Who is the manufacturer of OMNI Surgical System?

Sight Sciences, Inc. filed the 510(k) submission for OMNI Surgical System (K232214).

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: Special).

What are the predicate devices for OMNI Surgical System?

OMNI® Surgical System (K202678).

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

K232214 · Sight Sciences, Inc. · MRH · Aug 25, 2023 · General Hospital

Device Facts

Record ID	K232214
Device Name	OMNI Surgical System
Applicant	Sight Sciences, Inc.
Product Code	MRH · General Hospital
Decision Date	Aug 25, 2023
Decision	SESE
Submission Type	Special
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, polymeric microcatheter, and internal viscoelastic reservoir. Surgeon primes device with cohesive viscoelastic fluid (OVD) via Luer fitting. During procedure, surgeon uses advancement wheels to move microcatheter into Schlemm's canal; rack and pinion mechanism enables precise advancement/retraction. Retraction of microcatheter dispenses 21 microliters of viscoelastic fluid into Schlemm's canal and collector channels. Subsequent re-advancement and withdrawal of cannula cuts trabecular meshwork. Ambidextrous design allows use in either eye. Device is sterile, single-patient use. Increases viscoelastic delivery volume compared to predicate to facilitate canaloplasty; intended to reduce intraocular pressure in glaucoma patients.

Clinical Evidence

No new clinical data provided. Substantial equivalence is supported by bench testing (verification/validation) and clinical assessment leveraging data from the predicate OMNI device and reference iTrack device.

Technological Characteristics

Handheld, manual infusion pump/trabeculotome. Materials: ABS, polycarbonate, stainless steel, silicone, parylene, cyanoacrylate, acrylated urethane, polyimide. Dimensions: 200-micron microcatheter shaft, 0.0090-0.0110 inch tip. Mechanism: Rack and pinion for microcatheter advancement; syringe-like volume exchange for OVD delivery. Sterilization: Gamma radiation (SAL 10^-6). Shelf life: 37 months.

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 (K202678)

Reference Devices

OMNI® PLUS Surgical System (K201953)
ISCIENCE Interventional Ophthalmic Microcatheter (K080067)

