The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.

Device Description

The Vitrelect Syringe is designed to provide a means of fluid injection and aspiration. It is a luer-tip piston syringe consisting of a 1 mL hollow barrel with gradient markings and a plunger with an incorporated plunger stopper. The VitreJect Syringe barrel component is available in two configurations, a luer-slip or luer-lock tip, for the fitting of a compatible hypodermic needle. The VitreJect Syringe plunger is available in two configurations: standard dead space or low dead space. It is intended for manual use by health care professionals. The VitreJect Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Syringe is suitable for ophthalmic use.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the "VitreJect Syringe." It aims to demonstrate that the VitreJect Syringe is substantially equivalent to a legally marketed predicate device (StaClear Syringe, K200242).

This document describes non-clinical performance and biocompatibility testing for a medical device (syringe), not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text.

1. A table of acceptance criteria and the reported device performance

The document doesn't present a single structured table explicitly labeled "Acceptance Criteria and Reported Performance" with quantitative thresholds for all tests. However, it lists a series of tests performed and states that the device "met the applicable requirements" or "met the established safety and performance characteristics." For some specific characteristics, it even provides the performance achieved.

Here's a summarized table based on the information provided:

Characteristic Tested (Acceptance Criteria Implicitly Met)	Reported Device Performance	Associated Standard
Freedom from Extraneous Matter	Met requirements	ISO 7886-1
Lubricant Quantification	Met requirements	ISO 7886-1
Tolerance on Graduations	Met requirements (consistent with ISO 7886-1 compliant)	ISO 7886-1
Plunger Stopper Detachment	Met requirements	ISO 7886-1
Barrel Flange to Plunger Distance	Met requirements	ISO 7886-1
Dead Space	≤ 0.023 mL with 95% confidence / 95% reliability	ISO 7886-1
Freedom from Leakage	Met requirements	ISO 7886-1
Piston Operational Force	Met requirements	ISO 7886-1
Plunger Fit	Met requirements	ISO 7886-1
Luer Connector	Met requirements	ISO 80369-7
Particulate Matter in Injections	Met requirements	USP <788>
Particulate Matter in Ophthalmic Solutions	Met requirements	USP <789>
Biocompatibility: Non-cytotoxic	Non-cytotoxic	ISO 10993-5
Biocompatibility: Non-sensitizer	Non-sensitizer	ISO 10993-10
Biocompatibility: Non-irritant, Intracutaneous Reactivity	Non-irritant	ISO 10993-23
Biocompatibility: Non-irritant, Ocular	Non-irritant	ISO 10993-10
Biocompatibility: Non-irritant, Intravitreal Injection	Non-irritant	ISO 10993-10 (implied, or general biocompatibility)
Biocompatibility: Non-irritant, Intraocular	Non-irritant (specifically for intracameral use)	ISO 13485 (implied, or general biocompatibility)
Biocompatibility: Non-pyrogenic	Non-pyrogenic	ISO 10993-11, USP <151>
Biocompatibility: Non-toxic	Non-toxic	ISO 10993-11
Biocompatibility: Non-hemolytic	Non-hemolytic	ASTM F756, ISO 10993-4
Sterilization Assurance Level (SAL)	10^-6	ISO 11135-1
Shelf Life	5 years	(Multiple standards related to sterility, packaging, aging)
Toxicological Risk Assessment	Demonstrated acceptable level of risk	(Based on Chemical Characterization)

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (N numbers) used for each individual test. It generally states that "Performance testing was performed as per the design control system" and refers to ISO standards, which typically involve specific sample sizes.

Sample Size: Not explicitly stated for each test.
Data Provenance: The document does not specify the country of origin for the data. The tests are "non-clinical testing" (in vitro and in vivo studies) performed by the manufacturer (OcuJect, LLC). It's a regulatory submission, so the data is likely manufacturer-generated to support the device's claims. The studies were prospective in the sense that they were conducted specifically for this regulatory submission to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a physical medical device (syringe), not an AI/ML diagnostic tool. Ground truth in this context refers to the measured physical and biological properties of the device, established through standardized testing methodologies, not expert interpretation of medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the device is a physical medical device (syringe), not an AI/ML diagnostic tool. Adjudication methods are used in consensus labeling of data by human experts for AI models. The "ground truth" here is determined by direct measurement and standardized test results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the device is a physical medical device (syringe) and not an AI-powered diagnostic tool that assists human readers.

