Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance testing focus on mechanical features for sharps injury prevention, with no mention of AI or ML.

Therapeutic

No
The device is a safety needle intended for administration of drugs, not for treatment of a disease or condition itself.

Diagnostic

No
The device is described as a "Safety Needle" intended for "administration of drugs" and designed for "fluid injection and aspiration." It does not mention any diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like a needle, luer-tip syringe connection, spring-actuated sliding cap, and lock mechanism. The performance studies also focus on physical properties and sharps injury prevention features, not software performance.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as "for the administration of drugs" and "for intravitreal use" (for the VitreJect). This involves introducing substances into the body, which is the opposite of an IVD, which is used to examine specimens from the body.
Device Description: The description focuses on the physical characteristics of a hypodermic needle designed for injection and aspiration to and from the body.
No mention of testing specimens: There is no indication that this device is used to test blood, urine, tissue, or any other specimen taken from the body.
Performance Studies: The performance studies focus on the physical properties, safety features (like sharps injury prevention), and sterility of the needle, not on the accuracy or reliability of a diagnostic test.

In summary, the device is a medical device used for administering substances into the body, not for performing diagnostic tests on specimens from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

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/unlockede. 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 use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Safety Needle is suitable for ophthalmic use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intravitreal (for VitreJect Safety Needle)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinicians in a clinical setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

SteriCap Safety Needle
Non-clinical testing was performed to confirm the safety and effectiveness.
Tests conducted:

Dimensional and Physical Properties Verification (ISO 7864, ISO 80369-7)
Bond and Material Strength Verification (ISO 7864, ISO 80369-7)
Needle quality (ISO 9626, ISO 7864)
Color coding (ISO 6009, ISO 7864)
Luer connector (ISO 80369-7)
Particulate testing (USP )
Sharps Injury Prevention Feature (Internal Standards, ISO 23908) - Passed bench testing for sharps injury prevention feature activation, access in the safe mode, and destructive force, and demonstrate 0% injury rate.
Biocompatibility (ISO 10993-1) - Categorized as an externally communicating device with limited (, USP )
Sharps Injury Prevention Feature (Internal Standards, ISO 23908) - Passed bench testing for sharps injury prevention feature activation, access in the safe mode, and destructive force, and demonstrate 0% injury rate.
Biocompatibility (ISO 10993-1) - Categorized as an externally communicating device with limited (

Regulation Number and Section

§ 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).

Summary

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 |

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 ,
USP |
| 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 ,
USP ,
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
(
	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
	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	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 10993-
	Lubricant
Silicone	Identical		23, USP
	Spring
Stainless steel	Identical		, ISO
10993-4,
	Adhesive
Polyacrylate	Identical		ASTM F756
	Needle
cap
Polypropylene	Identical		ISO 7864,
ISO 9626,
ISO 6009,
ISO 80369-
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	Identical		ISO 7864,
ISO 9626,
ISO 6009
Configurations	31G x 4 mm
33G x 4 mm
30G x 5.5 mm
31G x 5.5 mm
33G x 5.5 mm
30G x 6 mm	Identical		ISO 7864,
ISO 9626,
ISO 6009
VitreJect Safety Needle
Characteristic	Subject Device
VitreJect Safety
Needle	Predicate
Device
VitreJect
Needle
(K230959)	Discussion	Associated
Testing
Standard
	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 ,
USP ,
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
(
	Non-toxic	Identical		ISO 10993-
11
	Non-hemolytic	Identical		ISO 10993-
4, ASTM
F756
	Non-irritant,
Ocular	Identical		ISO 10993-
10
	Non-irritant,
Intravitreal
Injection	Identical		ISO 13485
Characteristic	Subject Device
VitreJect Safety
Needle	Predicate
Device
VitreJect
Needle
(K230959)	Discussion	Associated
Testing
Standard
	Non-irritant,
Intraocular	Identical		ISO 13485
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
USP
	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

9

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.

10

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.

11

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 .

12

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 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 (, USP

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

13

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.

(