Related Devices

K202678 — OMNI Surgical System · Sight Sciences, Inc. · Mar 1, 2021
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
K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System · Nova Eye Inc. (Business Name Nova Eye Medical) · Mar 30, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 25, 2023 Sight Sciences, Inc. Ranjani Madhavan Senior Regulatory Affairs Specialist 4040 Campbell Ave.. Suite 100 Menlo Park, California 94025 Re: K232214 Trade/Device Name: OMNI Surgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH Dated: July 25, 2023 Received: July 26, 2023 Dear Ranjani Madhavan: 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 {1}------------------------------------------------ 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, # Claudine H. Krawczyk -S Claudine Krawczyk Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232214 Device Name OMNI Surgical System Indications for Use (Describe) The OMN® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of the 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}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the logo for Sight Sciences. The logo consists of a stylized blue symbol on the left, resembling three curved lines stacked on top of each other. To the right of the symbol is the company name, "SIGHT," in bold, followed by "SCIENCES" in a smaller font size directly below it. The overall design is clean and professional, suggesting a company in the science or technology sector. # 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: | Ranjani Madhavan Senior Regulatory Affairs specialist 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025 Tel: 818-585-1124 | | Date Prepared: | August 25, 2023 | | Device Name and Classification | | | Trade Name: Common Name: Classification Name: Regulation Number: Device Classification: Primary Product Code: Secondary Product Code: | OMNI® Surgical System Ophthalmic Infusion Pump Infusion Pump 21 CFR 880.5725 Class II MRH HMZ | | Predicate Device | | | Device Name: 510(k) Holder: 510(k) Number: Clearance Date: | OMNI® Surgical System Sight Sciences, Inc. K202678 March 1, 2021 | | Reference Device | | | Device Name 510(k) Holder 510(k) Number Clearance Date | OMNI® PLUS Surgical System Sight Sciences, Inc. K201953 August 11, 2020 | | Reference Device | | | Device Name 510(k) Holder 510(k) Number Clearance Date | ISCIENCE Interventional Ophthalmic Microcatheter ISCIENCE Interventional# K080067 July 18, 2008 | Note: *commercially available now as iTrack™ #IScience Interventional is now Nova Eye Medical {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Sight Sciences. The logo features a stylized blue symbol resembling three curved lines stacked on top of each other. To the right of the symbol, the word "SIGHT" is written in bold, dark blue capital letters. Below "SIGHT", the word "SCIENCES" is written in smaller, dark blue capital letters. ### 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. ## 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 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 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 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. The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. A single advancement wheel is located on each side of the handle. This allows the OMNI 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. 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 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 modified OMNI Surgical System (subject device) delivers a total viscoelastic fluid volume of 21 microliters throughout Schlemm's canal (approximately 10.5 microliters for each of the first two advancement/retraction cycles). {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Sight Sciences. The logo consists of a blue abstract symbol on the left, resembling interconnected waves or curves. To the right of the symbol is the company name, "SIGHT" in bold, uppercase letters, stacked above the word "SCIENCES" in a smaller font size. 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. The modified OMNI Surgical System (catalog number 1-106) has the identical indications for use as the current OMNI Surgical System and similar design; the modified OMNI has the identical design as the OMNI PLUS Surgical System reference device which includes the ability to dispense a nominal volume of 21 microliters of viscoelastic fluid. ## Comparison of Technological Characteristics with the Predicate Device The modified OMNI Surgical System (catalog number 1-106) has the same indications for use and similar technological characteristics as the OMNI Surgical System (cleared by FDA in K202678 on March 1, 2021). The primary functional difference between the predicate device and subject device is the volume of viscoelastic fluid that can be delivered during use. The technical features of the modified OMNI Surgical System are substantially equivalent (identical including the volume of viscoeleastic fluid that can be delivered during use) to the OMNI PLUS Surgical System reference device (cleared by FDA in K201953 on August 11, 2020). The predicate OMNI Surgical System delivers a nominal volume of approximately 11 microliters of viscoelastic fluid, whereas the subject OMNI design can deliver a nominal volume of approximately 21 microliters of viscoelastic fluid (this volume is identical to the volume that can be delivered by the reference device OMNI PLUS). In order to deliver the additional viscoelastic fluid, three internal components, consisting of the reservoir, plunger tube and distal O-ring, have modified dimensions to contain and dispense additional viscoelastic fluid as compared to the predicate OMNI device. Additionally, the technical features of the subject OMNI surgical system are similar, but not identical to the commercially available interventional ophthalmic microcatheter-iTrack reference device (K080067, formerly the iScience Interventional Canaloplasty Microcatheter). The subject OMNI surgical system and the iTrack device are both manually operated devices that utilize a microcatheter to access the 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 dispenses 2.25 microliters of viscoelastic fluid per click of the visco injector (without any limitation on the amount of OVD that can be delivered). The iTrack device serves as a reference device to support the scientific method used to assess substantial equivalence of the subject device that delivers a nominal 21 microliters 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. The technological attributes comparison between the modified OMNI Surgical System (subject device) with the OMNI Surgical system (predicate device), OMNI Plus Surgical System (reference Device) and the iTrack (reference device) are presented in Table 1 below. