OMNI Surgical System
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 |
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.
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
Reference Devices
- Harms Trabeculotomy Probe (Katena)
- Kahook Dual Blade (New World Medical)
- Nylon or Prolene Suture
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is 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.
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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
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### 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)
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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#### 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.<br>3000 Sand Hill Road<br>Building 3, Suite 105<br>Menlo Park, CA 94025<br>Tel: (877) 266-1144 | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------|
| OFFICIAL<br>CORRESPONDENT | Anne-Marie Ripley<br>Sight Sciences, Inc.<br>3000 Sand Hill Road<br>Bldg. 3, Suite 105<br>Menlo Park, CA 94025 | |
| | Anne@sightsciences.com<br>Mobile: 661-645-8546 | |
| DATE SUMMARY WAS<br>PREPARED: | December 21, 2017 | |
| TRADE NAME: | OMNI™ Surgical System | |
| CLASSIFICATION NAMES | Infusion Pump | Manual Ophthalmic<br>Instrument |
| REGULATION NUMBERS | 21 CFR 880.5725 | 21 CFR 886.4350 |
| DEVICE CLASSIFICATIONS | Class II | Class I |
| PRODUCT CODES | MRH (Pump, infusion,<br>ophthalmic) | HMZ (Trabeculotome) |
| | DEVICE NAME | 510(k) NUMBER |
|--------------------|-------------------------------------------------------|----------------|
| PREDICATE DEVICES: | iTrack Catheter (Ellex)<br>* primary predicate device | K080067 |
| | VISCO360 Viscosurgical System<br>(Sight Sciences) | K171905 |
| REFERENCE DEVICES: | DEVICE NAME | 510(k) NUMBER |
| | Harms Trabeculotomy Probe (Katena) | Class I exempt |
| | Kahook Dual Blade<br>(New World Medical) | Class I exempt |
| | Nylon or Prolene Suture | Multiple |
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### 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.
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#### 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.
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## Table 1: Technological Characteristics Comparison Sight Sciences OMNI Surgical System and the Predicate and Reference Devices
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack<br>(Primary Predicate) | Sight Sciences'<br>VISCO360<br>Viscosurgical System<br>(Predicate Device) | Katena's Harms<br>Trabeculotomy<br>Probe<br>(Reference Device) | New World<br>Medical's<br>Kahook Dual Blade<br>(Reference Device) | Nylon or Prolene<br>Suture<br>(Reference Device) |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | • Delivery of small<br>amounts of<br>viscoelastic fluid<br>during ophthalmic<br>surgery<br>• Cutting of trabecular<br>meshwork when a<br>trabeculotomy is<br>indicated | • Delivery of small<br>amounts of<br>viscoelastic fluid<br>during ophthalmic<br>surgery | • Delivery of small<br>amounts of<br>viscoelastic fluid<br>during ophthalmic<br>surgery | • Cutting of<br>trabecular<br>meshwork when a<br>trabeculotomy is<br>indicated | • Cutting of<br>trabecular<br>meshwork when<br>a trabeculotomy<br>is indicated | • Soft tissue<br>approximation<br>and various<br>other uses<br>including cutting<br>of trabecular<br>meshwork when<br>a trabeculotomy<br>is indicated |
