Who is the manufacturer of OMNI Surgical System?

Sight Sciences, Inc. filed the 510(k) submission for OMNI Surgical System (K173332).

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?

iTrack Catheter (Ellex) (K080067); VISCO360 Viscosurgical System (Sight Sciences) (K171905).

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

K173332 · Sight Sciences, Inc. · MRH · Dec 21, 2017 · General Hospital

Device Facts

Record ID	K173332
Device Name	OMNI Surgical System
Applicant	Sight Sciences, Inc.
Product Code	MRH · General Hospital
Decision Date	Dec 21, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

Device Story

OMNI Surgical System is a sterile, single-use, manually operated handheld instrument for ophthalmic surgery. Device features a cannula, microcatheter, internal viscoelastic reservoir, plunger tube, and finger wheels. Surgeon operates device by rotating finger wheels to advance/retract microcatheter (up to 20mm per cycle). Retraction of microcatheter drives plunger tube into reservoir, dispensing viscoelastic fluid into anterior segment of eye. Microcatheter is introduced into Schlemm's canal and pulled through to cut trabecular meshwork. Device is ambidextrous; surgeon rotates device 180 degrees to switch hands or eyes. Output is controlled delivery of viscoelastic and mechanical cutting of tissue. Benefits include combined viscodilation and trabeculotomy in one instrument, potentially reducing intraocular pressure in glaucoma patients.

Clinical Evidence

No clinical data. Evidence consists of bench testing including dimensional/visual inspections, mechanical testing (joint strength, actuation force), simulated use testing, and human cadaver eye performance testing. Acceptance criteria based on predicate VISCO360 performance and material strength.

Technological Characteristics

Handheld, manually operated infusion pump/trabeculotome. Materials: Stainless steel cannula, Polyamide (Nylon) microcatheter. Microcatheter OD: 200 microns. Dispensing principle: Syringe-like volume exchange via finger-wheel actuated plunger. Sterile, single-use. No software or energy source.

Indications for Use

Indicated for ophthalmic surgery requiring delivery of viscoelastic fluid and for trabeculotomy procedures to cut trabecular meshwork tissue.

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

iTrack Catheter (Ellex) (K080067)
VISCO360 Viscosurgical System (Sight Sciences) (K171905)

Reference Devices

Harms Trabeculotomy Probe (Katena)
Kahook Dual Blade (New World Medical)
Nylon or Prolene Suture

