The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.

The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.

Device Description

The VitreJect® / OcuSafe® Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The VitreJect® Needle has a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. The OcuSafe® Needle has a removable cap that is removed prior to the needle's use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The VitreJect®/OcuSafe® Needles are single use only, non-toxic, nonpyrogenic, and sterilized by ethylene oxide gas. The VitreJect®/OcuSafe® Needles are suitable for ophthalmic use.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device (VitreJect® Needle; OcuSafe® Needle), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of AI/device performance requiring human reader studies and expert adjudication. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts, MRMC studies, ground truth establishment methods for AI) is not applicable to this type of regulatory submission.

The document discusses non-clinical testing to confirm the safety and effectiveness of the device. The acceptance criteria are based on meeting established standards and demonstrating biocompatibility and performance similar to the predicate device.

Here's an attempt to answer your questions based on the available information, noting where information is not present or applicable:

Acceptance Criteria and Study for VitreJect® Needle / OcuSafe® Needle (K230959)

This 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (SteriCap® Mini Needle and Standard Needle, K212805) through comparison of technological characteristics and non-clinical performance testing, rather than a clinical trial involving human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are generally met by demonstrating compliance with recognized standards and proving that the device performs as intended and is biocompatible. The "reported device performance" is essentially the passing of these tests.

Acceptance Criteria Category	Specific Acceptance Criteria (based on standards)	Reported Device Performance (Summary)
Dimensional and Physical Properties	Compliant with ISO 7864 (Sterile hypodermic needles) and ISO 80369-7 (Small-bore connectors for liquids and gases in healthcare applications - Luer connectors)	Testing performed as per standards, implied to have passed. Specific test results not quantified in summary.
Bond and Material Strength	Compliant with ISO 7864, ISO 80369-7	Testing performed as per standards, implied to have passed. Specific test results not quantified in summary.
Needle Quality	Compliant with ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) and ISO 7864	Testing performed as per standards, implied to have passed. Specific test results not quantified in summary.
Color Coding	Compliant with ISO 6009 (Hypodermic syringes for medical use - Colour coding for identification) and ISO 7864	Testing performed as per standards, implied to have passed. Specific test results not quantified in summary.
Luer Connector	Compliant with ISO 80369-7	Testing performed as per standards, implied to have passed. Specific test results not quantified in summary.
Particulate Matter	Compliant with USP <788> (Particulate Matter in Injections) and USP <789> (Particulate Matter in Ophthalmic Solutions) for intraocular requirements (light obscuration and microscopy)	Passed particulate testing, including for intraocular requirements.
Biocompatibility (ISO 10993-1)	Cytotoxicity: Non-cytotoxic	Test article extracts showed no evidence of cytotoxic effect.
	Sensitization: Non-sensitizer	Test article extracts were not considered a sensitizer.
	Irritation (Intracutaneous): Non-irritant	Showed no evidence of erythema and edema.
	Irritation (Ocular): Non-irritant	Not considered an irritant to the ocular tissue of the rabbit.
	Irritation (Intravitreal Injection): Non-inflammatory	Not considered inflammatory to intraocular tissues of the rabbit.
	Irritation (Intraocular): Non-irritant	Not considered an irritant to the intraocular tissues of the rabbit.
	Acute Systemic Toxicity: Non-toxic	Did not show evidence of systemic toxicity.
	Pyrogenicity: Non-pyrogenic	Not considered pyrogenic.
	Hemolysis: Non-hemolytic	Not considered hemolytic.
Sterilization & Shelf Life	Provided Sterile, Single-Use, SAL: 10-6, Shelf Life: 5 years. EO residual and Endotoxin limits assessed (ISO 10993-7, USP <85>, USP <161>, AAMI TIR28, ISO 11135-1, etc.)	Met specified criteria for sterilization, shelf life, and residual limits.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many needles were tested for dimension, strength, or biocompatibility). These are typically determined by relevant industry standards and statistical methods for device testing.
Data Provenance: The data is generated from non-clinical laboratory testing performed by OcuJect, LLC (or their designated testing facilities) to support the regulatory submission. It is not patient data. It is retrospective in the sense that the testing was completed prior to the submission, but it is not from a real-world clinical patient population. The country of origin of the testing is not specified, but it would be expected to comply with US FDA requirements.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This question is not applicable as the "test set" here refers to physical devices undergoing non-clinical performance and biocompatibility assessments, not a dataset requiring expert human interpretation or ground truth labeling in the context of AI or diagnostic studies.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human interpretation or ground truth establishment requiring adjudication for this type of device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging diagnostic devices, not for a hypodermic needle.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical hypodermic needle, not an algorithm or AI system.