| Indication for<br>Use | The OMNI System is a<br>manually operated<br>device for delivery of<br>small amounts of<br>viscoelastic fluid, for<br>example Healon or<br>HealonGV from Abbott<br>Medical Optics (AMO),<br>Amvisc from Bausch &<br>Lomb, or PROVISC from<br>Alcon, during ophthalmic<br>surgery. It is also<br>indicated to cut<br>trabecular meshwork<br>tissue during<br>trabeculotomy<br>procedures. | The iScience<br>Interventional<br>Canaloplasty<br>Microcatheter is<br>indicated for fluid<br>infusion and aspiration<br>during surgery. The<br>iScience Interventional<br>Canaloplasty<br>Microcatheter is<br>indicated for<br>catheterization and<br>viscodilation of<br>Schlemm's canal to<br>reduce intraocular<br>pressure in adult<br>patients with open<br>angle glaucoma. | The VISCO360<br>Viscosurgical System<br>is a manually<br>operated device for<br>delivery of small<br>amounts of<br>viscoelastic fluid, for<br>example Healon or<br>HealonGV from<br>Abbott Medical Optics<br>(AMO), Amvisc from<br>Bausch & Lomb, or<br>PROVISC from Alcon,<br>during ophthalmic<br>surgery. | Cutting of trabecular<br>meshwork when a<br>trabeculotomy is<br>indicated | Cutting of trabecular<br>meshwork when a<br>trabeculotomy is<br>indicated | Soft tissue<br>approximation and<br>various other uses<br>including cutting of<br>trabecular<br>meshwork when a<br>trabeculotomy is<br>indicated |
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack<br>(Primary Predicate) | Sight Sciences'<br>VISCO360<br>Viscosurgical System<br>(Predicate Device) | Katena's Harms<br>Trabeculotomy<br>Probe<br>(Reference Device) | New World<br>Medical's<br>Kahook Dual Blade<br>(Reference Device) | Nylon or Prolene<br>Suture<br>(Reference Device) |
| Regulation | Primary: 880.5725<br>(Infusion Pump)<br>Secondary: 886.4350<br>(Manual ophthalmic<br>surgical instrument) | Primary: 876.1500<br>(Endoilluminator)<br>Secondary: 886.4350<br>(Manual ophthalmic<br>surgical instrument) | 880.5725 (Infusion<br>Pump) | 886.4350 (Manual<br>ophthalmic surgical<br>instrument) | 886.4350 (Manual<br>ophthalmic surgical<br>instrument) | 878.5010 and<br>878.5020<br>(Nonabsorbable<br>surgical suture) |
| Device Class | Class II | Class II | Class II | Class I, exempt | Class I, exempt | Class II |
| Product Code | Primary: MRH<br>(Ophthalmic Infusion<br>Pump, Class II)<br>Secondary: HMZ<br>(Trabeculotome, Manual<br>ophthalmic surgical<br>instrument, Class I<br>exempt) | Primary: MPA (for<br>endoilluminator, Class<br>II)<br>Secondary: HMX<br>(Ophthalmic Cannula,<br>Manual ophthalmic<br>surgical instrument,<br>Class I Exempt) | MRH (Ophthalmic<br>Infusion Pump, Class<br>II) | HMZ<br>(Trabeculotome,<br>Manual ophthalmic<br>surgical instrument,<br>Class I exempt) | HNN (Ophthalmic<br>Knife, Manual<br>ophthalmic surgical<br>instrument, Class I<br>exempt) | GAW and GAR<br>(Nonabsorbable,<br>Synthetic Suture,<br>Class II) |
| Target<br>Anatomy | Anterior Segment<br>including Schlemm's<br>Canal/Trabecular<br>Meshwork | Schlemm's<br>Canal/Trabecular<br>Meshwork | Anterior Segment<br>including Schlemm's<br>Canal | Schlemm's<br>Canal/Trabecular<br>Meshwork | Schlemm's<br>Canal/Trabecular<br>Meshwork | Anywhere, including<br>Schlemm's<br>Canal/Trabecular<br>Meshwork |
| Operating<br>Principle | Manual | · Manual (microcatheter)<br>• Powered<br>(endoilluminator) | Manual | Manual | Manual | Manual |
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack<br>(Primary Predicate) | Sight Sciences'<br>VISCO360<br>Viscosurgical System<br>(Predicate Device) | Katena's Harms<br>Trabeculotomy<br>Probe<br>(Reference Device) | New World<br>Medical's<br>Kahook Dual Blade<br>(Reference Device) | Nylon or Prolene<br>Suture<br>(Reference Device) |
