Who is the manufacturer of OMNI Surgical System?

Sight Sciences, Inc. filed the 510(k) submission for OMNI Surgical System (K202678).

What is the FDA product code for OMNI Surgical System?

MRH. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for OMNI Surgical System?

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

What are the predicate devices for OMNI Surgical System?

OMNI® Surgical System (K173332).

Who can help prepare an FDA 510(k) submission like OMNI Surgical System?

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

OMNI Surgical System

K202678 · Sight Sciences, Inc. · MRH · Mar 1, 2021 · General Hospital

Device Facts

Record ID	K202678
Device Name	OMNI Surgical System
Applicant	Sight Sciences, Inc.
Product Code	MRH · General Hospital
Decision Date	Mar 1, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The OMNI® Surgical System is an ophthalmic surgical tool for the delivery of controlled amounts of viscoelastic fluid into the anterior segment and the cutting of trabecular meshwork when a trabeculotomy is indicated.

Device Story

Handheld, manually operated ophthalmic surgical device; used by ophthalmologists to perform canaloplasty and trabeculotomy. Device features stainless-steel cannula with beveled tip for Schlemm's canal access; flexible polymeric microcatheter for viscodilation; internal reservoir and plunger tube for controlled delivery of cohesive viscoelastic fluid (OVD). Surgeon uses advancement wheels to navigate microcatheter into Schlemm's canal (up to 180 degrees per cycle); viscoelastic is dispensed automatically during microcatheter retraction. Trabeculotomy performed by re-advancing microcatheter and withdrawing cannula to cut trabecular meshwork. Device is sterile, single-use, and ambidextrous. Output is physical tissue modification and fluid delivery; assists in reducing intraocular pressure in glaucoma patients.

Clinical Evidence

Retrospective, multi-center, single-arm, consecutive case series (ROMEO study) of 129 patients (81 combined with cataract surgery, 48 standalone). Primary endpoints: IOP reduction and medication usage over 12 months. Results showed mean IOP reduction from baseline (19.5-20.0 mmHg) to 12 months (15.2-15.3 mmHg). Safety profile consistent with expected MIGS procedures; no serious device-related adverse events reported.

Technological Characteristics

Handheld, manual infusion pump. Materials: ABS, polycarbonate, stainless steel, silicone, parylene coating, cyanoacrylate, acrylated urethane, polyimide. Features: 200-micron microcatheter, rack-and-pinion advancement mechanism, Luer fitting for OVD cartridge. Sterilization: Gamma radiation (SAL 10^-6). No software or electronic components.

Indications for Use

Indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

OMNI® Surgical System (K173332)

Reference Devices

iScience Interventional Canaloplasty Microcatheter (iTrack™ Surgical System) (K080067)