7. The Type of Ground Truth Used

Not applicable in the conventional sense of ground truth for AI/diagnostic studies. For this device, the "ground truth" is defined by compliance with established international and US standards (e.g., ISO, USP, ASTM) for medical device performance, safety, and biocompatibility. The "truth" is whether the physical properties and biological interactions of the needle meet these predefined, objectively measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI or machine learning model, there is no training set or ground truth in this context.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 14, 2023

OcuJect, LLC % Heidi Busz Senior Regulatory Consultant Namsa 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426

Re: K230959

Trade/Device Name: VitreJect® Needle; OcuSafe® Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 9, 2023 Received: August 10, 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 (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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

Image /page/1/Picture/6 description: The image shows the name Courtney Evans -S on the left side of the image. On the right side of the image, it says Digitally signed by Courtney Evans -S. The date is also listed as 2023.09.14 23:40:05 -04'00'.

For CAPT Alan Stevens Assistant 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230959

Device Name VitreJect® Needle OcuSafe® Needle

Indications for Use (Describe)

The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.

The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

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, 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, 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 font, also in blue.

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: September 14, 2023

II. DEVICE

Name of Device: VitreJect® / OcuSafe® Needle Common or Usual Name: Needle, Hypodermic, Single Lumen Classification name: Hypodermic Single Lumen Needle (21 CFR 880.5570) Regulatory Class: 2 Product Code: FMI

III. PREDICATE DEVICE

SteriCap® Mini Needle and Standard Needle, K212805 The predicate devices have not been subject to a design-related recall.

IV. REFERENCE DEVICE

StaClear Syringe, K200242 Altaviz Needle Kit II, K231261

V. DEVICE DESCRIPTION

The VitreJect® Needle is offered in the following configurations:

-	30G x 5.5mm	30G x 6mm
31G x 4mm	31G x 5.5mm	31G x 6mm
33G x 4mm	33G x 5.5mm	33G x 6mm

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Image /page/4/Picture/0 description: The image contains the logo for OcuJect LLC Advanced Drug Delivery. The logo features three hexagons on the left side, with the top one being white, the middle one being dark blue, and the bottom one being light blue. To the right of the hexagons is the company name, "OcuJect LLC," in a stylized blue font, with the "LLC" being smaller and slightly offset. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a smaller, sans-serif blue font.

The OcuSafe® Needle is offered in the following configurations:

-	-	29G x 13mm
-	-	30G x 13mm
31G x 4mm	-	31G x 13mm
-	33G x 8mm	-

VI. INTENDED USE / INDICATIONS FOR USE

The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.

The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.

VII. OF TECHNOLOGICAL CHARACTERISTICS COMPARISON WITH THE PREDICATE DEVICE

The intended use of the subject device is identical to the predicate device; designed and intended to inject fluids into, or withdraw fluids from, the body. The technological characteristics of the VitreJect® / OcuSafe® Needles are substantially equivalent to the predicate SteriCap® Mini Needle / Standard Needle (K212805). The subject device and the predicate device have identical design, material, manufacturing process, sterilization method, operation method, and packaging configuration. The OcuSafe® Needle introduces an additional configuration (31G x 4 mm) and there are minor differences in biocompatibility and performance testing and indications for use as the VitreJect® / OcuSafe® Needles are additionally indicated for intravitreal use.

A comparison of the technological characteristics between the subject and primary predicate devices is illustrated in the table below:

Characteristic	Subject DeviceVitreJect®/OcuSafe®Needle	Predicate DeviceSteriCap® MiniNeedle / StandardNeedle(K212805)	AssociatedTesting Standard
Applicant	OcuJect, LLC	Identical	-
ProprietaryName	VitreJect®OcuSafe®	SteriCap®	-
Product Code	FMI	Identical	-
Intended Use	Intended to inject fluids*into, or withdraw fluidsfrom, the body.	Identical	*Namely drugsSupported byreferencedperformance andbiocompatibility
Characteristic	Subject DeviceVitreJect®/OcuSafe®Needle	Predicate DeviceSteriCap® MiniNeedle / StandardNeedle(K212805)	AssociatedTesting Standard
Indications	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.The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs.The OcuSafe® Needle is indicated for intravitreal use.	Equivalent, the predicate device does not identify specific clinical applications:The SteriCap® Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs.	testingISO 10993-1,ISO 10993-7,ISO 10993-10,USP <788>,USP <789>
Intended Usersand Environment	Health care professionals in a clinical setting	Identical	-
Principle ofOperation	Connects to a luer type syringe to serve as a conduit for the manual advancement and withdrawal of fluid	Identical	ISO 80369-7,ISO 7864,ISO 9626
FunctionalConstruct	Single lumen needle	Identical	ISO 7864,ISO 9626
Design/Construction	Needle Assembly:Cannula, needle hub, needle cap (spring loaded or removable)Designed to fit standard 6% luer fittings	Identical	ISO 80369-7,ISO 7864,ISO 9626
DeviceComponents andMaterials	Cannula: stainless steelLubricant: siliconeAdhesive: polyacrylateNeedle Cap: polypropyleneHub: polypropyleneSpring (VitreJect®):stainless steel	IdenticalStainless steel spring in SteriCap® model only	ISO 10993-1,ISO 10993-2,ISO 10993-4,ASTM F756,ISO 10993-5,ISO 10993-7,ISO 10993-10,ISO 10993-11,ISO 10993-12,ISO 10993-17,
Characteristic	Subject DeviceVitreJect®/OcuSafe®Needle	Predicate DeviceSteriCap® MiniNeedle / StandardNeedle(K212805)	AssociatedTesting Standard
Needle Length(Exposed)	VitreJect®:4 mm / 5.5 mm / 6 mmOcuSafe®:13 mm8 mm4 mm	Equivalent, thepredicate StandardNeedle is not offeredin 4 mm:SteriCap®:4 mm / 5.5 mm / 6 mmStandard:13 mm / 8 mm	ISO 7864,ISO 9626
Needle Gauge	VitreJect®: 30G, 31G and33G.OcuSafe®: 29G, 30G, 31Gand 33G.	IdenticalSteriCap®: 30G, 31Gand 33G.Standard Needle:29G, 30G, 31G and33G.	ISO 7864,ISO 9626
Cannula tipconfiguration	Lancet bevel	Identical	ISO 7864,ISO 9626
Sterilization andShelf Life	Provided Sterile,Single-Use100 individual blister-packeddevices packaged into a shelfcartonSterilization Method: EOSAL: 10-6Shelf Life: 5 yearsEthylene oxide residual wereassessed per ISO 10993-7.Endotoxins were tested asrecommended in FDAguidance Endotoxin TestingRecommendations forSingle-Use IntraocularOphthalmic Devices.	IdenticalReduced residual andendotoxin limits forophthalmic use notapplicable.	AAMI TIR28,ISO 11135-1,ISO 10993-7,USP <85>,USP <161>,ANSI/AAMIST72,ASTM F1980-16,ISO 7864,ISO 9626,ISO 80369-7,ASTM F88/F88-15,ASTM F1929-15,ASTM D4169-16
Characteristic	Subject DeviceVitreJect®/OcuSafe®Needle	Predicate DeviceSteriCap® MiniNeedle / StandardNeedle(K212805)	AssociatedTesting Standard
Biocompatibilityper ISO 10993-1	Non-cytotoxic	Identical	ISO 10993-5
	Non-sensitizer	Identical	ISO 10993-10
	Non-irritant, Intracutaneous	Identical	ISO 10993-23
	Non-irritant, Ocular	Equivalent, Ocular,	ISO 10993-10
	Non-irritant, IntravitrealInjection	Intravitreal Injectionand Intraocular	ISO 13485
	Non-irritant, Intraocular	Irritation testing notperformed on thepredicate device.	ISO 13485
	Non-pyrogenic	Identical	USP <151>, ISO10993-11
	Non-toxic	Identical	ISO 10993-11
	Non-hemolytic	Identical	ISO 10993-4,ASTM F756ISO 10993-3

Page 2 Traditional 510(k)

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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 hexagons of different shades of blue on the left side. To the right of the hexagons is the company name, "OcuJect LLC", in a stylized blue font. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a smaller, sans-serif blue font.

OcuJect, LLC
VitreJect® / OcuSafe® Needle

Page 3 Page 3
Traditional 510(k)

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Image /page/6/Picture/0 description: The image shows the logo for OcuJect LLC. The logo features three hexagons on the left side, with the top one being white, the middle one being dark blue, and the bottom one being light blue. To the right of the hexagons is the company name "OcuJect LLC" in a stylized blue font, with the "LLC" being smaller and slightly offset. Below the company name is the text "ADVANCED DRUG DELIVERY" in a smaller, sans-serif blue font.