| Design/Mechanism of Action | • Flexible microcatheter for<br>dispensation of<br>viscoelastic<br>• Microcatheter has a<br>round, bolus, atraumatic<br>tip<br>• Proximal handle<br>• Handle has internal<br>viscoelastic reservoir and<br>plunger tube<br>• Finger wheel for<br>advancing and retracting<br>microcatheter.<br>• Tactile and audible clicks<br>indicate precise<br>advancement.<br>• Viscoelastic dispensed<br>during retraction<br>• Flexible microcatheter<br>introduced into<br>Schlemm's canal and<br>pulled through to cut<br>trabecular meshwork | • Flexible microcatheter<br>for dispensation of<br>viscoelastic<br>• Microcatheter has a<br>round, bolus,<br>atraumatic tip<br>• Microcatheter attaches<br>at proximal end to Ellex<br>Viscolnjector to<br>dispense viscoelastic<br>using a knob<br>• Microcatheter manually<br>advanced by clinician<br>• Tactile and audible<br>clicks indicate precise<br>advancement.<br>• Optical fiber provide<br>illumination at tip of<br>catheter | • Flexible microcatheter<br>for dispensation of<br>viscoelastic<br>• Microcatheter has a<br>round, bolus,<br>atraumatic tip<br>• Proximal handle<br>• Handle has internal<br>viscoelastic reservoir<br>and plunger tube<br>• Finger wheel for<br>advancing and<br>retracting<br>microcatheter.<br>• Tactile and audible<br>clicks indicate precise<br>advancement.<br>• Viscoelastic dispensed<br>during retraction | • Proximal handle<br>• Distal blunt end<br>manually pulled<br>through trabecular<br>meshwork with<br>proximal handle | • Proximal handle<br>• Distal sharp end<br>manually pushed<br>through trabecular<br>meshwork with<br>proximal handle | Nonabsorbable,<br>sterile, flexible<br>thread pulled<br>through trabecular<br>meshwork |
| Viscoelastic | Supplied separately.<br>Viscoelastic loaded into<br>device prior to use. | Supplied<br>separately.<br>Cartridge attaches<br>to the device. | Supplied<br>separately.<br>Viscoelastic<br>loaded into device<br>prior to use. | N/A | N/A | N/A |
| Sterile and<br>Single Use | Provided sterile. Single use | Provided sterile.<br>Single use. | Provided sterile.<br>Single use. | Provided non-sterile.<br>Reusable. | Provided sterile.<br>Single use. | Provided sterile.<br>Single use. |
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack<br>(Primary Predicate) | Sight Sciences'<br>VISCO360<br>Viscosurgical System<br>(Predicate Device) | Katena's Harms<br>Trabeculotomy<br>Probe<br>(Reference Device) | New World<br>Medical's<br>Kahook Dual Blade<br>(Reference Device) | Nylon or Prolene<br>Suture<br>(Reference Device) |
| Passive or<br>Energized<br>Device to<br>Dispense<br>Viscoelastic | Passive | Passive | Passive | N/A | N/A | N/A |
| Dispensing<br>Control | Manual rotation of the<br>finger wheel at the distal<br>end of the device | Rotational action<br>via a knob on the<br>ViscoInjector to<br>dispense<br>viscoelastic fluid | Manual rotation<br>of the finger<br>wheel at the distal<br>end of the device | N/A | N/A | N/A |
| Dispensing<br>Mechanism | Syringe (Volume<br>exchange) | Syringe (Volume<br>exchange) | Syringe (Volume<br>exchange) | N/A | N/A | N/A |
| Materials | Cannula - Stainless steel<br>Microcatheter -<br>Polyamide (Nylon) | Microcatheter –<br>polyamide | Cannula - Stainless<br>steel<br>Microcatheter - Nylon | Stainless Steel &<br>Titanium | Stainless steel | Polypropylene or<br>nylon |
| Interface | Handheld | Handheld | Handheld | Handheld | Handheld | Handheld |
| Microcatheter<br>shaft/Probe<br>OD | 200 microns | 200 microns | 200 microns | 300 microns | N/A | Varies (typically 4-0<br>or 200 microns or 5-<br>0 or 150 microns for<br>suture<br>trabeculotomy) |
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#### 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.