Related Devices

K232214 — OMNI Surgical System · Sight Sciences, Inc. · Aug 25, 2023
K201953 — OMNI PLUS Surgical System · Sight Sciences, Inc. · Aug 11, 2020
K173332 — OMNI Surgical System · Sight Sciences, Inc. · Dec 21, 2017
K243503 — VIA360 Surgical System · New World Medical, Inc. · Feb 14, 2025
K080067 — ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER · Iscience Interventional · Jul 18, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. March 1, 2021 Sight Sciences, Inc. Edward Sinclair Vice President, Regulatory Affairs 4040 Campbell Ave, Suite 100 Menlo Park, California 94025 Re: K202678 Trade/Device Name: OMNI® Surgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH, HMZ Dated: January 18, 2021 Received: January 21, 2021 ### Dear Edward Sinclair: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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, LT Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202678 Device Name OMNI® Surgical System Indications for Use (Describe) The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. 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) | | #### 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}------------------------------------------------ ## 510(k) SUMMARY # Submitter Information | 510(k) Owner: | Sight Sciences, Inc. 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025 Tel: (877) 266-1144 | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Edward J. Sinclair Vice President, Regulatory Affairs 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025 Tel: 650-218-9149 | | Date Prepared: | March 1, 2021 | ### Device Name and Classification | Trade Name: | OMNI® Surgical System | |-------------------------|--------------------------| | Common Name: | Ophthalmic Infusion Pump | | Classification Name: | Infusion Pump | | Regulation Number: | 21 CFR 880.5725 | | Device Classification: | Class II | | Primary Product Code: | MRH | | Secondary Product Code: | HMZ | # Primary Predicate Device | Device Name: | OMNI® Surgical System | |-----------------|-----------------------| | 510(k) Holder: | Sight Sciences, Inc. | | 510(k) Number: | K173332 | | Clearance Date: | December 21, 2017 | ### Reference Device | Device Name: | iScience Interventional Canaloplasty Microcatheter (iTrack™ Surgical System) | | |-----------------|------------------------------------------------------------------------------|--| | 510(k) Holder: | Ellex iScience, Inc. | | | 510(k) Number: | K080067 | | | Clearance Date: | July 18, 2008 | | #### Intended Use {4}------------------------------------------------ The OMNI® Surgical System is an ophthalmic surgical tool for the delivery of controlled amounts of viscoelastic fluid into the anterior segment and the cutting of trabecular meshwork when a trabeculotomy is indicated. # Indications for Use The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. # Device Description The Sight Sciences OMNI Surgical System (with modified indication) is a handheld, manually operated device used by ophthalmologists to access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and to re-access Schlemm's canal and cut trabecular meshwork tissue ("trabeculotomy"). The OMNI Surgical System is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. Each OMNI Surgical System device dispenses fluid on the principle of exchanging volumes much like a syringe and is designed to function with commercially available cohesive viscoelastic fluids (also known as ophthalmic viscosurgical device, or "OVD"). The OMNI Surgical System device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI Surgical System device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter. The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. To perform the combined and sequential canaloplasty/trabeculotomy procedures, the canaloplasty is performed first, followed by trabeculotomy as explained in further detail below. Performing Canaloplasty First: the microcatheter is advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20mm). When the device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid along the length of Schlemm's canal and collector channels. The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating the advancement wheel. The microcatheter can be fully advanced/retracted multiple times, however, viscoelastic fluid can only be dispensed during the first two advancement/retraction cycles in order to dispense viscoelastic fluid along each hemisphere of {5}------------------------------------------------ Schlemm's canal. Thus, the OMNI Surgical System device is designed to be used twice within Schlemm's canal to deliver a controlled volume of viscoelastic fluid along the first 180 degrees of the canal, followed by a second delivery of viscoelastic fluid along the other 180 degrees. The OMNI Surgical System delivers a total viscoelastic fluid volume of 11 microliters throughout Schlemm's canal (approximately 5.5 microliters