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

This question is not applicable as the device is a physical medical device (syringe) and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this medical device is established through:

Standardized Physical and Chemical Measurements: Performed according to ISO, USP, and ASTM standards (e.g., dead space volume, operational force, particulate matter counts, dimensional specifications).
Biological Testing (In vitro and In vivo): Biocompatibility tests such as cytotoxicity, sensitization, irritation (intracutaneous, ocular, intravitreal, intraocular), systemic toxicity, pyrogenicity, and hemolysis.
Chemical Characterization and Toxicological Risk Assessment: To identify extractables/leachables and assess their risk.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device (syringe) and does not involve AI/ML requiring a training set.

9. How the ground truth for the training set was established

This question is not applicable as the device is a physical medical device (syringe) and does not involve AI/ML requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 8, 2023

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

Re: K230372

Trade/Device Name: VitreJect Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QLY, FMF, QNQ Dated: August 10, 2023 Received: August 11, 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.

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

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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 (OS) 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/5 description: The image contains a signature in black ink. The signature appears to be stylized and cursive. The signature is large and takes up most of the frame.

CAPT Alan M. 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) K230372

Device Name VitreJect Syringe

Indications for Use (Describe)

The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and 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 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 bold, blue font, with "LLC" in a smaller font size. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, blue font.

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 8, 2023

II. DEVICE

Name of Device:	VitreJect® Syringe
Common or Usual Name:	Syringe, Piston
Classification Name:	Piston Syringe (21 CFR 880.5860)
Regulatory Class:	II
Product Code:	QLY
Subsequent Code(s):	FMF, QNQ

PREDICATE DEVICE III.

StaClear Syringe, K200242 This predicate has not been subject to a design-related recall.

IV. REFERENCE DEVICE

MiniLoad® Syringe, K212544

V. DEVICE DESCRIPTION

The Vitrelect Syringe is designed to provide a means of fluid injection and aspiration. It is a luertip piston syringe consisting of a 1 mL hollow barrel with gradient markings and a plunger with an incorporated plunger stopper. The VitreJect Syringe barrel component is available in two configurations, a luer-slip or luer-lock tip, for the fitting of a compatible hypodermic needle. The VitreJect Syringe plunger is available in two configurations: standard dead space or low dead space. It is intended for manual use by health care professionals. The VitreJect Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Syringe is suitable for ophthalmic use.

INTENDED USE / INDICATIONS FOR USE VI.

The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body.

The VitreJect Syringe is indicated for intracameral and intravitreal use.

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Image /page/4/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three hexagons in 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, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif blue font.

WITH VII. OF TECHNOLOGICAL CHARACTERISTICS THE COMPARISON PREDICATE DEVICE

The technological characteristics of the VitreJect® Syringe are substantially equivalent to the predicate StaClear Syringe (K200242). The intended use of the subject device is identical to the predicate device; both are designed and intended to inject fluids into, or withdraw fluids from, the body. Both the Vitrelect® Syringe and the StaClear Syringe are indicated by intravitreal use, whereas the subject device is additionally indicated for intracameral use. The subject device and the predicate device have minor technological differences in device materials, dimensional specifications, connection type, and plunger type/specification. The subject device has the identical design, material, manufacturing process, sterilization method, and packaging configuration of the MiniLoad® Syringe (K212544). Further, the plunger/syringe interface of the VitreJect Syringe is identical to the MiniLoad® Syringe and the dead space specification of ≤ 0.023 mL with 95% confidence/95% reliability is in alignment with the specification established in the legally marketed MiniLoad® Syringe (K212544).

