>Specialty | General Hospital | Identical | | |
| Intended Users and<br>Environment | Clinicians in a<br>clinical setting. | Identical | | |
| VitreJect Safety Needle | | | | |
| Characteristic | Subject Device<br>VitreJect Safety<br>Needle | Predicate<br>Device<br>VitreJect<br>Needle<br>(K230959) | Discussion | Associated<br>Testing<br>Standard |
| Principle of<br>Operation…