Who is the manufacturer of SteriCap Safety Needle; VitreJect Safety Needle?

Ocuject, LLC filed the 510(k) submission for SteriCap Safety Needle; VitreJect Safety Needle (K233343).

What is the FDA product code for SteriCap Safety Needle; VitreJect Safety Needle?

FMI. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for SteriCap Safety Needle; VitreJect Safety Needle?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like SteriCap Safety Needle; VitreJect Safety Needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SteriCap Safety Needle; VitreJect Safety Needle

Q: What are the predicate devices for SteriCap Safety Needle; VitreJect Safety Needle?

SteriCap Mini Needle (K212805); VitreJect Needle (K230959).

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

Indications for 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)

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 Testing Standard | |---------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Subject Device SteriCap Safety Needle | Intended to inject fluids into, or withdraw fluids from, the body. | 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. | Identical intended use supported by referenced performance and biocompatibility testing. Equivalent indications for use. The existing integrated mechanism of the predicate SteriCap Mini Needle | ISO 7864, Internal Standards, ISO 23908, ISO 80369-7, ISO 10993, USP <788> | {5}------------------------------------------------ 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 Device SteriCap Mini Needle (K212805) | Intended to inject fluids into, or withdraw fluids from, the body. | The SteriCap Mini Needle is intended for use with a luer-tip syringe for the administration of drugs. | is not indicated as sharps injury prevention feature. | | |----------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Subject | VitreJect Safety Needle | | | | | Device VitreJect Safety Needle | Intended to inject fluids into, or withdraw fluids from, the body. | The VitreJect Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. 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. | Identical intended use supported by referenced performance and biocompatibility testing. Equivalent indications for use. The existing integrated mechanism of the predicate VitreJect Needle is not indicated as sharps injury prevention feature. | ISO 7864, Internal Standards, ISO 23908, ISO 80369-7, ISO 10993, USP <788>, USP <789> | | Predicate Device VitreJect Needle (K230959) | Intended to inject fluids into, or withdraw fluids from, the body. | The VitreJect Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect Needle is indicated for intravitreal use. | indicated as sharps injury prevention 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 SteriCap Safety Needle | Predicate Device SteriCap Mini Needle (K212805) | Discussion | Associated Testing Standard | | | Applicant | OcuJect, LLC | Identical | | | | | Proprietary Name | SteriCap | Identical | | | | | SteriCap Safety Needle | | | | | | | Characteristic | | Subject Device SteriCap Safety Needle | Predicate Device SteriCap Mini Needle (K212805) | Discussion | Associated Testing Standard | | Device | | Needle, Hypodermic, Single Lumen | Identical | | | | Regulation Number | | 21 CFR 880.5570 | Identical | | | | Product Code | | FMI | Identical | | | | Device Class | | II | Identical | | | | Regulation Medical Specialty | | General Hospital | Identical | | | | Intended Users and | | Clinicians in a clinical setting. | Identical | | | | Principle of Operation | | Connects to a luer type syringe to serve as a conduit for the movement of fluid. | Identical | | ISO 7864, ISO 9626, ISO 80369-7 | | Device Components | | Needle Assembly: needle, needle hub, spring-loaded needle cap) Designed to fit standard 6% luer fittings | Identical | | ISO 10993- 1, ISO 10993- 5, ISO 10993-7, ISO 10993- 10, ISO 10993- | | Material | Needle | Stainless steel | Identical | | 11, ISO 10993- | | | Needle hub | Polypropylene | Identical | | 12, ISO 7864, | | | Lubricant | Silicone | Identical | | ISO 9626, | | | Spring | Stainless steel | Identical | | ISO 6009, | | | Adhesive | Polyacrylate | Identical | | ISO 80369- | | | Needle cap | Polypropylene | Identical | | 7, Internal Standards, ISO 23908 | | Needle Length (Exposed) | | 4 mm, 5.5 mm, 6 mm | 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 or different questions of safety or | ISO 7864, ISO 9626, ISO 6009 | | Configurations | | 31G x 4 mm 33G x 4 mm | 31G x 4 mm 33G x 4 mm | effectiveness. All claim conformance to standards. | | | SteriCap Safety Needle | | | | | | | Characteristic | Subject Device SteriCap Safety Needle | Predicate Device SteriCap Mini Needle (K212805) | Discussion | Associated Testing Standard | | | | 30G x 5.5 mm 31G x 5.5 mm 33G x 5.5 mm 30G x 6 mm 31G x 6 mm 33G x 6 mm | 23G x 5.5 mm 25G x 5.5 mm 27G x 5.5 mm 29G x 5.5 mm 30G x 5.5 mm 32G x 5.5 mm 33G x 5.5 mm 30G x 6 mm 31G x 6 mm 33G x 6 mm | | | | | Connection | Luer-slip Luer-lock | Identical | | ISO 7864, ISO 80369-7 | | | Needle Color Coding | Conforms to ISO 6009 | Identical | | ISO 6009 | | | Sterilization and Shelf Life | Provided Sterile, Single-Use 100 individual blister packed devices packaged into shelf carton Sterilization Method: EO SAL: 10-6 Shelf Life: 5 years | Identical | | AAMI TIR28, ISO 11135, ISO 10993- 7, USP <85>, USP <161>, ANSI/AAMI ST72, ASTM F1980-16, ISO 7864, ISO 9626, ISO 80369- 7, ISO 11607- 1, ASTM F88/F88-15, ASTM D4169-16 | | | Biocompatibility per ISO 10993-1; categorization as externally communicating device with limited (<24 hours) direct tissue and indirect blood path contact | Non-cytotoxic | Identical | | ISO 10993-5 | | | | Non-sensitizer | Identical | | ISO 10993- 10 | | | | Non-irritant, Intracutaneous Reactivity | Identical | | ISO 10993- 10 | | | | Non-pyrogenic | Identical | | ISO 10993- 11, USP <151> | | | | Non-toxic | Identical | | ISO 10993- 11 | | | SteriCap Safety Needle | | | | | | | Characteristic | Subject Device SteriCap Safety Needle | Predicate Device SteriCap Mini Needle (K212805) | Discussion | Associated Testing Standard | | | Performance Data | Needle performance meets design specification and conforms to standard. | Identical | | ISO 7864, ISO 9626 | | | | Luer connection performance meets design specification and conforms to standard. | Identical | | ISO 80369-7 | | | | Particulates meet design specification and conforms to standard. | Identical | | USP <788> | | | | Sharps Injury Prevention Feature performance meets design specification and conforms to standard. | N/A The existing integrated mechanism is not indicated as sharps injury prevention feature | Passed bench testing for sharps injury prevention feature activation, access in the safe mode, and destructive force, and demonstrate 0% injury rate. | Internal Standards, ISO 23908 | | {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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 VitreJect Safety Needle | Predicate Device VitreJect Needle (K230959) | Discussion | Associated Testing Standard | | 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 Medical Specialty | General Hospital | Identical | | | | Intended Users and Environment | Clinicians in a clinical setting. | Identical | | | | VitreJect Safety Needle | | | | | | Characteristic | Subject Device VitreJect Safety Needle | Predicate Device VitreJect Needle (K230959) | Discussion | Associated Testing Standard | | Principle of Operation…

SteriCap Safety Needle; VitreJect Safety Needle

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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SteriCap Safety Needle; VitreJect Safety Needle

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Indications for Use

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Predicate Devices

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