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Image /page/7/Picture/0 description: The image shows the logo for OcuJect LLC. The logo features three hexagons on the left side, with the top one being white, the middle one being dark blue, and the bottom one being light blue. To the right of the hexagons is the company name, "OcuJect LLC", in a stylized blue font, with the "LLC" being smaller and slightly offset. Below the company name is the text "ADVANCED DRUG DELIVERY" in a smaller, sans-serif blue font.

VIII. PERFORMANCE DATA

The following non-clinical testing was performed to confirm the safety and effectiveness of the VitreJect® and OcuSafe® Needles compared to the predicate devices. Performance testing was performed as per the design control system. The following tests were conducted:

Dimensional and Physical Properties Verification ●
- o ISO 7864, ISO 80369-7
. Bond and Material Strength Verification
- o ISO 7864, ISO 80369-7
Needle quality
- o ISO 9626, ISO 7864
Color coding

●

o ISO 6009, ISO 7864
Luer connector
- o ISO 80369-7
Particulate testing
- o USP <788>, USP <789>
Biocompatibility (ISO 10993-1) ●

VitreJect® and OcuSafe® Needles are categorized as externally communicating devices with limited (<24 hours) direct tissue and indirect blood/tissue path contact. OcuJect, LLC

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Image /page/8/Picture/0 description: The image is a logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three interlocking hexagons in different shades of blue on the left side. To the right of the hexagons is the company name, "OcuJect LLC," in a modern, sans-serif font, with "LLC" in a smaller font size. Below the company name is the tagline "ADVANCED DRUG DELIVERY" in a similar font, emphasizing the company's focus.

completed the following biological safety tests:

Cytotoxicity о
Sensitization O
Irritation, Intracutaneous O
Irritation, Ocular O
Irritation, Intravitreal Injection O
Irritation, Intraocular O
Acute Systemic Toxicity O
Pyrogenicity o
Hemolysis O

The test article extracts showed no evidence of cvtotoxic effect, were not considered a sensitizer, showed no evidence of erythema and edema, were not considered an irritant to the ocular tissue of the rabbit, were not considered inflammatory to intraocular tissues of the rabbit, were not considered an irritant to the intraocular tissues of the rabbit, did not show evidence of systemic toxicity, were not considered pyrogenic, and were not considered hemolytic. The biological safety testing demonstrates the subject device is biocompatible for its intended use.

IX. SUBSTANTIAL EQUIVALENCE

The Vitrelect® and OcuSafe® Needles are substantially equivalent to the predicate device when evaluating intended use and technological characteristics.

The subject device has the identical intended use as the predicate device. The subject device is additionally indicated for intravitreal use.
The subject device and predicate device are substantially equivalent with only minor technological differences in configuration/size offering, biocompatibility and performance testing.
. To support intravitreal use, the subject device was tested for compliance with intraocular requirements for ethylene oxide residuals, endotoxin, particulate matter according to USP <789> (using both the light obscuration and microscopy test methods), and intraocular irritation testing and passed.
Biocompatibility testing and performance testing demonstrate the additional configuration/size offering and additional indication do not raise new or different questions of safety and effectiveness.

The biocompatibility testing data and particulate test data in conjunction with the performance test data demonstrating compliance with ISO 7864, ISO 9626, and ISO 80369-7 demonstrate that the VitreJect® and OcuSafe® Needles meet the established safety and performance characteristics of the device and demonstrate substantial equivalence.

X. CONCLUSIONS

The VitreJect® and OcuSafe® Needles met the established safety and performance characteristics

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Image /page/9/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three hexagons of varying shades of blue on the left side. To the right of the hexagons is the company name, "OcuJect LLC," in a stylized blue font. Below the company name is the tagline "ADVANCED DRUG DELIVERY," also in blue.

for a hypodermic single-lumen needle. Suitability of the subject devices for the additional configuration/size offering and additional indication of intravitreal use was evaluated through biocompatibility and performance testing. These differences do not raise any new or different questions of safety or effectiveness. Testing demonstrates the VitreJect® and OcuSafe® Needles are as safe and effective as the predicate device and will perform as intended.

The Vitrelect® and OcuSafe® Needles are biocompatible for the intended use and demonstrate equivalent performance to the predicate device. The VitreJect® and OcuSafe® Needles are substantially equivalent to the SteriCap® Mini Needle and Standard Needles cleared under K212805.

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).