for each of the first two advancement/retraction cycles). Performing Trabeculotomy Second: the beveled tip of the curved stainless-steel cannula is repositioned into the same Schlemm's canal location after finishing canaloplasty. The polymeric microcatheter is re-advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20 mm). With the microcatheter resting in the canal, the cannula is removed from the corneal incision and out of the eye causing the microcatheter to cut through the trabecular meshwork. This process can be repeated in the second Schlemm's hemisphere. # Comparison of Technological Characteristics with the Predicate The primary predicate in this 510(k) submission is the OMNI Surgical System described in K173332 and K201953, based on substantial equivalence to the Ellex iScience Interventional Canaloplasty Microcatheter ("iTrack Surgical System") cleared in K080067. The same iTrack Surgical System device (K080067) is also used as a reference device in this 510(k) submission. The Sight Sciences OMNI Surgical System subject device complies with the same product design requirements and applicable standards as the predicate OMNI Surgical System and shares the identical principle of operation, intended use, and key technological characteristics. Additionally, the technical features of the subject OMNI Surgical System are similar, but not identical to the commercially available Ellex iTrack Surgical System reference device. The different technological characteristics do not raise different questions of safety and effectiveness. The subject OMNI Surgical System with modified indications and the Ellex iTrack device are both manually operated devices that utilize a microcatheter to access Schlemm's canal and deliver viscoelastic fluid. Fluid is dispensed from each system on the principle of exchanging volumes much like a syringe. The iTrack device serves as a reference device to support the scientific methods to assess the safety and effectiveness of the device to lower IOP in glaucoma patients. The iTrack device is used in the same anatomical location as the OMNI device and is intended for use to perform canaloplasty to lower IOP in glaucoma patients, which is similar to the intended use proposed for the OMNI device. A comparison of the attributes of the subject OMNI Surgical System with the predicate OMNI Surgical System and the Ellex iTrack Surgical System (iScience Interventional Canaloplasty Microcatheter) reference device are listed in Table 1 below. Table 1. Technological Characteristics Comparison {6}------------------------------------------------ | Characteristic | OMNI Surgical System | OMNI Surgical System (K173332) | Ellex iTrack Surgical System (iScience Interventional Canaloplasty Microcatheter K080067) REFERENCE DEVICE | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | SUBJECT DEVICE Ophthalmic surgical tool for delivery of controlled amounts of viscoelastic fluid into the anterior segment and used to cut trabecular meshwork when a trabeculotomy is indicated | PRIMARY PREDICATE DEVICE Ophthalmic surgical tool for delivery of controlled amounts of viscoelastic fluid into the anterior segment and used to cut trabecular meshwork when a trabeculotomy is indicated | Delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery | | Indications for Use | The OMNI® Surgical System is indicated for canaloplasty (micro-catheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with open-angle glaucoma | The OMNI® Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or Healon GV® from Abbott Medical Optics, Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures | The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma | | Regulation | 880.5725 (Infusion Pump) | 880.5725 (Infusion Pump) | 886.4350 (Manual ophthalmic surgical instrument) 876.1500 (Endoscope and accessories) | | Device Class | Class II | Class II | Class II | | Product Code | Primary: MRH (Ophthalmic Infusion Pump) Secondary: HMZ (Trabeculotome) | Primary: MRH (Ophthalmic Infusion Pump) Secondary: HMZ (Trabeculotome) | Primary: MPA (Endoscope) Secondary: HMX (Manual Ophthalmic Surgical Instrument) | | Prescription Status | Prescription use only | Prescription use only | Prescription use only | | Target Anatomy | Schlemm's Canal and Trabecular Meshwork | Schlemm's Canal and Trabecular Meshwork | Schlemm's Canal and Trabecular Meshwork | | Operating Principle | Manual | Manual | • Manual (microcatheter) • Powered (endoilluminator) | | Design/ Mechanism of Action | • Stainless-steel cannula has sharp tip that can be used to pierce the trabecular meshwork and provide access into Schlemm's canal. Minor dimensional changes to cannula tip height and radius • Flexible microcatheter with rounded, atraumatic tip for dispensing of viscoelastic • Microcatheter is blue color to facilitate its visibility in Schlemm's canal as it is advanced/retracted through the cannula • Microcatheter allows access to 360° of Schlemm's canal in