Related Devices

K201953 — OMNI PLUS Surgical System · Sight Sciences, Inc. · Aug 11, 2020
K202678 — OMNI Surgical System · Sight Sciences, Inc. · Mar 1, 2021
K232214 — OMNI Surgical System · Sight Sciences, Inc. · Aug 25, 2023
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 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 the FDA logo, which 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. December 21, 2017 Sight Sciences, Inc. Anne-Marie Ripley VP, Clinical & Regulatory Affairs 3000 Sand Hill Road Building 3, Suite 105 Menlo Park, CA 94025 Re: K173332 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: October 19, 2017 Received: October 23, 2017 Dear Anne-Marie Ripley: 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. 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. {1}------------------------------------------------ You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Bradley S. Cunningham -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K173332 Device Name OMNI™ Surgical System Indications for Use (Describe) 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 (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. 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}------------------------------------------------ #### 1. 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | APPLICANT | Sight Sciences, Inc. 3000 Sand Hill Road Building 3, Suite 105 Menlo Park, CA 94025 Tel: (877) 266-1144 | | |-------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------| | OFFICIAL CORRESPONDENT | Anne-Marie Ripley Sight Sciences, Inc. 3000 Sand Hill Road Bldg. 3, Suite 105 Menlo Park, CA 94025 | | | | Anne@sightsciences.com Mobile: 661-645-8546 | | | DATE SUMMARY WAS PREPARED: | December 21, 2017 | | | TRADE NAME: | OMNI™ Surgical System | | | CLASSIFICATION NAMES | Infusion Pump | Manual Ophthalmic Instrument | | REGULATION NUMBERS | 21 CFR 880.5725 | 21 CFR 886.4350 | | DEVICE CLASSIFICATIONS | Class II | Class I | | PRODUCT CODES | MRH (Pump, infusion, ophthalmic) | HMZ (Trabeculotome) | | | DEVICE NAME | 510(k) NUMBER | |--------------------|-------------------------------------------------------|----------------| | PREDICATE DEVICES: | iTrack Catheter (Ellex) * primary predicate device | K080067 | | | VISCO360 Viscosurgical System (Sight Sciences) | K171905 | | REFERENCE DEVICES: | DEVICE NAME | 510(k) NUMBER | | | Harms Trabeculotomy Probe (Katena) | Class I exempt | | | Kahook Dual Blade (New World Medical) | Class I exempt | | | Nylon or Prolene Suture | Multiple | {4}------------------------------------------------ ### Description Of The Device: The Sight Sciences OMNI™ Surgical System ("OMNI") is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic into the anterior segment of the eye during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The OMNI dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir and plunger tube, and finger wheels. The finger wheels on the handle of the device are used advance and retract the microcatheter. In addition, when the device is being used to deliver viscoelastic, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The microcatheter can be advanced/retracted up to 20 mm per cycle. The microcatheter can be fully advanced/retracted up to 5 times (i.e. 5 full cycles of 20 mm each). Dispensation of viscoelastic can only occur during the first two 20-mm cycles. The wheels are located on both sides 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. Image /page/4/Figure/6 description: This image shows a diagram of the OMNI Surgical System. The diagram labels the different parts of the system, including the retainer pin, reservoir, cannula, microcatheter, and viscoelastic fluid. The diagram also shows the advancement wheels and the inside handle shell. {5}------------------------------------------------ #### Indications For Use: 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 (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. ### Intended Use (in comparison to predicate): The OMNI Surgical System and the predicate devices (iTrack and VISCO360) are surgical tools for delivery of small amounts of viscoelastic fluid into the anterior segment. Like the reference devices (Harms Trabeculotome, Kahook Dual Blade, and prolene/nylon sutures), the OMNI device may also be used to cut trabecular meshwork when a trabeculotomy is indicated. ### Technical Characteristics (in comparison to predicate): The technical features of the OMNI Surgical System are substantially equivalent to the Ellex iTrack™ Interventional Canaloplasty Microcatheter (K080067) and the Sight Sciences VISCO360® Viscosurgical System (K171905). Both are manually operated devices for the controlled delivery of small amounts of viscoelastic fluid. Fluid is dispensed from each system on the principle of exchanging volumes much like a syringe. The intended use and technical features of the OMNI are also substantially equivalent to the following reference devices: Katena Harms Trabeculotomy Probe (Class I Exempt), the New World Medical Kahook Dual Blade (Class I Exempt), and Nylon or Prolene Sutures (Class II). All of these devices are manually operated for the cutting of trabecular meshwork when a trabeculotomy is indicated. Table 1 compares the attributes of the OMNI with these predicate and reference devices. {6}------------------------------------------------ ## Table 1: Technological Characteristics Comparison Sight Sciences OMNI Surgical System and the Predicate and Reference Devices | Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack (Primary Predicate) | Sight Sciences' VISCO360 Viscosurgical System (Predicate Device) | Katena's Harms Trabeculotomy Probe (Reference Device) | New World Medical's Kahook Dual Blade (Reference Device) | Nylon or Prolene Suture (Reference Device) | |------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | • Delivery of small amounts of viscoelastic fluid during ophthalmic surgery • Cutting of trabecular meshwork when a trabeculotomy is indicated | • Delivery of small amounts of viscoelastic fluid during ophthalmic surgery | • Delivery of small amounts of viscoelastic fluid during ophthalmic surgery | • Cutting of trabecular meshwork when a trabeculotomy is indicated | • Cutting of trabecular meshwork when a trabeculotomy is indicated | • Soft tissue approximation and various other uses including cutting of trabecular meshwork when a trabeculotomy is indicated | | Indication for Use | The OMNI System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon or HealonGV from Abbott Medical Optics (AMO), 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. | The VISCO360 Viscosurgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon or HealonGV from Abbott Medical Optics (AMO), Amvisc from