VitreJect Syringe
Device Facts
| Record ID | K230372 |
|---|---|
| Device Name | VitreJect Syringe |
| Applicant | Ocuject, LLC |
| Product Code | QLY · General Hospital |
| Decision Date | Sep 8, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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 Story
VitreJect Syringe is a manual, single-use, luer-tip piston syringe (1 mL) for fluid injection/aspiration in ophthalmic procedures. Device consists of a hollow barrel with gradient markings and a plunger with an integrated stopper. Available in luer-slip or luer-lock configurations and standard or low dead space (LDS) plunger types. Operated manually by clinicians in clinical settings. Device facilitates precise dosing for intracameral and intravitreal administration. Benefits include accurate fluid delivery and aspiration with biocompatible materials. Sterilized by ethylene oxide.
Clinical Evidence
No clinical data. Safety and effectiveness supported by bench testing: ISO 7886-1 (performance, graduation, dead space, leakage, operational force), ISO 80369-7 (luer connector), USP <788>/<789> (particulate matter), and ISO 10993-1 (biocompatibility including cytotoxicity, sensitization, intracutaneous reactivity, ocular/intravitreal/intraocular irritation, systemic toxicity, pyrogenicity, and hemolysis). Chemical characterization and toxicological risk assessment confirmed biocompatibility.
Technological Characteristics
Piston syringe; 1 mL barrel (polypropylene); plunger (polyethylene/polyisoprene); lubricant (non-silicone oleamide slip agent); luer-slip or luer-lock tip; manual operation; EO sterilized; 5-year shelf life. Standards: ISO 7886-1, ISO 80369-7, ISO 10993 series, USP <788>, USP <789>, ASTM F756.
Indications for Use
Indicated for intracameral and intravitreal fluid injection or withdrawal in adults (>21 years) by clinicians in clinical settings.
Regulatory Classification
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.
Predicate Devices
- StaClear Syringe (K200242)
Reference Devices
- MiniLoad® Syringe (K212544)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is 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) | |
|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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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 Device<br>VitreJect® Syringe | Predicate StaClear<br>(K200242) | Device<br>Syringe | Associated<br>Testing<br>Standard | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------|
| 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: | FMF<br><br>QNQ – low dead space<br>specification identical<br>to MiniLoad Syringe | Identical<br><br>FMI - permanently<br>attached needle | | | |
| Regulation Medical<br>Specialty | General Hospital | Identical | | | |
| Intended Use | Intended to inject<br>fluids into, or<br>withdraw fluids from,<br>the body. | Identical | | Supported by<br>referenced<br>performance and<br>biocompatibility<br>testing | |
| Indications | The VitreJect®<br>Syringe is intended to<br>inject fluids into, or<br>withdraw fluids from,<br>the body. | Equivalent, the predicate<br>device does not indicate<br>for intracameral use. | | ISO 10993-1,<br>ISO 10993-7,<br>ISO 10993-10,<br>USP <788>,<br>USP <789> | |
| Characteristic | Subject Device<br>VitreJect® Syringe | Predicate<br>StaClear<br>(K200242) | Device<br>Syringe | Associated<br>Standard | Testing |
| | The VitreJect®<br>Syringe is indicated for<br>intracameral and<br>intravitreal use. | The StaClear Syringe is<br>intended to inject fluids<br>into, or withdraw fluids<br>from, the body. The<br>StaClear Syringe is<br>indicated for intravitreal<br>use. | | | |