Characteristic	Subject DeviceVitreJect® Syringe	Predicate StaClear(K200242)	DeviceSyringe	AssociatedTestingStandard
Applicant	OcuJect, LLC	TriboFilm Research, Inc.
Proprietary Name	VitreJect®	StaClear
Device	Syringe, Piston	Identical
Device Class	II	Identical
Regulation Number	21 CFR 880.5860	Identical
Product Code	QLY	Identical
Subsequent Codes:	FMFQNQ – low dead spacespecification identicalto MiniLoad Syringe	IdenticalFMI - permanentlyattached needle
Regulation MedicalSpecialty	General Hospital	Identical
Intended Use	Intended to injectfluids into, orwithdraw fluids from,the body.	Identical		Supported byreferencedperformance andbiocompatibilitytesting
Indications	The VitreJect®Syringe is intended toinject fluids into, orwithdraw fluids from,the body.	Equivalent, the predicatedevice does not indicatefor intracameral use.		ISO 10993-1,ISO 10993-7,ISO 10993-10,USP <788>,USP <789>
Characteristic	Subject DeviceVitreJect® Syringe	PredicateStaClear(K200242)	DeviceSyringe	AssociatedStandard	Testing
	The VitreJect®Syringe is indicated forintracameral andintravitreal use.	The StaClear Syringe isintended to inject fluidsinto, or withdraw fluidsfrom, the body. TheStaClear Syringe isindicated for intravitrealuse.
Intended UsePopulation, Users andEnvironment	Adults Only (greaterthan 21 years of age)Clinicians in a clinicalsetting.	UnknownIdentical
Principle of Operation	Manual advancementand withdrawal of theplunger within thebarrel	Identical		ISO 7886-1
Device Components	BarrelPlunger	Identical syringecomponentsStaClear Syringe haspermanently attachedneedle whereas VitreJectSyringe is a luer-tipsyringe.		ISO 10993-1,ISO 10993-2,ISO 10993-4,ISO 10993-5,ISO 10993-7,ISO 10993-10,ISO 10993-11,
Materials	Barrel	Polypropylene randomcopolymer	Equivalent,Polypropylene	ISO 10993-12,ISO 10993-17,
	Plunger	Polyethylene (HDPE)– plunger and stopperBlue Ink TitaniumDioxide	Equivalent,Polyethylene – plungerPolyisoprene – plungerstopper	ISO 10993-18,ISO 10993-23,ASTM F756ISO 7886-1
	Lubricant	Non-silicone(oleamide) slip agentmixed intoPolypropylene barrel	Equivalent,Silicone oil, cross-linkedwith inert argon gasplasma
	Barrel Volume	1 mL	Equivalent,0.25mL
	Barrel Length	Luer-Slip (LDS) –84.7 mmLuer Lock (LDS &STD) - 86 mm	Equivalent,StaClear Syringespecification unknown.
	BarrelDiameter	Outside~ 6.4 mm	Equivalent,StaClear Syringespecification unknown.
Characteristic	Subject Device VitreJect® Syringe	Predicate StaClear (K200242)	Device Syringe	Associated Standard	Testing
Barrel Inside Diameter	~ 4.6 mm	Equivalent, StaClear Syringe specification unknown.
Barrel Color	Transparent and Clear	Equivalent, StaClear Syringe specification unknown.
Barrel Printing	Black ink	Equivalent, StaClear Syringe specification unknown.
Plunger Length	Luer-Slip (LDS) – 94.3 mmLuer Lock (LDS) – 96.3 mmLuer Lock (STD) – 85.3 mm	Equivalent, StaClear Syringe specification unknown.
Plunger Color	Blue	Equivalent, StaClear Syringe specification unknown.
Plunger Type	Low dead space (LDS)Standard (STD)	Equivalent, StaClear Syringe specification unknown.		ISO 7886-1
Graduation	ISO 7886-1 compliantFull scale capacity testing as well as 0.05 mL fill volume to support dosing accuracy for ophthalmic use.	Identical		ISO 7886-1
Tip Type	Luer-slipLuer-lock	Equivalent, Permanently attached needle		ISO 7886-1ISO 80369-7
Dead Space Specification	≤ 0.023 mL with 95% confidence / 95% reliability	Equivalent, StaClear Syringe specification unknown		ISO 7886-1
Sterilization and Shelf Life	Provided Sterile, Single-Use100 individual blister packed devices packaged into shelf cartonSterilization Method: EO	Equivalent, Provided Sterile, Single-Use100 single-use syringes, EO sterile fluid path, in shelf cartonSterilization Method: EOSAL: 10-6		AAMI TIR28ISO 11135-1ISO 10993-7USP <85>ANSI/AAMI ST72ASTM F1980-16ISO 7886-1
Characteristic	Subject DeviceVitreJect® Syringe	PredicateStaClear(K200242)	DeviceSyringe	AssociatedTestingStandard
	SAL: 10-6Shelf Life: 5 years	Shelf Life: 1 year		ISO 80369-7ISO 11607-1ASTM F88/F88-15ASTM F1929-15ISTA 3A
BiocompatibilityISO 10993-1	Non-cytotoxic	Identical		ISO 10993-5
	Non-sensitizer	Identical		ISO 10993-10
	Non-irritant,IntracutaneousReactivity	Identical		ISO 10993-23
	Non-irritant, Ocular	Identical		ISO 10993-10
	Non-irritant,Intravitreal Injection	Identical		ISO 13485
	Non-irritant,Intraocular	Equivalent,Test not applicable toStaClear Syringe, which isnot indicated forintracameral use.		ISO 13485
	Non-pyrogenic	Identical		ISO 10993-11,USP <151>
	Non-toxic	Identical		ISO 10993-11
	Non-hemolytic	Identical		ASTM F756, ISO10993-4
Performance Data	Meets ISO 7886-1	Identical		ISO 7886-1
	Meets ISO 80369-7	Equivalent,Test not applicable toStaClear Syringe, whichhas a permanentlyattached needle.		ISO 80369-7
	Meets USP <788>	Identical		USP <788>
	Meets USP <789>	Identical		USP <789>