two 180° segments • Proximal handle changed to ovoid shape with elastomeric material for added grip • Proximal handle allows ambidextrous use in either patient eye • Internal viscoelastic reservoir and plunger tube with dimensional changes to allow dispensing of viscoelastic • Ovoid handle shape allows advancement wheels (finger wheels) to be reduced to two for advancing and retracting microcatheter up to 20mm using a rack and pinion mechanism • Tactile and audible clicks indicate precise advancement • Viscoelastic dispensed during retraction of first two cycles after priming with viscoelastic fluid • Flexible microcatheter introduced into Schlemm's canal and pulled through to cut trabecular meshwork • Priming Lock moved to accommodate new Luer fitting and prevents accidental dispensing during viscoelastic priming • Changes were made to the | • Stainless-steel cannula has sharp tip that can be used to pierce the trabecular meshwork and provide access into Schlemm's canal • Flexible microcatheter with rounded, atraumatic tip for dispensing of viscoelastic • Microcatheter is blue color to facilitate its visibility in Schlemm's canal as it is advanced/retracted through the cannula • Microcatheter allows access to 360° of Schlemm's canal in two 180° segments • Proximal handle has rectangular shape • Proximal handle allows ambidextrous use in either patient eye • Internal viscoelastic reservoir and plunger tube to allow dispensing of viscoelastic • Four advancement wheels (finger wheels) for advancing and retracting microcatheter up to 20mm using a rack and pinion mechanism • Tactile and audible clicks indicate precise advancement • Viscoelastic dispensed during retraction of first two cycles after priming with viscoelastic fluid • Flexible microcatheter introduced into Schlemm's canal and pulled through to cut trabecular meshwork • Priming Lock Pin prevents accidental dispensing during viscoelastic priming | • Flexible microcatheter for dispensation of viscoelastic fluid • Microcatheter has a round, bolus, atraumatic tip • Microcatheter allows access to 360° of Schlemm's canal in one pass • Microcatheter has internal catheter support wire • Tactile and audible clicks indicate precise advancement • Viscoelastic manually dispensed during retraction microcatheter • No cannula – a 27 ga needle (not included) is used to pierce the trabecular meshwork • Centrally located hub • Microcatheter attaches at proximal end to Ellex ViscoInjector • Viscoelastic cartridge placed into ViscoInjector • Microcatheter manually advanced/retracted by surgeon using microsurgical forceps (not included) • Knob on ViscoInjector turned to dispense viscoelastic during microcatheter retraction • Microcatheter is clear and transparent but incorporates a red light at its tip to facilitate visibility in Schlemm's canal | | Characteristic | OMNI Surgical System SUBJECT DEVICE | OMNI Surgical System (K173332) PRIMARY PREDICATE DEVICE | Ellex iTrack Surgical System (iScience Interventional Canaloplasty Microcatheter K080067) REFERENCE DEVICE | | | reservoir, Luer fitting and a new bonding adhesive was used | | | | Dispensing Control | After priming, viscoelastic dispensing control occurs through manual rotation of either advancement wheel at the distal end of the device. Synchronization of the two wheels was reversed for ease of use | After priming, viscoelastic dispensing control occurs through manual rotation of either of the advancement wheels at the distal end of the device | Rotational action via a knob on the ViscoInjector to dispense viscoelastic fluid | | Dispensing Mechanism | Internal reservoir with plunger tube (syringe-like volume exchange). Three internal component dimensions modified to reduce air bubble formation during priming | Internal reservoir with plunger tube (syringe-like volume exchange). | OVD cartridge attaches to the device inside the Ellex ViscoInjector (syringe-like volume exchange) | | Viscoelastic Fluid (OVD) and Priming Method | Cohesive viscoelastic fluid (OVD or ophthalmic viscosurgical device) is supplied separately. Viscoelastic loaded into device (primed) prior to use by attaching OVD cartridge directly to a Luer fitting that replaces the cap on proximal end of OMNI device handle for ease of priming | Cohesive viscoelastic fluid (OVD or ophthalmic viscosurgical device) is supplied separately. Viscoelastic loaded into device (primed) prior to use by attaching OVD cartridge to a supplied Nozzle that is inserted into a on proximal end of OMNI device handle | Cohesive viscoelastic fluid (OVD or ophthalmic viscosurgical device) is supplied separately. OVD cartridge attaches to the device inside the Ellex ViscoInjector | | OVD Volume Dispensed | 11 μL | 9 μL | Not stated | | Materials | Medical grade materials, including ABS, polycarbonate, stainless steel, silicone, parylene coating, cyanoacrylate, acrylated urethane, polyimide | Medical grade materials, including ABS, polycarbonate, stainless stee…