| Intended Use<br>Population, Users and<br>Environment | Adults Only (greater<br>than 21 years of age)<br>Clinicians in a clinical<br>setting. | Unknown<br>Identical | | | |
| Principle of Operation | Manual advancement<br>and withdrawal of the<br>plunger within the<br>barrel | Identical | | ISO 7886-1 | |
| Device Components | Barrel<br>Plunger | Identical syringe<br>components<br>StaClear Syringe has<br>permanently attached<br>needle whereas VitreJect<br>Syringe is a luer-tip<br>syringe. | | ISO 10993-1,<br>ISO 10993-2,<br>ISO 10993-4,<br>ISO 10993-5,<br>ISO 10993-7,<br>ISO 10993-10,<br>ISO 10993-11, | |
| Materials | Barrel | Polypropylene random<br>copolymer | Equivalent,<br>Polypropylene | ISO 10993-12,<br>ISO 10993-17, | |
| | Plunger | Polyethylene (HDPE)<br>– plunger and stopper<br>Blue Ink Titanium<br>Dioxide | Equivalent,<br>Polyethylene – plunger<br>Polyisoprene – plunger<br>stopper | ISO 10993-18,<br>ISO 10993-23,<br>ASTM F756<br>ISO 7886-1 | |
| | Lubricant | Non-silicone<br>(oleamide) slip agent<br>mixed into<br>Polypropylene barrel | Equivalent,<br>Silicone oil, cross-linked<br>with inert argon gas<br>plasma | | |
| | Barrel Volume | 1 mL | Equivalent,<br>0.25mL | | |
| | Barrel Length | Luer-Slip (LDS) –<br>84.7 mm<br>Luer Lock (LDS &<br>STD) - 86 mm | Equivalent,<br>StaClear Syringe<br>specification unknown. | | |
| | Barrel<br>Diameter | Outside<br>~ 6.4 mm | Equivalent,<br>StaClear Syringe<br>specification 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 mm<br>Luer Lock (LDS) – 96.3 mm<br>Luer Lock (STD) – 85.3 mm | Equivalent, StaClear Syringe specification unknown. | | | |
| Plunger Color | Blue | Equivalent, StaClear Syringe specification unknown. | | | |
| Plunger Type | Low dead space (LDS)<br>Standard (STD) | Equivalent, StaClear Syringe specification unknown. | | ISO 7886-1 | |
| Graduation | ISO 7886-1 compliant<br><br>Full 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-slip<br>Luer-lock | Equivalent, Permanently attached needle | | ISO 7886-1<br>ISO 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-Use<br>100 individual blister packed devices packaged into shelf carton<br>Sterilization Method: EO | Equivalent, Provided Sterile, Single-Use<br>100 single-use syringes, EO sterile fluid path, in shelf carton<br>Sterilization Method: EO<br>SAL: 10-6 | | AAMI TIR28<br>ISO 11135-1<br>ISO 10993-7<br>USP <85><br>ANSI/AAMI ST72<br>ASTM F1980-16<br>ISO 7886-1 | |
| Characteristic | Subject Device<br>VitreJect® Syringe | Predicate<br>StaClear<br>(K200242) | Device<br>Syringe | Associated<br>Testing<br>Standard | |
| | SAL: 10-6<br>Shelf Life: 5 years | Shelf Life: 1 year | | ISO 80369-7<br>ISO 11607-1<br>ASTM F88/F88-15<br>ASTM F1929-15<br>ISTA 3A | |
| Biocompatibility<br>ISO 10993-1 | Non-cytotoxic | Identical | | ISO 10993-5 | |
| | Non-sensitizer | Identical | | ISO 10993-10 | |
| | Non-irritant,<br>Intracutaneous<br>Reactivity | Identical | | ISO 10993-23 | |
| | Non-irritant, Ocular | Identical | | ISO 10993-10 | |
| | Non-irritant,<br>Intravitreal Injection | Identical | | ISO 13485 | |
| | Non-irritant,<br>Intraocular | Equivalent,<br>Test not applicable to<br>StaClear Syringe, which is<br>not indicated for<br>intracameral use. | | ISO 13485 | |
| | Non-pyrogenic | Identical | | ISO 10993-11,<br>USP <151> | |
| | Non-toxic | Identical | | ISO 10993-11 | |
| | Non-hemolytic | Identical | | ASTM F756, ISO<br>10993-4 | |
| Performance Data | Meets ISO 7886-1 | Identical | | ISO 7886-1 | |
| | Meets ISO 80369-7 | Equivalent,<br>Test not applicable to<br>StaClear Syringe, which<br>has a permanently<br>attached 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.