A comparison of the technological characteristics between the subject and predicate device are illustrated in the table below:

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Image /page/5/Picture/0 description: The image shows the logo for OcuJect LLC. 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 LLC," in a stylized blue font, with the "LLC" in smaller letters. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif blue font.

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Image /page/6/Picture/0 description: The image shows the logo for OcuJect LLC. 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 stylized blue font, with "LLC" in smaller letters. Below the company name is the text "ADVANCED DRUG DELIVERY" in a smaller, sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for OcuJect LLC. The logo consists of three hexagons in 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, with the "LLC" in a smaller font. 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 Syringe as compared to the predicate device. Performance testing was performed as per the design control system. The following tests were conducted:

ISO 7886-1
- o Freedom from Extraneous Matter
- Lubricant Quantification o
- Tolerance on Graduations O

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Image /page/8/Picture/0 description: The image shows the logo for OcuJect LLC, a company specializing in advanced drug delivery. The logo features three 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 font, also in blue.

Plunger Stopper Detachment O
Barrel Flange to Plunger Distance O
Dead Space O
Freedom from Leakage O
Piston Operational Force O
Plunger Fit о
ISO 80369-7 ●
- o Luer Connector
Particulate Testing
- o USP <788> Particulate Matter in Injections
- USP <789> Particulate Matter in Ophthalmic Solutions o
Biocompatibility (ISO 10993-1) ●

VitreJect Syringe is categorized as an externally communicating device with prolonged (>24 h to 30 d) tissue/blood path indirect contact (fluid path). OcuJect, LLC completed the following biological safety tests:

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

The results of the in vitro and in vivo studies were acceptable. A chemical characterization study was performed to identify and quantitate the extractables and/or leachables that may be released from the test article. A toxicological risk assessment was then conducted on the chemical characterization testing data to address the biological endpoints of systemic toxicity (subacute/subchronic) and genotoxicity and summarize the biological safety of the VitreJect Syringe. The toxicological risk assessment demonstrated an acceptable level of risk of systemic exposure to the extractable compounds. Therefore, this biological safety testing demonstrates the subject device is biocompatible for its intended use.

SUBSTANTIAL EQUIVALENCE IX.

The VitreJect Syringe is 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. ●

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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 interlocking 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 next to it. Below the company name, the words "ADVANCED DRUG DELIVERY" are written in a smaller, sans-serif font.

The subject device and the predicate device are indicated for intravitreal use. The subject ● device is additionally indicated for intracameral use. This additional indication was evaluated through intraocular injection irritation testing, demonstrating that the VitreJect Syringe is biocompatible for intracameral use. This difference in indication for use does not raise new or different questions of safety and effectiveness.
The subject device and predicate device are substantially equivalent with only minor technological differences in device materials, dimensional specifications, connection type, plunger type. OcuJect completed performance testing according to ISO 7886-1, ISO 80369-7, USP <788> and USP <789> and the VitreJect Syringe met the applicable requirements. The ISO 7886-1. USP <788> and USP <789> standards were also utilized by the StaClear Syringe to demonstrate performance. The VitreJect Syringe demonstrates its performance characteristics are substantially equivalent to the predicate and reference device.
Biocompatibility testing demonstrates the subject device is as safe and effective as the ● legally marketed predicate device, and that minor differences in technological characteristics do not raise new or different questions of safety and effectiveness compared to the predicate device.

The biocompatibility testing data and particulate test data in conjunction with the performance test data in compliance with ISO 7886-1 demonstrate that the VitreJect Syringe met the established safety and performance characteristics of the device and demonstrate substantial equivalence.

X. CONCLUSIONS

The VitreJect Syringe met the established safety and performance characteristics for a piston syringe. Suitability of the subject device for the additional indication of intracameral and intravitreal use was evaluated through endotoxin, biocompatibility, and particulate testing. The additional indication for intracameral administration routes does not raise any new or different questions of safety or effectiveness. Testing demonstrates the VitreJect Syringe is as safe and effective as the predicate device and will perform as intended. The Vitrelect Syringe is substantially equivalent to the StaClear Syringe cleared under K200242.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).