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for Sight Sciences. The logo consists of a blue abstract symbol on the left, resembling interconnected rings or a stylized eye. To the right of the symbol, the words "SIGHT" and "SCIENCES" are stacked vertically, both in a bold, sans-serif font and in the same shade of blue as the symbol. ## Table 1: Technological Characteristics Comparison Modified OMNI Surgical System and Predicate Devices | | OMNI Surgical System | OMNI Surgical System | OMNI PLUS Surgical System | ISCIENCE INTERVENTIONAL | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | (Catalog #1-106) | Predicate | Reference Device | OPHTHALMIC MICROCATHETER | | | SUBJECT DEVICE | (K202678) | (K201953) | Reference Device | | | | | | (K080067) | | Intended Use | 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 | 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 | 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 | 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 primary open-angle glaucoma | 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 primary open-angle glaucoma | The OMNI PLUS Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® PRO or Healon GV® PRO from Johnson & Johnson Vision, 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) | Primary: 880.5725 (Infusion Pump) Secondary: 886.4350 (Manual ophthalmic surgical instrument) | 886.4350 (Manual ophthalmic surgical instrument) 876.1500 (Endoscope and accessories) | | Device Class | Class II | 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: MRH (Ophthalmic Infusion Pump) Secondary: HMZ (Trabeculotome) | Primary: MPA (Endoscope) Secondary: HMX (Manual Ophthalmic Surgical Ins trument) | | Prescription | Prescription use only | Prescription use only | Prescription use only | Prescription use only | | Status | | | | | | Target Anatomy | Schlemm's Canal and Trabecular Meshwork | Schlemm's Canal and Trabecular Meshwork | Anterior Segment including Schlemm's Canal/Trabecular Meshwork | Schlemm's Canal and Trabecular Mesh work | | Operating | Manual | Manual | Manual | Manual | | Principle | | | | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Sight Sciences. The logo consists of a blue, stylized "S" symbol on the left, followed by the words "SIGHT" and "SCIENCES" stacked on top of each other in a sans-serif font. The color scheme is primarily blue, giving the logo a clean and professional appearance. OMNI Surgical System | Characteristic | OMNI Surgical System (Catalog #1-106) SUBJECT DEVICE | OMNI Surgical System Predicate (K202678) | OMNI PLUS Surgical System Reference Device (K201953) | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER Reference Device (K080067) | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design/ Mechanis m of Action | • Flexible microcatheter with rounded, atraumatic tip for dispensing of viscoelastic • Proximal handle – changed to ovoid shape • Handle has internal viscoelastic reservoir and plunger tube with dimensional changes to allow dispensing of additional viscoelastic • Two 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 | • Flexible microcatheter with rounded, atraumatic tip for dispensing of viscoelastic • Proximal handle – changed to ovoid shape • Handle has internal viscoelastic reservoir and plunger tube with dimensional changes to allow dispensing of additional viscoelastic • Two 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 | • Flexible microcatheter with rounded, atraumatic tip for dispensing of viscoelastic • Proximal handle – changed to ovoid shape • Handle has internal viscoelastic reservoir and plunger tube with dimensional changes to allow dispensing of additional viscoelastic • Two 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 | • Flexible microcatheter for dispensation of viscoelastic fluid • Microcatheter has a round, bolus, atraumatic tip • The Microcatheter is connected to the ViscoInjector™ and primed with viscoelastic fluid from a cartridge retained with the ViscoInjector. • The Microcatheter is connected to a powered iLumin™ Fiberoptic Illuminator which illuminates the Microcatheter tip. • The surgeon directs the microcatheter using micro forceps through the surgical incision into the ostium of the Schlemm's canal. • The Microcatheter can access 360° of the Schlemm's canal in one pass. • As surgeon withdraws the microcatheter from the Schlemm's canal, viscoelastic fluid is delivered into the canal by the surgeon by manual clockwise rotation of the knob on ViscoInjector. • Clicks on the ViscoInjector™ tactilely indicate precise delivery of viscoelastic fluid. | | Dispensing Control | After priming, viscoelastic fluid dispensing control occurs through manual rotation of the advancement wheels at the distal end of the device. The | After priming, viscoelastic fluid dispensing control occurs through manual rotation of the advancement wheels at the distal end of the device. The ovoid | After priming, viscoelastic fluid dispensing control occurs through manual rotation of the advancement wheels at the distal end of the device. The ovoid shape of | Rotational action via a knob on the Visco Injector to dispense viscoelastic fluid | | Characteristic | OMNI Surgical System (Catalog #1-106) SUBJECT DEVICE | OMNI Surgical System Predicate (K202678) | OMNI PLUS Surgical System Reference Device (K201953) | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER Reference Device (K080067) | | | ovoid shape of the handle allows a single advancement wheel on each side of the handle while maintaining the ability for ambidextrous use in either patient eye. Synchronization of the advancement wheels and microcatheter movement was achieved for ease of use by adding a gear in the rack and pinion mechanism. | shape of the handle allows a single advancement wheel on each side of the handle while maintaining the ability for ambidextrous use in either patient eye. Synchronization of the advancement wheels and microcatheter movement was achieved for ease of use by adding a gear in the rack and pinion mechanism. | the handle allows a single advancement wheel on each side of the handle while maintaining the ability for ambidextrous use in either patient eye. Synchronization of the advancement wheels and microcatheter movement was achieved for ease of use by adding a gear in the rack and pinion mechanism. | | | Dispensing Mechanism | Internal reservoir with plunger tube (syringe-like volume exchange). Three components consisting of the Reservoir, Plunger Tube and Distal O-Ring have modified dimensions to contain and dispense larger volume of viscoelastic fluid (OVD) | Internal reservoir with plunger tube (syringe-like volume exchange). | Internal reservoir with plunger tube (syringe-like volume exchange). Three components consisting of the Reservoir, Plunger Tube and Distal O- Ring have modified dimensions to contain and dispense larger volume of viscoelastic fluid (OVD) | OVD cartridge attaches to the device, inside the 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 Luer fitting on proximal end of OMNI device handle | 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 Luer fitting on proximal end of OMNI device handle | 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 Luer fitting on proximal end of OMNI device handle | Cohesive viscoelastic fluid (OVD or oph thalmic viscosurgical device) is supplied separately. OVD cartridge attaches to the device inside the Ellex ViscoInjector | | OVD Volume Dispensed | $21 ± 3 µL$ (10.5 $µL$ on first microcatheter retraction cycle and 10.5 $µL$ on the second cycle) | $11 µL$ | $21 ± 3 µL$ (10.5 $µL$ on first microcatheter retraction cycle and 10.5 $µL$ on the second cycle) | 2.25 $µL$ per click of the Viscoinjector (no limit of total volume that can be delivered) | | Materials | Medical grade materials, including ABS, polycarbonate, stainless steel, | Medical grade materials, including ABS, polycarbonate, stainless steel, silicone, parylene | Medical grade materials, including ABS, polycarbonate, stainless steel, silicone, parylene coating. | Microcatheter – polyimide tubing and an outer sheath of polyethylene | | Characteristic | OMNI Surgical System (Catalog #1-106) SUBJECT DEVICE | OMNI Surgical System Predicate (K202678) | OMNI PLUS Surgical System Reference Device (K201953) | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER Reference Device (K080067) | | | silicone, parylene coating, cyanoacrylate, acrylated uretha ne, polyimide. | coating, cyanoacrylate, acrylated urethane, polyimide. | cyanoacrylate, acrylated urethane, polyimide. | terephthalate (PET) shrink tubing, with a lubricious coating | | User Interface | Handheld | Handheld | Handheld…