Bausch & Lomb, or PROVISC from Alcon, during ophthalmic surgery. | Cutting of trabecular meshwork when a trabeculotomy is indicated | Cutting of trabecular meshwork when a trabeculotomy is indicated | Soft tissue approximation and various other uses including cutting of trabecular meshwork when a trabeculotomy is indicated | | Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack (Primary Predicate) | Sight Sciences' VISCO360 Viscosurgical System (Predicate Device) | Katena's Harms Trabeculotomy Probe (Reference Device) | New World Medical's Kahook Dual Blade (Reference Device) | Nylon or Prolene Suture (Reference Device) | | Regulation | Primary: 880.5725 (Infusion Pump) Secondary: 886.4350 (Manual ophthalmic surgical instrument) | Primary: 876.1500 (Endoilluminator) Secondary: 886.4350 (Manual ophthalmic surgical instrument) | 880.5725 (Infusion Pump) | 886.4350 (Manual ophthalmic surgical instrument) | 886.4350 (Manual ophthalmic surgical instrument) | 878.5010 and 878.5020 (Nonabsorbable surgical suture) | | Device Class | Class II | Class II | Class II | Class I, exempt | Class I, exempt | Class II | | Product Code | Primary: MRH (Ophthalmic Infusion Pump, Class II) Secondary: HMZ (Trabeculotome, Manual ophthalmic surgical instrument, Class I exempt) | Primary: MPA (for endoilluminator, Class II) Secondary: HMX (Ophthalmic Cannula, Manual ophthalmic surgical instrument, Class I Exempt) | MRH (Ophthalmic Infusion Pump, Class II) | HMZ (Trabeculotome, Manual ophthalmic surgical instrument, Class I exempt) | HNN (Ophthalmic Knife, Manual ophthalmic surgical instrument, Class I exempt) | GAW and GAR (Nonabsorbable, Synthetic Suture, Class II) | | Target Anatomy | Anterior Segment including Schlemm's Canal/Trabecular Meshwork | Schlemm's Canal/Trabecular Meshwork | Anterior Segment including Schlemm's Canal | Schlemm's Canal/Trabecular Meshwork | Schlemm's Canal/Trabecular Meshwork | Anywhere, including Schlemm's Canal/Trabecular Meshwork | | Operating Principle | Manual | · Manual (microcatheter) • Powered (endoilluminator) | Manual | Manual | Manual | Manual | | Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack (Primary Predicate) | Sight Sciences' VISCO360 Viscosurgical System (Predicate Device) | Katena's Harms Trabeculotomy Probe (Reference Device) | New World Medical's Kahook Dual Blade (Reference Device) | Nylon or Prolene Suture (Reference Device) | | Design/Mechanism of Action | • Flexible microcatheter for dispensation of viscoelastic • Microcatheter has a round, bolus, atraumatic tip • Proximal handle • Handle has internal viscoelastic reservoir and plunger tube • Finger wheel for advancing and retracting microcatheter. • Tactile and audible clicks indicate precise advancement. • Viscoelastic dispensed during retraction • Flexible microcatheter introduced into Schlemm's canal and pulled through to cut trabecular meshwork | • Flexible microcatheter for dispensation of viscoelastic • Microcatheter has a round, bolus, atraumatic tip • Microcatheter attaches at proximal end to Ellex Viscolnjector to dispense viscoelastic using a knob • Microcatheter manually advanced by clinician • Tactile and audible clicks indicate precise advancement. • Optical fiber provide illumination at tip of catheter | • Flexible microcatheter for dispensation of viscoelastic • Microcatheter has a round, bolus, atraumatic tip • Proximal handle • Handle has internal viscoelastic reservoir and plunger tube • Finger wheel for advancing and retracting microcatheter. • Tactile and audible clicks indicate precise advancement. • Viscoelastic dispensed during retraction | • Proximal handle • Distal blunt end manually pulled through trabecular meshwork with proximal handle | • Proximal handle • Distal sharp end manually pushed through trabecular meshwork with proximal handle | Nonabsorbable, sterile, flexible thread pulled through trabecular meshwork | | Viscoelastic | Supplied separately. Viscoelastic loaded into device prior to use. | Supplied separately. Cartridge attaches to the device. | Supplied separately. Viscoelastic loaded into device prior to use. | N/A | N/A | N/A | | Sterile and Single Use | Provided sterile. Single use | Provided sterile. Single use. | Provided sterile. Single use. | Provided non-sterile. Reusable. | Provided sterile. Single use. | Provided sterile. Single use. | | Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack (Primary Predicate) | Sight Sciences' VISCO360 Viscosurgical System (Predicate Device) | Katena's Harms Trabeculotomy Probe (Reference Device) | New World Medical's Kahook Dual Blade (Reference Device) | Nylon or Prolene Suture (Reference Device) | | Passive or Energized Device to Dispense Viscoelastic | Passive | Passive | Passive | N/A | N/A | N/A | | Dispensing Control | Manual rotation of the finger wheel at the distal end of the device | Rotational action via a knob on the ViscoInjector to dispense viscoelastic fluid | Manual rotation of the finger wheel at the distal end of the device | N/A | N/A | N/A | | Dispensing Mechanism | Syringe (Volume exchange) | Syringe (Volume exchange) | Syringe (Volume exchange) | N/A | N/A | N/A | | Materials | Cannula - Stainless steel Microcatheter - Polyamide (Nylon) | Microcatheter – polyamide | Cannula - Stainless steel Microcatheter - Nylon | Stainless Steel & Titanium | Stainless steel | Polypropylene or nylon | | Interface | Handheld | Handheld | Handheld | Handheld | Handheld | Handheld | | Microcatheter shaft/Probe OD | 200 microns | 200 microns | 200 microns | 300 microns | N/A | Varies (typically 4-0 or 200 microns or 5- 0 or 150 microns for suture trabeculotomy) | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ #### Performance Data: The OMNI's descriptive characteristics are well-defined and adequate to ensure equivalence to the predicate devices. Additionally, the following performance testing and inspection was conducted on the OMNI device: dimensional and visual inspections, visual inspection of labeling and component inspections, mechanical testing of joint strength and actuation force, simulated use testing, and human cadaver eye performance testing. Acceptance criteria was based on predicate VISCO360's dispensing performance, intrinsic strength of the materials, and the load and conditions to which the OMNI would be subjected during use. Testing demonstrated that the OMNI performs as intended and is functionally equivalent to the predicate devices. #### Conclusion: The Sight Sciences OMNI Surgical System meets all product design requirements and applicable standards. The OMNI System shares the same intended use, key technological characteristics, and principle of operation as the predicate devices. Therefore, the device has been shown to be substantially equivalent to the predicate devices.